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Sakshi, Kshirsagar* Varsha Bhati Kiran Pathade Pavan Chalak Nikhil Gore. "Formulation Development of Paracetamol and Ibuprofen Suspension." International Journal of Pharmaceutical Sciences 3, no. 3 (2025): 1570–76. https://doi.org/10.5281/zenodo.15040458.
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The objective of this study was to develop a stable and effective suspension formulation of paracetamol and ibuprofen, and to compare its characteristics with marketed formulations. Five marketed formulations, namely Combiflam, Ibujesic Plus, Adiflam Plus, Aldigesic Plus, and Ibuflamar Plus, were evaluated for their physical, chemical, and microbiological properties. The results showed that the developed formulation had a pH of 5.5, viscosity of 1000 cps, and assay of 99.5% for paracetamol and 98.5% for ibuprofen. The suspension was stable for 6 months at 25°C/60% RH and 40°C/75% RH. The comparative study revealed that the developed formulation had similar characteristics to the marketed formulations, with some advantages in terms of stability and bioavailability.
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Chinthala, Shanthi P., and Ramamohan R. Thummaluru. "Formulation and In Vivo Evaluation of Trilayer Matrix Tablets of Rosuvastatin Solid Dispersions by Geomatrix Technology." International Journal of Pharmaceutical Sciences and Drug Research 13, no. 03 (2020): 334–42. http://dx.doi.org/10.25004/ijpsdr.2021.130314.
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The current research aims to enhance the aqueous solubility and sustains the drug release of rosuvastatin BCS Class II drug. Fifteen (15) solid dispersion (SD) formulations of rosuvastatin were prepared by solvent evaporation technique and evaluated. In vitro drug dissolution study indicated a higher drug dissolution rate for SD13 of 99.74 ± 5.39 % within 60 min. Eight formulations of rosuvastatin trilayer matrix tablets (AF10- HF10) were prepared using optimized SD13 by direct compression method. These trilayer formulations are characterized for flow properties and physicochemical parameters. The maximum drug release was exhibited by trilayer matrix formulation (HF10) of 99.48 ± 5.40 % throughout 24 hours. The zero-order described the optimized formulation (HF10) release profile and best fitted to Higuchi and Korsmeyer-Peppa’s model. The results demonstrated the sustainability of rosuvastatin trilayer tablets with enhanced release time and linearity up to 24 hours. From in vivo bioavailability studies, Cmax of the rosuvastatin optimized ER tablets and the marketed product was found to be 28.46 ± 0.07 ng/mL and 30.94 ± 0.75 ng/mL, respectively. Tmax of both rosuvastatin optimized ER tablets formulation and rosuvastatin marketed product was 5 ± 0.06 and 4 ± 0.03 h, respectively. AUC0-∞ infinity for the optimized formulation was higher (395.54 ± 1.37 ng.h/mL) than the rosuvastatin marketed product formulation 212.54 ± 0.42 ng.h/mL. Statistically, the AUC0-t of the optimized ER tablets formulation was significantly higher (p is less than 0.05) than rosuvastatin marketed product formulation. In vivo, pharmacokinetic studies in rabbits confirmed the prolonged-release by showing an increase in bioavailability for rosuvastatin from optimized ER tablets than marketed formulation.
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Pandey, Prateek, Anil Sharma, Hariom Sharma, Girish Kumar Vyas, and Manmohan Sharma. "Novel Researched Herbal Sunscreen Cream SPF Determination by In-Vitro Model." Asian Journal of Pharmaceutical Research and Development 11, no. 2 (2023): 83–90. http://dx.doi.org/10.22270/ajprd.v11i2.1246.
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INTRODUCTION: Researchers' interest in creating novel cosmetic formulations has increased due to consumer interest in herbal cosmetics and increased patent activity. The rights of indigenous traditional knowledge and benefit sharing are also safeguarded under IPR.
 OBJECTIVE: To formulate and evaluate herbal sunscreen with determination of Sun Protection Factor (SPF) and anti-oxidant activity. To compare Sun Protection Factor of developed formulation with marketed formulation.
 METHOD: The formulation was developed according to the prepared formula. And multiple tests were done for evaluation i.e., physical observation, spreadability, extrudability, occlusion study, stability study and SPF determination. All the evaluations were found satisfactory. Characterisation of SPF was calculated according to the and UV-Vis Spectrophotometer (LABMAN Scientific instruments Pvt. Ltd.).
 RESULTS:The synergistic activity of all herbal compounds utilized in herbal sunscreen formulations, such as Cucumis sativus, Solanum Lycopersicon, and Aloe barbadensis Efficacy of photoprotection found in following order Marketed formulation > F3 > F2 > F1. For prepared formulation F3 provided better results in comparison to Formulation1 and Formulation 2. Formulation 3 was compared with marketed preparation and it showed good SPF value nearer to market preparation. Overall results were satisfactory. These results reveal that the prepared F3 herbal sunscreen have good SPF and good sun protection activity.
 CONCLUSION: Formulation 3, which consists of three formulations, has been found to be effective as sunscreen in every way. Since few people use sunscreen, there is a need to raise public knowledge of the risks associated with sun exposure as well as the advantages of using sun protection products on a regular basis to lessen these effects. This kind of research will be useful in offering consumers with an all-inclusive solution or product that will protect them from the damaging effects of sunlight.
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Mubeen, Ahamed Mueen, Atchaya A, Ilakiya S, Rasitha Banu U, Rojamani K, and Vijayalakshmi S. "Comparative standardization studies of marketed Polyherbal tablets." International Journal of Multidisciplinary Research and Growth Evaluation 4, no. 2 (2023): 346–50. http://dx.doi.org/10.54660/.ijmrge.2023.4.2.346-350.
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Siddha and Ayurvedha is one of the oldest traditional systems of medicine in the world. There are different formulations which are adequately increase delivery of the drug to our body sites; one of basic formulation is tablet. Tablet is one of the conventional formulations in solid oral dosage form, which are usually used in traditional system of medicines and allopathic medicines. Allopathic formulations like tablets usually maintaining their standards based on the various pharmacopoeia but Ayurvedhic and Siddha proprietary medicines shows lots of troubles in their standardization parameters, why because they consist of multiple herbal crude drugs in one formulation, so it should be prescribed with proper standardization parameters. The present work deals with to evaluation two marketed formulation by performing basic quality control parameters of tablets such as Organoleptic properties, Weight variation, Hardness, Friability, Disintegration of herbal tablets {Alsactil [A] and Alsarex [B]} From the analysis of above parameters, results was observed and all the parameters of both drugs passes the test, within the reference values.
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Patel, Lisa J., Manan A. Raval, Samir G. Patel, and Archita J. Patel. "Development and Validation of Stability Indicating High-Performance Thin-Layer Chromatographic (HPTLC) Method for Quantification of Asiaticoside from Centella asiatica L. and its Marketed Formulation." Journal of AOAC INTERNATIONAL 102, no. 4 (2019): 1014–20. http://dx.doi.org/10.5740/jaoacint.18-0381.
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Abstract Background: Ayurvedic medicines help in healing disease with fewer undesirable effects in comparison with an allopathic system of medicine to treat central nervous system (CNS) disorders, as the latter is more expensive. Centella asiatica L. is often used in Ayurvedic formulations for the treatment of CNS disorders. Objective: A stability test using an HPTLC method for the estimation of an important marker asiaticoside (ASI) from C. asiatica powder and marketed formulation was developed. Methods: The marker compound ASI from plant powders and marketed formulations were resolved using toluene–ethyl acetate–methanol–glacial acetic acid (2+7+3+1, v/v/v/v) as the mobile phase and then was derivatized. The plant powder and marketed formulation were also subjected to stability studies. Results: The Rf value of ASI was found in range of 0.43–0.47 for the standard ASI, plant powder, and marketed formulation. It was found that the plant powder and formulation exhibited first-order degradation kinetics. Conclusions: The contents of ASI in the formulation (Churna) and its flow characters reduced at the end of the 6 months during an accelerated stability study. The developed method can be used to quantify ASI in the presence of its degradation products. Highlights: The developed method helps in determining batch to batch variation in the content of ASI in herbal formulations.
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Nikam, Shreya. "ANTI-ACNE GEL OF ISOTRETINOIN: FORMULATION AND EVALUATION." Asian Journal of Pharmaceutical and Clinical Research 10, no. 11 (2017): 257. http://dx.doi.org/10.22159/ajpcr.2017.v10i11.19614.
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Objective: Isotretinoin is a very effective drug in the treatment of acne vulgaris by topically. The objective of present study was formulation development of anti-acne gel using Isotretinoine and span 80 for topical delivery to cure nodulosystic acne vulgaris. Furthermore, the comparative study of all the evaluation parameters done with marketed formulation of same drug.Methods: Formulation of anti-acne gel of isotretinoin using Carbopol 940 as a polymer and incorporating isotretinoin in form of topical semi-solid gel using magnetic stirrer, Cremophor RH 40, and butylated hydroxytoluene. Drug was uniformly dispersed in Cremophor RH 40 and the respected solvents. Ethanol, isopropyl alcohol, and glycerin were used as solvents in 15% quantity. Further, the formulation was evaluated for physicochemical evaluation of gel formulations. The prepared gel were optimized statistically and characterized for pH, spredability, drug content, viscosity, in vitro diffusion study, acute skin irritation test, and antimicrobial activity. Evaluation test was also compared with marketed formulation of isotretinoin, that is, Sortet gel. The antibacterial and anti-acne activity of different formulations was determined by modified agar well diffusion method on the culture of Propionibacterium acne also compared with marketed formulation.Results: The optimized batch (B10) showed highest spreadability (32.422 g/cm3) in all formulations and also have high percentage of drug contents (95.60%). The spreadability value was 17.998 g/cm3 showing good spreadability. The viscosity of optimized batch was observed less as compared to other formulations, ultimately showed releases also more. In the in vitro diffusion study, B10 batch release 85.69% of the drug as compared to Sotret gel. The antibacterial activity was studied on anaerobic microorganism P. acne, compared with marketed Sortet gel. Optimized batch showed maximum zone of inhibition to P. acne below marketed formulations and standard benzyl peroxide gel.Conclusion: The topical anti-acne gel of isotertinoin was successfully formulated and evaluated for different parameters. The results indicate that the active component, that is, isotertinoin is more effective when subjected in gel formulations and produces effective anti-acne activity in the management of nodulosystic acne vulgaris.
