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Journal articles on the topic 'Drug-excipient compatibility'

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Published: 4 June 2021
Last updated: 17 February 2022

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1

Sims, Jonathan L., Judith A. Carreira, Daniel J. Carrier, Simon R. Crabtree, Lynne Easton, Stephen A. Hancock, and Carol E. Simcox. "A New Approach to Accelerated Drug-Excipient Compatibility Testing." Pharmaceutical Development and Technology 8, no. 2 (January 2003): 119–26. http://dx.doi.org/10.1081/pdt-120018476.

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2

da Silveira, Lucas Melo, Ariadne Botto Fiorot, Thiago Padovani Xavier, Maria Irene Yoshida, and Marcelo Antonio de Oliveira. "Drug-excipient compatibility assessment of solid formulations containing meloxicam." European Journal of Pharmaceutical Sciences 112 (January 2018): 146–51. http://dx.doi.org/10.1016/j.ejps.2017.11.015.

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3

CARLSON, E., W. CHANDLER, I. GALDO, T. KUDLA, and C. TA. "Automated Integrated Forced Degradation and Drug-Excipient Compatibility Studies." Journal of the Association for Laboratory Automation 10, no. 6 (December 2005): 374–80. http://dx.doi.org/10.1016/j.jala.2005.09.005.

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4

Mohamed, Amir Ibrahim, Amal Abd-Elaal El-Khamery, Mohamed Ismail Herry, and Alaa Ibrahim Mohamed. "Compatibility Determination of Drug-Polymer, Drug-Excipient & Drug-Intravenous Admixtures Using Chemometric-assisted UVspectrophotometry." Current Pharmaceutical Analysis 16, no. 2 (January 23, 2020): 125–42. http://dx.doi.org/10.2174/1573412914666181011142351.

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Purpose: A new multivariate chemometric approach was developed for fast and economic compatibility determinations of ranitidine hydrochloride (as model drug) with certain pharmaceutical; polymers (Alginate & Chitosan), excipient (Lactose) and intravenous fluids (Dextrose, Ringer & Dextrose/ Ringer). Binary mixtures of the drug and each item were prepared and investigated by chemometric- assisted UV- spectrophotometry as well as by HPLC reference method. Methods: Five drug concentration levels (0.004-0.025mg/ml) of test-mixtures were used and the average drug recovery percent after two and seven days of storage from initial concentration was determined. Physico-chemical techniques including DSC, XRD, & FTIR were also performed to investigate the nature of the observed drug-additive interactions. Results: UV-chemometric and HPLC results showed that ranitidine stability in mixture aqueous solutions appears to be concentration dependent. The ranitidine content remained greater than 90% in alginate & chitosan test mixtures at all used drug concentrations (0.004-0.025mg/ml), while in lactose, dextrose, ringer & dextrose/ringer test mixtures fell below 90% at low drug concentrations (0.004- 0.009mg/ml), which suggests more ranitidine compatibility with alginate & chitosan rather than the other additives. Conclusion: The developed chemometric method, employing UV absorbance data successfully used as simple, rapid, and economic alternative tool in drug-additive compatibility determinations.
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5

Chadha, Renu, and Swati Bhandari. "Drug–excipient compatibility screening—Role of thermoanalytical and spectroscopic techniques." Journal of Pharmaceutical and Biomedical Analysis 87 (January 2014): 82–97. http://dx.doi.org/10.1016/j.jpba.2013.06.016.

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6

Chaves, Luíse L., Larissa A. Rolim, Maria L. C. M. Gonçalves, Alexandre C. C. Vieira, Lariza D. S. Alves, Monica F. R. Soares, José L. Soares-Sobrinho, Maria C. A. Lima, and Pedro J. Rolim-Neto. "Study of stability and drug-excipient compatibility of diethylcarbamazine citrate." Journal of Thermal Analysis and Calorimetry 111, no. 3 (November 8, 2012): 2179–86. http://dx.doi.org/10.1007/s10973-012-2775-7.

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7

Wang, Nannan, Huimin Sun, Jie Dong, and Defang Ouyang. "PharmDE: A new expert system for drug-excipient compatibility evaluation." International Journal of Pharmaceutics 607 (September 2021): 120962. http://dx.doi.org/10.1016/j.ijpharm.2021.120962.

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8

Tita, Ioana Cristina, Lavinia Lupa, Bogdan Tita, Roxana Liana Stan, and Laura Vicas. "Compatibility Studies of Valsartan with Different Pharmaceutical Excipients." Revista de Chimie 70, no. 7 (August 15, 2019): 2590–600. http://dx.doi.org/10.37358/rc.19.7.7386.

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Compatibility studies between active drugs and excipients are substantial in the pharmaceutical technology. Thermal analysis has been extensively used to obtain information about drug-excipient interactions and to perform pre-formulation studies of pharmaceutical dosage forms. The objective of the present study was to evaluate the compatibility of the valsartan (VALS) with pharmaceutical excipients of common use including diluents, binders, disintegrants, lubricants and solubilising agents. Thermogravimetry (TG), derivative thermogravimetry (DTG), but especially differential scanning calorimetry (DSC) were used for a first screening to find small variations in peak temperature and/or their associated enthalpy for six drug/excipient mixtures (starch, cross caramelose sodique, microcrystalline cellulose 102, povidone K30, lactose monohydrate and magnesium stearate), which indicate some degree of interaction. Additional methods using Fourier transformed infrared spectroscopy (FT-IR) and X-ray powder diffraction (XRPD) confirmed the incompatibility of VALS with starch, povidone K30, lactose monohydrate and magnesium stearate. Those excipients should be avoided in the development of solid dosage forms.
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9

Serajuddin, Abu T. M., Ajit B. Thakur, Rabin N. Ghoshal, Michael G. Fakes, Sunanda A. Ranadive, Kenneth R. Morris, and Sailesh A. Varia. "Selection of solid dosage form composition through drug–excipient compatibility testing." Journal of Pharmaceutical Sciences 88, no. 7 (July 1999): 696–704. http://dx.doi.org/10.1021/js980434g.

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10

Thomas, V. Hayden, and Maryanne Naath. "Design and utilization of the drug–excipient chemical compatibility automated system." International Journal of Pharmaceutics 359, no. 1-2 (July 2008): 150–57. http://dx.doi.org/10.1016/j.ijpharm.2008.03.043.

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11

Maximiano, Flávia Pires, Kátia Monteiro Novack, Maria Terezinha Bahia, Lívia Lira de Sá-Barreto, and Marcílio Sérgio Soares da Cunha-Filho. "Polymorphic screen and drug–excipient compatibility studies of the antichagasic benznidazole." Journal of Thermal Analysis and Calorimetry 106, no. 3 (February 15, 2011): 819–24. http://dx.doi.org/10.1007/s10973-011-1371-6.

