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Nolly, Robert J., Patrick Rodrigues, and Laura Thoma. "Weight Variability of Scored and Unscored Psychotropic Drug Tablets Split by a Uniquely Designed Tablet Splitting Device." Hospital Pharmacy 40, no. 4 (April 2005): 321–25. http://dx.doi.org/10.1177/001857870504000406.
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Tablets of three psychotropic drugs were split using a uniquely designed tablet splitting device, the Tru-Cut Multi-Tablet Cutter, and evaluated for weight variation utilizing criteria based on the United States Pharmacopeia (USP) <27> Uniformity of Dosage Units Content Uniformity Criteria. Whole tablets of Risperdal 2 mg and 4 mg, Paxil 20 mg and 40 mg, and Zoloft 100 mg were split by a device that positioned tablets in tablet specific disposable trays for splitting. Each half tablet weight was recorded utilizing a digital electronic balance. Weight variability was determined by comparing actual half tablet weight to theoretical half tablet weight and calculation of the relative standard deviation. Results showed half tablets of all drugs met the weight variation criteria resulting in uniform half tablet dosages as defined by the criteria.
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Cardoso-Palacios, Carlos, and Ingela Lanekoff. "Direct Analysis of Pharmaceutical Drugs Using Nano-DESI MS." Journal of Analytical Methods in Chemistry 2016 (2016): 1–6. http://dx.doi.org/10.1155/2016/3591908.
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Counterfeit pharmaceutical drugs imply an increasing threat to the global public health. It is necessary to have systems to control the products that reach the market and to detect falsified medicines. In this work, molecules in several pharmaceutical tablets were directly analyzed using nanospray desorption electrospray ionization mass spectrometry (nano-DESI MS). Nano-DESI is an ambient surface sampling technique which enables sampling of molecules directly from the surface of the tablets without any sample pretreatment. Both the active pharmaceutical ingredients (APIs) and some excipients were detected in all analyzed tablets. Principal component analysis was used to analyze mass spectral features from different tablets showing strong clustering between tablets with different APIs. The obtained results suggest nano-DESI MS as future tool for forensic analysis to discern APIs present in unknown tablet samples.
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Swetanshu, ,., and Vijay Sharma. "Formulation, Optimization and Evaluation of Bilayer Tablet of Antihypertensive Drug." Journal of Drug Delivery and Therapeutics 9, no. 4 (July 15, 2019): 704–8. http://dx.doi.org/10.22270/jddt.v9i4.3098.
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Hypertension or high blood pressure occurs when the high cardiac output exerts pressure on the arterial wall as the blood flow increases. Bi-layer tablets are prepared with one layer of drug for immediate release while second layer designed to release drug later, either as second dose or in an extended release manner. Bi-layered tablet is suitable for sequential release of two drugs in combination, separate two incompatible substances, and also for sustained release tablet in which one layer is immediate release as initial dose and second layer is maintenance dose. Bilayer tablet is suitable for sequential release of two drugs in combination, separate two incompatible substances and also for sustained release tablet in which one Layer is immediate release as initial dose and second layer is maintenance dose. The preparation of tablets in the form of multi layers is used to provide systems for the administration of drugs.
Keywords: Hypertension, Bi-layered tablet, Enalapril, Immediate release and Sustained release.
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Latifiana, Umi, Deny Budi Legowo, Erna Fitriany, Andri Priyoherianto, and Muhammad Novianto Ainul Huri. "Uji Mutu Fisik Metoklopramid HCl Tablet Chewable dengan Variasi Jenis Pengisi sebagai Diluent menggunakan Metode Granulasi Basah." Indonesian Journal of Pharmaceutical Education 1, no. 2 (June 2, 2021): 76–85. http://dx.doi.org/10.37311/ijpe.v1i2.10638.
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Metoclopramide HCl are used to reduce vomiting and nausea. The availability on the market in the form of tablet, syrup and injection. Patient tend to prefer take drugs by oral use because it was easier. Chewable tablet is the new product as the alternative ways to treatment children and adult patient who had difficulity problem of swallowing drugs. Objectives: This research aims to formulate the chewable metoclopramide HCl tablets using diluent variations to get a better physical quality test. Chewable tablets of metoclopramide HCl are made using diluent variations, they are mannitol, sucrose, lactose. Formula I mannitol, formula II sucrose, and formula III lactose. Chewable tablet preparations are made by the wet granulation method. Data collection was performed on physical characteristics including organoleptic, weight uniformity, uniformity of size, tablet hardness, tablet fragility, disintegration time, metoclopramide HCl levels. Physical quality test results were statistically analyzed to determine the effect of variations in the diluent on the characteristics of chewable tablets. The results of this research have an influence on the physical quality and uniformity of contents of various types of diluent variations between each formulation. In this research, fillers have an important role in the preparation of chewable metoclopramide tablets to determine the physical quality of the tablets and the uniformity of their contents. The variation of diluent that gives better results is mannitol. This is because formulas that use mannitol have uniformity in content that meets the requirements, faster disintegration time, and physical quality of tablets that still meet the requirements, when compared to the first and second formulations. The variation of diluent that gives better results is mannitol.
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Veronin, Michael A., Eunah Lee, and E. Neil Lewis. "“Insight” into Drug Quality: Comparison of Simvastatin Tablets from the US and Canada Obtained via the Internet." Annals of Pharmacotherapy 41, no. 7-8 (July 2007): 1111–15. http://dx.doi.org/10.1345/aph.1h680.
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Background: Recently, there has been much debate in the US concerning drug importation from Canadian Internet pharmacies. The Food and Drug Administration and US drug manufacturers assert that drugs obtained from international markets via the Internet present a health risk to consumers from substandard products. The public's perception is that drugs from Canada are as safe as those from the US. Objective: To determine whether simvastatin tablets obtained via the Internet from Canadian generic manufacturers are comparable in blend uniformity, a major attribute of tablet quality, with the US innovator product. Methods: Generic simvastatin tablets from 4 Canadian Internet pharmacy Web sites and the US innovator product were obtained for pharmaceutical analysis, Tablet samples were analyzed using near-infrared spectroscopic imaging techniques, which are designed to detect formulation defects of drug products during the manufacturing process. Digital images were created, revealing the tablets’ internal structures. Results: The blend uniformity of the active pharmaceutical ingredient in the tablet samples from Canada was determined and compared with that of the US innovator product. Results indicated that there is little significant difference in blend uniformity among US innovator and Canadian generic tablets. Conclusions: Results of this study suggest comparable quality assurance manufacturing standards for the US innovator product and the Canadian generic drug products tested. These findings have clinical, legal, and economic implications that should be addressed by policy makers to safeguard consumers who choose to purchase Canadian-manufactured drugs via the Internet.
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Triastutik, Irsalina, Lusia Oktora Ruma Kumala Sari, and Lina Winarti. "Optimasi Hydroxypropyl Methylcellulose dan Chitosan pada Tablet Floating-Mucoadhesive Diltiazem Hidroklorida Menggunakan Desain Faktorial." Pustaka Kesehatan 8, no. 3 (September 19, 2020): 159. http://dx.doi.org/10.19184/pk.v8i3.11419.
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Diltiazem HCl is one of the drugs used for hypertension treatment. It requires frequent dosing, which is why diltiazem HCl needs to be formulated into preparations using a controlled release drug delivery system. The combination of floating and the mucoadhesive system is expected to increase the stomach's retention of the dosage form. This study aimed to determine the optimum composition of hydroxypropyl methylcellulose (HPMC K100M) and chitosan for floating mucoadhesive diltiazem HCl tablet. Tablets that have been prepared were evaluated for the tablet's physical characterization, powder flowability test, dissolution test, floating ability, and mucoadhesive test. Tablets were optimized using a factorial design, and the data were analyzed using design expert 11.0.0. The results showed that the optimum formula for polymer combination in diltiazem HCl tablet was 175 mg for HPMC K100M and 50 mg for chitosan. The combination of polymers with this amount can produce a floating lag time of 45,333 seconds, floating duration time >12 hours, and the strength of mucoadhesive is 81,633 grams.
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Carnwath, T. "Temazepam tablets as drugs of misuse." BMJ 307, no. 6900 (August 7, 1993): 385–86. http://dx.doi.org/10.1136/bmj.307.6900.385-c.
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Puspadina, Valiandri, Deny Budi Legowo, Erna Fitriany, Andri Priyoherianto, and Winda Damayanti. "EFFECT OF VARIATION OF LUBRICANT CONCENTRATION (MAGNESIUM STEARATE) ON THE PHYSICAL QUALITY OF METOCLOPRAMID HCl TABLETS WITH DIRECT PRINTING METHOD." Indonesian Journal of Pharmaceutical Education 1, no. 2 (May 27, 2021): 67–75. http://dx.doi.org/10.37311/ijpe.v1i2.10567.
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Metoclopramide HCl is used to relieve nausea and vomiting. Market availability in the form of tablets, syrup and injection. The most preferred drug use by patients is oral medication because of its ease of use. Chewable tablets are a new product as an alternative for treatment in pediatric and adult patients who have difficulty swallowing drugs. This study aims to formulate the chewable tablet preparations of metoclopramide HCl using variations in lubricant concentrations. The variations of magnesium stearate with concentrations of 1%, 2%, and 3% using the direct printing method made to obtain a better physical quality test including organoleptics, weight uniformity, uniformity of size, tablet hardness, tablet brittleness, tablet crush time, uniformity of content. The results of the physical quality test were statistically analyzed using one way ANOVA to determine the effect of variations in the concentration of lubricants on the characteristics of chewable tablets. The results showed that variations in the concentration of magnesium stearate lubricant in the manufacture of metoclopramide HCl chewable tablets had an effect on the physical quality of metoclopramide HCl chewable tablets. The concentration of magnesium stearate which produces metoclopramide HCl chewable tablets with good physical properties is 2%.