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Mhaske, Nilesh Sureshrao, and S. Sathesh Kumar. "In-vivo Pharmacokinetic Evaluation of Venlafaxine HCl Sustained Release Tablet Formulation." INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE 15, no. 03 (2024): 1158–63. http://dx.doi.org/10.25258/ijpqa.15.3.09.
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An optimized Venlafaxine SR tablets formulation, was chosen for in‐vivo study against the commercial marketed Venlafaxine SR formulation. The non-compartmental pharmacokinetic specifications of both reference and standard were determined, after dosing via oral route. The peak plasma concentration (Cmax) of optimized Venlafaxine SR tablets was found as 964.66 ± 53.15ng/ml in 5 hr, while Cmax of marketed Venlafaxine SR tablets formulation was found as 872.33 ± 28.43 ng/ml in same time i.e. 5 hr. The Cmax data suggests that absorption of drug in plasma from was in sustained manner from both the formulations, showing typical absorption pattern of SR product. The AUC0-t for optimized and marketed Venlafaxine SR tablets was found to be 12981.63 ± 505.25 and 12023.83 ± 668.29 ng/ml*h, while AUC0-∞ was found to be 13921.51 ± 417.40 and 13099.63 ± 742.21 ng/ml*h, respectively. The PK parameter showed the Tmax and AUC for optimized Venlafaxine SR tablets as compared to its marketed product formulation. Pharmacokinetic parameter clearly suggested prolong release and availability of Venlafaxine in plasma from SR tablets formulation. Overall, the results suggest that the optimized SR formulation of Venlafaxine provides effective extended and controlled drug delivery, highlighting its potential clinical relevance in the treatment of depression and anxiety disorders.
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Dileep, Singh* Kavita Lovanshi Rita Mourya. "Formulation And Evaluation of Anti-Dandruff Herbal Shampoo." International Journal of Pharmaceutical Sciences 3, no. 4 (2025): 3157–63. https://doi.org/10.5281/zenodo.15296399.
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Shampoos are the cosmetics preparations meant for cleansing the hair and scalp by removal of the dirt. The study was aimed at formulating and evaluating a poly herbal shampoo containing extract of plant materials such as reetha, neem, henna and curry leaves. The evaluation parameters such as colour, pH, clarity, viscosity, foam ability, dirt dispersion and antimicrobial studies were performed. The formulated shampoo was compared with commercially available marketed formulation. From the studies. Found that the formulation (F3) gives good results as compared to marketed formulation.
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Vure, Prasad, and Sundeep Chaurasia. "Development of Effervescent Tablets of Alendronate Sodium with Improved Intestinal Permeation." International Journal of Pharmaceutical Sciences and Nanotechnology 11, no. 1 (2018): 3990–97. http://dx.doi.org/10.37285/ijpsn.2018.11.1.7.
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The aim of the present study is to develop effervescent tablets of alendronate sodium to improve their intestinal permeability to treat osteoporosis. Effervescent tablets of alendronate sodium were developed with different ratios of acid to alkaline components having a pH of about 3 to about 6.5. The tablets were prepared by direct compression method. The physical mixture blend was evaluated for angle of repose, true density, bulk density, compressibility index. The formulated tablets were subjected to thickness, weight variation, hardness, friability, drug content and pH. The in vitro dissolution studies were carried out using the USP Type 2 apparatus. Formulation F14 was considered as optimized formulation because it shows drug release pattern higher than that of the other formulations and conventional marketed formulation. Ex vivo permeation studies were performed for the optimized formulation (F14) and that of the conventional marketed formulation. The drug release of the formulation (F14) was higher than the marketed formulation. Accelerated stability studies of the optimized formulation indicated that there were no signs of visually distinguishable changes, drug content and in vitro dispersion time. Thus, an increase in drug release may enhance absorption, in turn may enhance bioavailability. 
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Wening, PhD, Klaus, Sebastian Schwier, PhD, Hans-J. Stahlberg, MD, and Eric Galia, PhD. "Application of hot-melt extrusion technology in immediate-release abuse-deterrent formulations." Journal of Opioid Management 13, no. 6 (2017): 473. http://dx.doi.org/10.5055/jom.2017.0422.
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Objective: Hot-melt extrusion (HME) technology has been used for manufacturing extended-release abuse-deterrent formulations (ADFs) of opioid-type analgesics with improved tamper-resistant properties. Our objective was to describe application of this technology to immediate-release (IR) ADFs.Design: For development of a sample IR ADF (hydrocodone 10 mg/acetaminophen 325 mg) based on HME, feasibility studies were performed using different excipients. The formulation selected for further development was evaluated via in vitro test battery. Moreover, in vivo performance of IR ADF technologies was investigated in an open-label, randomized, cross-over, phase 1, relative oral bioavailability study with another opioid (model compound).Setting: Single-center bioavailability trial.Participants: Twenty-four healthy white male subjects.Interventions: ADF IR formulation of an opioid and marketed IR formulation.Main Outcome Measure(s): For feasibility and in vitro studies, dissolution profiles, syringeability, particle size distribution after physical manipulation, and extractability were evaluated. For the phase 1 study, pharmacokinetic parameters were evaluated and compared for ADF IR and a marketed IR formulation.Results: After manipulation, the majority of particles from the ADF IR formulation were >500 μm and, thus, not considered suitable for intranasal abuse, while the majority of particles for the reference marketed IR formulation were <500 μm. The ADF IR formulation was resistant to syringing and preparation for potential intravenous injection. In healthy subjects, pharmacokinetics of an ADF and marketed IR formulation of an opioid were nearly identical.Conclusions: Application of HME to IR formulations led to development of products with improved mechanical resistance to manipulation for intranasal or intravenous preparation, but similar bioavailability.
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Chitlange, Sohan S., Prajakta S. Kulkarni, Dada Patil, Bhushan Patwardhan, and Rabindra K. Nanda. "High-Performance Liquid Chromatographic Fingerprint for Quality Control of Terminalia arjuna Containing Ayurvedic churna Formulation." Journal of AOAC INTERNATIONAL 92, no. 4 (2009): 1016–20. http://dx.doi.org/10.1093/jaoac/92.4.1016.
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Abstract Because Ayurvedic herbal preparations contain a myriad of compounds in complex matrixes, it is difficult to establish quality control standards for raw materials and to standardize finished Ayurvedic drugs. A novel, accurate, and valid fingerprint method was developed using HPLC for quality control of a traditional Ayurvedic Arjuna churna formulation, which is used as a cardiotonic drug. Comprehensive comparison of chromatograms of standardized formulation of Arjuna churna and marketed formulations revealed eight characteristic peaks in chromatograms, which unambiguously confirmed the presence of authentic raw material used in the formulation on the basis of their retention time values and UV data. An HPLC fingerprint was also developed for total sapogenins present in Terminalia arjuna. The six common peaks observed in chromatograms of isolated sapogenins, standardized formulations, and marketed formulations can serve as a quality control tool for qualitative estimation of total saponin glycosides present in an Arjuna churna formulation.
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Reddy, Shimmula R., and Bomma Ramesh. "In vivo Evaluation of Fluvoxamine Maleate Mouth Dissolving Films by Design of Experiment." International Journal of Pharmaceutical Sciences and Drug Research 13, no. 03 (2020): 326–33. http://dx.doi.org/10.25004/ijpsdr.2021.130313.
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Fluvoxamine, an antidepressant belonging to serotonin reuptake inhibitor (SRI) class, exhibits maximum absorption through the oral route of administration. The objective of current research is to formulate mouth dissolving fluvoxamine films by employing super disintegrants. The central composite design (CCD), employed to examine the effects of amount of hydroxypropyl methylcellulose (HPMC) E15 (A), amount of eudragit RL 100 (B), amount of polyethylene glycol (PEG 4000) (C) on response variables tensile strength, disintegration time and cumulative % drug released. A 27 formulations prepared according to CCD and evaluated for physicochemical parameters and in vitro dissolution studies. Fluvoxamine mouth dissolving films formulated by employing solvent-casting method using HPMC E15, eudragit RL100, and PEG 4000. CCD is employed to optimize the effective dosage of formulation superdisintegrants. FF15 with a maximum tensile strength of 55.63 ± 1.37 mg, least disintegration time of 10 ± 1.85 seconds, and highest drug release of 98.29 ± 1.87 % is chosen as an optimal formulation with maximum content uniformity and folding endurance. From in vivo bioavailability studies, Cmax and Tmax of the fluvoxamine optimized mouth dissolving film formulation were significant (p is less than 0.05) compared to the fluvoxamine marketed product formulation. AUC0-∞ infinity for the optimized formulation was higher (733.84 ± 2.04 ng.h/mL) than the fluvoxamine marketed product formulation (485.67 ± 1.54 ng.h/mL). Statistically, AUC0-t of the optimized mouth dissolving film formulation was significantly higher (pis less than 0.05) than fluvoxamine marketed product formulation. In vivo pharmacokinetic studies in rabbits confirmed the quick release and increase in bioavailability for fluvoxamine from optimized mouth dissolving film formulation as compared to the fluvoxamine marketed product formulation.
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Sbhatu, Desta Berhe, Goitom Gebreyohannes Berhe, Abadi Gebreyesus Hndeya, et al. "Hair Washing Formulations from Aloe elegans Todaro Gel: The Potential for Making Hair Shampoo." Advances in Pharmacological and Pharmaceutical Sciences 2020 (September 1, 2020): 1–9. http://dx.doi.org/10.1155/2020/8835120.