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12

Chaiya, Pornsit, and Thawatchai Phaechamud. "Differential Scanning Calorimetric Analysis for Incompatibility: Sodium Stearate/Magnesium Stearate and Acidic Compounds." Key Engineering Materials 859 (August 2020): 307–12. http://dx.doi.org/10.4028/www.scientific.net/kem.859.307.

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Compatibility investigation was performed between stearate lubricants (sodium stearate and magnesium stearate) and acidic pharmaceutical compounds (ibuprofen, indomethacin and valproic acid) and citric acid as acidic pharmaceutical excipient using differential scanning calorimetry (DSC). Alteration in DSC thermogram was found in all mixtures. There was a presence of melting endothermic peak of stearic acid in all mixtures (except that of stearate lubricants and indomethacin) indicating breakage of salt form of stearate lubricants depended on the physicochemical properties of drug compounds and pharmaceutical excipient. Therefore, the avoidance for using stearate lubricants with acidic pharmaceutical compounds and excipient should be concerned in development of pharmaceutical formulations.
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13

Schlich, Michele, Francesco Lai, Anna Maria Fadda, Chiara Sinico, and Elena Pini. "Drug-Excipients Compatibility Studies in Proniosomal Formulation: A Case Study with Resveratrol." Journal of Nanoscience and Nanotechnology 21, no. 5 (May 1, 2021): 2917–21. http://dx.doi.org/10.1166/jnn.2021.19056.

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Proniosomal drug delivery system is one of the advancements in nanotechnology. Similarly to traditional dosage forms, chemical and physical compatibility of proniosomes components with the active ingredient(s) is a key step in the preformulation process of such systems. In this work, the compatibility of resveratrol with selected excipients in the development of proniosomal formulation was investigated by thermal and spectroscopic techniques. To evaluate the drug-excipient compatibility, different techniques such as differential scanning calorimetric study, attenuated total reflectance Fourier transform infrared spectroscopy study and powder X-ray diffraction were adopted. The results showed that the excipients used in the formulation were compatible with resveratrol.
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14

Li, Yu, Xiangwen Kong, and Fan Hu. "Crystal Transition and Drug-excipient Compatibility of Clarithromycin in Sustained Release Tablets." Current Pharmaceutical Analysis 16, no. 7 (August 17, 2020): 950–59. http://dx.doi.org/10.2174/1573412915666190328234326.

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Background: Clarithromycin is widely used for infections of helicobacter pylori. Clarithromycin belongs to polymorphic drug. Crystalline state changes of clarithromycin in sustained release tablets were found. Objective: The aim of this study was to find the influential factor of the crystal transition of clarithromycin in preparation process of sustained-release tablets and to investigate the possible interactions between the clarithromycin and pharmaceutical excipients. Methods and Results: The crystal transition of active pharmaceuticals ingredients from form II to form I in portion in clarithromycin sustained release tablets were confirmed by x-ray powder diffraction. The techniques including differential scanning calorimetry and infrared spectroscopy, x-ray powder diffraction were used for assessing the compatibility between clarithromycin and several excipients as magnesium stearate, lactose, sodium carboxymethyl cellulose, polyvinyl-pyrrolidone K-30 and microcrystalline cellulose. All of these methods showed compatibilities between clarithromycin and the selected excipients. Alcohol prescription simulation was also done, which showed incompatibility between clarithromycin and concentration alcohol. Conclusion: It was confirmed that the reason for the incompatibility of clarithromycin with high concentration of alcohol was crystal transition.
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15

Balestrieri, Fabrizio, Andrea D. Magrì, Antonio L. Magrì, Domenico Marini, and Amalia Sacchini. "Application of differential scanning calorimetry to the study of drug-excipient compatibility." Thermochimica Acta 285, no. 2 (August 1996): 337–45. http://dx.doi.org/10.1016/0040-6031(96)02904-8.

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16

Wyttenbach, Nicole, Christian Birringer, Jochem Alsenz, and Martin Kuentz. "Drug-Excipient Compatibility Testing Using a High-Throughput Approach and Statistical Design." Pharmaceutical Development and Technology 10, no. 4 (January 2005): 499–505. http://dx.doi.org/10.1080/10837450500299875.

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17

Gao, Rui, Yi Jin, Qing-Yi Yang, Bai-Wang Sun, and Jun Lin. "Study of stability and drug-excipient compatibility of estradiol and pharmaceutical excipients." Journal of Thermal Analysis and Calorimetry 120, no. 1 (November 1, 2014): 839–45. http://dx.doi.org/10.1007/s10973-014-4234-0.

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18

V, Kishan, Swathi Yambadi, and Ramesh Bomma. "Drug Excipient Compatibility, Development and Preliminary Clinical Studies of Tizanidine Hydrochloride Floating Drug Delivery System." International Journal of Pharmaceutical Sciences and Nanotechnology 14, no. 1 (January 1, 2021): 5334–42. http://dx.doi.org/10.37285/ijpsn.2021.14.1.9.

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The objective of this investigation was to develop formulation of floating matrix tablets of tizanidine HCl to prolong the gastric residence time by using hydroxy propyl methyl cellulose (HPMC K15M) or xanthan gum as sole release retardant and to check the clinical response. The drug-excipients compatibility studies were conducted using DSC and also by visual observation. Incorporation of NaHCO3 in the formulation resulted incompatibility with drug and therefore, the composition was modified by replacing NaHCO3 with CaCO3 in remaining formulations. Floating matrix tablets of tizanidine were developed by direct compression method and the developed ten formulations exhibited satisfactory physicochemical characteristics and in-vitro buoyancy. Formulation (F9) was selected as optimized formulation based on physicochemical characters, in-vitro buoyancy and drug release, and was used in in-vivo radiographic studies in human volunteers by incorporating BaSO4. In radiographic studies, the gastric retention time of floating tablets was found to be 4 ± 0.86 h (n=3). Optimized floating tablets (F9) were used to know the clinical effects in patients suffering from spasticity under the observation of clinician. The optimized tizanidine HCl floating matrix tablets were developed and found to have gastric retention behaviour in stomach and further were found to have good clinical effects in patients suffering from spasticity during preliminary clinical studies.
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19

Tiwari, Sandip Prasad, and Gali Vidyasagar. "Identification, Characterization and Drug-Excipient Compatibility of Diltiazem Hydrochloride by Physico-Chemical Techniques." UK Journal of Pharmaceutical Biosciences 2, no. 5 (October 1, 2014): 49. http://dx.doi.org/10.20510/ukjpb/2/i5/91134.

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20

Pires, Felipe Q., Tamara Angelo, Joyce K. R. Silva, Lívia C. L. Sá-Barreto, Eliana M. Lima, Guilherme M. Gelfuso, Tais Gratieri, and Marcílio S. S. Cunha-Filho. "Use of mixture design in drug-excipient compatibility determinations: Thymol nanoparticles case study." Journal of Pharmaceutical and Biomedical Analysis 137 (April 2017): 196–203. http://dx.doi.org/10.1016/j.jpba.2017.01.037.