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Coutinho, Ana Luisa, Asmita Adhikari, and James Polli. "10122 Development of an In Vitro in Vivo Correlation of Itraconazole Spray-Dried Dispersion Tablets." Journal of Clinical and Translational Science 5, s1 (March 2021): 96–97. http://dx.doi.org/10.1017/cts.2021.649.
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ABSTRACT IMPACT: As the number of poorly water-soluble drugs in development increases, our research will expand on the science behind improving drug solubility and absorption and ensuring that promising poorly-water solubility drugs do not fail drug development. OBJECTIVES/GOALS: Spray-dried dispersion (SDD) tablet formulation is an approach to increase oral drug solubility and absorption. Methods to predict SDD performance in humans are poorly developed. We aim to develop an in vivo in vitro correlation (IVIVC) between in vitro dissolution and in vivo absorption of itraconazole SDD tablets. METHODS/STUDY POPULATION: This research project involves tablet manufacturing, in vitro dissolution experiments, and a clinical study. We manufactured fast-, medium-, and slow-release SDD tablets containing amorphous solid dispersion of itraconazole (100 mg) and different grades of the polymer hypromellose acetate succinate (HPMC-AS). Tablets differed in slug pressure, tablet compression force, and formulation composition. Dissolution studies were performed using the United States Pharmacopeia (USP) type II apparatus. The clinical study is an ongoing randomized, cross-over, open-label, fasted, single-dose trial in healthy participants (n=12). An IVIVC will be created by comparing the rank order of drug in vitro dissolution with in vivo absorption. RESULTS/ANTICIPATED RESULTS: Tablet manufacturing was successful, and the tablets displayed the same dissolution rate ranking order as anticipated. Fast-release tablets showed the highest percentage of drug dissolved by 10 min (74%) compared to medium- (62%) and slow-release (1.2%) tablets. Percentage drug dissolved differs by at least 10% at all time points among the different release-rate tablets. The clinical study is currently ongoing, and we expect that the pharmacokinetic (PK) profiles differ among the different tablets. We predict that the rank order of tablet absorption in humans will agree with the order of drug dissolved observed in the dissolution experiments. DISCUSSION/SIGNIFICANCE OF FINDINGS: Spray-dried dispersions are a formulation method to try to improve drug solubility and oral drug absorption. This research will elucidate manufacturing parameters that can impact tablet performance and expand on the ability of in vitro dissolution to predict human PK and streamline drug development of poorly soluble drug candidates.
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Jacques, Emmanuel Reginald, and Paschalis Alexandridis. "Tablet Scoring: Current Practice, Fundamentals, and Knowledge Gaps." Applied Sciences 9, no. 15 (July 29, 2019): 3066. http://dx.doi.org/10.3390/app9153066.
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Oral solid dosage formulations and/or tablets have remained the preferred route of administration by both patients and health care practitioners. Oral tablets are easy to administer, they are non-invasive and cause less risk adversity. Because of the lack of commercially available tablet dose options, tablets are being split or partitioned by users. Tablet scoring refers to the breakage of a tablet to attain a desired efficacy dose and is an emerging concept in the pharmaceutical industry. The primary reason for the tablet scoring practice is to adjust the dose: dose tapering or dose titrating. Other reasons for tablet partitioning are to facilitate dose administration, particularly among the pediatric and the geriatric patient population, and to mitigating the high cost of prescription drugs. The scope of this review is to: (1) evaluate the advantages and inconveniences associated with tablet scoring/portioning, and (2) identify factors in the formulation and the manufacturing of tablets that influence tablet splitting. Whereas tablet partitioning has been a common practice, there is a lack of understanding regarding the fundamentals underpinning the performance of tablets with respect to splitting. Several factors can influence tablet partitioning: tablet size, shape, and thickness. A requirement has recently been set by the European Pharmacopoeia and the U.S. Food and Drug Administration for the uniformity of mass of subdivided tablets. For breaking ease, an in-vivo reference test and a routinely applicable in-vitro test need to be established.
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Aabed, Wafa’ J., Asma H. Radwan, Abdel Naser Zaid, and Naser Y. Shraim. "Extemporaneous Compounding and Physiological Modeling of Amlodipine/Valsartan Suspension." International Journal of Hypertension 2021 (March 12, 2021): 1–10. http://dx.doi.org/10.1155/2021/6695744.
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Background and Objectives. In case of absent liquid dosage form, crushing a tablet or dispersing a capsule would be the most convenient option for using these drugs in patients with dysphagia difficulties. The aims of the study were to prepare an extemporaneous suspension of amlodipine and valsartan from the available commercial tablets and to evaluate the stability and dissolution properties of the compounded suspension. Method. Amlodipine/valsartan extemporaneous suspension was prepared from available commercial tablets such as Valzadepine®. The dissolution profiles for the extemporaneous preparation and the commercial tablet were determined in different pH media. The physical, chemical, and microbial stability of the compounded formulation was evaluated over one-month period at room temperature. Moreover, in silico modeling using GastroPlus™ software was used to build absorption models for both drugs based on the in vitro dissolution data. The simulated plasma profiles for both active ingredients were compared with the in vivo plasma profiles to examine the similarity of the extemporaneous suspension and the commercial tablets. Results. The amlodipine/valsartan extemporaneous suspension was successfully prepared with acceptable organoleptic properties. The suspension was stable for four-week period preserving its physical and chemical features. The release profiles of valsartan and amlodipine from the suspension were similar to those from source tablet Valzadepine®. In silico modeling predicted the similarity of the extemporaneous suspension and the commercial tablets. Conclusion. Amlodipine/valsartan extemporaneous suspension could be prepared from available commercial tablets. Moreover, GastroPlus™ can be applied along with the in vitro dissolution in order to affirm similarity in extemporaneous compounding situations.
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Masih, Ashish, Amar Kumar, Shivam Singh, and Ajay Kumar Tiwari. "FAST DISSOLVING TABLETS: A REVIEW." International Journal of Current Pharmaceutical Research 9, no. 2 (March 1, 2017): 8. http://dx.doi.org/10.22159/ijcpr.2017v9i2.17382.
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Fast dissolving tablets emerge as one of the popular and widely accepted dosage forms, especially for pediatric patients because of incomplete development of the muscular and nervous system and a case of geriatric patients suffering from Parkinson’s disorder or hand tremors. Few solid dosage forms like capsules and tablets are present days facing the problems like difficulty in swallowing (dysphagia), resulting in many incidences of non-compliance and making the therapy ineffective. Oral dosage form and oral route are the most preferred route of administration for various drugs have limitations like first-pass metabolism, psychiatric patients, bedridden and uncooperative patients. FDTs are disintegrating or dissolve quickly in the saliva without a need of water. Fast dissolving tablets are designed to dissolve in saliva remarkably faster, within a few seconds (less than 60 seconds), and those are real fast-dissolving tablets. FDTs formulations contain super disintegrants to enhance the disintegration rate of a tablet in the buccal cavity. FDTs have advantages such as easy portability and manufacturing, accurate dosing, good chemical and physical stability and an ideal alternative for geriatric and pediatric patients. FDTs have disintegrated quickly, absorb faster so, in vitro drug release time improve and this property of drugs (dosage form) enhanced bioavailability. FDT formulations have the advantage of both conventional tablet formulation and liquid dosage form. There are several technologies that are conventional or patented based on spray drying, cotton candy process, sublimation, melt granulation, direct compression freezes drying/lyophilization, phase transition process, mass extrusion, etc. have been developed for manufacturing of FDTs. In this review contain brief information about FDTs including definition, advantages, needs or requirements of FDTs, salient features of FDTs, limitations, challenges to developing FDT, marketed formulations of fast dissolving tablets, etc.
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Lordi, Nicholas G., and Alberto M. Cuitino. "Compaction of Pharmaceuticals." MRS Bulletin 22, no. 12 (December 1997): 34–37. http://dx.doi.org/10.1557/s0883769400034722.
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It has been estimated that more than 80% of all medication doses are administered as tablets—that is, in unit dosage forms prepared by compacting powders in dies. For drugs with acceptable oral-absorption profiles, the compacted tablet is the first choice as a delivery system in drug development. Modern tablets range in size from 25 milligrams (veterinary implants) to several grams (veterinary “boluses”). The most common tablet shape is the double convex-faced disk. Shapes range from capsule to triangular forms, in many instances with bisects embossed or debossed with identification codes and company logos. Tablets may be either film- or sugar-coated, may be designed for immediate or extended release, or may be prepared as multilayer or laminated forms. In addition to oral administration, tablets may be predissolved or designed to be disintegrated in the mouth, or may be administered by injection or as suppositories. Production rates for over-the-counter products such as acetaminophen tablets can exceed three 1,000-kg batches per week, requiring high-speed multiple-station tablet presses for production. In contrast, implants—which have low-volume market requirements—must be made under aseptic conditions on special singlestation presses.