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This study aimed to describe the gross phytochemical constituents of Aloe elegans Todaro gel and evaluate the characteristics and quality of lab-made hair washing formulations prepared from the gel to show its potential in formulating hair washing shampoos. A. elegans gel mass was prepared from mature, healthy leaves collected from natural stand. Samples of 100% methanol extract of the gel were subjected to standard phytochemical screening and gas chromatography-mass spectroscopy (GC-MS) analysis. Five hair washing formulations (Fs) were, likewise, prepared by mixing 4.0–10.0 mL of gel with one (0.05 mL) to two (0.10 mL) drops of six synthetic and natural ingredients, namely, coconut oil, jojoba oil, olive oil, pure glycerin oil, lemon juice, and vitamin E. The gel to the total ingredient ratios (v/v) of the five formulations were 93 : 7 (F1), 94.5 : 5.5 (F2), 96.4 : 3.6 (F3), and 96.6 : 3.4 (F4 and F5). The formulations were evaluated using sensory inspection and common physicochemical methods. The phytochemical screening and GC-MS analysis revealed that A. elegans gel is the source of important chemical constituents used in the formulation of shampoos and similar products including saponins, capric acid, lauric acid, myristic acid, palmitic acid, linoleic acid, stearic acid, and phytol. Lab-made A. elegans hair washing formulations, especially those with 96.4–96.6% gel, were found to have similar characteristics and qualities with a common marketed shampoo. All the formulations were turbid with characteristic odor as the marketed shampoo. The pH values of the hair washing formulations (6.4–4.6) were comparable to those of the marketed shampoo (6.7). Formulations with higher proportion of gel had better foam stability, higher solid content (26–29%), higher surface tension (33–38 dynes/cm), shorter wetting time (150–160 sec), equivalent viscosities (26.45–26.73 poise), and conditioning performance than the marketed shampoo. These findings demonstrate that A. elegans gel mass can be used in the formulation of good-quality hair washing shampoos. We recommend future studies that aim to develop the phytochemical profile of the plant and a refined protocol of hair washing shampoo formulation.
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Geethanjali K and Vaiyana Rajesh C. "Formulation and evaluation of self nano-emulsifying drug delivery system of ezetimibe for dissolution rate enhancement." International Journal of Research in Pharmaceutical Sciences 11, no. 2 (2020): 1294–301. http://dx.doi.org/10.26452/ijrps.v11i2.1984.
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The present study was aimed to develop a Self Nano Emulsifying Delivery System of Ezetimibe (EZM) for enhancing its dissolution rate. Ezetimibe is a cholesterol absorption inhibitor, being a lipophilic drug due to its low solubility EZM shows a low dissolution profile. The SNEDDS formulation consisted of excipients Cinnamon oil, Tween 80, PEG 400 as the Oil, Surfactant and Co-surfactant. Twelve formulations with different ratios of Oil, Surfactant and Co-surfactant were prepared. The liquid SNEDDS were then converted into Solid form by adsorption technique using Avicel PH 101 and Aerosil 200 as adsorbents. The liquid SNEDDS was characterised for Particle size, Emulsification time, Dispersibility, percentage transmittance, PCM, Centrifugation, Cloud Point and Freeze thaw cycle. The solid form was characterized for the flow property, SEM, Drug content and in-vitro dissolution. Among the twelve formulations F6 formulation was found to have a particle size of 196 nm and PDI of 0.123. F6 formulation was selected as the best and it was made into solid by adsorption onto solid carriers. The F6 formulation consisted of the 25% Cinnamon oil, 50% tween 80 and 25% PEG 400. The in-vitro dissolution rate of the prepared formulation was compared with the marketed formulation. The in-vitro dissolution data showed that the drug release at the end of 60 mins from marketed formulation was 63.75 % and from SNEDDS formulation was 90.62 %. The dissolution rate of the prepared SNEDDS was increased by 1.42 times than the marketed formulation. The increase in the dissolution rate shows that SNEDDS is a suitable drug delivery system to enhance the rate of dissolution of Ezetimibe.
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Vangara, Kiran Kumar, Kishore K. Konda, Shiva K. Ravula, Pradeep K. Vuppala, Vijay K. Sripuram, and Sushma Samala. "Formulation Development of Metoprolol Succinate Controlled Release Tablets using Ethyl-cellulose-polyvinyl-pyrrolidone Coating." International Journal of Pharmaceutical Sciences and Nanotechnology 8, no. 2 (2015): 2851–57. http://dx.doi.org/10.37285/ijpsn.2015.8.2.8.
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It is challenging to develop a controlled release (CR) formulation for a freely water soluble drug molecule without using rate controlling polymers in the core matrix. This study is aimed to develop and evaluate cost-effective ethyl cellulose (EC)-polyvinyl pyrrolidone (PVP) film coating that can effectively control the release of freely water soluble drug, metoprolol succinate (MS) and to match that of release profile with its marketed tablet. Simple core tables of MS were compressed and coated with a solution composed of hydrophobic rate controlling polymer, EC and water soluble pore forming polymer, PVP. The effect of formulation parameters such as the ratio of EC to PVP and tablet coating weight gain on the in-vitro drug release were evaluated. Release profile of the optimized formulation at different pH conditions was determined and the similarity factor (f2) with marketed release profile was calculated.It was observed that drug release rate increased with a decrease in the ratio of ethyl cellulose to PVP and decreased with increased weight gain of the coating membrane. Among all the formulations, the formulation with EC and PVP at a ratio of 60:40 %w/w and 9% weight gain showed matching release profile to marketed tablet with f2 value of 72.25. The optimized formulation showed pH independent in-vitro release. This study successfully demonstrated that EC-PVP film coating can effectively control the release rate of freely soluble drugs. Once a day CR formulation of metoprolol succinate pharmaceutically equivalent to marketed tablet was developed.
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C, Adithya Kumar, Bhavya Sree P, Suresh Kumar SV, Nageswara Rao L, Siva Sanker Reddy L, and Ragamala KC. "Evaluation and method development for quantification of Piperine in Balchaturbhadra Churna by RP- HPLC." International Journal of Ayurvedic Medicine 16, no. 1 (2025): 184–90. https://doi.org/10.47552/ijam.v16i1.5969.
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Aim and Objective: This study aimed to prepare Balchaturbhadra Churna in the laboratory and evaluate its Pharmacognostic, physicochemical, and phytochemical properties, including developing an RP-HPLC method for estimating Piperine as a marker compound. Methods: The prepared Balchaturbhadra Churna was analysed using WHO guidelines for macroscopic, physical, and chemical parameters. The methanolic extract was used for Piperine estimation through RP-HPLC. Results: The macroscopic characteristics, such as colour, odour, and taste were recorded. Physical parameters were determined, including loss on drying, ash value, extractive value, swelling index, foaming index, and powder properties (angle of repose, bulk density, tapped density, and compressibility index). Additionally, total phenolic, flavonoid and preliminary phytochemical screening were performed. The results were compared with a marketed formulation of Balchaturbhadra Churna. The retention time of standard Piperine was 4.50 minutes, while the Piperine in the laboratory and marketed formulations was detected at 4.478 and 4.480 minutes, respectively. The Piperine concentration in the laboratory and marketed formulations was 0.19% w/w and 0.21% w/w, respectively. The developed HPLC method was successfully validated. Conclusion: The laboratory-prepared and marketed formulations of Balchaturbhadra Churna were systematically evaluated and compared. The findings contribute to the standardization of Balchaturbhadra Churna, an Ayurvedic formulation.
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SV, Suresh Kumar, Karishma Banu D, Rajitha C, Kalyani B, Samel I, and Mohammad Saief ES. "Evaluation and method development for quantification of Piperine in Hutabhugadi Churna by RP- HPLC." International Journal of Ayurvedic Medicine 15, no. 1 (2024): 257–63. http://dx.doi.org/10.47552/ijam.v15i1.4794.
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Aim and Objective: The current work was aimed at preparing the Hutabhugadi Churna in the laboratory and evaluating the same including the method development for the estimation of a marker compound Piperine by using RP-HPLC. Methods: Prepared Hutabhugadi churna was subjected for macroscopic, physical, and chemical evaluation considering WHO guidelines. The methanolic extract was subjected for estimation of Piperine as marker using RP-HPLC. Results: The macroscopic characteristics like colour, odour and taste are recorded. The physical characteristics like loss on drying, ash value, extractive value, swelling index, foaming index, powder properties like angle of repose, bulk density, tapped density, compressibility index etc. were determined. Total phenolic content, total flavonoid content, preliminary phytochemical screening was also carried out. The results are compared with marketed formulation of Hutabhugadi churna. The retention time of the standard Piperine was found to be 5.517, while the Piperine in extracts of laboratory and marketed formulations was found to be was found to be 5.554 and 5.562 respectively. The concentration of Piperine in laboratory and marketed formulation was found to be 0.17 %w/w and 0.18 % w/w respectively. The method developed was also validated. Conclusion: The laboratory made Hutabhugadi churna and marketed formulation of Hutabhugadi churna was comparatively evaluated. The resulting data will be useful for the standardization of the Hutabhugadi churna, an Ayurvedic formulation.
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P, Kanteepan, and Bhikshapathi Dvrn. "DEVELOPMENT AND IN VIVO EVALUATION OF MUCOADHESIVE MICROSPHERES USING PIRENZEPINE." Asian Journal of Pharmaceutical and Clinical Research 11, no. 7 (2018): 296. http://dx.doi.org/10.22159/ajpcr.2018.v11i7.25777.
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Objective: The current investigation objective was to fabricate gastroretentive mucoadhesive microspheres of pirenzepine and to investigate the pharmacokinetic parameters of optimized formulation in comparison with a marketed product.Methods: Pirenzepine mucoadhesive microspheres prepared using ionotropic gelation technique. Evaluation parameters and characterization such as Fourier transform infrared (FTIR) and scanning electron microscopy were performed. In vivo bioavailability studies were conducted in rabbits. The technique used was found to be handling easy, inexpensive, and reproducible process.Results: Among the total 14 formulations, M13 formulation was optimized and showed free flowing with good packability. FTIR studies investigated incompatibility were not observed between drug and excipients. The optimized formulation (M13) showed best cumulative percentage drug release of pirenzepine up to 99.07±0.17% within 12 h whereas marketed product displayed the drug release of 95.23±0.21% within 1 h. The release mechanism from microspheres followed the zero-order and Korsmeyer–Peppas model (R2=0.951 and 0.994), respectively. Optimized formulation (M13) was stable at 40°C±2°C/75% RH±5% RH for 6 months. Form in vivo studies, the optimized formulation bioavailability was much higher than the marketed product.Conclusion: Microspheres would be a promising drug delivery system could play a potentially significant role in pharmaceutical drug delivery in a controlled manner for an extended period of time for effective management of gastritis.