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21

Wu, Yongmei, Mandar Dali, Abhishek Gupta, and Krishnaswamy Raghavan. "Understanding drug-excipient compatibility: Oxidation of compound A in a solid dosage form." Pharmaceutical Development and Technology 14, no. 5 (September 11, 2009): 556–64. http://dx.doi.org/10.1080/10837450903182140.

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22

Bruni, Giovanna, Vittorio Berbenni, Chiara Milanese, Alessandro Girella, and Amedeo Marini. "Drug-excipient compatibility studies in binary and ternary mixtures by physico-chemical techniques." Journal of Thermal Analysis and Calorimetry 102, no. 1 (August 28, 2009): 193–201. http://dx.doi.org/10.1007/s10973-009-0382-z.

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23

Sharma, Shyam Bihari, Suman Jain, and K. Ganesan. "Preformulation Studies of Pralidoxime Chloride for Formulation Development of Microspheres." Journal of Drug Delivery and Therapeutics 9, no. 4-s (August 15, 2019): 338–42. http://dx.doi.org/10.22270/jddt.v9i4-s.3336.

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Microspheres are one of the novel drug delivery system which possess several applications and are made up of assorted polymers. Microspheres can be defined as solid, approximately spherical particles ranging in size from 1 to 1000 μm range in diameter having a core of drug and entirely outer layers of polymers as coating material. They are made up of polymeric, waxy or other protective materials i.e. biodegradable synthetic polymer and modified natural products such as starches, gums, proteins, fats and waxes. Preformulation is a group of studies that focus on the physicochemical properties of a new drug candidate that could affect the drug performance and the development of a dosage form. This couldprovide important information for formulation design or support the need for molecular modification. Every drug has intrinsic chemical and physical properties which has been consider before development of pharmaceutical formulation. This property provides the framework for drugs combination with pharmaceutical ingredients in the fabrication of dosage form. Objective of preformulation study is to develop the elegant, stable, effective and safe dosage form by establishing kinetic rate profile, compatibility with the other ingredients and establish Physico-chemical parameter of new drug substances. The purpose of the present study was to systematically investigate some of the important physicochemical properties of pralidoxime chloride for preparation of microspheres. The physicochemical properties such as solubility, pKa, dissolution, melting point, assay development, excipient compatibility etc. of pralidoxime chloride was carried out. Before selection of excipients, the Preformulation study of drug pralidoxime is completed for successful formulation of microspheres. The result of Preformulation studies shows good flow properties, excipient compatibility, solubility efficiency and melting point. From this study we concluded that pralidoximewith HPMC and EC can be used to formulate pralidoxime microspheres for modified release. Keywords: Microspheres, Preformulation, Pralidoxime chloride, Physico-chemical parameter.
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24

Verma, Rajan K., and Sanjay Garg. "Selection of excipients for extended release formulations of glipizide through drug–excipient compatibility testing." Journal of Pharmaceutical and Biomedical Analysis 38, no. 4 (July 2005): 633–44. http://dx.doi.org/10.1016/j.jpba.2005.02.026.

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25

Sharma, Megha, Seema Kohli, and Abhisek Pal. "PREPARATION AND EVALUATION OF CONTROLLED RELEASE FLOATING MICROSPHERES OF REPAGLINIDE: OPTIMIZATION AND IN-VITRO STUDIES." Asian Journal of Pharmaceutical and Clinical Research 10, no. 3 (March 1, 2017): 103. http://dx.doi.org/10.22159/ajpcr.2017.v10i3.15310.

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ABSTRACTObjective: To develop and evaluate floating microspheres of repaglinide (RG).Materials and Methods: RG loaded noneffervescent microspheres of different ratios of ethylcellulose (EC) and hydroxypropyl methylcellulose (HPMCK4M) were prepared using polyvinyl alcohol as emulsifier by solvent evaporation technique. Various process variables such as polymer ratio, stirringspeed, concentration of drug, and emulsifying agent were studied. Compatibility of drug and polymers was studied by Fourier-transform infraredspectroscopy (FTIR). Characterization, in-vitro evaluation, and kinetic studies were performed.Results: FTIR spectra have revealed no drug-excipient incompatibility. The average particle size of microspheres was in the range of 312-359 μm. Theresults showed that floating microspheres were successfully prepared with good yield (56.15-64.3%), high entrapment efficiency (58.22-70.14%),and good floating behavior (63.1-76.2%), respectively. In-vitro release data indicates appreciable amount of drug is released (62.28-73.27%) from themicrospheres in gastric fluid. The mechanism of drug release founds to follow first order kinetics (r2=0.986).Conclusion: The developed floating microspheres of RG may be used for prolonged drug release for at least 12 hrs, thereby improving bioavailabilityand patient compliance.Keywords: Repaglinide, Compatibility, Kinetic, Ethylcellulose.
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26

Enéas, Paula Cristina Rezende, Renata Barbosa de Oliveira, and Gerson Antônio Pianetti. "Oxcarbazepine: validation and application of an analytical method." Brazilian Journal of Pharmaceutical Sciences 46, no. 2 (June 2010): 265–72. http://dx.doi.org/10.1590/s1984-82502010000200013.

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Oxcarbazepine (OXC) is an important anticonvulsant and mood stabilizing drug. A pharmacopoeial monograph for OXC is not yet available and therefore the development and validation of a new analytical method for quantification of this drug is essential. In the present study, a UV spectrophotometric method for the determination of OXC was developed. The various parameters, such as linearity, precision, accuracy and specificity, were studied according to International Conference on Harmonization Guidelines. Batches of 150 mg OXC capsules were prepared and analyzed using the validated UV method. The formulations were also evaluated for parameters including drug-excipient compatibility, flowability, uniformity of weight, disintegration time, assay, uniformity of content and the amount of drug dissolved during the first hour.
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27

Pani, Nihar, Lila Nath, and Sujata Acharya. "Compatibility studies of nateglinide with excipients in immediate release tablets." Acta Pharmaceutica 61, no. 2 (June 1, 2011): 237–47. http://dx.doi.org/10.2478/v10007-011-0016-4.