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Musumeci, Daniele, Chunhua Hu, and Michael Ward. "Fighting Counterfeit Drugs Using Micro-X-Ray Diffraction." Acta Crystallographica Section A Foundations and Advances 70, a1 (August 5, 2014): C1134. http://dx.doi.org/10.1107/s2053273314088652.
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A new protocol using micro-X-ray diffraction is developed to certify the authenticity of drug tablets, and therefore to prevent, deter, or detect counterfeit medicinal products. The method uses X-ray to map hidden patterns printed under the tablet coating and on packages. The patterns such as barcodes and logos are made of compounds approvoved by the Food and Drug Administration. The method is nondestructive, automated and user-friendly. The protocol relies on verification of phase, composition, and pattern readout in a single measurement, which reduces the risk of circumvention.
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Bhattacharya, Suhasis, Tanmay Mohanta, Sujit Das, and Rumpa Basak. "Orodispersible Tablet in Treatment of Migraine: Opportunities, Challenges and Recent Advancements." Journal of Drug Delivery and Therapeutics 11, no. 4 (July 15, 2021): 149–56. http://dx.doi.org/10.22270/jddt.v11i4.4878.
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The most comfortable and choicely path of drug administration is oral route. Orodispersible tablets bring a revolution among all routes of drug administration as well as oral route of drug administration also. Orodispersible tablets are unit dosage form but it has unique characteristics. It disintegrates in the mouth within a minute for the presence of saliva where the presence of super disintegrates in the preparation. Especially, old and child have no chance to swallow as a result it is very acceptable for them. Migraine is a very well-known irritating condition for adult and female. Migraine is a debilitating and common neurovascular illness associated with symptoms of one-sided headache, nausea with or without vomiting, photophobia and/or phonophobia. But these symptoms are subjective and vary from patient to patient. Orodispersible tablets are most important solution of migraine like emergency condition and helping human by transferring from hell to heaven. Very short half-life, quick disintegration, quick onset of action and better bioavailability brings the orodispersible tablets into the top position of the management of migraine. Sumatriptan, zolmitriptan like drugs are helping their hands to reduce migraine. Lastly, there are lots of drugs are investigating for this purpose and our hope that the orodispersible tablet can give the pioneer and will give the migraine free era to us and our futures.
Keywords: Orodispersible tablet, migraine, sumatriptan, super disintegrate, fast dissolving
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Shah, Suchi M., Anil P. Singh, and Parth K. Vachhani. "Drug price control order: the impact on pharmacoeconomics." International Journal of Basic & Clinical Pharmacology 8, no. 10 (September 25, 2019): 2220. http://dx.doi.org/10.18203/2319-2003.ijbcp20194259.
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Background: The objective of the present study was to analyze the prices of metformin, losartan, atorvastatin, paracetamol and aspirin for the doses which are included in the list of Drug Price Control Order (DPCO) 2013.Methods: Current index medical specialties India, 37th year, April-July 2015 issue was used for analysis. The retail prices of the drugs in INR were tabulated in Microsoft Office Excel 2013. The prices of the above listed drugs were compared with prices of DPCO 2013 for the same doses of drugs. The analysis of drugs costing more than the prices listed in the DPCO with the margin of the difference in percentage was carried out.Results: Out of 25 brands of metformin 500 mg tablet, 11 (44%) brands had price higher than listed in DPCO 2013. Similarly, prices for losartan 25 mg and 50 mg tablets, 8 (25%) out of 32 and 11 (31.42%) out of 35 were higher respectively. For atorvastatin 5 mg and 10 mg tablets, 2 (9.52%) out of 21 and 8 (13.55%) out of 59 brands had higher prices. For paracetamol 500 mg tablet, 12 (63.15%) out of 19 brands were priced higher than DPCO list. For aspirin 100 mg tablet and 325 mg tablet, 3 (100%) out of 3 brands and 1 (100%) out of 1 brand had higher prices.Conclusions: Many of the brand formulations have higher prices than the DPCO 2013 issued by government of India. The clinicians prescribing these drugs should be aware of these brand formulations to reduce the cost of the drug therapy.
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Kim, Ki Hyun, Minju Jun, and Mi-Kyung Lee. "Bioavailability of the Common Cold Medicines in Jellies for Oral Administration." Pharmaceutics 12, no. 11 (November 10, 2020): 1073. http://dx.doi.org/10.3390/pharmaceutics12111073.
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Jellies for oral administration have been suggested as alternative dosage forms to conventional tablets for improved palatability and compliances for pediatric and geriatric patients. To evaluate the effect of jelly formulation on the bioavailability of cold medicines, two types of jellies were prepared for a fixed-dose combination of acetaminophen (AAP), chlorpheniramine maleate (CPM), dextromethorphan hydrobromide (DMH), and dl-methylephedrine hydrochloride (MEH). Jelly-S and Jelly-H were fabricated using carrageenan and locust bean gum in the absence and presence of xanthan gum, respectively. In vitro dissolution and in vivo absorption of the four drugs in the jellies were compared with other conventional formulations, a syrup and two types of immediate-release (IR) tablets with different hardness, Tablet-S (15 kPa) and Tablet-H (20 kPa). All the formulations exhibited more than 80% dissolution rate within 2 h even though the syrup, Jelly-S, and Tablet-S showed higher 30-min dissolution compared to Jelly-H and Tablet-H. The dissolution rates from the jellies decreased with increasing pH, which resulted in the slowest dissolution in pH 6.8 compared to the syrup and IR tablets. When administered orally to beagle dogs, all five formulations were determined not to be bioequivalent. However, Jelly-S and Jelly-H showed 0.82–1.05 of the geometric mean ratios (GMRs) of AUC0-t for all four drugs compared to the syrup suggesting comparable absorption. In two IR tablets, GMRs of AUC0-t were in a range of 0.55–0.95 indicating a tendency of lower absorption than the syrup and jellies. In conclusion, jelly can be a patient-centered formulation with comparable bioavailability to syrup.
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Blatnik, Sandra Urek, Rok Dreu, and Stanko Srčič. "Influence of pH modifiers on the dissolution and stability of hydrochlorothiazide in the bi- and three-layer tablets." Acta Pharmaceutica 65, no. 4 (December 1, 2015): 383–97. http://dx.doi.org/10.1515/acph-2015-0031.
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Abstract During the past few years, the studies of bi- and multi-layered tablets increased due to the consumption of several different drugs per day by a patient and requests for appropriate patient compliance. The demographic shift toward older population increases the use of combination therapy as polypharmacy. Hydrochlorothiazide (HCTZ), as a model drug, is most commonly used in the treatment of hypertension, congestive heart failure and as a diuretic. The aim of the present study is to investigate the effect of the local environment on dissolution and stability behaviour of HCTZ in fixed multilayered tablet combinations, which are commonly used in polypharmacy. For this purposes, three different systems were introduced: (i) two conventional tablets (HCTZ and pH modifying placebo), (ii) 2-layer tablets (HCTZ, pH modifying placebo) and (iii) 3-layer tablets (HCTZ, barrier and pH modifying placebo). Disintegration of tablets, dissolution of HCTZ from tablets and HCTZ related substances were monitored for all systems. Results showed that there was a significant difference between dissolution profiles of the conventional two-tablet system (HCTZ tablet and pH modifying tablet) and the 2-layer and 3-layer tablets, which include the pH modifying layer. In the case of the conventional two-tablets system, 85 % of HCTZ was dissolved in less than 15 minutes. The dissolution profiles of HCTZ from 2-layered and 3-layered tablets showed a decrease in the dissolution rate. In addition, during the stability studies, it has been confirmed that the typical degradation product of HCTZ is formed, impurity B (4-amino-6-chloro-1,3-benzenedisulfonamide), which implies formation of formaldehyde as hydrolytic impurity not reported in the Ph. Eur. (16). Both impurities are particularly raised in 2-layered tablets with alkaline and neutral placebo layers. Stability of HCTZ was improved in the case of the 3-layer tablet, where the intermediate separation layer of glycerol monostearate was present. It is presumed that the HCTZ dissolution rate was decreased due to formation of non-soluble substances as a result of HCTZ degradation in the presence of alkaline layer.
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Mondal, Nita. "THE ROLE OF MATRIX TABLET IN DRUG DELIVERY SYSTEM." International Journal of Applied Pharmaceutics 10, no. 1 (January 6, 2018): 1. http://dx.doi.org/10.22159//ijap.2018v10i1.21935.
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Matrix tablet is an important tool for controlled and sustained release dosage forms. The oral route remains the most common route for the administration of drugs. Tablets offer the lowest cost approach to sustained and controlled release dosage forms. The hydrophilic polymer matrix is widely used in this dosage form. The use of different polymers in controlling the release of drugs has become the most important tool in the formulation of matrix tablets. The drug releases by both dissolution-controlled as well as diffusion-controlled mechanisms from the matrix. The development of oral controlled release systems has been a challenge to formulation scientists due to their inability to restrain and localize the system at targeted areas of the gastrointestinal tract. There are several advantages of matrix devices including improved patient compliance due to less frequent drug administration, reduction of fluctuation in steady-state drug levels, maximum utilization of the drug, increased safety margin of a potent drug. This review aims on the discussion of different materials used to prepare matrix tablets, different types of matrix tablets and the drug release mechanism from the matrices.
