A A COMPARATIVE STUDY OF QUALITY CONTROL TESTING ON CANDESARTAN CILEXETIL CONVENTIONAL TABLETS IN IRAQ

Objective: The present study was performed to compare the quality of conventional tablets loaded with candesartan cilexetil. The selected candesartan cilexetil tablets were commercialized in the Iraq market and produced by different companies. Methods: Different batches of candesartan cilexetil oral tablets (the concentration of candesartan was 8 mg) were subjected to quality control tests. Tests included weight variation, friability, hardness, drug content, disintegration time and in vitro release study. The protocols of these tests were performed according to USP pharmacopeia. Results: The results, in this study, revealed that all the used batches of candesartan cilexetil oral tablets complied with the specification of USP pharmacopeia for weight uniformity, friability value (% loss) was<1. Hardness results of the tablets were 4.9-6.6 Kg/cm2, which was within the required limits (i.e. 4-8 Kg/cm2). Disintegration time was<15 min in both Simulated Gastric Fluid (SGF) and Simulated Intestinal Fluid (SIF). The percentage of drug content in all marketed tablets was found between 96.2 % and 99.8 %, reflecting compliance with the pharmacopeia limits (i.e. 85-115 %). An in vitro release study indicated that the release of all marketed tablets exceeds 80 % within 15 min. Conclusion: All the studied tablets, loaded with candesartan cilexetil, were produced within the standard criteria of tablet production. The quality control analysis of the selected tablets, in this study, revealed satisfactory pharmaceutical properties (including safety and effectiveness) that comply within the limits of USP pharmacopeia.

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QUALITY CONTROL TESTING OF CONVENTIONAL CLOPIDOGREL BISULFATE TABLETS MARKETED IN IRAQ

International Journal of Applied Pharmaceutics ◽

10.22159/ijap.2022v14i1.43331 ◽

2022 ◽

pp. 221-225

Author(s):

MAZIN THAMIR ABDUL-HASAN ◽

ABULFADHEL JABER NEAMAH Al-SHAIBANI ◽

ALI N. WANNAS ◽

KARRAR MOHAMMED HASAN AL-GBURI

Keyword(s):

Quality Control ◽

In Vitro Release ◽

Gastric Fluid ◽

Disintegration Time ◽

Drug Content ◽

Clopidogrel Bisulfate ◽

Weight Variation ◽

Release Study ◽

Vitro Release

Objective: This study was employed to evaluate the quality of marketed oral tablets containing clopidogrel bisulfate. Tablets produced by various companies and commercialized in the Iraq market were used in the study. Methods: Batches of clopidogrel bisulfate conventional tablets (containing 75 mg of drug) were exposed to the quality control tests. These tests involved friability, weight variation, hardness, drug content, disintegration time, and in vitro release study; these tests were conducted depending on USP pharmacopeia. Results: The data indicate that all batches of clopidogrel bisulfate complied with the limitations of USP pharmacopeia for variation of weight, results of the hardness of tablets were 7.2-9.6 Kg/cm2. Friability value (% loss) was less than one, which was within the required limits. The time of disintegration was less than 25 min in both artificial gastric fluid (AGF) and artificial intestinal fluid (AIF). Drug content was observed between 97.1 % and 99.8 %, indicating compliance with the limits of pharmacopeia (85-115 %). An in vitro release study of batches was greater than 80 % within 25 min. Conclusion: All batches of clopidogrel bisulfate were manufactured within the criteria of tablet manufacturing. The quality control tests of tablets showed acceptable pharmaceutical properties (effectiveness and safety) that lie within the limits of USP pharmacopeia.