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Compatibility studies of nateglinide with excipients in immediate release tabletsExperiments were done to assess the compatibility of nateglinide with selected excipients in the development of immediate release tablets of nateglinide by thermal and isothermal stress testing (IST) techniques. To evaluate the drug-excipient compatibility, different techniques such as differential scanning calorimetric (DSC) study, infra-red (IR) spectrophotometric study and isothermal stress testing were adopted. The results of DSC study showed that magnesium stearate exhibited some interaction with nateglinide. However, the results of IR, and IST studies showed that all the excipients used in the formula were compatible with nateglinide. Optimized formulations developed using the compatible excipients were found to be stable over 3 months of accelerated stability studies (40 ± 2°C and 75 ± 5% RH). Overall, compatibility of excipients with nateglinide was successfully evaluated using a combination of thermal and IST methods and the formulations developed using the compatible excipients were found to be stable.
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28

Pakhale, Nilesh V., S. B. Gondkar, and R. B. Saudagar. "Formulation Development and Evalua Tion of Fluoxetine Effervescent Floating Tablet." Journal of Drug Delivery and Therapeutics 9, no. 4-A (August 30, 2019): 358–66. http://dx.doi.org/10.22270/jddt.v9i4-a.3490.

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The objective of the present study was to formulate and evaluate Effervescent Floating Tablet of Fluoxetine for the treatment of antidepressant agent. Tablets were prepared by direct compression using directly compressible polymers such as HPMC K4M, and Carbopol 934 were evaluated for drug-excipient compatibility, density, buoyancy test, swelling study, drug content and In-Vitro release profile. Sodium bicarbonate and citric acid were used producing effervescent base for buoyancy of tablets. Analysis of drug release from tablet indicates drug release by zero order, first order rate kinetics. No significant change was observed in physical appearance, drug content, floatability or in-vitro dissolution pattern after storage at 450C/750C RH for three months. Keywords: Floating effervescent tablet, GIT, Fluoxetine , HPMC K4M, Carbopol 934.
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29

Selzer, Torsten, Manfred Radau, and Jörg Kreuter. "Use of isothermal heat conduction microcalorimetry to evaluate stability and excipient compatibility of a solid drug." International Journal of Pharmaceutics 171, no. 2 (September 1998): 227–41. http://dx.doi.org/10.1016/s0378-5173(98)00177-x.

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30

Harding, L., S. Qi, G. Hill, M. Reading, and D. Q. M. Craig. "The development of microthermal analysis and photothermal microspectroscopy as novel approaches to drug–excipient compatibility studies." International Journal of Pharmaceutics 354, no. 1-2 (April 2008): 149–57. http://dx.doi.org/10.1016/j.ijpharm.2007.11.009.

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31

Jagdale, Swati C., and Payal V. Kothekar. "Development of Emulgel Delivery of Mupirocin for Treatment of Skin Infection." Recent Patents on Anti-Infective Drug Discovery 15, no. 2 (December 30, 2020): 137–56. http://dx.doi.org/10.2174/1386207323999200819153404.

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Aim:: To design controlled release topical delivery of mupirocin for the treatment of skin infection. Background:: Mupirocin is an antibacterial drug. Mupirocin works to kill the bacteria, which include strains of Staphylococcus aureus and Streptococcus pyogenes. It is also used for the treatment of inflammation of a hair follicle. The half-life of mupirocin is only 20-40 min. It has very slight solubility in water. Patent literature had shown work on ointment, antibiotic composition, nasal and topical composition. Emulgel is a duel control release system for the topical delivery of hydrophobic drugs. Objective:: The objective was to formulate emulgel with controlled delivery of mupirocin using Sepineo P 600. Methods:: Soya oil, tween 80 and polyethylene glycol 400 (Oil:Surfactant:Cosurfactant) were used for emulsion formulation. Emulgel was optimized by 32 factorial design. Sepineo P 600 and hydroxy propyl methyl cellulose K4M were used as independent variables. Drug excipient compatibility analysis was carried out by FTIR, UV and DSC spectra. Emulgel was evaluated for its physical characterization, in vitro release, ex vivo release, antimicrobial and anti-inflammatory study. Results:: DSC, UV and FTIR analysis confirmed drug excipient compatibility. FE SEM showed a size range between 228-255 nm. Zeta potential was found to be -25.1 mV, which showed good stability of the emulsion. Design expert software showed F2 as an optimized batch. Release studies indicated that the controlled release of drugs forms Sepineo P 600 gel due to its higher gelling capacity. Batch F2 showed comparable results with marketed formulation against Staphylococcus aureus. For batch F2, 40 μg/ml was the minimal inhibitory concentration. Conclusion:: Antimicrobial and anti-inflammatory study proved successful development of stably controlled release mupirocin emulgel.
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32

Sharma, Hemanta Kumar, and Lila Kanta Nath. "Study of the Effect of Dillenia indica Fruit Mucilage on the Properties of Metformin Hydrochloride Loaded Spray Dried Microspheres." International Scholarly Research Notices 2014 (November 20, 2014): 1–6. http://dx.doi.org/10.1155/2014/628382.

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Natural materials are preferred over synthetic counterparts because of their biodegradable and biocompatible nature. The present work was proposed to utilize mucilage from natural source for the development of controlled release formulation of metformin hydrochloride. Natural mucilaginous substance extracted from Dillenia indica L. (DI) fruit was used in fabricating controlled release microspheres. The microspheres were prepared by spray drying method under different formulation parameters. The prepared microspheres were studied for particle size, drug excipient compatibility, particle shape and surface morphologies, drug entrapment efficiency, mucoadhesivity, and in vitro drug release properties. The prepared microspheres exhibited mucoadhesive properties and demonstrated controlled release of metformin hydrochloride. The study reveals that the natural materials can be used for formulation of controlled release microspheres and would provide ample opportunities for further study.
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33

de Carvalho, Murilo Ferreira, Luane Ferreira Garcia, Isaac Yves Lopes de Macedo, Ricardo Neves Marreto, Mayk Teles de Oliveira, Renê Oliveira do Couto, Carlos Eduardo Peixoto da Cunha, et al. "Electroanalysis Applied to Compatibility and Stability Assays of Drugs: Carvedilol Study Case." Pharmaceuticals 13, no. 4 (April 17, 2020): 70. http://dx.doi.org/10.3390/ph13040070.

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Carvedilol (CRV) is a non-selective blocker of α and β adrenergic receptors, which has been extensively used for the treatment of hypertension and congestive heart failure. Owing to its poor biopharmaceutical properties, CRV has been incorporated into different types of drug delivery systems and this necessitates the importance of investigating their compatibility and stability. In this sense, we have investigated the applicability of several electroanalytical tools to assess CRV compatibility with lipid excipients. Voltammetric and electrochemical impedance spectroscopy techniques were used to evaluate the redox behavior of CRV and lipid excipients. Results showed that Plurol® isostearic, liquid excipient, and stearic acid presented the greatest anode peak potential variation, and these were considered suitable excipients for CRV formulation. CRV showed the highest stability at room temperature and at 50 °C when mixed with stearic acid (7% w/w). The results also provided evidence that electrochemical methods might be feasible to complement standard stability/compatibility studies related to redox reactions.
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34

., Pooja, Pankaj Kumar Sharma, and Viswanath Agrahari. "DESIGN AND EVALUATION OF SELF-NANO EMULSIFYING DRUG DELIVERY SYSTEMS OF ALVERINE FOR ENHANCEMENT OF SOLUBILITY." International Research Journal of Pharmacy 12, no. 7 (July 31, 2021): 25–31. http://dx.doi.org/10.7897/2230-8407.1207153.