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Reddy M., Sunitha, and Lavanya Muppa. "A REVIEW OF CHALLENGES AND POSSIBILITIES OF BILAYER TABLET TECHNOLOGY." International Journal of Advanced Research 9, no. 08 (August 31, 2021): 676–81. http://dx.doi.org/10.21474/ijar01/13315.
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Bilayer tablet making process involves certain challenges as well as advantages. Bilayer tablets are the prescriptions which comprise of two same or various medications consolidated in a solitary portion for viable treatment of the illness. Persistent consistence and cost measure are two significant boundaries in treatments. Bilayer tablets manage these focuses adequately. To deliver a decent quality bi-layer tablet, the apparatus should be built according to GMP. Different hardware are accessible to beat normal bi-layer issues, for example, layer detachment, lacking hardness, weight control, cross defilement between the layers and so forth. Bilayer tablets give one of the significant plan approaches where inconsistent medications, with an alternate sign, and same medication with various delivery rate can be combined in a solid unit. Bilayer tablet is reasonable for consecutive arrival of two medications in blend, and for supported delivery tablets in which one layer is promptly delivered as introductory portion and the subsequent layer is a controlled portion. Controlled delivery dose structures have been broadly used to improve treatment with a few significant medications. Utilization of bilayer tablet is an altogether different viewpoint for calming and pain relieving drugs. This review article clarifies what are the outcomes to be looked and how to be faced during bilayer tablet production.
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RADA, SANTOSH KUMAR, and T. Naga Satya Yagnesh. "OPTIMISATION OF STARCH OXALATE AS A NOVEL SUPERDISINTEGRANT IN FAST DISSOLVING SYSTEMS OF POORLY SOLUBLE DRUGS." Journal of Drug Delivery and Therapeutics 9, no. 1-s (February 15, 2019): 185–95. http://dx.doi.org/10.22270/jddt.v9i1-s.2385.
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Objective: To enhance the solubility of poorly soluble drugs by using 23 factorial design in the formulation of fast dissolving tablets by employing starch oxalate as a superdisintegrant.
Methods: Starch oxalate was synthesized by gelatinization process. The physical and micromeritic properties were performed to evaluate the synthesized starch oxalate. By using 23 factorial design, atenolol fast dissolving tablet was prepared by employing starch oxalate as a superdisintegrant in different proportions in each case by direct compression method. In the evaluation of fast dissolving tablets the drug content, hardness, friability, disintegration time and other dissolution characteristics were utilized.
Results: The starch oxalate prepared was found to be fine, free-flowing completely amorphous powder. The compatibility between atenolol and starch oxalate were studied and showed no interaction. The drug content, hardness, and friability have been effective with regard to all the formulated fast dissolving tablets employing starch oxalate. The optimised formulation F8 has the least disintegration time i.e., 24±0.06s. The In–vitro wetting time was less (i.e., 28s) in optimized formulation F8. The water absorption ratio of the formulated tablets was found to be more in F8 formulation 94.42±0.18%. The cumulative drug dissolved in the optimized formulation F8 was found to be 98.70±0.24% in 5 min.
Conclusion: The dissolution efficiency of atenolol was enhanced when starch oxalate was found to be a superdisintegrant when combined with sodium starch glycolate, crospovidone and, hence to provide immediate release of the formulated fast dissolving tablets contained drug it could be used.
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Peters, I. O. M., A. Willemsen, J. J. de Bruyne, and R. C. Nap. "Aspirin Medication in Dogs." Veterinary and Comparative Orthopaedics and Traumatology 4, no. 03 (1991): 95–99. http://dx.doi.org/10.1055/s-0038-1633260.
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SummaryAspirin (acetylsalicylic acid; ASA) is widely used in both human and veterinary medicine. Therapeutic plasma salicylate concentrations (PSCs) can be reached using enteric-coated ASA tablets, but a delay in the initial rise and large fluctuations in the PSCs have been reported. From experiments described previously, the authors concluded that the large type enteric-coated ASA tablets were not suitable for use in beagle dogs.In the first experiment described here, these large type tablets were administered to large mongrel dogs. Although the mean PSC reached therapeutic levels after 44 h, in individual dogs subtherapeutic concentrations were frequently recorded. In the second experiment microgranulated type enteric-coated ASA tablets were given to beagle dogs in a crossover design study. PSCs in all dogs exceeded minimal therapeutic levels 6 h after tablet administration. Stable therapeutic PSCs were found in both groups on different feeding regimens. In the third experiment the two types of enteric-coated ASA tablets were administered to fasting beagles. Comparable therapeutic PSCs were reached with both formulations.From the present studies it can be concluded that the large type enteric-coated ASA tablet is not suitable for use in large mongrel dogs. Secondly, it can be concluded that the microgranulated type enteric-coated ASA tablet is suitable for the use in beagle dogs. In the third experiment it was proven that fasting eliminated the differences in mean PSC curves between the two types of ASA medication.On the basis of canine gastric physiology the authors expect similar types of large enteric-coated tablets of other drugs to generate comparably poor plasma concentrations. The gastric evacuation of tablets is primarily related to the tablet dimensions and digestibility, and not to the drug contained by these tablets.
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S., Aher Smita, Saudagar R. B., and Shinde Mayuri S. "REVIEW: FAST DISSOLVING TABLET." International Journal of Current Pharmaceutical Research 10, no. 2 (March 15, 2018): 5. http://dx.doi.org/10.22159/ijcpr.2018v10i2.25876.
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Fast dissolving tablets is one of the most widely accepted dosage forms and also most popular dosage form, especially for pediatric patients because of incomplete development of the muscular and nervous system and a case of geriatric patients suffering from Parkinson’s disorder or hand tremors. Some solid dosage forms like tablets and capsules are present days facing the problems like difficulty in swallowing (dysphagia), resulting in many incidences of non-compliance and making the therapy ineffective. Oral dosage form and oral route are the most preferred route of administration for various drugs have limitations like the first-pass metabolism. Fast dissolving tablets are one of them. FDT have benefits such as accurate dosing, easy portability and manufacturing, good physical and chemical stability and an ideal alternative for pediatric and geriatric patients. Some tablets are designed to dissolve fastly in saliva, within a few seconds, and are true fast-dissolving tablets. Others contain agents to enhance the rate of tablet disintegration in the oral cavity and are more appropriately termed fast-disintegrating tablets, as they may take up to a minute to completely disintegrate.
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Schykovskiy, O. E., and Т. V. Кrutskikh. "Pharmaceutical development with commercialization of generic drugs with poor soluble substance – tablets of drug nimodipine." Farmatsevtychnyi zhurnal, no. 3-4 (August 14, 2018): 60–70. http://dx.doi.org/10.32352/0367-3057.3-4.17.07.
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The pharmaceutical development of solid dosage forms which containing a poor soluble substance deserves special attention, because a composition and a technology of production such drugs directly effects on release the active pharmaceutical ingredient in the human body and, as a consequence, on pharmacological effectiveness of this drug. The search of therapeutically effective, economically viable and industrially reproducible technology for the production of such drugs is very important for the pharmaceutical industry.
The purpose of our work was the pharmaceutical development of the generic drug, which contains a poor soluble in water substance nimodipine. The subject of the research is the substance nimodipine and the samples of tablets obtained with the help of various technological methods from this substance. All analytical and pharmaco-technological researches were implemented according to generally accepted methods that accordance with the requirements of the State Pharmacopoeia of Ukraine.
Laboratory batches were developed using technological methods of physical modification of a substance, such as: micronization, sonocrystalllization, solid dispersion by melting, solid dispersion by solvent evaporation, complexation with β-cyclodextrins. Researches of the comparative in vitro dissolution kinetics of substance nimodipin from these laboratory batches made it possible to establish optimal technology for the commercial production of a generic drug. Researches on influence quantity of disintegrant and lubricant in the composition of tablets on the pharmacopoeial parameters of the quality were done.
According to the results of the pharmaceutical development, it can be argued that the use of the technological method for production a solid dispersion with the aid of a solvent is most appropriate for the production of tablets of a generic drug with a substance nimodipine, which is confirmed by the results of the comparative in vitro dissolution kinetics in three media and clinical trials. The required quantity of disintegrat (not less than 2.5% per tablet) and lubricant (not less than 0.4% per tablet) in the composition of generic tablets were defined.
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Katsiotis, Christos S., Michelle Åhlén, Maria Strømme, and Ken Welch. "3D-Printed Mesoporous Carrier System for Delivery of Poorly Soluble Drugs." Pharmaceutics 13, no. 7 (July 18, 2021): 1096. http://dx.doi.org/10.3390/pharmaceutics13071096.
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Fused deposition modelling (FDM) is the most extensively employed 3D-printing technique used in pharmaceutical applications, and offers fast and facile formulation development of personalized dosage forms. In the present study, mesoporous materials were incorporated into a thermoplastic filament produced via hot-melt extrusion and used to produce oral dosage forms via FDM. Mesoporous materials are known to be highly effective for the amorphization and stabilization of poorly soluble drugs, and were therefore studied in order to determine their ability to enhance the drug-release properties in 3D-printed tablets. Celecoxib was selected as the model poorly soluble drug, and was loaded into mesoporous silica (MCM-41) or mesoporous magnesium carbonate. In vitro drug release tests showed that the printed tablets produced up to 3.6 and 1.5 times higher drug concentrations, and up to 4.4 and 1.9 times higher release percentages, compared to the crystalline drug or the corresponding plain drug-loaded mesoporous materials, respectively. This novel approach utilizing drug-loaded mesoporous materials in a printed tablet via FDM shows great promise in achieving personalized oral dosage forms for poorly soluble drugs.