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In-Vitro Comparative Quality Evaluation of Marketed Cefuroxime 250 mg Tablets in Bangladesh

European Journal of Medical and Health Sciences ◽

10.34104/ejmhs.020012015 ◽

2020 ◽

pp. 12-15

Keyword(s):

Quality Control ◽

Quality Evaluation ◽

In Vitro Release ◽

Control Parameters ◽

Dissolution Tests ◽

Quality Control Parameters ◽

Retail Outlets ◽

Release Study ◽

Vitro Release

The study evaluated different quality control parameters of five brands of Cefuroxime 250mg tablets which are already marketed in Bangladesh. Five brands of the drug sourced from different retail outlets to assess the quality assessment and comparison of the tablets using the in-vitro release study. The brands were subjected to various official tests including uniformity of weight, thickness test, dissolution tests, and cumulative % of drug release and friability test. This research further focuses on the requirement of manufacturers to construct quality into their products during manufacture and also sustain the built-in quality from batch to batch in line with the principles of cGMP.

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INTEND, DEPICTION IN VITRO AND IN VIVO APPRAISAL OF GLIPIZIDE FLOATING MICROSPHERES USING ETHYL CELLLULOSE AND HYDROXYL PROPYL METHYL CELLULOSE AS POLYMER BY SUBSTANTIALLY MODIFIED METHOD

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2016.v9i5.12621 ◽

2016 ◽

Vol 9 (5) ◽

pp. 112

Author(s):

Rishikesh Gupta ◽

Sk Prajapati ◽

Snigdha Pattnaik ◽

Peeyush Bhardwaj

Keyword(s):

Particle Size ◽

In Vitro Release ◽

Methyl Cellulose ◽

Gastric Fluid ◽

Simulated Gastric Fluid ◽

Size Analysis ◽

Release Study ◽

Tapped Density ◽

Vitro Release

ABSTRACTObjective: The purpose of this research was to formulate and evaluate floating microsphere of glipizide.Methods: Glipizide microsphere containing ethyl cellulose (EC) and hydroxyl propyl methyl cellulose (HPMC) were prepared by solvent evaporationmethod. Polymer to drug ratio affected characteristics of microspheres. Microspheres were discrete, spherical, and perforated form. The microspheresexhibited good floating property and achieved good gastric retention.Result: In vitro performance was evaluated by the usual pharmacopoeial and other tests such as drug polymer compatibility (Fourier transforminfrared scan), yield (%), micrometric properties such as tapped density (%). Compressibility particle size analysis (by optical microscopy), drugentrapment efficiency, surface topography (scanning electron microscope), and in vitro release study. On the basis of results, increasing the polymerratio increased the particle size (195.6±20.24 to 200.89±16.61), increased tapped density (maximum 0.29.60±0.00037 HGF4, batch), and decreased% compressibility (2.13±0.188). Drug loaded floating microspheres were found to be float more than 12 hrs on simulated gastric fluid (pH-1.2).Maximum drug entrapment was found in batch HGF3 (Drug:HPMC:EC) (1:1:3). Electron microscopy showed its perforated surface with hollowness.After 10 hrs, maximum release was found to be 78.0% (batch-GF1).Conclusion: The release study was performed in simulated gastric fluid with 0.02% tween80. The best release result was obtained at the ratio ofdrug: polymer (1:1).Keywords: Floating microspheres, Glipizide, Gastrorentensive system, In vitro release.

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Formulation and Development of Fast Disintegrating Azelnidipine Tablets: Functionality of Superdisintegrants

International Journal of Pharmaceutical Sciences Review and Research ◽

10.47583/ijpsrr.2021.v68i02.017 ◽

2021 ◽

Vol 68 (2) ◽

Author(s):

S.K. Sathish ◽

V.P. Pandey

Keyword(s):