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Background: The aim of this study is to develop a liquid self-nano emulsifying drug delivery system for alverine (liquid-SNEDDS).Excipients in the alverine SNEDDS include Ethyl oleate as the oil phase, Tween 80 as a surfactant, and PEG600, Propylene glycol as a cosurfactant.The prepared eleven formulations of alverine SNEDDS were performed for emulsification time, percentage transmittance, particle size, drug release, in vitro dissolution and stability studies.The optimised alverine liquid SNEDDS formulation (D1) was studied for drug-excipient compatibility using infrared spectroscopy, as well as particle size, zeta potential, transmission electron microscopy, and stability. Alverine SNEDDS have a spherical shape with uniform particle distribution, according to their morphology. D1's optimised formulation's drug release percentage (96.6). The stability data revealed no discernible changes in drug content, emulsifying properties, drug release, or appearance. As a result, a potential SNEDDS formulation of alverine with improved solubility, dissolution rate, and bioavailability was developed.
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Sachan, Nikhil K., Seema Pushkar, Anupam K. Sachan, and S. K. Ghosh. "Thermal Stability and Drug-Excipient Compatibility Studies of Peppermint and Caraway Oils for Formulation of Chewable Tablets." Asian Journal of Chemistry 25, no. 11 (2013): 5930–34. http://dx.doi.org/10.14233/ajchem.2013.14186.

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Patole, Vinita, Rajnigandha Gaikwad, and Kishanchandra Khandelwal. "THYME OIL LOADED CASSAVA STARCH TRANSDERMAL FILM FOR WOUND HEALING." INDIAN DRUGS 58, no. 02 (May 15, 2021): 76–81. http://dx.doi.org/10.53879/id.58.02.12004.

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Biodegradable cassava starch-based transdermal film loaded with thyme volatile oil was prepared by solvent casting method for wound healing activity. The stretchability, water vapour permeability and antimicrobial properties of the film were measured. The films were evaluated for drug-excipient compatibility studies by Fourier transformed infrared spectroscopy (FTIR). The formulated film loaded with thyme volatile oil exhibited good anti-microbial activity against Staphylococcus aureus and Pseudomonas aeruginosa. The film was tested to determine its potential to increase the number of capillaries on the treated chick chorioallantoic membrane (CAM) surfaces using nine days old fertilized chick eggs. These thyme oil films loaded with cassava starch displayed angiogenic potential, which is required in the treatment of wound healing.
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V, Kishan, Ramireddy Amarnath Reddy, and Ramesh Bomma. "Drug-Excipient Interaction during Formulation Development, in vitro andin vivo Evaluation of Gastroretentive Drug Delivery System for Nizatidine." International Journal of Pharmaceutical Sciences and Nanotechnology 6, no. 4 (December 31, 2013): 2281–93. http://dx.doi.org/10.37285/ijpsn.2013.6.4.11.

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The present investigation dealswith the development and evaluation of floating tablets of nizatidine to prolong the gastric residence time, increase local delivery of drug to the H2-receptor of the parietal cell wall to reduce stomach acid secretion. The drug-excipient compatibility studies were conducted by using FTIR, DSC and visual observations. Citric acid inclusion in formulations resulted in incompatibility and the composition was modified to eliminate the problem of incompatibility. Floating matrix tablets of nizatidine were developed by direct compression method using hydroxypropyl methylcellulose (HPMC K4M) and polyox WSR 1105 alone as release retardants and sodium bicarbonate as a gas-generating agent. Alleleven formulations exhibited satisfactory physicochemical characteristics andin vitro buoyancy. Formulations F6 and F10 exhibited controlled and prolonged drug release for 10 h with zero order release. Formulation (F10) was selected as optimized formulation based on physicochemical properties and in vitro drug release and was used inradiographic studies by incorporating BaSO4. The radiographic studies were conducted in comparison with plain controlled release tablets. These studies revealed that gastric retention time of floating and plain controlled release tablets in fasting state were 2 ± 0.86 h and ≤ 0.5 h respectively in human volunteers. Gastric retention time of floating and plain controlled release tablets in fed state were 5.33 ± 0.57 h and 1.66 ± 0.28 h respectively in human volunteers. In conclusion, optimal floating matrix tablet for nizatidine with desired in vitro buoyancy, in vivo gastric retention time and prolonged release could be prepare
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D. V. R. N., Bhikshapathi, and Muralichand G. "Development, Solubility Enhancement and Characterization of Nimodipine Solid Dispersions." International Journal of Pharmaceutical Sciences and Nanotechnology 11, no. 5 (September 30, 2018): 4231–39. http://dx.doi.org/10.37285/ijpsn.2018.11.5.2.

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The main aim of this study was to formulate and characterize nimodipine solid dispersions using various novel polymers. Solid dispersions were prepared by solvent evaporation method in order to improve the solubility and overall bioavailability of nimodipine. Solubility and dissolution studies indicate that Kolliwax RH 40 is the most suitable polymer. The solubility studies was corresponded with dissolution data and the formulation SD15 was found to be having highest drug release of about 98.96 ± 5.15% in about 90 minutes. In vitro release data from several formulations containing Nimodipine was determined kinetically using different mathematical models like Zero order, First order, Higuchi, and Korsmeyer–Peppas model. XRD and SEM studies indicate no crystallinity in the optimized formulation SD15. FTIR studies suggested good drug excipient compatibility between all components of prepared formulation. These results confirm the viability of enhancing the solubility of nimodipine by formulating the drug as solid dispersions in Kolliwax.
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Khan, Dilawar, Daniel Kirby, Simon Bryson, Maryam Shah, and Mohammed Afzal. "P23 Accelerating and de-risking the production of paediatric oral formulations." Archives of Disease in Childhood 105, no. 9 (August 19, 2020): e18.1-e18. http://dx.doi.org/10.1136/archdischild-2020-nppg.32.