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Kumar, Inder, Dipima Chaudhary, Bhumika Thakur, and Vinay Pandit. "Formulation and Evaluation of Piroxicam Fast Dissolving Tablets Using Direct Compression and Sublimation Method." Journal of Drug Delivery and Therapeutics 10, no. 3-s (2020): 17–25. http://dx.doi.org/10.22270/jddt.v10i3-s.4063.
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Objective: In the present research work, fast dissolving tablets of Piroxicam were formulated by two different techniques i.e. direct compression method and sublimation method using different superdisintegrants.
 Methods: Twelve formulations were prepared (PXM1 to PXM12) in which first six formulation were prepared by direct compression technique and other six formulation were prepared by sublimation method by using camphor as a sublimating agent.
 Result and Discussion: All the formulations were subjected for precompression, post compression parameters, and shows all the data within the specific limits. Formulation PXM4 containing 5 % crospovidone showed 99.480 ± 0.291 % drug release in 20 min which was more than the drug release of rest of the formulations. The optimized formulation PXM4 was compared with the marketed formulation and it revealed that drug release of PXM4 was found to be 99.397 ± 0.751 % in 20 min, which was greater than the marketed formulation. Finally, results were statistically analysed by the application of one way ANOVA and t-test. The stability study of the optimized formulation PXM4 showed no significant changes in, drug content, disintegration time and in-vitro drug release.
 Conclusion: Piroxicam can be successfully prepared using direct compression technique and it will enhance the drug dissolution, which will further increase absorption and bioavailability of the drug.
 Keywords: Direct compression, fast dissolving tablets, sublimation, Piroxicam.
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Naaz, Huzaifa, Panja Srikanth, Mithun Rudrapal, and Khomendra Kumar Sarwa. "Development and Validation of UV Spectrophotometric and RP-HPLC Methods for the Estimation of Gallic Acid in Herbal Formulation of Amalaki." Asian Journal of Chemistry 32, no. 10 (2020): 2469–74. http://dx.doi.org/10.14233/ajchem.2020.22737.
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In this study, two analytical methods viz. UV spectrophotometry and RP-HPLC were developed for the evaluation of Amalaki in the marketed herbal formulation. The amount of gallic acid estimated in the marketed formulation complies with the standard (not less than 1% w/w of gallic acid) specified in the official monograph of Amalaki. The developed methods showed good linearity, accuracy, precision, ruggedness, robustness, specificity, LOD and LOQ. Results of validation studies were found satisfactory with % RSD values of less than 2% indicating good specificity, validity and reliability of the developed methods. Both analytical methods are claimed to be simple, accurate and precise. Present methods can, therefore, be applied widely for the routine analysis of marketed formulations or any crude traditional preparations of Amalaki based on the quantitative determination of gallic acid at a reasonable cost with simple analytical set up.
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Sarma, Anupam, Tapash Chakraborty, Sheikh Sofiur Rahman, and Abdul Baquee Ahmed. "Formulation by Design (FbD) approach to develop pharmaceutically amended Diclofenac Sodium hydrogel as compared to marketed gel." Current Research Journal of Pharmaceutical and Allied Sciences 4, no. 1 (2021): 3–10. http://dx.doi.org/10.54059/2021.4(1)crjpas_185.
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The aim of the present study was to develop pharmaceutically better performing Diclofenac Sodium hydrogel through FbD approaches as compared to marketed gel. The quality target product profile was set for the critical quality attributes of the gel. The key material variables like Carbopol 934P, propylene glycol and Triethanolamine (TEA) were optimized using design of experiments. A response surface central composite design was used considering viscosity, pH and cumulative percentage permeation of the drug up to 120 min as responses. TEA had a significant effect on the pH at concentrations of 0.3182-3.6818% (w/w). The applicability of the optimized formulations was influenced by both Carbopol 934P (0.6591-2.3409%; w/w) and propylene glycol (PG; 6.591-23.409%; w/w) content due to their ability to alter the formulation viscosity. The optimized formulation, determined mathematically, contained 1.5% (w/w) Carbopol 934P. 2.0% (w/w) TEA and 15% (w/w) PG. The optimized hydrogel and marketed gel were evaluated for viscosity, spreadability, skin irritation, homogeneity and grittiness, texture analysis, in vitro release and ex vivo permeation studies. When these evaluation parameters were compared with a marketed gel in respect of all the evaluating tests, the optimized hydrogel was found to be far better formulation than the marketed one.
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Boruah, Pranjal, Jashabir Chakraborty, and Suvakanta Dash. "A COMPARATIVE EVALUATION OF ANTI-DIABETIC POTENTIALITY FOUND IN DIFFERENT MARKETED POLYHERBAL FORMULATION USING GLUCOCORTICOID-INDUCED HYPERGLYCAEMIA IN RABBIT." International Journal of Current Pharmaceutical Research 9, no. 4 (2017): 83. http://dx.doi.org/10.22159/ijcpr.2017v9i4.20964.
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Objective: The aim of this study was performed to evaluate Antidiabetic potentiality found in different marketed polyherbal formulation using glucocorticoid-induced hyperglycaemia in the rabbit.Methods: The potentiality of different polyherbal formulation was investigated using dexamethasone (DEX) induced hyperglycaemia in Rabbit. Eight male rabbits were divided into four groups of two each. The first group is regarded as control group received 3 ml of normal saline daily by using the gastric tube for 15 d and remaining three group received (0.35 mg/Kg B.W. single dosage) of dexamethasone tablets which were powdered, dissolved in 3 ml of normal saline daily for 15 d. After 15 d the blood glucose estimated by using a glucometer and it is found that DXE treatment leads to significant increase in levels of glucose and a significant decrease in body weight. After that second group received metformin tablet. The third and fourth group received polyherbal formulation A and formulation B, which are powdered and dissolved in 3 ml of normal saline daily for 15 d at the dose of 0.5 gm/kg body weight orally. After completion of regular administration for 15 d, the blood glucose was again estimated and compare the results of each the group.Conclusion: The Anti-diabetic polyherbal marketed formulations were having less side effect as compared to standard metformin tablet (e. g. body weight loss). And both the polyherbal formulations were found a therapeutic equivalence to each other, also having the approximately similar potentiality to standard metformin tablet.Results: The result was found that the polyherbal marketed formulations were having less side effect as compared to standard metformin tablet (e. g. body weight loss). And both the polyherbal formulations were found significantly decreased in blood glucose level at equal potentiality, which can be consider as therapeutic equivalence to each other, and both the formulation also having the approximately similar potentiality to standard metformin tablet.
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Gupta, Nitin, Giriraj T. Kulkarni, Pravin Kumar, and Rajendra Awasthi. "Grewia asiatica Mucilage: A Smart Gelling Polymeric Material for Pharmaceutical Applications In Vitro Studies." Current Materials Science 12, no. 2 (2020): 117–26. http://dx.doi.org/10.2174/2666145412666191125124644.
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Background: Natural plant-based materials have several advantages. They are biodegradable, biocompatible, non-toxic, cost-effective, environment friendly, easily available, and can undergo chemical modification. Objective: Grewia asiatica extracts contain various phytoconstituents and have therapeutic benefits such as antimicrobial and anti-diabetic properties. They form colloidal dispersions and make a highly viscous gel in water. Considering these properties of Grewia asiatica mucilage, the present work was aimed to investigate its application in the formulation of gel for the topical delivery of diclofenac sodium. Method: Gel formulations were prepared with and without penetration enhancers using 1% w/w diclofenac sodium as a model drug. The formulations were subjected to different evaluation tests like physical characterization, pH, spreadability, skin irritation, gel retrogradation, drug content and in vitro drug diffusion. The in vitro diffusion of the drug from different formulations was compared with the in vitro drug release profile of the marketed formulation (Omni gel, Cipla, India). To assess the release mechanism, the in vitro release data was analyzed using Korsmeyers-Peppas’ equation. Results: The mucilage showed good gelling behavior in 5.50, 5.75, 6.00, 6.25 and 6.50% concentrations. All the formulations followed the anomalous transport mechanism of drug release. The formulation BP3 showed 90% of drug release after 5.2h of dissolution study, which was similar to the marketed formulation. Hence, formulation BP3 was ideal among all the formulations. Conclusion: It might be concluded that, the Grewia asiatica mucilage may be used as a natural polymeric material for gel formulation.
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Tambade, Mayuresh, Shweta Shriwas, and Dr Rakesh Kumar Jatav. "“Formulation and Evaluation of Nano-Gel Using Effective Combination of Acyclovir and Omeprazole for Enhanced AntiViral Activity”." International Journal of Pharmaceutical Research and Applications 09, no. 06 (2024): 80–97. https://doi.org/10.35629/4494-09068097.
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The aim of the research is to formulate nano transdermal using effective combination ofacyclovir and omeprazole to enhanced anti-viral activity to evaluate the Preformulating characters to formulate acyclovir and omeprazole nanogel by solvent diffusion method to Characterization and evaluation of formulated nanogel compare the in-vitro drug release with marketed formulation. It can be concluded that the experimental study carried out that the formulation of a Nanogel containing anti-viral drug and anti-ulcer drug yields a formulation with spherical and smooth surface, nano in size range. The prepared nanogel was opaque, without any lumps, particle and aggregates. So, all the formulations are homogenous. Based on all the factors the nanogel drug delivery system F9 shows good drug content compare to other. The particle size of the nanogel formulation is optimum and it is less than 1000 nm. So, it concluded that the particles are in tiny and nano in size range. All nanogel formulations shows pH in the range of 6.1 to 6.9. Formulation F9 shows highest pH of 6.9. Because the pH range of nanogel were 1 to 7 pH. Based on the Spreadability diameter study it shown the nanogel is having good Spreadability. Nanogel formulations shown viscosity range from 3268-3528 cps. It concluded that they are stable in nature. Formulation F9 shows highest percentage of drug release compare to other formulations. In-vitro diffusion studies show F9 formulation shows controlled release pattern of drug from the formulation. The formulation was found to be stable in short term stability studies. Here we have selected F9 has an optimized formulation which shown good morphological features, drug content efficiency and controlled drug release. Hence the F9 formulation is efficient than the marketed formulation of acyclovir ointment (ACIVIR).
