scholarly journals Quality analysis of different marketed brands of paracetamol available in Bangladesh

2015 ◽  
Vol 4 (9) ◽  
pp. 432-435
Author(s):  
Auditi Kar ◽  
Mohammad Nurul Amin ◽  
Mohammad Salim Hossain ◽  
Md. Emdadul Hasan Mukul ◽  
Md. Saif Uddin Rashed ◽  
...  
Keyword(s):  
Pharmaceutical Journal ◽  
Quality Analysis ◽  
Dissolution Profile ◽  
Disintegration Time ◽  
Weight Variation ◽  
Tablet Formulations ◽  
Almost All ◽  
Tablet Hardness ◽  
Standard Techniques

Paracetamol is a widely used analgesic and antipyretic drug worldwide. The present study was conducted to analyze the quality of seven marketed brands of paracetamol tablet formulation manufactured by different multinational and national companies. The tablet formulations of different brands were tested for various parameters like weight variation, hardness, friability, disintegration time and dissolution profile using standard techniques to evaluate their quality. The values were compared with the standards. Weight variation value requirement was complied by all brands. All studied samples except two local products complied with the standard specification for tablet hardness. All brands showed impressive friability values and products of multinational companies comparatively exhibited the highest values. Disintegration time for all brands was within 15 minutes also complying the USP (United State of Pharmacopeia) recommendation. Moreover, the release rate of different brands of paracetamol was satisfactory within 45 minutes and ranged from 79.82% to 103.53%. Therefore, it can be concluded that almost all the brands of paracetamol that are available in Bangladesh meet the USP specification for quality control analysis.Kar et al., International Current Pharmaceutical Journal, August 2015, 4(9): 432-435

scholarly journals Eight enteric-coated 50 mg diclofenac sodium tablet formulations marketed in Saudi Arabia: in vitro quality evaluation

2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Muhammad M. Hammami ◽  
Rajaa F. Hussein ◽  
Reem AlSwayeh ◽  
Syed N. Alvi
Keyword(s):  
Quality Evaluation ◽  
Diclofenac Sodium ◽  
Dissolution Profile ◽  
Disintegration Time ◽  
United States Pharmacopoeia ◽  
Weight Variation ◽  
Tablet Formulations ◽  
Enteric Coated

Abstract Objective To evaluate in vitro quality of enteric-coated 50 mg diclofenac sodium tablet formulations on Saudi market. Results A reference and seven generic (G1-7) formulations were commercially available in December 2019/January 2020 and were assessed within 25–75% of manufacture-expiration period. Weight variation (range as% difference from mean, n = 20), active substance content (ASC, mean (SD) as% difference from label, n = 20), hardness (mean (SD), n = 10), and friability (% weight loss, n = 20) were 97–103%, 102.0% (3.4%), 15.4 (1.1) kg, and 0.24%, respectively, for the reference. For G2-7, they were ≤ ±5%, 98.6% (4.0%) to 109.9% (1.8%), 11.9 (0.9) to 18.3 (0.8) kg, and ≤ 0.00 to 0.75%, respectively. G1 ASC, hardness, and friability were 111.3% (1.7%), 20.1 (1.7) kg, and 1.10%, respectively. Disintegration time (n = 6) and dissolution profile (n = 8) were also determined. No formulation disintegrated or released ˃ 0.1% of label ASC in 0.1 N HCl for 2 h. The reference disintegrated in 15:00 min:seconds and released a mean (range) of 100% (99–103%) of label ASC by 45 min in phosphate buffer (pH = 6.8). G1-7 disintegrated in 8:53 to 20:37 min:seconds and released 81% (69–90%) (G1) to 109%. Except for borderline performance of G1, all formulations passed in vitro quality tests according to United States Pharmacopoeia.

scholarly journals In-vitro comparative evaluation of quality control parameters between paracetamol and paracetamol/caffeine tablets available in Bangladesh

2012 ◽  
Vol 1 (5) ◽  
pp. 103-109 ◽  
Author(s):  
Palash Karmakar ◽  
Md Golam Kibria
Keyword(s):  
Quality Control ◽  
Pharmaceutical Journal ◽  
Dissolution Profile ◽  
Control Parameters ◽  
Disintegration Time ◽  
Weight Variation ◽  
Quality Control Parameters ◽  
Standard Quality ◽  
Tablet Hardness