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Background & AimAs part of the EU paediatric regulation, the paediatric use marketing authorisation (PUMA) was introduced, with an aim to stimulate research in existing compounds that are off-patent and/or to help transform known off-label use into authorised use.1 However, success has been limited, with only a few products gaining a PUMA, such as Sialanar 320 micrograms/mL glycopyrronium (equivalent to 400 micrograms/mL glycopyrronium bromide). A distinct challenge to overcome in this area is the development of more ‘age appropriate formulations’, particularly with an excipient composition and load that is suitable for paediatric patients. This project aims to establish an excipient screening platform, supplemented with analytical characterisation of materials, which will act as a decision making tool to accelerate and de-risk the production of age appropriate paediatric medicines.MethodTo develop this excipient screening platform, a list of drugs that require an age appropriate formulation was produced using the ‘needs for paediatric medicines’ documents provided by the European medicines agency (EMA),2whilst common problematic excipients in paediatrics were identified using an EMA reflection paper.3 Literature and prescribing data were also reviewed to ensure drugs selected would benefit from an age appropriate formulation. Differential scanning calorimetry (DSC) to determine compatibility of selected drugs with widely used excipients was carried out using a TA DSCQ200 instrument (TA Instruments, New Castle, DE) with TA Instruments Universal Analysis 2000 software. Data was collected under nitrogen atmosphere (50 mL min−1) using pierced flat-bottomed TZero aluminium pans (sample mass about 2 mg) and heating rate of 10 °C min−1 in the range from 50 to 400°C. For samples containing both the drug and an excipient, 1 mg of each was measured out and gently mixed with a spatula for one minute.ResultsThe most common class of drugs identified as requiring age appropriate formulations were related to cardiovascular disorders and neurology, whilst the majority of drugs identified also exhibit poor aqueous solubilities. Some identified problematic excipients include ethanol, sodium benzoate and sorbitol; however, these excipients may still be used in paediatric formulations, as long as they are below certain concentrations (for example, ethanol concentration should not exceed 0.5% w/v for under 6 years old). Two drugs identified through the initial screening, carvedilol and nifedipine, were analysed by DSC, alone and then alongside starch from corn and starch 1500; the resulting DSC curves showed no changes in peak size, position (peak onset temperatures for nifedipine and carvedilol were observed at 173.2°C and 117.3°C, respectively) and shape, as well as no additional peaks, therefore suggesting compatibility between the tested samples.ConclusionThis first phase of the development of an excipient screening platform will continue to scan several different excipients with selected active pharmaceutical ingredients (APIs) in order to create compatibility profiles. The excipient screening platform generated will accelerate and de-risk the production of age appropriate formulations, as it would allow screening for potential incompatibilities and acceptability, alongside informing formulation of appropriate oral paediatric dosage forms.ReferencesEuropean Commission. State of Paediatric Medicines in the EU. 10 years of the EU Paediatric Regulation. COM (2017) 626. Available at: https://ec.europa.eu/health/sites/health/files/files/paediatrics/docs/2017_childrensmedicines_report_en.pdfNeeds for paediatric medicines - European Medicines Agency [Internet]. 2019 [cited 28 June 2019]. Available from: https://www.ema.europa.eu/en/human-regulatory/research-development/paediatric-medicines/needs-paediatric-medicinesReflection paper: formulations of choice for the paediatric population [Internet]. European Medicines Agency. 2019 [cited 28 June 2019]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-formulations-choice-paediatric-population_en.pdf
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Patil, Pravin S., and Shashikant C. Dhawale. "DEVELOPMENT OF RITONAVIR LOADED NANOPARTICLES: IN VITRO AND IN VIVO CHARACTERIZATION." Asian Journal of Pharmaceutical and Clinical Research 11, no. 3 (March 1, 2018): 284. http://dx.doi.org/10.22159/ajpcr.2018.v11i3.23145.

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Objective: The purpose of the present investigation was to develop a nanosuspension to improve dissolution rate and oral bioavailability of ritonavir.Methods: Extended-release ritonavir loaded nanoparticles were prepared using the polymeric system by nanoprecipitation technique. Further, the effect of Eudragit RL100 (polymeric matrix) and polyvinyl alcohol (surfactant) was investigated on particle size and distribution, drug content, entrapment efficiency, and in vitro drug release from nanosuspension where a strong influence of polymeric contents was observed. Drug-excipient compatibility and amorphous nature of drug in prepared nanoparticles were confirmed by Fourier transform infrared spectroscopy, differential scanning calorimetry, and powder X-ray diffraction studies, respectively.Results: Hydrophobic portions of Eudragit RL100 could result in enhanced encapsulation efficiency. However, increase in polymer and surfactant contents lead to enlarged particle size proportionately as confirmed by transmission electron microscopy. Nanosuspension showed a significant rise in dissolution rate with complete in vitro drug release as well as higher bioavailability in rats compared to the pure drug.Conclusion: The nanoprecipitation technique used in present research could be further explored for the development of different antiretroviral drug carrier therapeutics.
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Gande, Suresh, S. Srikanth Reddy, and Bhikshapathi D. V. R. N. "Enhancement of Nimodipine Solubility by Self-Nano-emulsifying Drug Delivery System." International Journal of Pharmaceutical Sciences and Nanotechnology 12, no. 5 (September 30, 2019): 4648–56. http://dx.doi.org/10.37285/ijpsn.2019.12.5.5.

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Self-nanoemulsifying drug delivery system (SNEDDS) of Nimodipine was developed with the purpose of improving the bioavailability of the drug. Based on the results of Nimodipine solubility studies Peceol, Transcutol P and PEG 400 were optimized as oil, surfactant and co-surfactant for the formulation and Pseudo ternary plots was constructed by Chemix software. Fifteen formulations of Nimodipine SNEDDS prepared and analyzed for particle size, emulsification time, percentage drug release, percentage transmittance, in vitro drug dissolution studies and thermodynamic stability. The optimized Nimodipine SNEDDS formulation (F13) subjected to drug-excipient compatibility studies by FTIR. They are analyzed for zeta potential, SEM and stability. The particle size of optimized Nimodipine SNEDDS formulation was 25.9 nm, PDI is 0.382 and zeta potential -12.7 mV that are optimal for the stability of emulsion. SEM studies of Nimodipine SNEDDS indicated spherical shape and uniform particle distribution. The drug release of formulation F13 (98.25±4.77%) was higher than pure drug (38.49±3.88%). The stability studies indicated no change in drug content, drug release, emulsifying properties and appearance. Hence a potential SNEDDS formulation of Nimodipine developed with increased dissolution rate, bioavailability and solubility.
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42

Sharma, Hemanta Kumar, Sunita Lahkar, and Lila Kanta Nath. "Formulation and in vitro evaluation of metformin hydrochloride loaded microspheres prepared with polysaccharide extracted from natural sources." Acta Pharmaceutica 63, no. 2 (June 1, 2013): 209–22. http://dx.doi.org/10.2478/acph-2013-0019.

