scholarly journals QUALITY CONTROL TESTING OF CONVENTIONAL CLOPIDOGREL BISULFATE TABLETS MARKETED IN IRAQ

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.

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

2020 ◽  
pp. 103-108
Author(s):  
KARRAR TALIB KHUDHAIR ALBO HAMRAH ◽  
ABULFADHEL JABER NEAMAH AL-SHAIBANI ◽  
SARMAD SABAH AL-EDRESI ◽  
KARRAR MOHAMMED HASAN AL-GBURI
Keyword(s):  
Quality Control ◽  
Candesartan Cilexetil ◽  
In Vitro Release ◽  
Simulated Gastric Fluid ◽  
Control Analysis ◽  
Disintegration Time ◽  
Drug Content ◽  
Release Study ◽  
Vitro Release

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.

Formulation and Evaluation of Sustained Release Dosage Forms of Norfloxacin

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.

scholarly journals Design and evaluation of Pulsatile drug delivery of Losartan Potassium

2014 ◽  
Vol 12 (2) ◽  
pp. 119-123
Author(s):  
MS Ashwini ◽  
Mohammed Gulzar Ahmed
Keyword(s):  
In Vitro Release ◽  
Losartan Potassium ◽  
Stability Studies ◽  
In Vitro Drug Release ◽  
Drug Content ◽  
Weight Variation ◽  
Release Studies ◽  
The Stability ◽  
Vitro Release

The study was designed for the investigation of pulsatile device to achieve time or site specific release of Losartan potassium based on chronopharmaceutical considerations. The basic design involves the preparation of cross linked hard gelatin capsules by using formaldehyde, then the drug diluent mixture were prepared and loaded in, which was separated by using hydrogel plugs of different polymers of different viscosities. Prepared formulations were subjected to evaluation of various parameters like weight variation, percentage drug content, in vitro drug release and stability studies. Weight variation and percentage drug content results showed that they were within the limits of official standards. The in-vitro release studies revealed that the capsules plugged with polymer HPMC showed better pulsatile or sustained release property as compared to the other formulations. The stability studies were carried out for all the formulations and formulations F1 & F2 were found to be stable. Dhaka Univ. J. Pharm. Sci. 12(2): 119-123, 2013 (December) DOI: http://dx.doi.org/10.3329/dujps.v12i2.17610

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

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.

scholarly journals Use of hydrophilic and hydrophobic polymers for the development of controlled release tizanidine matrix tablets

2014 ◽  
Vol 50 (4) ◽  
pp. 799-818 ◽  
Author(s):  
Tariq Ali ◽  
Muhammad Harris Shoaib ◽  
Rabia Ismail Yousuf ◽  
Sabahat Jabeen ◽  
Iyad Naeem Muhammad ◽  
...  
Keyword(s):  
Controlled Release ◽  
Drug Release ◽  
In Vitro Release ◽  
Angle Of Repose ◽  
In Vitro Dissolution ◽  
Physical Parameters ◽  
Disintegration Time ◽  
Weight Variation ◽  
Vitro Release

The aim of the present study was to develop tizanidine controlled release matrix. Formulations were designed using central composite method with the help of design expert version 7.0 software. Avicel pH 101 in the range of 14-50% was used as a filler, while HPMC K4M and K100M in the range of 25-55%, Ethylcellulose 10 ST and 10FP in the range of 15 - 45% and Kollidon SR in the range of 25-60% were used as controlled release agents in designing different formulations. Various physical parameters including powder flow for blends and weight variation, thickness, hardness, friability, disintegration time and in-vitro release were tested for tablets. Assay of tablets were also performed as specified in USP 35 NF 32. Physical parameters of both powder blend and compressed tablets such as compressibility index, angle of repose, weight variation, thickness, hardness, friability, disintegration time and assay were evaluated and found to be satisfactory for formulations K4M2, K4M3, K4M9, K100M2, K100M3, K100M9, E10FP2, E10FP9, KSR2, KSR3 & KSR9. In vitro dissolution study was conducted in 900 ml of 0.1N HCl, phosphate buffer pH 4.5 and 6.8 medium using USP Apparatus II. In vitro release profiles indicated that formulations prepared with Ethocel 10 standard were unable to control the release of drug while formulations K4M2, K100M9, E10FP2 & KSR2 having polymer content ranging from 40-55% showed a controlled drug release pattern in the above mentioned medium. Zero-order drug release kinetics was observed for formulations K4M2, K100M9, E10FP2 & KSR2. Similarity test (f2) results for K4M2, E10FP2 & KSR2 were found to be comparable with reference formulation K100M9. Response Surface plots were also prepared for evaluating the effect of independent variable on the responses. Stability study was performed as per ICH guidelines and the calculated shelf life was 24-30 months for formulation K4M2, K100M9 and E10FP2.