Paracetamol is a widely used non-prescription analgesic and antipyretic medicine. The study was conducted to assess the comparative in-vitro quality control parameters through the evaluation of weight variation, hardness, friability, disintegration time and dissolution profile between the commercially available tablet brands of paraceta-mol and paracetamol/caffeine combination in Bangladesh. Tablets of five top level manufacturers those have both of the formulations were evaluated in two groups. Both similarities and dissimilarities were found between the groups. All tablets either paracetamol (1.07 to 2.14%) or paracetamol/caffeine (0.98 to 2.09%) showed acceptable weight variation and friability (below 1%). Formulations were somewhat different in their hardness, disintegration time and dissolution profile. All tablets of paracetamol/caffeine were found harder than paracetamol tablets of the same manufacturer. 1 out of 5 for paracetamol and 3 out of 5 for paracetamol/caffeine tablets exceeded the limit of tablet hardness or crushing strength. The disintegration time in 0.1N HCl of paracetamol tablet brands (24 seconds to 4 minutes 52 seconds) were less than the paracetamol/caffeine (6 minutes 33 seconds to 17 minutes 43 seconds) brands. On the other hand in phosphate buffer, pH 7.4, paracetamol/caffeine tablets dissolved quickly and showed better release profile than tablets containing only paracetamol. It can be concluded that standard quality control parameters always should be maintained not only for paracetamol or its combination but also for all kinds of medicine for getting better drug products.DOI: http://dx.doi.org/10.3329/icpj.v1i5.10282International Current Pharmaceutical Journal 2012, 1(5): 103-109

scholarly journals In vitro Quality Analysis of Different Brands of Alprazolam Tablet Available in Bangladesh

2015 ◽  
Vol 16 (2) ◽  
pp. 185-188
Author(s):  
Golam Sarwar ◽  
Abhijit Das ◽  
Md Golam Kibria ◽  
Palash Karmakar ◽  
Mohammad Mafruhi Sattar
Keyword(s):  
Chemical Properties ◽  
Pharmaceutical Journal ◽  
Quality Analysis ◽  
Water Medium ◽  
Clinical Effects ◽  
Dissolution Profile ◽  
Disintegration Time ◽  
Weight Variation ◽  
Physico Chemical

Alprazolam is a benzodiazepine anxiolytic commonly prescribed as a sleeping aid and for the treatment of anxiety disorders. The current study was undertaken with the aim of analyzing quality of commercially available brands of alprazolam tablets available in Bangladesh. To assess the quality, locally available 0.25 mg alprazolam tablet of seven different manufacturers were selected and certain physico-chemical parameters like weight variation, hardness, friability, disintegration time and dissolution profile etc. were evaluated using in-vitro analytical methods. All the tablet brands met the requirements of British Pharmacopoeia as they showed acceptable weight variation and friability (below 1%). Brands were slightly different in hardness, disintegration time and dissolution profile from each other. The hardness of all the brands was found to be in the range of 1.50±0.18 to 4.21±0.11 kg-ft. In water medium the disintegration time of all brands were found to be 0.57±0.45 to 2.22±0.23 min. Five out of seven brands showed better dissolution profile as they released more than 90% drug in 30 min. The study revealed that most of the marketed alprazolam tablets met the BP standards for physico-chemical properties which are the indicators of drug quality. It can be concluded that drug products should always comply standard quality parameters that are the prerequisites for getting satisfactory clinical effects. DOI: http://dx.doi.org/10.3329/bpj.v16i2.22302 Bangladesh Pharmaceutical Journal 16(2): 185-188, 2013

scholarly journals In vitro Comparative Quality Evaluation of Different Brands of Marketed Paracetamol Tablets Available in Bangladesh

2021 ◽  
pp. 26-32
Author(s):  
Mahfuza Rahman ◽  
Khurshida Akter ◽  
Md. Shahin Sarker ◽  
Jinat Fatema Sharna ◽  
Mir Imam Ibne Wahed
Keyword(s):  
Quality Parameters ◽  
Dissolution Time ◽  
Disintegration Time ◽  
Hardness Tester ◽  
Weight Variation ◽  
Retail Outlets ◽  
General Quality ◽  
Almost All