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The present work envisages utilisation of biodegradable and biocompatible material from natural sources for the development of controlled release microspheres of metformin hydrochloride (MetH). Natural polysaccharides extracted from Dillenia indica L. (DI), Abelmoschus esculentus L. (AE) and Bora rice flour were used in fabricating controlled release microspheres. The microspheres were prepared by the emulsion solvent diffusion technique with different proportions of natural materials and were studied for entrapment efficiency, particle size, particle shape, surface morphology, drug excipient compatibility, mucoadhesivity and in vitro release properties. The prepared microspheres showed mucoadhesive properties and controlled release of metformin hydrochloride. The study has revealed that natural materials can be used for formulation of controlled release microspheres and will provide ample opportunities for further study
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Chourasia, Ayushi, and Shikha Agrawal. "DEVELOPMENT AND EVALUATION OF CIPROFLOXACIN HYDROCHLORIDE LOADED OCULAR INSERT BY USING “PLANTAGO OVATA” AS NATURAL POLYMER." International Journal of Current Pharmaceutical Research 10, no. 4 (July 16, 2018): 79. http://dx.doi.org/10.22159/ijcpr.2018v10i4.28474.

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Objective: The present work focus in the direction of “Development and evaluation of Ciprofloxacin Hydrochloride loaded ocular insert by using “plantago ovata” as natural polymer”. The current work was carried out to evaluate the control release profile of ocular insert. Natural polymer in ocular insert was used for studying the long acting property. Natural polymer is also used to enhance the bioavailability of drug and reduce toxicity. It is also used to increase the duration of action of drug for prolongs action and gives better in vitro performance as compare than to the conventional ocular formulation.Methods: Solvent casting method was used in the formulation of Ciprofloxacin Hydrochloride loaded ocular inserts. Different ocular insert formulations of varying polymer concentration were prepared. Ocular insert formulation H-1 to H-3 was prepared by using different concentration of HPMC and formulation P-1 to P-4 was prepared by using different concentration of Plantago Ovata.Results: The ocular inserts formulation was within the acceptable limits. All the pre formulation parameters of polymers such as derived properties, compressibility index, Hausner’s ratio, viscosity, melting point, swelling ratio, loss on drying, PH of mucilage solution and pre formulation of active pharmaceutical ingredient such as estimation of drug by using UV spectroscopy, determination of melting point, solubility, partition coefficient and FTIR for compatibility study of drug and excipient were evaluation. FTIR analysis also confirmed no drug-excipient interaction.Conclusion: Prepared inserts in the present study were semitransparent. The mixing of the drug in to the polymer is uniform, due to this; the drug content of all formulation is good. Formulation P4 was selected because it showed better release profile, drug content and other physicochemical properties than other formulated batch when compare. All the prepared inserts showed in vitro drug release for the period of 4 h as compare to the marketed formulation. An in vitro drug release study revealed that ocular formulation gives a prolong action. The formulation was found to be long acting.
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Chaudhari, Pallavi M., and Madhavi A. Kuchekar. "DEVELOPMENT AND EVALUATION OF NANOEMULSION AS A CARRIER FOR TOPICAL DELIVERY SYSTEM BY BOX-BEHNKEN DESIGN." Asian Journal of Pharmaceutical and Clinical Research 11, no. 8 (August 7, 2018): 286. http://dx.doi.org/10.22159/ajpcr.2018.v11i8.26359.

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Objective: The aim of this study was to develop a nanoemulsion for topical delivery. Methods: Topical nanoemulsion was prepared by homogenization method. Box-behnken design was utilized to study the effect of oil, surfactant and Co-surfactant, on droplet size, entrapment efficiency and drug release. Nabumetone a non-steroidal anti-inflammatory drug was incorporated in castor oil with Tween 80 and Polyethylene glycol 600 to form the nanoemulsion by homogenization method. The nanoemulsion was further subjected to different evaluation parameters and ex-vivo study. The crystalline nature of drug was confirmed by powder X-ray diffraction studies. Drug-excipient compatibility was confirmed by Fourier transform infrared (FTIR) spectroscopy, differential scanning calorimetry (DSC), respectively. Results: The average globule size of nabumetone-containing nanoemulsion decreased with decrease in concentration of oil and surfactant. Nanoemulsion was evaluated by pH, rheology, globule size, zeta potential, scanning electron microscopy, DSC, FTIR spectroscopy, and stability. In vitro drug release shows maximum 84.35% permeation rate through cellophane membrane and ex-vivo drug release shows 86.32% permeation rate through goat skin. Conclusion: Thus, the nanoemulsion formulated showed good results regarding topical delivery.
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Ige, Pradum, Sagar Pardeshi, and Raju Sonawane. "Development of pH-Dependent Nanospheres for Nebulisation- In vitro Diffusion, Aerodynamic and Cytotoxicity Studies." Drug Research 68, no. 12 (April 17, 2018): 680–86. http://dx.doi.org/10.1055/a-0595-7678.

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AbstractThe aim of this work was to evaluate the in vitro performance of nebulized nanosuspension formulation when nebulized using ultrasonic nebulizer. The present investigation deals with successful formulation of Beclomethasone dipropionate loaded HPMCP nanospheres prepared by solvent evaporation technique using PEG 400 as a stabilizer. Beclomethasone dipropionate is a water insoluble drug molecule was encapsulated in HPMCP nanospheres to have pH dependent solubility at basic pH for targeted drug delivery in lung and studied for in vitro cytotoxicity and immediate release capability. The synthesized nanospheres were characterized through drug excipient compatibility, surface topography; mean particle size , zeta potential, PDI, entrapment efficiency and drug loading, in vitro diffusion, aerodynamic, in vitro cytotoxicity and stability studies. The mean particle size and PDI of the optimized batch (F1) had 197.6±0.40 nm and 0.324 ±0.35, respectively. The % entrapment efficiency and % drug loading was found to be 86.56±1.32 and 8.30±0.27, respectively. The optimized batch F1 showed % cumulative drug release 94.77±0.24 at 1 h. The formulation showed cell viability up to 91.28%. It can be concluded that, Beclomethasone dipropionate loaded HPMCP nanospheres was found to be safe, stable with significant increase in solubility and bypass the liver.
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Narala, Arjun, and Kishan Veerabrahma. "Preparation, Characterization and Evaluation of Quetiapine Fumarate Solid Lipid Nanoparticles to Improve the Oral Bioavailability." Journal of Pharmaceutics 2013 (June 3, 2013): 1–7. http://dx.doi.org/10.1155/2013/265741.

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Quetiapine fumarate is an antipsychotic drug with poor oral bioavailability (9%) due to first-pass metabolism. Present work is an attempt to improve oral bioavailability of quetiapine fumarate by incorporating in solid lipid nanoparticles (SLN). Six quetiapine fumarate SLN formulations were developed using three different lipids by hot homogenisation followed by ultrasonication. The drug excipient compatibility was studied by differential scanning calorimetry (DSC). Stable quetiapine fumarate SLNs having a mean particle size of 200–250 nm with entrapment efficiency varying in between 80% and 92% were developed. The physical stability of optimized formulation F3 was checked at room temperature for 2 months. Comparative bioavailability studies were conducted in male Wistar rats after oral administration of quetiapine fumarate suspension and SLN formulation. The relative bioavailability of quetiapine fumarate from optimized SLN preparation was increased by 3.71 times when compared with the reference quetiapine fumarate suspension. The obtained results are indicative of SLNs as potential lipid carriers for improving the bioavailability of quetiapine fumarate by minimizing first-pass metabolism.
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47

Bhusara, Hiral S., Ara T. Patel, and Mayuree D. Patel. "Development of gastroretentiv floating tablets of losartan potassium by sublimation method." International Journal of Pharmaceutical Chemistry and Analysis 8, no. 2 (July 15, 2021): 66–74. http://dx.doi.org/10.18231/j.ijpca.2021.014.