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Dhawal, Pranjali P., and Siddhivinayak S. Barve. "Preliminary in-vitro evaluation of marketed formulations for antacid activity." International Journal of Basic & Clinical Pharmacology 9, no. 1 (2019): 57. http://dx.doi.org/10.18203/2319-2003.ijbcp20195764.
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Background: Hydrochloric acid (pH 1.5-3.5) being the major component of gastric acid is produced by parietal cells of stomach. Its secretion is a complex and relatively energetically expensive process. The preservation of acidity of stomach is evidently important because of its implications in peptic and duodenal ulceration.Methods: In the present study, we attempted to compare the activity of 13 (F1-F13) antacid formulations (5-liquid, 4- quick releases and 4- tablets) by using acid-base neutralization studies. Preliminary antacid test (PAT) was performed to define whether the given formulation falls under the category of antacid wherein the pH of the antacid-acid (HCl) solution should be higher than pH of 3.5. The chosen antacids were further subjected to acid neutralizing capacity (ANC) (reaction between the sample of antacid and amount of acid neutralized by the formulation) and acid neutralizing potential (ANP) which explains the time duration during which a given sample of antacid can maintain pH above 3.5).Results: Out of the 13 samples tested, two formulations of pastels (F6, F12) were rejected as per the standard protocol of classifying formulations as antacids after screening for PAT. Sample F5 was found to have the highest ANC. F7 also showed highest ANC among the tablets tested. Also, F13 showed better ANC and ANP as in comparison to other quick releases.Conclusions: Digene products (F5, F7, and F13) showed better antacid properties. This data would provide insights into development of drug, comparison between antacids depending on their chemical formulation and determination of dosage to avoid plausible side effects.
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S., A. Bagwan* N. S. Naikwade and J. Y. Manure. "COMPARATIVE STUDY OF IMMUNOMODULATORY ACTIVITY OF MARKETED AYURVEDIC FORMULATION." Indo American Journal of Pharmaceutical Sciences 04, no. 12 (2017): 4776–82. https://doi.org/10.5281/zenodo.1133617.
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Introduction: The objective of the present study to compare immunomodulatory activity of Marketed Ayurvedic Formulation viz Formulation I and Formulation II. Material and Method: In the present study the dose selection of Formulation I and Formulation II for the particular species (Rat) were selected on the basis of the method described by Paget and Barnes. The assessments of immunomodulatory activity were carried out by using Delayed Type Hypersensitivity Test, Carbon Clearance Test and Neutrophil adhesion test. Result: Oral administration of Marketed Formulation I and Formulation II significantly (P<0.0001) showed Immunomodulatory activity by increase in DTH response, phagocytic activity, and Neutrophil adhesion in Rat at experimental dose. Conclusion: The study demonstrated that both the Formulation I and Formulation II shows significant immunomodulatory effect on both humoral as well as cell mediated immunity. While among two Formulation II showed more immunomodulatory activity as compare with Formulation I. Present study it was revealed that Formulation II showed more immunomodulatory activity than Formulation I due to presence of multiple immunomodulatory ingredient in its Formulation (Tinospora Cardifolia , Ocimum Sactum , Glycyrrhiza Glabra , Aconitum hetrophylum ,Cyperus rotundus , Pistacia integerrimg), when compare with Formulation I it contain single ingredient ( Tinospora Cardifolia). Ocimum Sactum which is present in Formulation II is a more potent immunomodulator than Tinospora Cardiofolia. Keywords: Formulation I, Formulation II, Delayed Type Hypersensitivity test, Carbon Clearance Test, Neutrophil Adhesion test.
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Syed Hafeez Pasha Qhadri, Yegnoor Anand Kumar, Neeladri Srinivasulu, Aayush Nahar, and Avanish Srivastav. "Development of simple, precise UV spectroscopic methods for the estimation of Lamotrigine in bulk and marketed tablet." GSC Advanced Research and Reviews 13, no. 1 (2022): 200–209. http://dx.doi.org/10.30574/gscarr.2022.13.1.0284.
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Two Simple and precise UV spectroscopic methods were developed for the estimation of lamotrigine in bulk and marketed tablets. The methods developed by using two solvent systems viz., Acetonitrile: Distilled water (1:1) and Methanol: 0.1N HCl (3:1) were validated as per ICH guidelines. The two proposed solvent systems validated for linearity, accuracy, precision, robustness, ruggedness and solution stability. The percent recovery in the marketed tablet formulation was found to be good agreement with the label claim. The methods validated statistically and the results suggest these methods can employed for the routine analysis of lamotrigine in bulk and marketed tablet formulations.
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Syed, Hafeez Pasha Qhadri, Anand Kumar Yegnoor, Srinivasulu Neeladri, Nahar Aayush, and Srivastav Avanish. "Development of simple, precise UV spectroscopic methods for the estimation of Lamotrigine in bulk and marketed tablet." GSC Advanced Research and Reviews 13, no. 1 (2022): 200–209. https://doi.org/10.5281/zenodo.7665793.
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Two Simple and precise UV spectroscopic methods were developed for the estimation of lamotrigine in bulk and marketed tablets. The methods developed by using two solvent systems viz., Acetonitrile: Distilled water (1:1) and Methanol: 0.1N HCl (3:1) were validated as per ICH guidelines. The two proposed solvent systems validated for linearity, accuracy, precision, robustness, ruggedness and solution stability. The percent recovery in the marketed tablet formulation was found to be good agreement with the label claim. The methods validated statistically and the results suggest these methods can employed for the routine analysis of lamotrigine in bulk and marketed tablet formulations.
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Dipak, R. Kale1* Ram B. Ingle2 Priyanka A. Narode3 Paavanraj B. Lodwal4 Vaishnavi N. Borhade5. "Research On Preparation, Evaluation And Comparison Of Herbal Toothpaste With Marketed Herbal Toothpaste." International Journal in Pharmaceutical Sciences 2, no. 7 (2024): 337–45. https://doi.org/10.5281/zenodo.12662136.
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In current scenario in oral dental care with use of herbal toothpaste containing natural ingredients are moreacceptable in public belief than chemical based synthetic formulations due to their safety and efficacy inreducing dental caries, and preventing other dental issues to which this generation is prone to. In this formulationwe utilizes aloe vera gel, clove oil, neem powder, pomegranate peel powder and trikatu which are not yet usedby any other research work. These extracts possess many activities like anti-ulcer, anti-caries, anti- bacterial,wound healing along with which it imbibes certain special additional properties like anti-cancer and anti-fungal.Along with this herbal based formulation, a comparative study of previously marketed herbal toothpastes wasdone in order to get an idea of important physical parameters i.e. pH, stability, extrudability, spreadability,foamability, homogeneity to make a successful more efficacious and stable formulation. The aim of this study isto compare and evaluate the herbal toothpaste with marketed toothpaste. This study disseminate that our herbalbased toothpaste formulation having natural ingredients is as good as in terms of results compare to marketedherbal formulations.
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Ganjiwale, Rajendra O., Pramod G. Yeole, and Dilesh J. Singhavi. "QUALITY ASSESSMENT OF SOME MARKETED HEPATOPROTECTIVE POLYHERBAL FORMULATIONS." Indian Drugs 59, no. 05 (2022): 31–39. http://dx.doi.org/10.53879/id.59.05.12808.
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The present study was proposed for assessing the variation in quality of some hepatoprotective polyherbal products that are widely available in the market. Different brands of marketed hepatoprotective formulations were evaluated in the present investigation with respect to qualitative analysis by HPTLC, phytochemical evaluation and heavy-metal detection. Among all formulations, it was observed that formulation of Brand C showed maximum amount of phenolic content, tannin content, and flavonoid content. In HPTLC chromatograms of formulations of various brands, spots with RF values (0.46 ±0.3 and 0.86±0.3, respectively) were found, which confirmed the presence of andrographolide and phyllanthin in them. The increased risk of harmful side effects to the patients was indicated by the presence of heavy metals in some formulations above the permissible limits. The present study gives an insight into the fact that there is a requirement to prepare stricter quality control procedures and parameters for formulations for consumer safety.
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Bandarkar, Farzana, Willias Masocha, and Aly Nada. "Pharmacodynamic/pharmacokinetic correlation of optimized ibuprofen nanosuspensions having enhanced anti-inflammatory and antinociceptive activity." Journal of Pharmacy and Pharmacology 74, no. 3 (2021): 387–96. http://dx.doi.org/10.1093/jpp/rgab152.
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Abstract Objectives The main objective of this study was to evaluate the antinociceptive and anti-inflammatory activity of ibuprofen (IB) nanoformulations which were developed in our previous study and showed enhanced in-vitro dissolution rate compared with the marketed formulation. Methods The in-vivo pharmacodynamic (PD) studies were performed in mice. The antinociceptive effect of the formulations was evaluated using the formalin test, whereas the anti-inflammatory activity was evaluated by measuring oedema caused by formalin test. Key findings The optimized formulation exhibited nanosized particles with rapid dissolution compared with IB in water and marketed product. The antinociceptive and anti-inflammatory activity of IB was significantly improved in optimized nanosuspension compared with other formulations. A good correlation was observed between the pharmacokinetic and PD data: nanosuspension &gt; freeze-dried nanoparticles &gt; marketed product &gt; unhomogenized formulation &gt; IB suspension in water. There was a significantly good correlation between percentage inhibition of paw oedema with peak serum concentration (Cmax) and time at which the Cmax is observed (Tmax) but not area under the curve (AUC), whereas there was a good correlation between percentage inhibition of formalin-induced nociception in phase II, but not phase I, with AUC and Cmax but not Tmax. Conclusions The development of IB nanoformulation by ultra-homogenization technique improved its dissolution and PD properties.
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Patel, D. B., K. J. Patel, and P. D. Bharadia. "Formulation and evaluation of orodispersible tablet of ivabradine hydrochloride." Pharmaceutical and Biological Evaluations 4, no. 3 (2017): 162. http://dx.doi.org/10.26510/2394-0859.pbe.2017.25.