Dissolution Rate ◽

In Vitro Release ◽

Disintegration Time ◽

Drug Content ◽

Kneading Method ◽

Dissolution Efficiency ◽

The Individual ◽

Main Effects ◽

Vitro Release

Azelnidipine, a calcium channel blocker, is used for hypertension and angina pectoris. Azelnidipine fast-disintegrating tablets (FDT) have been prepared by kneading method. In the present study cyclodextrins (?CD and HP?CD) and surfactants (Kolliphor HS15) were tried to enhance the solubility and dissolution rate of Azelnidipine. The individual main effects and combined (interaction) effects of cyclodextrins and surfactants on the solubility and dissolution rate of Azelnidipine was evaluated in a series of 22 factorial experiments.) The hardness, friability, drug content and disintegration time, in vitro release and stability parameter has been studied. Hardness of the tablets was in the range 6.0 –7.5 kg/sq.cm. Percent weight loss in the friability test was less than 0.85% with all the formulations. The disintegration time was in the range 1 –3.5 min. with all the tablets prepared. Drug content of the tablets was within 100 ± 2% of the labeled claim. The dissolution efficiency was also increased from 4.56% for formulation E1 to 41.54 % and 36.59 % respectively for formulations E4 and E8. The formulation did not show any change in disintegration time and drug content after stability period. It was concluded that fast disintegrating Azelnidipine tablets can be prepared by kneading method using super disintegrants.

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FORMULATION AND EVALUATION OF IMPLANTABLE DRUG DELIVERY SYSTEM OF TEMOZOLOMIDE BY USING HYDROPHILIC POLYMER

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2017.v10i11.20070 ◽

2017 ◽

Vol 10 (11) ◽

pp. 239

Author(s):

Sindhu Vemula ◽

Bhavya S ◽

Suresh Kumar P ◽

Jeyabaskaran M ◽

Praveenkumar T ◽

...

Keyword(s):

Drug Delivery ◽

Drug Delivery System ◽

Delivery System ◽

In Vitro Release ◽

Hydrophilic Polymer ◽

Short Term ◽

Drug Content ◽

Release Study ◽

Vitro Release

Objective: The present research study was carried out to formulate and evaluate the implants of temozolomide using hydrophilic polymer.Methods: Temozolomide implants were formulated using extrusion method with different grades of carbopol. The powdered blend was evaluated for micromeritic properties such as angle of repose, bulk density, tapped density, Carr’s index, and Hausner’s ratio. The formulated implants were analyzed for drug content uniformity, thickness, weight variation, and short-term stability study. In vitro release study of implants was performed using 0.1N hydrochloric acid, and it is maintained at 37°C±0.5°C.Results: In vitro release study demonstrated that the release rate of temozolomide from the implant matrix was a function of concentration of the polymer. As the concentration of polymer was increased, drug release from the matrix was extended. The release of drug from all implant formulations was found to be uniform and was extended over a period of 12 hrs. The implant formulations were found sterile, uniform in weight and size. The drug content was found to be in the range of 97.2-101.33%.Conclusion: Drug interaction studies revealed that there were no chemical interactions between temozolomide and polymers used in the study. Short-term stability studies of implants revealed that implants were stable, and there were no significant changes in the physical appearance and drug content of the implant formulations. The results of the study demonstrated that implantable drug delivery system of temozolomide can be formulated using hydrophilic polymer.

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Formulation and Development of Fast Disintegrating Efonidipine Tablets: Functionality of Superdisintegrants

International Journal of Pharmaceutical Sciences Review and Research ◽

10.47583/ijpsrr.2021.v68i01.016 ◽

2021 ◽

Vol 68 (1) ◽

Author(s):

S.K. Sathish ◽

V.P. Pandey

Keyword(s):

Dissolution Rate ◽

In Vitro Release ◽

Disintegration Time ◽

Drug Content ◽

Kneading Method ◽

Dissolution Efficiency ◽

The Individual ◽

Main Effects ◽

Vitro Release

Efnodipine, a calcium channel blocker, is used for hypertension and angina pectoris. Efnodipine fast-disintegrating tablets (FDT) have been prepared by kneading method. In the present study cyclodextrins (?CD and HP?CD) and surfactants (Kolliphor HS15) were tried to enhance the solubility and dissolution rate of Efnodipine. The individual main effects and combined (interaction) effects of cyclodextrins and surfactants on the solubility and dissolution rate of Efnodipine was evaluated in a series of 22 factorial experiments.) The hardness, friability, drug content and disintegration time, in vitro release and stability parameter has been studied. Hardness of the tablets was in the range 6.0 –7.5 kg/sq.cm. Percent weight loss in the friability test was less than 0.85% with all the formulations. The disintegration time was in the range 1 –3.5 min. with all the tablets prepared. Drug content of the tablets was within100 ± 2% of the labeled claim. The dissolution efficiency was also increased from 4.56% for formulation E1 to 41.54 % and 36.59 % respectively for formulations E4 and E8. The formulation did not show any change in disintegration time and drug content after stability period. It was concluded that fast disintegrating Efnodipine tablets can be prepared by kneading method using super disintegrants.