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The purpose of present study was to formulate and Evaluate Sustained release floating tablet of losartan Potassium using Camphor and Polyethylene Oxide as Pore formation for floating and release retarding agent respectively to improve gastric residence time and patient compliance in management of hypertension. The tablet was prepared by direct compression by using HPMC K4 as dry binder. Camphor and PEO as floating and release retarding agent for sustained release floating tablet. Post compression was done to increase the hardness and floating time of tablet. Release modifier was used to speed up the release of drug from sustained release floating tablet. The effect of two independent variables like amount of Sublimating agent (camphor) and amount of Polyethylene oxide (PEO) on Q30min, Q360min, and Q720min was optimized using 32 factorial design and analyzed using the software design expert 10.0.3. The observed (actual values) responses were coincided well with the predicted values, given by the optimization technique. The floating tablet were characterized by FTIR for drug excipient compatibility.
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48

Mandava, Kiranmai, Kruthika Lalit, and Venu Madhav Katla. "Formulation and Evaluation of Ketoprofen Using β-Cyclodextrin Capped Silver Nanoparticles." International Journal of Pharmaceutical Sciences and Nanotechnology 14, no. 3 (May 6, 2021): 5501–7. http://dx.doi.org/10.37285/ijpsn.2021.14.3.7.

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The objective of the study was to develop silver nanoparticles loaded with Ketoprofen (Ag-KP) for increasing the drug solubility and thereby its bioavailability. Ag-KP were prepared by the solvent evaporation method using β-Cyclodextrin as a biodegradable polymer. Different formulations of Ag-KP were characterized for the drug entrapment efficiency, Fourier Transform Infrared Spectroscopy (FTIR), particle size analysis, X-ray diffraction studies (XRD), scanning electron microscopy (SEM) and in-vitro dissolution studies. The optimized formulation (F6) has shown an average particle size of 167.8 ± 3.46 nm,zeta potential of -23.7 ± 1.46 mV. FTIR revealed that the drug showed good excipient compatibility. XRD studies showed that the drug has changed from crystalline to amorphous state. In all formulations, F6 formulation (optimized) exhibited high drug entrapment efficiency (∼93%). SEM studies indicated the shape of Ag-KP was roughly spherical with smooth surface. In vitro dissolution studies showed that Ag-KP from F6 formulation was 94.3 ± 4.9% but for the marketed formulation, it is only 84.6 ± 3.7% in 12 hours and F6 was found to be found stable for three months at both refrigerated and room temperature (RT).
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Al-dhahir, Rasha Khalid, and Myasar Al-kotaji. "FORMULATION OF ORALLY DISINTEGRATING TABLETS OF CINNARIZINE BY USING DIRECT COMPRESSION METHOD." International Journal of Applied Pharmaceutics 11, no. 1 (January 9, 2019): 117. http://dx.doi.org/10.22159/ijap.2019v11i1.29599.

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Objective: The aim of this work was to formulate and evaluate orally disintegrating tablets of cinnarizine that were prepared by direct compression method using different types of diluents and super disintegrants. The rationale behind this work was to accelerate the disintegration of the tablet to provide rapid dissolution, quick action and enhanced bioavailability of the drug.Methods: The tablets were prepared by direct compression method using different types of diluents as mannitol, microcrystalline cellulose (MCC), and lactose. Different super disintegrants were used such as crospovidone (CP), sodium starch glycolate (SSG) and Kyron T-314; Kyron T-314 was used in different concentrations of 5%, 6%, 7%, and 8%. The prepared formulae (F1-F9c) were subjected to flowability studies and post-compression evaluation studies. The optimized formula was selected depending on the time of disintegration and dissolution; then it was subjected to drug-excipient compatibility study and stability study.Results: Flowability results were ranging from excellent, excellent to good, and good to fair according to the type of the diluent used. All of the prepared tablets showed acceptable hardness, friability, drug content, and disintegration. A rapid disintegration of 11.66±2.25 s with the highest percentage 2 min-drug release of 74.55±3.01% was obtained by using the diluent lactose and the super disintegrant Kyron T-314 (8%) in the formula F9c. The infrared spectroscopic studies of the formula F9c showed no drug-excipient interaction. In addition, the stability study indicated that the optimized formula is a stable formula.Conclusion: Formula F9c of a rapidly disintegrating tablet was easy to be manufactured, and the results showed that this formula had a rapid disintegration, high dissolution profile, no noticeable chemical incompatibility and it was stable upon storage.
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Vimalson, D. Christopher, S. Parimalakrishnan, N. S. Jeganathan, and S. Anbazhagan. "SOLID DISPERSION TECHNIQUE TO ENHANCE THE SOLUBILITY AND DISSOLUTION OF FEBUXOSTAT AN BCS CLASS II DRUG." International Journal of Applied Pharmaceutics 11, no. 1 (January 9, 2019): 241. http://dx.doi.org/10.22159/ijap.2019v11i1.30539.

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Objective: The present study was aimed to enhance the solubility of poorly water-soluble drug (BCS Class II) Febuxostat using water-soluble polymers.Methods: Pre-formulation studies like drug excipient compatibility studies by Fourier-transform infrared spectroscopyDifferential scanning calorimetry and determination of saturation solubility of drug individually in various media like distilled water and pH 7.4 phosphate buffer. Solid dispersions of Febuxostat was prepared using Polyethylene glycol (PEG 6000) (fusion method) and Polyvinyl pyrrolidone (PVP K30) (solvent evaporation method) in various ratios like 1:1, 1:2, 1:3 and 1:4 separately. The formulated solid dispersions were evaluated for percentage yield, drug content and in vitro dissolution studies.Results: From the results of pre-formulation studies it was revealed that there was no interaction between drug and excipients and the pure drug was poorly soluble in water. The percentage yield of all formulations was in the range of 54-78 %, and drug content was in the range of 43-78 mg. The solid dispersion containing polyvinylpyrrolidone K 30 in 1:4 ratio showed the highest amount of drug release at the end of 30 min than other formulations.Conclusion: Finally it was concluded that solid dispersion prepared with PVP K-30 in 1:4 ratio by solvent evaporation method was more soluble than by fusion method.
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