scholarly journals Direct Compression and in vitro Release of Chlorpheniramine Maleate from Tablets Containing Fluid Bed Dried and Lyophilized Microcrystalline Cellulose Derived from Cocos nucifera

2019 ◽  
pp. 1-15
Author(s):  
Nkemakolam Nwachukwu ◽  
Kenneth Chinedu Ugoeze ◽  
Ogbonna Okorie ◽  
Sabinus Ifeanyi Ofoefule
Keyword(s):  
Microcrystalline Cellulose ◽  
Cocos Nucifera ◽  
In Vitro Release ◽  
Mineral Acid ◽  
Chlorpheniramine Maleate ◽  
Disintegration Time ◽  
Weight Variation ◽  
Fluid Bed ◽  
Vitro Release

Aims: To investigate the mechanical and in vitro release properties of chlorpheniramine maleate (CM) tablets formulated with fluid bed dried and lyophilized microcrystalline cellulose (MCC) derived from the fruit husk of Cocos nucifera (CN). Study Design: Experimental design. Place and Duration of Study: Department of Pharmaceutical Technology and Industrial Pharmacy, University of Nigeria, Nsukka from January, 2015 to December, 2016. Methods: Chips of matured (CN) fruit husk were de-lignified by soda treatment methods to obtain alpha cellulose which was hydrolyzed with mineral acid (Hydrochloric acid) to obtain CN-MCC. A portion of the damp CN-MCC was fluid bed dried at 60°C for 2 h (coded MCCF-Cocos) and the remaining CN-MCC was lyophilized at -45°C for 3 h (coded MCCL-Cocos). The MCC powders were blended with 20, 30 and 40% w/w CM and directly compressed at 9.81 mega Pascal (mPa). The CM tablets containing MCCF-Cocos (coded CM-CF) and MCCL-Cocos (coded CM-CL) were evaluated using standard methods. Results: Both batches had tablets with minimal weight variation; CM-CL tablets were mechanically stronger (P = .037) and less friable than CM-CF tablets.  CM-CL tablets took a longer time to disintegrate than CM-CF tablets. Comparatively, CM tablets containing AVC-102 (coded CM-AV) were mechanically stronger, less friable and had a longer disintegration time than CM-CL and CM-CF tablets. The dilution potential of CM-AV was greater than CM-CL and CM-CF tablets. CM release was faster in CM-CF. There was more than 80 % release of CM from CM-CF, CM-CL and CM-AV tablets within 30 min. Although CM-CL tablets were mechanically stronger than CM-CF, the data for all batches of the tablets obtained fell within the British Pharmacopoeia set limits for uncoated tablets. Conclusion: Chlorpheniramine maleate tablets containing fluid bed dried and lyophilized microcrystalline cellulose obtained from C. nucifera had good mechanical and in vitro release properties.

scholarly journals 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

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.

scholarly journals FORMULATION AND EVALUATION OF MEDICATED LOZENGES FOR SORE THROAT

2020 ◽  
pp. 62-67
Author(s):  
RUPALI CHANDA ◽  
LAVANYA NALLAGUNTLA
Keyword(s):  
Sore Throat ◽  
Solid Dispersion ◽  
In Vitro Release ◽  
Infrared Study ◽  
Weight Variation ◽  
Release Study ◽  
Long Acting ◽  
H1 Receptor Antagonist ◽  
Vitro Release