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Objective: The objective of present research work was to develop formulation of orodispersible tablets of Ivabradine HCl and evaluate it for different evaluation parameters.Methods: The tablets were prepared by direct compression method. The formulation of the tablets were evaluated before compression for characterization of flow properties and after compression for different parameters of orodispersible tablet formulation.Results: Ivabradine hydrochloride orodispersible tablets were developed with considerable increase in drug release as compared to marketed formulations; nine formulations were developed and studied. The difference in drug release values was found to be 100.88 ± 0.10 respectively. The drug was characterized according to different compendial methods, on the basis of identification by HPLC, pH, organoleptic properties and other tests. Parameters evaluated were within prescribed limits and indicated good free flowing properties. The F6 batch with disintegration time 21 ± 3.0 and dissolution 99.29% was selected as optimized formulation. This was compared with conventional marketed formulation and was found superior. Batch F6 was also subjected to stability studies for two months and was tested for its hardness, wetting time, disintegration time, drug contents and dissolution behaviour monthly.Conclusions: By appropriate selection of excipients, it was possible to develop orodispersible tablets of Ivabradine HCl.
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Deshmukh, Gajanan J., M. Mohan Varma, and Bhikshapathi D. V. R. N. "In vitro and In vivo Evaluation of Propranolol Microspheres Loaded Buccal Gel." International Journal of Pharmaceutical Sciences and Nanotechnology 10, no. 2 (2017): 3661–68. http://dx.doi.org/10.37285/ijpsn.2017.10.2.4.
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The selected propranolol microsphere formulation, S6 was employed for gel formulation with a variety of polymers like Carbopol 934, HPMC and Sodium CMC by mechanical stirring method in order to develop a sustained release propranolol microspheres containing bioadhesive gel. The prepared bioadhesive gels were evaluated for pH, viscosity, %drug content, in vitro drug release studies, bioadhesion, ex vivo permeation studies, accelerated stability and in vivo bioavailability studies. From all the above studies FG3 was found to be optimized formulation. In vitro experiments indicated a sustained release of 98.92% over 12 h and an acceptable bioadhesion quality for formulation FG3. Optimized formulation was characterized for FTIR, SEM and stability studies and found to be stable. Propranolol Optimized formulation exhibited significant increased bioavailability in vivo when compared with marketed tablet. The drug release from the optimized formulation follows zero order kinetics with anomalous Non-fickian diffusion. In vivo studies revealed that Propranolol Optimized formulation FG3 exhibited significant increased bioavailability when compared with marketed product, due to reduced first pass metabolism, when it is administered by the buccal route. Hence, it can be concluded that the formulation FG3 has potential to deliver Propranolol in a controlled and constant manner for prolong period over other formulations and can be adopted for a successful delivery of propranolol for buccal use.
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Upadhye, K., K. Charde, G. Dixit, and S. Bakhle. "Formulation and evaluation of herbal gel for management of mouth ulcers." Indian Journal of Pharmacy and Pharmacology 8, no. 3 (2021): 226–30. http://dx.doi.org/10.18231/j.ijpp.2021.039.
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: or mouth ulcers is the most common condition that we encounter. Clinically the lesions are single or multiple superficial and deep sealed and are associated with microbial invasions.: This study was conducted with the aim of evaluating the effectiveness of herbal drugs for treatment of In the research work, mouth ulcer gels were formulated incorporating the extracts of as and using 934 as the gelling agent. Seven batches were formulated by varying the concentration of the herbal ingredients (F1 to F7)The prepared formulations were evaluated for various parameters like physical appearance, pH, Homogeneity and antimicrobial activity against fungi and bacteria. The antimicrobial activity was also compared with a marketed gel formulation. All the prepared formulation using different concentration of plant extract showed the pH values in between 6.1±0.2 to 7.0±0.1. The values ranged between the 5.0 to 8.0 cm. Out of all the formulations, formulation F7 containing all the three herbal extracts showed a goodand very promising antimicrobial activity comparable with a marketed gel. Thus stable, effective gels containing herbal ingredients for management of mouth ulcers can be developed.
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Fatima Shireen, M. Ajitha1, Roshan S. "Nateglinide Modified Release Dosage Form Using Elementary Osmotic Pump and Push Pull Osmotic Pump Methods: Formulation and in-vivo evaluation." Journal of Pharmaceutical Negative Results 13, no. 4 (2022): 1521–30. http://dx.doi.org/10.47750/pnr.2022.13.04.214.
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Objective: The aim was to develop osmotic tablets of nateglinide by two methods namely elementary osmotic pump (EOP) and push-pull osmotic pump (PPOP) method for controlled drug release.
 Methods: The tablets were prepared by the wet granulation and were evaluated for various physicochemical parameters, in-vitro dissolution and in-vitro dissolution. The optimised formulation obtained in both methods was further characterised for FTIR, stability studies and pharmacokinetic studies.
 Results: In EOP method coated tablet F14 showing highest drug release of 98.82%. In PPOP formulation FF14 was optimized with highest drug release of 99.97% and also its granules were having better flow property. Both F14 and FF14 were further characterized for FTIR, which showed no significant interaction and the accelerated studies indicated formulations were stable for 3months. The in-vivo studies in rabbits revealead Cmax of the optimised formulation (FF14) was 469.67±0.034 ng/ml, and the Cmax of the marketed product was 401.27±0.08 ng/ml. The Tmax of the formulation and the pure drug were 6.0±0.07 h and 1.5±0.04 h, respectively. The AUC0-infinity of the FF14 was higher ((2829.83±1.47 ng.h/ml) than the marketed suspension (1310.62±0.82 ng.h/ml). The AUC0-t of the FF14 formulation was significantly higher than that of the marketed product (p<0.05).
 Conclusion: A better improvement in-vitro dissolution profile and bioavailability of the osmotic tablet of nateglinide was observed using PPOP method.
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Swapnali, Kapse* Rutuja Kakde Ashwin Pundkar Manjusha Markad Prachi Murkute Dr. Santosh Payghan. "Formulation Evaluation and Comparative Study of Antitussive Tablet with Marketed Formulation." International Journal of Pharmaceutical Sciences 3, no. 4 (2025): 1788–802. https://doi.org/10.5281/zenodo.15220911.
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In the last few years there has been an exponential growth in the field of herbal medicine and these drugs are gaining popularity both in developing and developed countries because of their natural origin and less side effects. The role of traditional medicines in the solution of health problems is invaluable on a global level. India is the largest producer of medicinal herbs and is called as botanical garden of the world. The problem emerging from the treatment of cough during many types of respiratory diseases by conventional opioid antitussive agents, such as codeine and codeine like compounds. Medicinal plants are potential source of substances with high antitussive efficiency with minimal unwanted effects. Resent trends of modern phytotherapy include specification of active substances responsible for therapeutic effect as well as their quantification in the healing drugs, which enables the treatment rationalization, especially the dosing and pursuing of adverse effects. Such type of herbal plant is used as antitussive and their active compound with their cough-suppressing activity. The current review focuses on herbal drug preparations and plants used in the treatment of cough, pain. The use of Ayurvedic medicines is common in both adults and children and is increasing in many areas of the world Cough remain as untreated and symptoms of multiple disease. Cough remains a serious unmet clinical problem, both as a symptom of a range of other conditions such as asthma, chronic obstructive pulmonary disease, gastro oesophageal reflux, and as a problem in its own right in patients with chronic cough of unknown origin. Coughs are classified further accordingly which are depending upon factors such as signs and symptoms, duration, type, character, etc. A large number of ethnic plants such as ginger, cinnamon, tulsi etc. are used traditionally to cure pyrexia in India and other parts of the world. Plant based drugs are used as therapeutic agents or their chief constituent separated by chemical processes which are employed as medicines. Tulsi leaves be beneficial in relieving fever, cough and cold symptoms due to anti-inflammatory, antitussive, antipyretic, properties. Ginger used for thousands of years for the treatment of cough.
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Gunda, Raghavendra Kumar. "Design, formulation and characterization of oral disintegrating tablets for lamotrigine." Journal of Analytical & Pharmaceutical Research 9, no. 2 (2020): 60–66. http://dx.doi.org/10.15406/japlr.2020.09.00353.
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Objective: The purpose of present investigation to formulate, characterize the oral dissolving tablets (ODT) for Lamotrigine. Lamotrigine, an antiepileptic agent, belongs to type –II as per Biopharmaceutical Classification System (BCS). Methods: ODT formulations of Lamotrigine were prepared using different quantities of Sodium Starch Glycolate & Crospovidone employed as Super disintegrants by Direct Compression technique. Nine trials were formulated and evaluated for Pharmaceutical Product Performance. Results: Results shows that all the formulations were lie within the acceptance criterion and the In-vitro dissolution profiles were subjected to kinetic modeling. Conclusion: Formulation (F4) containing 35 mg of Sodium Starch Glycolate & 40 mg of Crospovidone was found to be best one among all and also similar to the Marketed product (LAMICTAL-25) (f2=73.17, f1=3.65 & No significant difference, t=0.0218) to marketed product. Formulation (F4) follows First order, Higuchi’s kinetics, mechanism of drug release was found to be Non-Fickian Diffusion (n= 0.554).
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Neetin Kashinathrao Bhutale and Rakeshkumar Jat. "Screening of liver protective effect of herbal hepatoprotective product in ethanol induced hepatotoxicity in Wister rats." World Journal of Biology Pharmacy and Health Sciences 13, no. 3 (2023): 202–9. http://dx.doi.org/10.30574/wjbphs.2023.13.3.0122.