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Development, in vitro and in vivo Evaluations of Solid-Lipid Microparticles based on Solidified Micellar Carrier System for Oral Delivery of Cefepime

International Journal of Pharmaceutical Sciences and Nanotechnology ◽

10.37285/ijpsn.2017.10.1.3 ◽

2017 ◽

Vol 10 (1) ◽

pp. 3582-3593

Author(s):

Chukwuebuka Umeyor ◽

Uchechukwu Nnadozie ◽

Anthony Attama

Keyword(s):

Oral Delivery ◽

In Vitro Release ◽

Carrier System ◽

Solid Lipid ◽

Solid Lipid Microparticles ◽

Release Study ◽

Lipid Microparticles ◽

Vitro Release

This study seeks to formulate and evaluate a solid lipid nanoparticle-based, solidified micellar carrier system for oral delivery of cefepime. Cefepime has enjoyed a lot of therapeutic usage in the treatment of susceptible bacterial infections; however, its use is limited due to its administration as an injection only with poor patient compliance. Since oral drug administration encourage high patient compliance with resultant effect in improved therapy, cefepime was formulated as solid lipid microparticles for oral delivery using the concept of solidified micellar carrier system. The carrier system was evaluated based on particle yield, particle size and morphology, encapsulation efficiency (EE %), and thermal analysis using differential scanning calorimeter (DSC). Preliminary microbiological studies were done using gram positive and negative bacteria. In vitro release study was performed using biorelevant media, while in vivo release study was performed in white albino rats. The yield of solid lipid microparticles (SLM) ranged from 84.2 – 98.0 %. The SLM were spherical with size ranges of 3.8 ± 1.2 to 42.0 ± 1.4 µm. The EE % calculated ranged from 83.6 – 94.8 %. Thermal analysis showed that SLM was less crystalline with high potential for drug entrapment. Microbial studies showed that cefepime retained its broad spectrum anti-bacterial activity. In vitro release showed sustained release of cefepime from SLM, and in vivo release study showed high concentration of cefepime released in the plasma of study rats. The study showed that smart engineering of solidified micellar carrier system could be used to improve oral delivery of cefepime.

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Formulation and Evaluation of Sustained Release Dosage Forms of Norfloxacin

International Journal of Pharmaceutical Sciences and Nanotechnology ◽

10.37285/ijpsn.2018.11.6.6 ◽

2018 ◽

Vol 11 (6) ◽

pp. 4331-4337

Author(s):

C Suja ◽

Sismy C

Keyword(s):

Sustained Release ◽

Guar Gum ◽

In Vitro Release ◽

Angle Of Repose ◽

Prolonged Release ◽

Weight Variation ◽

Sustained Release Tablets ◽

Release Study ◽

Vitro Release

The goal of this study was to formulate and evaluate norfloxacin sustained release tablets. Norfloxacin sustained release tablets were prepared by wet granulation method using two polymers such as HPMC K 100 M (hydrophilic polymer) and guar gum (natural polymer) and with three polymer ratios (0.5, 1.0 and 1.5). The prepared granules were evaluated to preformulation studies such as angle of repose, bulk density, tapped density, bulkiness, compressibility index and Hauser’s ratio. All the parameters shows that the granules having good flow properties. Then the formulated tablets were taken to evaluation studies such as hardness, weight variation, friability, drug content and thickness. All the parameters were within the acceptable limits. IR spectral analysis showed that there was no interaction between the drug and polymers. The in vitro release study was performed in phosphate buffer pH 7.4 at 293 nm. The in vitro release study showed that if the polymer ratio is increased, then the release of the drug is prolonged. HPMC K 100M shows a prolonged release when compared to guar gum.

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