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Kenyon, Allen S., Paul E. Flinn, and Thomas P. Layloff. "Rapid Screening of Pharmaceuticals by Thin-Layer Chromatography: Analysis of Essential Drugs by Visual Methods." Journal of AOAC INTERNATIONAL 78, no. 1 (January 1, 1995): 41–49. http://dx.doi.org/10.1093/jaoac/78.1.41.
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Abstract A method for rapidly screening pharmaceuticals by thin-layer chromatography has been designed for use in areas with limited resources and by operators with limited training. An apparatus for performing the analysis in a plastic bag under equilibrium conditions was designed. Results can be reproduced by different operators and in different locations. The analysis can be performed without electricity or in a remote area, away from a laboratory. It is especially suited for field use in developing countries. The method is low cost, maintenance-free, fast, and reliable; it also uses limited volumes of solvents. The analyses can be performed without weighing if reference materials can be supplied in tablet form, provided the drug content is listed and only one unit is required for each analysis. All procedures were developed for the analysis of drugs from a partial list of essential drugs established by the World Health Organization. Three drugs were selected and prepared in the form of reference tablets. Comparisons with the analyses of the drugs in standard dosage forms were made by using reference tablets and primary USP standards. Comparable results were obtained, proving that the screening process can be conducted by using reference tablets and without weighing either the sample or the reference. The method has been successfully demonstrated and used in Swaziland, by high school teachers in the United States, and by personnel from the Ministry of Health in Saudi Arabia. Personnel can be trained in a short time to perform screening analysis of drugs.
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Rao, Y. Madhusudan, N. Doodipala, C. R. Palem, and S. Reddy. "Pharmaceutical Development and Clinical Pharmacokinetic Evaluation of Gastroretentive Floating Matrix Tablets of Levofloxacin." International Journal of Pharmaceutical Sciences and Nanotechnology 4, no. 3 (November 30, 2011): 1463–70. http://dx.doi.org/10.37285/ijpsn.2011.4.3.4.
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The most common approach for achieving sustained drug release is by the use of hydrophilic polymeric excipients directly compressed with active ingredients into tablets. Hydrophilic polymers swell in the presence of water to form hydrogel structures from which drugs are released by slow diffusion. The purpose of this study was to prepare a floating drug delivery system of levofloxacin, a fluoroquinolone antibiotic. Levofloxacin is highly soluble in acidic media and precipitates in alkaline media, thereby losing its solubility. We designed a gastroretentive system of levofloxacin to enhance bioavailability by retaining them in the acidic environment of the stomach. Tablets were prepared by the direct compression technique using polymers such as hydroxypropyl- methylcellulose (HPMC K4M, HPMC K15M, and HPMC K100M). Sodium bicarbonate was utilized as a gas-generating agent. Tables were evaluated for their physical characteristics such as hardness, thickness, friability, weight variation, drug content, swelling studies, and floating properties. Tablet formulations were evaluated by in vitro dissolution studies. Formulations showed a floating lag time of 30 seconds and a floating time above 12 hours. Among these formulations F3, F7 and F11 exhibited controlled and prolonged drug release profiles while floating over the dissolution medium. The best formulation (F3) was selected based on in vitro characteristics and further tested in healthy volunteers by radiographic studies of tablets by incorporating BaSO4. These clinical studies revealed that the tablets remained in the stomach for 240 ± 30 minutes in fasting human volunteers, indicating gastric retention of the system.
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Domanina, A. M., M. V. Chernikov, I. P. Remezova, E. F. Stepanova, A. M. Shevchenko, and A. V. Morozov. "Preparation of 2-phenyl-9-diethylaminoethylimidazo[1,2-α]benzimidazole dinitrate tablets and development of quality control methods." Drug development & registration 10, no. 2 (May 29, 2021): 62–67. http://dx.doi.org/10.33380/2305-2066-2021-10-2-62-67.
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Introduction. Currently, for the treatment of gastric ulcer, drugs with a combined effect are used. To eliminate possible side effects of the drugs used, the search for new molecules to create more effective and safe histamine H2 receptors continues. As a possible solution to these problems, we investigated the substance dinitrate of 2-phenyl-9-diethylaminoethylimidazo[1,2-α]benzimidazole (DFDB).Aim. The aim of this study was to obtain 2-phenyl-9-diethylaminoethylimidazo[1,2-α]benzimidazole dinitrate tablets and develop methods for quality control.Materials and methods. The object of study was tablets based on the substance DF DB. The physicochemical and technological properties of the tablet dosage form were studied. Pharmaco-technological and physico-chemical indicators were determined according to the methods of the State Pharmacopoeia of the XIV edition. Identification and quantitative determination of DFDB in tablets was performed by HPLC.Results and discussion. Based on the physico-chemical properties and determination of the main technological indicators of DFDB, an optimal tableting technology has been developed. The optimal composition of tablets has been developed. Identification of tablets is proposed to be carried out using HPLC in comparison with the standard sample of DFDB. Related impurities, according to the data obtained, do not exceed 0.1 %. We found that the tablets do not have an antimicrobial effect. The analyzed tablets correspond to category 3A. The content of DFDB should be from 95 to 105 % of the declared amount in one tablet. During the analysis, we conducted biopharmaceutical and technological studies of the finished dosage form during storage under the conditions of long-term stability testing in polymer cans with screw-on lids. It is shown that the selected composition of excipients and the production technology ensure the stability of the finished dosage form for two years of storage under the observed conditions. To select the tableting technology, the main technological properties of the DFDB substance are analyzed. The choice of excipients and the composition of the film coating was carried out.Conclusion. The technology is developed and standardization of tablets based on the substance DFDB is proposed.
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Sonare, Makrand A., and Manoj Kumar Samantaray. "Pharmaceutical evaluation of Haridra Khanda tablet." Journal of Ayurveda and Integrated Medical Sciences (JAIMS) 5, no. 05 (October 25, 2020): 175–78. http://dx.doi.org/10.21760/jaims.5.5.24.
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Haridra Khanda is unique classical formulation indicated in Udarda, Shitapitta, Kotha. (Urticarial rashes) Khanda or Granules are a comparatively unusual means of administering drugs that possess an unpleasant taste. Haridra Khanda is classical Ayurvedic medicine and available market. Keeping the issue of palatability and invention of patient friendly dosage form in mind, the efforts was made for preparation of tablet out of classical Ayurvedic formulation - Haridra Khanda. The preparation of Haridra Khanda granules were made by standard operative procedure.Binding agents were added to Haridra Khanda . Haridra Khanda was added to mass mixer to ensure homogeneity and easy mixing of all binding agents. And later this mixture was subjected to single punch tablet machine for preparation of 1000 mg tablet. All the Analytical parameters were passed by the Haridra Khanda tablets. Physician can prescribed the tablets to the patients which feel the powdered dosage uncomfortable. Depending on the Roga and Rogibala, tablets of various sizes can be punched and used clinically. This can work more efficiently in pediatric practice.
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Kumar Pal, Manish, and Ganesh Deshmukh. "DESIGN AND CHARACTERIZATION OF CHLORZOXAZONE FLOATING BIOADHESIVE DRUG DELIVERY SYSTEM." Asian Journal of Pharmaceutical and Clinical Research 11, no. 11 (November 7, 2018): 222. http://dx.doi.org/10.22159/ajpcr.2018.v11i11.27693.
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Objective: The objective of the work is to formulate chlorzoxazone floating bioadhesive tablets which will significantly improve the bioavailability of drugs under the condition of prolonged use of drugs and reduce the total dosage of administered drug and reduce the side effect.Methods: Floating bioadhesive tablet was prepared by direct compression of polymer such as HPMCK4M and Carbopol934p in combination.Result: After analysis of different evaluation parameter and drug release, F9 batch was selected as promising formulation for delivery of chlorzoxazone floating bioadhesive tablets with 92.1% drug release at 12th h.Conclusion: It was observed that the combination of polymers in 22.5% (HPMCK4M) and 12.5% (Carbopol 934p) give the best drug release and sustain the drug release for 12 h. Among the other batches, F9 batch was selected as an optimized batch because the pre- and post-compression parameters results are satisfactory.
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Thoma, K., and T. Zimmer. "Retardation of weakly basic drugs with diffusion tablets." International Journal of Pharmaceutics 58, no. 3 (February 1990): 197–202. http://dx.doi.org/10.1016/0378-5173(90)90195-a.
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Signori, Alessio, Francesco Saccà, Roberta Lanzillo, Giorgia Teresa Maniscalco, Elisabetta Signoriello, Anna Maria Repice, Pietro Annovazzi, et al. "Cladribine vs other drugs in MS." Neurology - Neuroimmunology Neuroinflammation 7, no. 6 (August 14, 2020): e878. http://dx.doi.org/10.1212/nxi.0000000000000878.