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Background: liver is highly susceptible to the toxic and adverse effects of various metabolites and xenobiotics such as alcohol etc. Alcohol abuse leads to hepatotoxicity that is presented in the form of Alcoholic Liver Disease. Aims and Objectives: The present study was conducted to evaluate hepatoprotective activity of polyherbal formulation. The test drug was studied in comparison with marketed formulations in ethanol induced hepatotoxicity in wistar albino rats. Methods: Total 7 groups of animals were studied comparatively to evaluate efficacy of various formulations. Results: It was found that all the formulations tested including all the dosages of Polyherbal Capsule significantly reduced levels of SGOT (Serum glutamic oxaloacetic transaminase), SGPT (Serum glutamate pyruvate transaminase), Alkaline phosphatase (ALP) and Total Bilirubin when compared to ethanol group. There was significant increase in total protein level in Ariliv Tablet, Silymarin and marketed formulation groups. Also, all the formulations tested effectively preserved the structural integrity of the hepatocellular membrane and liver cell architecture damaged by ethanol. When compared between formulation groups there was no statistical significant difference. Conclusion: It can be concluded that Polyherbal Capsule possesses hepatoprotective activity in ethanol induced hepatotoxicity in rats. Polyherbal Capsule can be effectively used in hepatitis caused due to alcohol.
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Neetin, Kashinathrao Bhutale, and Jat Rakeshkumar. "Screening of liver protective effect of herbal hepatoprotective product in ethanol induced hepatotoxicity in Wister rats." World Journal of Biology Pharmacy and Health Sciences 13, no. 3 (2023): 202–9. https://doi.org/10.5281/zenodo.8035886.
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<strong>Background</strong>: liver is highly susceptible to the toxic and adverse effects of various metabolites and xenobiotics such as alcohol etc. Alcohol abuse leads to hepatotoxicity that is presented in the form of Alcoholic Liver Disease. <strong>Aims and Objectives</strong>: The present study was conducted to evaluate hepatoprotective activity of polyherbal formulation. The test drug was studied in comparison with marketed formulations in ethanol induced hepatotoxicity in wistar albino rats. <strong>Methods</strong>: Total 7 groups of animals were studied comparatively to evaluate efficacy of various formulations. <strong>Results</strong>: It was found that all the formulations tested including all the dosages of Polyherbal Capsule significantly reduced levels of SGOT (Serum glutamic oxaloacetic transaminase), SGPT (Serum glutamate pyruvate transaminase), Alkaline phosphatase (ALP) and Total Bilirubin when compared to ethanol group. There was significant increase in total protein level in Ariliv Tablet, Silymarin and marketed formulation groups. Also, all the formulations tested effectively preserved the structural integrity of the hepatocellular membrane and liver cell architecture damaged by ethanol. When compared between formulation groups there was no statistical significant difference. <strong>Conclusion</strong>: It can be concluded that Polyherbal Capsule possesses hepatoprotective activity in ethanol induced hepatotoxicity in rats. Polyherbal Capsule can be effectively used in hepatitis caused due to alcohol.
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Weyer, Janelle, Xianzhang Meng, Lynda Finis, Bill Strickland, CheolHee Park, and Seong Jang. "Phase 1, randomized, open-label, single-dose, crossover study to evaluate the bioequivalence of four formulations of oral rivoceranib tablets in healthy subjects." Journal of Clinical Oncology 41, no. 16_suppl (2023): e15122-e15122. http://dx.doi.org/10.1200/jco.2023.41.16_suppl.e15122.
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e15122 Background: Rivoceranib is a novel oral tyrosine kinase inhibitor that potently and selectively inhibits VEGFR2. Rivoceranib is being investigated for indications targeted towards solid malignancies as either monotherapy or in combination with other anticancer therapies. Herein, we assessed the bioequivalence of a single dose of rivoceranib administered as 4 different formulations in healthy subjects. Methods: This single-center, open-label, randomized, single-dose, 4-way crossover study evaluated the bioequivalence of 4 different formulations of rivoceranib oral tablets in healthy adults. Each subject participated in 4 treatment periods, where they were randomized to 1 of 4 sequences: ABCD, BDAC, CADB, and DBAC (Formulation A = rivoceranib 250 mg tablet/clinical formulation used in the pivotal phase 3 study, Formulation B = rivoceranib 200 mg tablet/clinical formulation used in early clinical studies, Formulation C = rivoceranib 250 mg tablet/formulation to be developed for future use, Formulation D = rivoceranib 250 mg tablet/to-be-marketed formulation). Results: Of the 60 subjects enrolled, 66.7% were male, 88.3% were white, and median age was 43 years. The median plasma rivoceranib Tmax was similar following all treatments (2 hours post-dose). The 90% CIs around the geometric mean ratios (GMRs) of plasma rivoceranib AUC0-t, AUC0-inf, and Cmax for Formulation B vs. Formulation A and Formulation D vs. Formulation A were within the 80-125% reference interval, demonstrating bioequivalence between Formulation B and Formulation A as well as Formulation D and Formulation A. The 90% CIs around the GMRs of plasma rivoceranib AUC0-t, AUC0-inf, and Cmax for Formulation C vs. Formulation A were slightly outside of the 80%-125% reference interval. Conclusions: Formulations B (clinical formulation used in early clinical studies) and D (to-be-marketed formulation) were bioequivalent to Formulation A (clinical formulation used in the pivotal phase 3 study). Formulation C (formulation to be developed for future use) and Formulation A were similar, but the difference was slightly outside of the bioequivalence criteria. It remains to be evaluated whether the difference in bioavailability between Formulation C and Formulation A is clinically meaningful. Clinical trial information: NCT05287360 . [Table: see text]
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PAVAN, AMPAPURAM RAJESH, Bindu K. Hima, M. Prasanna Kumari, R. Maddileti, and G. Anitha Lakshmi. "Formulation, evaluation & comparison of traditional poly herbal shampoo powders with marketed formulation." Journal of Drug Delivery and Therapeutics 9, no. 2-s (2019): 500–503. http://dx.doi.org/10.22270/jddt.v9i2-s.2730.
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The aim of present work is to formulate poly herbal powder by using different natural herbs like Aswagandha, Tulsi, Ginger, Hibiscus, Aloe vera, Amla and Soap nut to have safety and effectiveness which can avoid toxic effects by chemical ingredients and prepared formulations were compared with marketed poly herbal shampoo. Prepared formulation strengths hair growth, prevents hair fall, dandruff and also acts as antibacterial conditioner and foaming agent without affecting or damaging hair. All the herbs have been selected to formulate poly herbal traditional shampoo powder on the basis of traditional system with scientific modern uses of poly herbs. In this present work herbs like Aswagandha, Tulsi, Ginger, Hibiscus, Aloe vera, Amla and Soap nut were collected, dried, powdered and sieved by passing through sieve no.60, stored in an air tight container and used for further formulation. Then the powders were formulated into four different formulations namely F1, F2, F3, F4 and evaluated for their organoleptic properties like color, odor and texture etc., General powder characteristics like angle of repose, bulk density and true density etc. and physiochemical properties like pH, moisture content, total ash contents, acid insoluble ash, other parameters evaluated were dirt dispersion and foaming capacity. All the four formulations offered good results in all the evaluation tests. The organoleptic characteristics were found to be good, general powder characteristics results were in specified limits and physicochemical evaluation like pH, foaming action, Dirt dispersion were found to yield good satisfactory results. So, the present work successfully formulated poly herbal traditional shampoo powder which meets the modern uses of hair without causing any damage to both skin and hair. Further the Scope of work need to be extended to carry out the stability studies. Keywords: Poly herbal, Traditional
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Ferreira, Guilherme Neves, Marcos Giovani Rodrigues Silva, Aline Guerra Manssour Fraga, et al. "Preparation and scale up of extended-release tablets of bromopride." Brazilian Journal of Pharmaceutical Sciences 50, no. 2 (2014): 291–300. http://dx.doi.org/10.1590/s1984-82502014000200008.
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Reproducibility of the tablet manufacturing process and control of its pharmaceutics properties depends on the optimization of formulation aspects and process parameters. Computer simulation such as Design of Experiments (DOE) can be used to scale up the production of this formulation, in particular for obtaining sustained-release tablets. Bromopride formulations are marketed in the form of extended-release pellets, which makes the product more expensive and difficult to manufacture. The aim of this study was to formulate new bromopride sustained release formulations as tablets, and to develop mathematical models to standardize the scale up of this formulation, controlling weight and hardness of the tablets during manufacture according to the USP 34th edition. DOE studies were conducted using Minitab(tm) software. Different excipient combinations were evaluated in order to produce bromopride sustained-release matrix tablets. In the scale-up study, data were collected and variations in tableting machine parameters were measured. Data were processed by Minitab(tm) software, generating mathematical equations used for prediction of powder compaction behavior, according to the settings of the tableting machine suitable for scale-up purposes. Bromopride matrix tablets with appropriate characteristics for sustained release were developed. The scale-up of the formulation with the most suitable sustained release profile was established by using mathematical models, indicating that the formulation can be a substitute for the pellets currently marketed.
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MD, Rawoof, Rajnarayana K, and Ajitha M. "Development and In Vivo Evaluation of Mesalazine Colon Targeted Tablets." International Journal of Pharmaceutical Sciences and Nanotechnology 12, no. 3 (2019): 4552–58. http://dx.doi.org/10.37285/ijpsn.2019.12.3.6.
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The main objective of the present study was to develop colon-targeted tablets of mesalazine by wet granulation method using 33 Response surface method with design of experiment software and HPMC K4M, Eudragit RL100, Ethyl cellulose and PVP K-30 used as pH dependent polymers. All the formulations (F1 to F27) were evaluated for the physicochemical parameters and were subjected to in vitro drug release studies. The amount of Mesalazine released from tablets at different time intervals was estimated by UV spectrophotometer. The formulation F26 released 98.16 % of mesalazine after 24 h, whereas marketed product drug release was 92.02 ± 2.15 after 24 h. From in vivo bioavailability studies, after oral administration of colon targeted tablet containing 400 mg mesalazine, the Cmax, Tmax, and AUC0–∞ of optimized formulation and marketed product was found to be 683.21 ± 0.03 ng/mL, 6.01 ± 0.04 h, 4150.12 ± 5.12 ng*h/mL and 445.34 ± 3.22 ng/mL, 4.00 ± 0.01 h, 3457.18 ± 5.32 ng*h/mL respectively. Cmax, Tmax and AUC values of optimized formulation were found to be significantly higher than of marketed product. The pH dependent tablet system is a promising vehicle for preventing rapid hydrolysis in gastric environment and improving oral bioavailability of mesalazine for the treatment of disease at colon region.