Aim: This study was performed to evaluate the quality of five brands of Paracetamol 500mg tablets from different manufacturers. Methods: The general quality parameters of these tablets like weight variation, hardness, thickness, diameter, friability, disintegration time and also dissolution time were evaluated according to the established protocols. For measuring weight variation, an electric analytical balance was used. The hardness, thickness and diameter were determined by an automated hardness tester. Friability was measured by a friabilator. Disintegration time and dissolution time were analyzed by disintegration apparatus and dissolution tester respectively. Results: In this study, all the five brands of the tablets passed the BP or USP standards for in vitro evaluation tests with a very slight deviation. All brands complied with the standards for weight variation (550.1±5.88 mg to 631.1±4.71 mg), hardness (121.60±6.6 N to 220.20±7.6), disintegration time (3 minutes 15 seconds to 5 minutes 30 seconds). However, in case of friability, although brand A showed slight deviation, the remaining had shown the satisfactory results with the standard. In addition, the drug release rate of different brands of paracetamol was satisfactory within 30 minutes and ranged from 90.88% to 103.75%. Conclusion: It can be concluded that almost all the tablets of paracetamol purchased from retail outlets in Bangladesh are manufactured and marketed according to GMP. Further work is recommended on bioequivalence of these tablets.

scholarly journals In vitro Comparative Quality Evaluation of Formulated and Marketed Losartan Potassium 25 Mg Tablets

2021 ◽  
pp. 239-245
Author(s):  
Md. Emran Hossain ◽  
Sukria Hossain ◽  
Md. Shahin Sarker ◽  
Mst. Mahfuza Rahman ◽  
Mir Imam Ibne Wahed
Keyword(s):  
Quality Control ◽  
Drug Product ◽  
Qualitative Evaluation ◽  
Quality Standard ◽  
Losartan Potassium ◽  
Dissolution Profile ◽  
Disintegration Time ◽  
Weight Variation

Background: The outcome of the drug therapy depends largely on the quality of the drug product. The lower quality of the drug product can be the reason for therapeutic failure. The present study was designed to evaluate the quality standard of Losartan Potassium tablet brands available in Bangladesh market to get an idea of quality standard of drug product people consuming in this country. Materials and methods: Three brands of losartan potassium were chosen randomly. Tablets of each brand were collected from individual retail outlets to gauge the qualitative evaluation and compare them by in-vitro drug release study. They were subjected to various quality control tests to measure the hardness, thickness, weight variation, friability, disintegration time, potency, stability, and dissolution profile. All these tests were performed according to the U.S. Pharmacopeia (USP) specification. Researchers further formulated a batch of tablet of Losartan Potassium and compared them with the existing brands. The formulation was prepared by optimizing the existing one available in the USP. Test results of the existing brands were taken into consideration during the optimization of the formulation. Results and discussion: Two brands passed the weight variation test, while one brand exceeded the range (±5%). The potency was determined instantly and 15 days after keeping the tablets in a stability chamber at 75% humidity and 60oC temperature. The potency of two brands degraded below the lower limit specified by the USP, while that of the remaining one was within the limits. Results of other tests were within the specified limits. Tablets prepared in the lab using an optimized formulation showed a better dissolution rate than the existing brands. Conclusion: Some of the brands failed to meet the desired quality, so the quality control system of that companies should be upgraded and a proper monitoring system should be developed by the drug administration.

scholarly journals Comparative Evaluation of Some Commercial Clopidogrel Tablets Available in Yemen

2018 ◽  
Vol 13 (2) ◽  
pp. 79
Author(s):  
Bassam Abduh Ali ◽  
Mohammed Gameel Al-haddad ◽  
Abdullah Ahmed Areqi
Keyword(s):  
Quality Parameters ◽  
In Vitro Dissolution ◽  
Dissolution Time ◽  
Dissolution Profile ◽  
Disintegration Time ◽  
Weight Variation ◽  
Quality Control Parameters ◽  
Variation Range