Objective: The objective of the present work was to formulate and evaluate lozenges for a sore throat using Loratadine. Loratadine is a long-acting peripheral H1-receptor antagonist which is mainly used as an antihistamine. Loratadine lozenges were prepared to prevent the itching and inflammation in sore throat. Methods: Solid dispersion of Loratadine was prepared using β-cyclodextrin in the ratios of 1:1, 1:2, and 1:3 to enhance the solubility of Loratadine. The prepared solid dispersion of Loratadine was analyzed for solubility enhancement. Loratadine lozenges were then formulated with mannitol, sucrose, acacia, xanthan gum, liquid glucose by heat, and congealing technique. The prepared lozenges were evaluated for drug-excipient incompatibility study, diameter, thickness, weight variation, hardness, friability, in vitro release study, and drug content. Results: The results of the Fourier transform infrared study showed that there was no interaction between the selected drug and excipients. In vitro drug release study of Loratadine lozenges were performed in pH 6.8 phosphate buffer, wherein >90% of the drug was released within 30 min for all the formulations. The lozenges were optimized based on in vitro release data. Formulation F7 of Loratadine lozenges exhibited 99.1% release in 30 min. Stability studies revealed that the formulation was stable. Conclusion: From the present work, it was concluded that the Loratadine lozenges can be considered as a suitable delivery system for the treatment of sore throat.

DESIGN AND CHARACTERIZATION OF ACECLOFENAC FAST DISSOLVING TABLETS USING SUPER DISINTEGRATING AGENTS

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (01) ◽  
pp. 34-40
Author(s):  
V.L Narasaiah ◽  
◽  
Ch. Praneetha ◽  
P Mallika ◽  
K. Pullamma ◽  
...  
Keyword(s):  
Drug Release ◽  
In Vitro Release ◽  
In Vitro Dissolution ◽  
Wet Granulation ◽  
Content Uniformity ◽  
Disintegration Time ◽  
First Order ◽  
Drug Content ◽  
Weight Variation

The aim of this project was to develop fast dissolving tablets (FDT) of aceclofenac by wet granulation using super disintegrating agents such as cross carmellose sodium (CCS), Crospovidone (CP) and sodium starch glycolate (SSG) were formulated and evaluated. The tablets evaluated for thickness, hardness, friability weight variation, drug content, water absorption ratio, wetting time, disintegration time and in vitro dissolution studies. The in vitro release studies were conducted in pH 7.4 phosphate buffer. Different release models like zero order, first order, Higuchi and Korsmeyer-Peppas were applied to in vitro drug release data in order to evaluate drug release mechanisms and kinetics. The formulation ‘F4’ showed satisfactory physico-chemical properties and drug content uniformity. The formulation ‘F4’ follows first order kinetics and the mechanism of drug release was governed by Higuchi. The ‘n’ value showed between <0.5, it was followed that Fickian transport. The FTIR studies were conducted and it shows that there is no interaction between drug and excipients.

scholarly journals FORMULATION AND EVALUATION OF METOCLOPRAMIDE HCL RECTAL SUPPOSITORIES

2019 ◽  
Author(s):  
Deborah Ejiogu Chioma ◽  
Felix Sunday Yusuf
Keyword(s):  
Drug Release ◽  
Release Kinetics ◽  
Diffusion Mechanism ◽  
In Vitro Release ◽  
Content Uniformity ◽  
Disintegration Time ◽  
Weight Variation ◽  
Rectal Suppositories ◽  
Vitro Release

Metoclopramide hydrochloride is a dopamine receptor antagonist, used mostly for stomach and esophageal problems as it is a prokinetic agent. The aim of the present study was to design and evaluate the suppositories of Metoclopramide HCl.  Six different, rectal suppositories were developed by fusion (pour-moulding) method by employing various hydrophilic and hydrophobic polymeric bases like gelatin, PEG-400 and hydrogenated vegetable oil using propylene glycol as plasticizer and beeswax as hardening agent.  Metoclopramide HCl suppositories were evaluated for appearance, weight variation, drug content uniformity, liquefaction time and temperature, micro-melting range, disintegration and in-vitro release study.  The in-vitro release rate data was evaluated statistically and was found that from all the formulations the drug release is by diffusion mechanism. Optimum formulation of batch S1 has shown 83.427% Metoclopramide HCl in a study of 2 hrs. These drug release results are supported by the disintegration time of suppositories. Lesser the disintegration time faster the drug release. All formulations has shown zero, first and Higuchi release kinetics. The result suggests that the Metoclopramide HCl suppositories can be prepared by employing hydrophilic and hydrophobic polymers.

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