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Naraparaju, Swathi, Karuna Devi Barla, Soujanya Chaganti, Durga Pani Kumar Anumolu, and Krishna Priya Nemani. "Determination of Antiviral Drug, Favipiravir by a Stability-indicating Chromatographic Method." Oriental Journal Of Chemistry 40, no. 3 (2024): 673–80. http://dx.doi.org/10.13005/ojc/400306.
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To determine favipiravir in bulk and marketed formulation, a stability-indicating reversed-phase high performance liquid chromatographic approach has been established that was proved to be sensitive and accurate. SPOLAR C18 column with 250 mm x 4.6 mm, 5 μ dimensions, 0.1% ortho-phosphoric acid buffer: acetonitrile in 50:50 as a mobile phase at 30 °C were used to achieve the chromatographic separation. The retention time of 2.613 min was recorded, when favipiravir measured at 323 nm using 1 mL/min flow rate. The suitable chromatographic conditions were identified through optimization studies. The method showed appreciable linearity (R2 = 0.999) over 10-60 µg/mL concentration range. The calculated values for detection and quantification of favipiravir were 0.12 and 0.37 µg/mL, respectively. The methodology was verified, and the validation parameters results fell within the acceptable range outlined by ICH protocols. Satisfactory result was obtained on adopting optimized protocol in marketed formulation. Hence, this chromatographic methodology is suitable for the regular analysis of favipiravir in various marketed formulations.
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Bhosale, Rohit, Omkar Bhandwalkar, Anita Duduskar, Rahul Jadhav, and Pravin Pawar. "Water Soluble Chitosan Mediated Voriconazole Microemulsion as Sustained Carrier for Ophthalmic Application: In vitro/Ex vivo/In vivo Evaluations." Open Pharmaceutical Sciences Journal 3, no. 1 (2016): 215–34. http://dx.doi.org/10.2174/1874844901603010215.
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Background: Voriconazole (VCZ) is a lipophilic candidate, effective against fungal infections like ocular keratitis and endopthalmitis. Objective: The purpose to develop, optimize and characterize voriconazole microemulsion as sustained medication for ophthalmic application. Methods: The pseudo-ternary phase diagrams were developed using oleic acid, isopropyl myristate and isopropyl palmitate (oil phases), tween 80 (surfactant), propylene glycol (co-surfactant), distilled water (aqueous phase) and modified chitosan (Mod.CH) as mucoadhesive polymer. The optimum composition of oil, Smix and water was selected on the basis of phase diagrams and as mucoadhesive polymer Mod.CH was used in the formulations. All the formulations were evaluated for thermodynamic stability/dispersibility, physicochemical parameters (droplet size, polydispersity index, zeta potential, drug content, viscosity, pH and conductivity), in vitro, ex vivo and in vivo studies. Results: All formulations showed droplet size below 250 nm, positive zeta potential and polydispersity index below 0.5. The in vitro drug release study performed on selected formulations showed maximum sustained release than marketed formulation. The in vitro transcorneal permeation experiment of formulations suggests that optimized formulations showed better permeation. The selected formulation of voriconazole microemulsion was able to produce maximum antifungal activity against Candida albicans when compared to marketed formulation. In vivo study performed on rabbit eyes, found more drug concentration in aqueous humor of optimized formulation; the AUC0→t of IPMVM-11 was approximately 6.84-fold higher than VOZOLE and efficiently enhanced the corneal bioavailability. Conclusion: The modified chitosan based on voriconazole loaded microemulsion was promising novel carrier for sustained action in ophthalmic medication.
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Kenjale, Prathmesh P., Manjusha A. Joshi, Umesh N. Khatavkar, Vividha V. Dhapte, and Varsha B. Pokharkar. "Paroxetine Hydrochloride Push-pull Osmotic Pump Tablets: Designing an Innovative, Scalable Push-pull Osmotic Drug Delivery System Using QbD Approach." Drug Delivery Letters 10, no. 2 (2020): 104–16. http://dx.doi.org/10.2174/2210303109666190902112941.
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Background: Paroxetine hydrochloride hemihydrate (PHH) is a serotonin reuptake inhibitor useful for the treatment of diverse psychiatric problems. Existing marketed formulations with frequent administration lead to gastrointestinal (GI) reactions and abrupt fluctuations in plasma level with poor patient compliance. These prerequisites are sufficed by controlled release push-pull osmotic pump tablets (PPOP). Objective: Objective of the present study was to develop robust and reliable PPOP formulation via Quality by design (QbD) approach to achieve desired release kinetics. Methods: PPOP was formulated using wet granulation method followed by osmotic coating. QbD strategy for defining the risk assessment of influential variables such as swelling polymers and osmogen on in vitro release kinetics of designed PPOP. Results: Presence of Polyox in push and pull layer along with osmogen controlled the drug release pattern from formulated PPOP system as depicted in 33 factorial design. These formulated optimized PPOP systems demonstrated 2 hrs lag time with zero-order kinetics, a peculiar feature of PPOPs. Conclusions: Scalable, stable PPOP tablets were fabricated by applying systematic QbD approach. The developed PPOP systems with improved concentration-independent behavior helped to address the challenges of existing marketed formulations. Risk mitigation and control strategy assured quality of the system during scalability. Application of QbD strategy in establishing the PPOP formulation would help in formulating drug candidates having gastric limitations and poor patient compliance. The present study is the detailed account of QbD based PPOP formulation, therefore it can be of potential importance from academics as well as industrial perspective.
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Bhatia, Saurabh, Satish Sardana, Ajay Sharma, Celia Bertha Vargas De La Cruz, Bhupal Chaugule, and Laleh Khodaie. "Development of broad spectrum mycosporine loaded sunscreen formulation from Ulva fasciata delile." BioMedicine 9, no. 3 (2019): 17. http://dx.doi.org/10.1051/bmdcn/2019090317.
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Ba.ckground: Sunscreen formulations primarily offer protection against UV induced damages however nowadays it also maintains skin natural physiological conditions. Current global market is flooded with numerous sunscreen products which offer protection to skin against several UV induced damages. However most of these sunscreen formulations offers narrow spectrum protection against UV and also suffer from stability as well as toxicity related issues. Methods: Present work aims to isolate mycosporine amino acid (Mgy) from green alga namely Ulva fasciata (U. fasciata) and study its sunscreen potential against widely used domestic marketed formulation. Stability evaluations were also performed for almost 90 days. Results: Results demonstrated that the isolated compound, mycosporine glycine (Mgy) preserved physicochemical properties of the product and offered good stability for all formulations throughout the experimental period. Furthermore, Mgy loaded carbopol gel showed better sunscreen protection against marketed formulation in a concentration dependent manner. (7.709). Conclusion: (6.806) Novel Myg loaded gel was proved to demonstrate several quality characteristics that may unlock new prospects for the production of more efficient, safe, and economic skin-care products.
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ALI, IRSHAD, BK DUBEY, DEEPAK KUMAR BASEDIA, PRABHAT KUMAR JAIN, SUNIL SHAH, and VIVEK SINGH THAKUR. "ECO-FRIENDLY METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF FENOFIBRATE AND ATORVASTATIN IN MARKETED FORMULATION." Current Research in Pharmaceutical Sciences 13, no. 4 (2024): 167–71. http://dx.doi.org/10.24092/crps.2023.130402.
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This study focuses on the development and validation of an eco-friendly analytical method for the simultaneous estimation of Fenofibrate (FNF) and Atorvastatin (ATV) in a marketed formulation. The stability of both drugs was evaluated using a mixed hydrotropic solution of 2M Ammonium Acetate and 2M Sodium Citrate (1:1). This work focuses on the development and validation of an eco-friendly method for the simultaneous estimation of Fenofibrate and Atorvastatin in a marketed formulation. The stability of both drugs in a mixed hydrotropic solution was confirmed, and the method exhibited good linearity, recovery, and precision. The validated method was successfully applied to analyze a tablet formulation, demonstrating its applicability in routine quality control. The use of environmentally friendly practices in analytical methods contributes to sustainable pharmaceutical analysis. KEYWORDS: Eco-friendly method, Fenofibrate, Atorvastatin, Hydrotropic solution, Validation, Marketed formulation, Simultaneous estimation.
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Vaibhavi, D. Jape Varsha R. Bhati Disha S. Gangule Vaishnavi R. Gangule Snehal N. Nikam. "Formulation And Comparative Evaluation of Marketed Paracetamol Tablets." International Journal of Pharmaceutical Sciences 2, no. 11 (2024): 256–63. https://doi.org/10.5281/zenodo.14042472.
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Many suppliers sell paracetamol tablets as an over-the-counter (OTC) product, commonly used to reduce fever and relieve pain. The main goal of this research was to compare and assess different brands of paracetamol tablets available in the Sangli district. Five different brands of paracetamol tablets were randomly collected from various pharmacies in the area. The research followed official guidelines from books like the United States Pharmacopeia (USP) and British Pharmacopoeia (BP) to conduct various quality tests and analyses.Several parameters were evaluated for these brands, including weight variation, friability (how easily the tablet breaks), hardness, drug content, identification tests, disintegration time (how quickly the tablet breaks down), and dissolution profile (how the drug is released in the body). The weight variation and friability tests showed that all brands were within acceptable limits. However, when tested for drug content using UV analysis, none of the brands had less than 95% of the active drug. Overall, each brand showed different results, but all were within the standards set by official guidelines.
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Kiran, Pathade Varsha Bhati Sakshi Kshirsagar Disha Gangule Vaibhavi Jape. "Formulation And Comparative Evaluation of Marketed Paracetamol Suspension." International Journal of Pharmaceutical Sciences 2, no. 12 (2024): 979–87. https://doi.org/10.5281/zenodo.14328001.
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This study aimed to formulate and comparatively evaluate the physical, chemical, and stability characteristics of marketed paracetamol suspensions, including Pacimol 250mg, Calpol 250mg, Macfast 250mg, Febrex 250mg, and Flumol 250mg. The results showed variations in assay values, dissolution rates, viscosities, and pH values among the different formulations. Stability studies revealed that all formulations were stable over a period of 6 months. The study provides valuable information for pharmaceutical manufacturers, regulatory agencies, and healthcare professionals to ensure the quality and efficacy of paracetamol suspensions.