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ObjectiveCladribine tablets were tested against placebo in randomized controlled trials (RCTs). In this study, the effectiveness of cladribine vs other approved drugs in patients with relapsing-remitting MS (RRMS) was compared by matching RCT to observational data.MethodsData from the pivotal trial assessing cladribine tablets vs placebo (CLARITY) were propensity score matched to data from the Italian multicenter database i-MuST. This database included 3,150 patients diagnosed between 2010 and 2018 at 24 Italian MS centers who started a disease-modifying drug. The annualized relapse rate (ARR) over 2 years from treatment start and the 24-week confirmed disability progression were compared between patients treated with cladribine and other approved drugs (interferon, glatiramer acetate, fingolimod, natalizumab, and dimethyl fumarate), with comparisons with placebo as a reference. Treatment effects were estimated by the inverse probability weighting negative binomial regression model for ARR and Cox model for disability progression. The treatment effect has also been evaluated according to baseline disease activity.ResultsAll weighted baseline characteristics were well balanced between groups. All drugs tested had an effect vs placebo close to that detected in the RCT. Patients treated with cladribine had a significantly lower ARR compared with interferon (relapse ratio [RR] = 0.48; p < 0.001), glatiramer acetate (RR = 0.49; p < 0.001), and dimethyl fumarate (RR = 0.6; p = 0.001); a similar ARR to that with fingolimod (RR = 0.74; p = 0.24); and a significantly higher ARR than natalizumab (RR = 2.13; p = 0.014), confirming results obtained by indirect treatment comparisons from RCTs (network meta-analyses). The relative effect of cladribine tablets 10 mg (cumulative dose 3.5 mg/kg over 2 years) was higher in patients with high disease activity vs all treatments except fingolimod and natalizumab. Effects on disability progression were largely nonsignificant, probably due to lack of power for such analysis.ConclusionIn patients with RRMS, cladribine tablets showed lower ARR compared with matched patients who started interferon, glatiramer acetate, or dimethyl fumarate; was similar to fingolimod; and was higher than natalizumab. The beneficial effect of cladribine tablets was generally amplified in the subgroup of patients with high disease activity.Classification of evidenceThis study provides Class III evidence that for patients with RRMS, cladribine-treated patients had lower ARR compared with interferon, glatiramer acetate, or dimethyl fumarate; similar ARR compared with fingolimod; and higher ARR compared with natalizumab.
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CHOURASIYA, ANJALI, NARENDRA GEHALOT, and SURESH CHANDRA MAHAJAN. "A REVIEW ON AN EMERGIN TREND BILAYER FLOATING DRUG DELIVERY SYSTEM." Current Research in Pharmaceutical Sciences 11, no. 2 (July 8, 2021): 44–49. http://dx.doi.org/10.24092/crps.2021.110201.
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NDDS is advanced drug delivery system which improves drug potency, control drug release to give a sustained therapeutic effect, provide greater safety, finally it is to target a drug specifically to a desired tissue. Novel drug delivery system have been developed to overcome the limitation of conventional drug delivery systems, such as of gastric retention by decreasing fluctuations in the concentration of the drug in blood,resulting in the reduction in unwanted toxicity and poor efficiency. As compared to traditional dosage forms bilayer tablets are more efficient for sequential release of two drugs that can be different or identical. Bilayer tablet is also capable of separating two incompatible substances and also for sustained release. Gastro retentive drug delivery system retains the period of dosage forms in the stomach or upper gastro intes-tinal tract ,as to improve bioavailability and the therapeutic efficacy of the drugs. Mainly the bilayer drug delivery system is suitable for drugs whose therapethic windows are narrow in the gastrointestinal tract (GIT) and also they have low elimination half life: 3-4 h. The purpose of this review is to disclose the challenges faced during the formulation of bilayer tablets. Finally, the whole article is firmly analyzed in a concluding paragraph. KEYWORDS: Conventional drug delivery systems, Bilayer tablet, Gastro retentive, Bioavailability
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Pundir, Sarika, and Ashutosh Badola. "Formulation and Evaluation of Atenolol and Indapamide SR Matrix Tablets for Treatment of Hypertension." International Journal of Pharmaceutical Sciences and Nanotechnology 7, no. 2 (May 31, 2014): 2450–58. http://dx.doi.org/10.37285/ijpsn.2014.7.2.7.
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In the present study we have formulated (F1 to F6) matrix tablets of atenolol and indapamide for the management of hypertension. As in simultaneous estimation of these drugs it was found that a confined release can be formulated. In the formulation of SR matrix tablet by using different concentration of delayed release agent DCP and pregelatinized starch as disintegrant we prepared tablets by wet granulation method. For sustained release action HPMC polymers were used for film coating. Preformulation studies were performed prior to compression. The compressed SR matrix tablets were evaluated for weight variation, hardness, friability, drug content, disintegration time and in vitro drug release using USP dissolution apparatus type 2 (paddle). It was found that the optimized formulation showed 49.33%, 48.90%, 48.52%, 47.65%, 46.84% and 46.51% release for atenolol in 12 hours respectively. However, indapamide released 49.62%, 49.39%, 48.72%, 48.27%, 47.59% and 47.36% at the end of 12 hr. The IR spectrum study revealed that there is no disturbance in the principal peaks of pure drugs atenolol and indapamide. This confirms the integrity of pure drugs and no incompatibility of them with excipients. The stability studies were carried out for the optimized batch for one months and it showed satisfactory results. The kinetic studies of the formulations revealed that diffusion is the predominant mechanism of drug and release follows Zero-order, Super case II transport.
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Kumar, Vishal, Attish Bhardwaj, Navdeep Singh, Kamya Goyal, and Shammy Jindal. "A Review on Tablet Dosage Form: Recent Advancements with Special Emphasis on Rapid Disintegrating Tablet." Asian Journal of Research in Pharmaceutical Sciences 11, no. 3 (August 14, 2021): 237–46. http://dx.doi.org/10.52711/2231-5659.2021.00038.
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Tablets are the most commonly prescribed dosage form as offer a convenient form of drug administration provides dosage uniformity from tablet to tablet, stable over extended and diverse storage conditions, can be produced on high-speed compression, labelling, and packaging equipment. Advancements in technology and modification in standard compressed tablet are to achieve better acceptability as well as bioavailability. Various types of newer and more efficient tablets are developed to create a delivery system that is relatively simple to administration. In one sense osmotic pump systems are another type of membrane-controlled release drug delivery system and work in the following way. Drug is incorporated in a tablet core which is water soluble, and which will solubilize or suspend the drug in the presence of water. Also, a multi-layer tablet dosage form over a more conventional mono-layer tablet is useful. In FDDS Gastro retentive dosage form improves bioavailability, therapeutic efficacy and allows a reduction in the dose because of steady therapeutic levels of drug. The another system is MADDS Mucoadhesion is commonly used to describe an interaction between the mucin layer, which lines the entire GI tract, and a bio adhesive polymer, which could be natural or synthetic in origin. An ideal controlled drug delivery system is one which delivers the drugs at a predetermined rate, locally or systematically, for a specified period of time and an ideal targeted drug delivery system is the one which delivers the drugs only to its sites of action and not to the non-targeted organs or tissues. So, in this review article we will study the basic fundamentals of tablets their technologies, and types of systems with available marketed products of various dosage forms.
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Pingale, Prashant L. "FORMULATION, CHARACTERIZATION AND IN-VITRO DISSOLUTION STUDIES OF METADOXINE TABLETS PREPARED BY VARIOUS GRANULATION METHODS." Journal of Medical pharmaceutical and allied sciences 10, no. 2 (May 15, 2021): 2712–19. http://dx.doi.org/10.22270/jmpas.v10i2.1066.
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Pharmaceutical tablets are robust, flat, or biconvex dishes, according to the Indian Pharmacopoeia. Depending on a range of medicinal substances, they vary in shape and differ greatly in size and weight. In the era of increasing health awareness and strict standards set by regulatory authorities such as the US FDA, WHO, and globalization, it has become mandatory for the producer to launch a product cost-effectively. In the tablet dosage form, two classes of drugs are administered orally. Narrow extensions of the parietal peritoneum that suspend the diaphragm's liver are the right and left coronary ligaments. To produce an effective and reliable product, the drug must have a fine particle size and a large surface area. The tablet coating takes place inside a perforated rotating drum in a controlled atmosphere. Tablets are lifted and turned into the center of the drum from the sides. To make the tablet surface easier to swallow, every tablet surface is exposed to an even amount of deposited/sprayed coating. The purpose of the present investigation is to formulate a tablet of Metadoxine, which improves cognitive impairment and the main psychological symptoms due to occasional or prolonged alcohol abuse, such as aggressiveness, agitation, mood, and behavioral disturbances. The tablets were prepared using direct compression, dry granulation, and wet granulation method and a comparison of the same with an innovator’s product. Keywords: Tablets, Metadoxine, Dry granulation, direct compression, wet granulation.
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Stamate, Monica Cretan, Carmen Gafitanu, Ciprian Stamate, and Eliza Gafitanu. "The Characterization of Ketoprofen-Hydroxypropyl–β-Cyclodextrin Complex with Modified Drugs Release Properties." Solid State Phenomena 188 (May 2012): 70–75. http://dx.doi.org/10.4028/www.scientific.net/ssp.188.70.
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Since, anti-inflamatory drugs have a high demand due to increased incidence of pain associated with different pathology; the objectives of this paper are the synthesis, the physicochemical characterization and analysis of the tribological properties for the ketoprofen-cyclodextrin complexes. The analysis of solubility for these complexes was carried out using MathCAD software. Tribological factors were evaluated by the wear resistance of cylindrical tablets containing ketoprofen-cyclodextrin complex, methocel and magnesium stearate. The tablets with ketoprofen-cyclodextrin complexes provide good solubility and wear resistance and these are ideal for preparation of extended release systems like implantable tablets or for orally administration tablets.
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Nair, Manju K., and Neha M. S. "Cost variation analysis of antihypertensive drugs acting through renin angiotensin aldosterone axis modulation." International Journal of Basic & Clinical Pharmacology 6, no. 5 (April 24, 2017): 1085. http://dx.doi.org/10.18203/2319-2003.ijbcp20171500.
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Background: Several brands of antihypertensive drugs are available in the Indian market with huge price variations. This study was undertaken to find out the percentage cost variation and cost ratio of antihypertensive drugs acting through renin angiotensin aldosterone axis modulation.Methods: Costs of different brands of renin angiotensin aldosterone axis modulatory drugs with antihypertensive action for the same dosage form and strength were found out using current index of medical specialties-134, July-October 2016. The maximum and minimum price of different brands of each drug was noted. Data was entered in Microsoft excel 2010. Percentage cost variation and cost ratio was calculated for each drug.Results: 16 antihypertensive drugs were analysed. Most of them were tablets. Ramipril and Valsartan were available as capsules also. Among tablets, percentage cost variation was highest for Atenolol 12.5 mg (683.93%) and least for Bisoprolol 2.5 mg (3.6538%). Valsartan capsules (160 mg) had no difference in the costs between the available 2 brands. Cost ratio ranged from 1.04 to 7.84 among the tablet form of drugs.Conclusions: There is a huge difference in the cost of antihypertensive drugs manufactured by different companies in the same strength and dosage form. To promote rational drug use and cost effective therapy, it is essential to create an awareness among clinicians regarding the availability of multiple brands for these drugs and the discrepancies in their costs.
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Saini, Seema, and Rajeev Garg. "Design expert assisted mathematical optimization of solubility and study of fast disintegrating tablets of Lercanidipine Hydrochloride." Journal of Drug Delivery and Therapeutics 9, no. 1-s (February 15, 2019): 172–80. http://dx.doi.org/10.22270/jddt.v9i1-s.2406.
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90% of drugs being researched today, posses poor solubility setback which inturn renders the drug with slower rate of absorption from the buccal route; hence dissolution is the rate limiting step for such lipophilic drugs. So, there is a need to keep a check on the dissolution profile of these drugs to ensure maximum therapeutic utilization. The dissolution rate therefore becomes a primary factor which governs the rate and extent of its absorption. Enormous work is being performed in the field of enhancement of solubility and dissolution behaviour of such drugs. Advancements and innovations have developed solid dispersion (SD) technique as the novel method for the solubility enhancement. Precision of dosing and patient's compliance is a crucial prerequisite for the management of chronic Antihypertensive treatment, So there arised a need to formulate a system which should resolve the difficulties associated with conventional tablets. This issue can be better tackled with the formulation of orally fast disintegrating tablets. The aim of the present study was to improve the solubility and dissolution rate of Lercanidipine hydrochloride (LRH) by formulating a solid dispersion with Polyvinyl pyrollidine (PVP-K30) and Guargum. Full Factorial designs are exploited to learn and research the effects of different variables on the quality determinant parameters. An appropriate statistical model was selected for the scrutiny of the enhanced dissolution pattern. Finally, these solid dispersions were incorporated into fast disintegrating tablets.
Keywords: Lercanidipine Hydrochloride, Solid dispersion, Statistical design approach, Melt fusion method, Fast disintegrating tablet, In vivo studies
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Molavi, Fatima, Hamed Hamishehkar, and Ali Nokhodchi. "Impact of Tablet Shape on Drug Dissolution Rate Through Immediate Released Tablets." Advanced Pharmaceutical Bulletin 10, no. 4 (August 9, 2020): 656–61. http://dx.doi.org/10.34172/apb.2020.079.
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Purpose : The aim of this study was to evaluate the influence of the geometric shape on the dissolution rate of the domperidone, a drug model for immediate release dosage form. In this regard, a lack of sufficient information about the effective dissolution rate of the drugs regarding their shapes has made this issue an interesting subject for researchers. Methods: For this purpose, three tablet shapes, namely flat and biconvex both in a round and oblong shapes, with different four sizes were modelled for the preparation of domperidone tablet. In vitro dissolution test was accomplished using a USP dissolution apparatus II. The drug dissolution rate was assessed by calculating various dissolution parameters; e.g., dissolution efficiency (DE), mean dissolution rate (MDR), mean dissolution time (MDT), and difference and similarity factors (f1 and f2 ). Results: Regarding the disintegration time, the larger tablets showed a faster disintegration time. When the size of the tablets was smaller, the amount of released drug was significantly decreased. In addition, #9 tablets with a flat or biconvex geometry had obvious effects on the DE values. Generally, biconvex tablets had higher DE percentage than the flat tablets. Conclusion: Noticeable differences in dissolution parameters by considering the different geometric shapes play an important role in the drug release kinetics which makes a significant effect on quick onset of action in oral administration.
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Chatap, V. K., and Deshbandhu Joshi. "Recent Advanced of Multiple Unite Pellet System (MUPS) Technology in Formulation of Pharmaceutical Products: A Review." International Journal of Contemporary Research and Review 9, no. 10 (December 29, 2020): 20202–14. http://dx.doi.org/10.15520/ijcrr.v9i10.879.
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The oral route of drug administration is the most important and most user-friendly route of administration. In recent years, Multiple Unit Pellet Systems (MUPS) tablets are widely used in solid dosage form design. MUPS is considered to provide pharmacokinetic advantages compared to monolithic dosage forms. Combination of drug substances and release profiles can be provided by formulating the MUPS tablets with different pellet qualities or combining pellets with drugs in powder or granulated form. MUPS tablet contains several hundred of coated pellets of active pharmaceutical ingredients which delivered the drug at predetermined rate and absorption to provide constant blood profile. MUPS are easily administered as disintegratable tablet which disperse into their subunits across the stomach and the small intestine, leading to predictable oral transition and constant bioavailability.
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Khan, Azhar Danish. "COMPARATIVE QUALITY EVALUATION OF TWO BRANDS OF PARACETAMOL TABLETS OBTAINED FROM THE MARKET." INTERNATIONAL JOURNAL OF PHARMACEUTICAL EDUCATION AND RESEARCH (IJPER) 1, no. 1 (April 8, 2019): 14–18. http://dx.doi.org/10.37021/ijper.v1i1.14.
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Introduction: Paracetamol tablets are very common over the counter (OTC) products among the patients as a good analgesics s. It is the drug of choice in patients that cannot be treated with non-steroidal anti-inflammatory drugs (NSAID), such as people with bronchial asthma, peptic ulcer disease, hemophilia, salicylate-sensitized people and children under 12 years of age, pregnant or breastfeeding women. Objective: The objective of this study was to compare the quality of the paracetamol tablet formulations those are locally available in India pharmaceutical market manufactured by various pharmaceutical companies with pharmacopeia standards. Materials and Methods: The two popular brands (A & B) of paracetamol conventional tablet of 500 mg strength were chosen. The paracetamol tablets were obtained from the local medical shops. To compare the quality of tablet formulations of different brands various official parameters like friability, hardness, weight variation, disintegration time and dissolution were performed as per the standards mentioned in pharmacopoeia. Result and Conclusion: The result of all these parameters of different brands was in the Pharmacopoeial limits so it could be concluded that marketed pharmaceutical tablets of paracetamol of these brands are safe, effective and efficacious.
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Shani, Jashovam, Shimon Benita, Muhamed Abdulrazik, and Aharon Yerushalmi. "Efficacy of Sustained-Release Radioprotective Drugs in vivo." Zeitschrift für Naturforschung C 42, no. 11-12 (December 1, 1987): 1323–27. http://dx.doi.org/10.1515/znc-1987-11-1229.
Full textAbstract:
In previous publications from this laboratory we suggested the use of radioprotective drugs in a sustained-release form as a practical way to cope with their high toxicity and quick metabolism and excretion. Cysteine and cysteamine, well-established radioprotectants, were used as model drugs and compressed at various concentrations (0-65%) into an insoluble tablet matrix, composed of ethylcellulose and stearic acid at various ratios and compression pressures. We demonstrated in vitro that when the release rate of the radioprotectants was measured under nitrogen, the kinetic data conformed with the Higuchi square root of time equation, indicating that the release of both drugs correlates with Higuchi’s diffusional mechanism. In the present in vivo study, tablets containing cysteine or cysteamine in a slow-release matrix were implanted, into the stomachs of female rats. The rats were irradiated at various time intervals up to 12 h after implantation and their survival recorded daily. Utilizing a 1:3 ratio of ethylcellulose: stearic acid as a matrix, the protective effect of the drugs was remarkable eight hours after tablet implantation. The results reported indicate that slow-release tablet formulation is a possible method for delivering of radioprotective drugs over an extended period of time.
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Pundir, Sarika, and Ashutosh Badola. "Formulation and Evaluation of Atenolol and Indapamide SR Matrix Tablet for Treatment of Hypertension." International Journal of Pharmaceutical and Life Sciences 2, no. 4 (November 24, 2013): 141–57. http://dx.doi.org/10.3329/ijpls.v2i4.17114.
Full textAbstract:
In the present study we have formulated (f1 to f6) matrix tablets of Atenolol and Indapamide for the management of hypertension. As in simultaneous estimation of these drugs it was found that a confined release can be formulated. In the formulation of SR matrix tablet by using different concentration of delayed release agent DCP and pregelatinised starch as disintegrant we prepared tablets by wet granulation method. For sustained release action HPMC polymers were used for film coating. Preformulation studies were performed prior to compression. The compressed SR matrix tablets were evaluated for weight variation, hardness, friability, drug content, disintegration time and invitro drug release using USP dissolution apparatus type 2 (paddle). It was found that the optimized formulation showed 49.33%, 48.90%, 48.52%, 47.65%, 46.84% and 46.51% release for Atenolol in 12 hours respectively. However, Indapamide released 49.62%, 49.39%, 48.72%, 48.27%, 47.59% and 47.36% at the end of 12hrs. The IR spectrum study revealed that there is no disturbance in the principal peaks of pure drugs Atenolol and Indapamide. This confirms the integrity of pure drugs and no incompatibility of them with excipients. The stability studies were carried out for the optimized batch for one months and it showed satisfactory results. The kinetic studies of the formulations revealed that diffusion is the predominant mechanism of drug and release follows Zero order, Super case II transport. DOI: http://dx.doi.org/10.3329/ijpls.v2i4.17114 International Journal of Pharmaceutical and Life Sciences Volume 2, Issue 4: October 2013; 141-157
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Sungthongjeen, Srisagul, and Satit Puttipipatkhachorn. "Comparison between Ethylcellulose Aqueous Colloidal Dispersion and Ethylcellulose Ethanolic Solution as Rupturable Coating Materials for Pulsatile Release Tablets." Advanced Materials Research 506 (April 2012): 489–92. http://dx.doi.org/10.4028/www.scientific.net/amr.506.489.
Full textAbstract:
Pulsatile release dosage forms which time of drug release can be determined have shown advantages for various drugs such as chronopharmacological drugs and drugs with high first pass metabolism. The pulsatile release tablets consisting of drug-containing cores coated with inner swelling layer containing a superdisintegrant (croscarmellose sodium (Ac-Di-Sol®)) and outer rupturable layer (ethylcellulose (EC)) were previously developed. In this study, two different types of EC coating membrane, EC ethanolic solution (ECS) versus EC aqueous colloidal dispersion (ECD), were compared. Propranolol HCl was used as a model drug. Effect of rupturable coating level on lag time and drug release was investigated. The results demonstrated that using ECS could provide the pulsatile release tablets with obviously longer lag time than ECD. With ECS, increasing of rupturable coating level increased lag time of the pulsatile release tablets because of the lowered water uptake. In addition, rapid drug release after the predetermined lag time was achieved in the pulsatile release tablets using ECS. However, the pulsatile tablets with ECD ruptured within a few minutes even high levels of rupturable coating were used. It was suggested that the different performance of the pulsatile release tablets with different types of EC might be related to the discrepancy in physical properties of the obtained EC membrane.
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H. Aodah, Alhussain, Mohamed H. Fayed, Ahmed Alalaiwe, Bader B. Alsulays, Mohammed F. Aldawsari, and El-Sayed Khafagy. "Design, Optimization, and Correlation of In Vitro/In Vivo Disintegration of Novel Fast Orally Disintegrating Tablet of High Dose Metformin Hydrochloride Using Moisture Activated Dry Granulation Process and Quality by Design Approach." Pharmaceutics 12, no. 7 (June 27, 2020): 598. http://dx.doi.org/10.3390/pharmaceutics12070598.
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Compression of cohesive, poorly compactable, and high-dose metformin hydrochloride into the orally disintegrating tablet (ODT) is challenging. The objective of this study was to develop metformin ODT using the moisture activated dry granulation (MADG) process. There are no reports in the literature regarding the development of ODT based on MADG technology. The feasibility of developing metformin ODT was assessed utilizing a 32 full factorial design to elucidate the influence of water amount (X1) and the amount of pregelatinized starch (PGS; X2) as independent variables on key granules and tablets’ characteristics. The prepared granules and tablets were characterized for granule size, bulk density, flow properties, tablets’ weight variation, breaking force, friability, capping tendency, in vitro and in vivo disintegration, and drug release. Regression analysis showed that X1 and X2 had a significant (p ≤ 0.05) impact on key granules and tablets’ properties with a predominant effect of the water amount. Otherwise, the amount of PGS had a pronounced effect on tablet disintegration. Optimized ODT was found to show better mechanical strength, low friability, and short disintegration time in the oral cavity. Finally, this technique is expected to provide better ODT for many kinds of high-dose drugs that can improve the quality of life of patients.
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Singh, Abhay, Sudip Das, Sabnam Gupta, and Suman Ghosh. "The Challenges of Producing Bilayer Tablet: A Review." Journal of Drug Delivery and Therapeutics 11, no. 4-S (August 15, 2021): 171–75. http://dx.doi.org/10.22270/jddt.v11i4-s.4922.
Full textAbstract:
Bilayer tablets are the advanced form of conventional immediate release tablet system, which consist of either two similar or different drugs combined in a single dose for effective treatment of the disease improving patient compliance. However, the multilayer tablet technology is demanding It also necessitates meticulous selection of excipients and manufacturing conditions for each technological stage. The aim of this review is to provide an outline of state of art of bilayer tablet technology and emphasise the difficulties experienced during Bilayer tablet manufacturing along with its intend solutions for these challenges.
Keyword: Bilayer tablet, Conventional release, Challenges encountered, Compliance.
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Sawatdee, Somchai, Apichart Atipairin, Attawadee Sae Yoon, Teerapol Srichana, Narumon Changsan, and Tan Suwandecha. "Formulation Development of Albendazole-Loaded Self-Microemulsifying Chewable Tablets to Enhance Dissolution and Bioavailability." Pharmaceutics 11, no. 3 (March 20, 2019): 134. http://dx.doi.org/10.3390/pharmaceutics11030134.
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Albendazole is an anthelmintic agent with poor solubility and absorption. We developed a chewable tablet (200 mg drug equivalent), containing a self-microemulsifying drug delivery system (SMEDDS), with oral disintegrating properties. The emulsion was developed using sesame and soybean oils along with surfactant/co-surfactants, and the tablets were prepared by wet granulation using superdisintegrants and adsorbents. Infra-red (IR) spectral studies revealed no interaction between the drug and excipients, and all physical and chemical parameters were within acceptable limits. Stability studies for the formulation indicated no significant change over time. An in vitro release study indicated 100% drug release within 30 min, and in vivo plasma concentrations indicated that the area under the curve (AUC) of albendazole in rats administered SMEDDS chewable tablets was significantly higher than in those administered commercial tablets or powder (p-value < 0.05). The systemic bioavailability of albendazole achieved through the SMEDDS tablets was 1.3 times higher than that achieved by the administration of comparable quantities of albendazole commercial tablets. This was due to the higher dissolution of albendazole SMEDDS in the chewable tablets. We conclude that the SMEDDS chewable formulation can be used to improve the dissolution and systemic availability of poorly water-soluble drugs.
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Zgonjanin, Dragana, Eva Loncar, and Milos Tasic. "Analysis of forensic samples of "Ecstasy" tablets seized in Novi Sad during the 2004 year." Acta Periodica Technologica, no. 36 (2005): 247–59. http://dx.doi.org/10.2298/apt0536247z.
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The paper presents results of the analysis of illicit synthetic drugs in the form of tablets distributed under the name "Ecstasy", seized by the police in the broader area of Novi Sad 2004. A huge number of tablets has been analyzed (n=121), of various colours and with impressed symbols from the total amount of 93 seizures, which totally amounted to 1458 tablets. Regarding the number of seizures ecstasy (3,4-methylendioxy-N-meth-yl-amphetamine - MDMA) is dominant among all, and according to the quantity of seized tablets it is amphetamine (AP), while other amphetamine-type drugs (methamphetamine MA 3,4-methylendioxiamphetamine - MDA, 3,4-methylendioxi-N-ethyl-amphetamine MDEA) have been found in rather small quantities and very rarely. Tablets mostly contain caffeine as an additive. In the analytical procedure, the samples of tablets were subjected to liquid-liquid extraction and afterwards analyzed on the GCD (GC-EI) Hewlett-Packard instrument. The method is fast reliable and reproducible for the analysis of amphetamine, methamphetamine MDA, MDMA, MDEA, as well as various additives in the samples of seized tablets.
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Shen, Yudong, Xingya Li, and Yuan Le. "Amorphous Nanoparticulate Formulation of Sirolimus and Its Tablets." Pharmaceutics 10, no. 3 (September 11, 2018): 155. http://dx.doi.org/10.3390/pharmaceutics10030155.
Full textAbstract:
Nanocrystallization and amorphization have proven to be two effective strategies to improve the bioavailability of water-insoluble drugs. The purpose of our work was to develop a nano-formulated tablet of sirolimus (SRL) for enhanced dissolution. Amorphous SRL nanocomposites were prepared using anti-solvent precipitation via a high-gravity rotating packed bed. Various factors that affect particle size and size distribution, such as excipients, rotating speed, antisolvent/solvent flow rate, were investigated. Structure, stability and in vitro dissolution of the as-prepared SRL were evaluated. Furthermore, the nanoparticulated SRL tablet formula was screened to control drug release. Importantly, SRL tablets exhibit different dissolution profile by adjusting HPMC (hydroxypropyl methyl cellulose) content, which makes them more suitable for various formulation developments.