Clopidogrel is a medication to reduce the risk of heart disease and taken orally. Quality of drug characterizes the production process and every phamaceutical company strives for it but often it is very difficult to achieve. This study was to investigate quality control parameters of some marketed Clopidogrel tablets. To assess the quality, eight different marketed brands of Clopidogrel 75 mg tablets available in Yemeni market collected from different pharmacies in Hodeida city. Different quality parameters like weight variation, hardness, thickness and friability were determined according to established protocols. Then the in-vitro dissolution test, potency, disintegration time were also carried out. UV-spectrophotometer was used to determine the percentage released and assay at 218 nm. All the brands comply the requirements of Pharmacopoeia as they showed acceptable weight variation range. Friability of all brands was less than 1% and no significant differences in disintegration times as they disintegrated within 15 minutes. In case of dissolution profile, all brands except C6 showed acceptable dissolution time as they released more than 60% of drug in 45 minute. The hardness of only two brands was within the range. All brands also meet the potency specifications. This study suggested that most commercially Clopidogrel tablets in Yemen maintain the quality and comply with the pharmacopeia specifications.

scholarly journals COMPARATIVE QUALITY EVALUATION OF TWO BRANDS OF PARACETAMOL TABLETS OBTAINED FROM THE MARKET

2019 ◽  
Vol 1 (1) ◽  
pp. 14-18
Author(s):  
Azhar Danish Khan
Keyword(s):  
Disintegration Time ◽  
Over The Counter ◽  
Ulcer Disease ◽  
Pharmaceutical Tablets ◽  
Conventional Tablet ◽  
Drug Of Choice ◽  
Weight Variation ◽  
Inflammatory Drugs ◽  
Tablet Formulations

Introduction: Paracetamol tablets are very common over the counter (OTC) products among the patients as a good analgesics s. It is the drug of choice in patients that cannot be treated with non-steroidal anti-inflammatory drugs (NSAID), such as people with bronchial asthma, peptic ulcer disease, hemophilia, salicylate-sensitized people and children under 12 years of age, pregnant or breastfeeding women. Objective: The objective of this study was to compare the quality of the paracetamol tablet formulations those are locally available in India pharmaceutical market manufactured by various pharmaceutical companies with pharmacopeia standards. Materials and Methods: The two popular brands (A & B) of paracetamol conventional tablet of 500 mg strength were chosen. The paracetamol tablets were obtained from the local medical shops. To compare the quality of tablet formulations of different brands various official parameters like friability, hardness, weight variation, disintegration time and dissolution were performed as per the standards mentioned in pharmacopoeia. Result and Conclusion: The result of all these parameters of different brands was in the Pharmacopoeial limits so it could be concluded that marketed pharmaceutical tablets of paracetamol of these brands are safe, effective and efficacious.

scholarly journals Evaluating the Flow and Release Profiles of Ibuprofen Formulations by Increasing the Binder Concentration

2021 ◽  
Vol 16 (2) ◽  
pp. 111-117
Author(s):  
B.B. Mohammed ◽  
E.J. John ◽  
G.T. Abdulsalam ◽  
K.P. Bahago
Keyword(s):  
Release Rate ◽  
Active Drug ◽  
Release Profile ◽  
Wet Granulation ◽  
Flow Properties ◽  
Disintegration Time ◽  
Weight Variation ◽  
Tablet Dissolution ◽  
Tablet Formulations ◽  
Release Profiles

Background: Tablets must be able to release the active drug in the gastrointestinal tract for absorption. The release profile of solid pharmaceutical dosage formulations can be quantified by assessing the disintegration and dissolution times tests. Binders are adhesives either from sugar or polymeric material that are added to tablet formulations to provide the cohesiveness required for the bonding together of the granules under compaction to form tablets.Objective: The objective of the study was to formulate and assess ibuprofen tablets using different concentrations of binders (Acacia and Gelatin).Methods: The granules were prepared using wet granulation method and analysed for flow properties based on USP/NF protocols. After granule compression, the tablets release profiles were thereafter assessed via the tablet dissolution and disintegration tests.Results: Weight variation, thickness and diameter were within the acceptable values for all batches indicative of a uniform flow. Batches with binder concentrations of 10 % and 20 % failed disintegration test due to a disintegration time above 15 min while the release rate for batches 1 and 4 was about 88 % in 60 min as against the other batches whose release rate was less than 50 % in 60 min as a result of increasing their binder concentrations.Conclusion: The study concluded that increasing the concentration of acacia and gelatin above 5% led to a decrease in percentage of drug released and an increase in disintegration time above 30 mins because 5% batches gave the best release profiles.

scholarly journals Formulation and Evaluation of Effects of Superdisintegrants on Immediate Release Tablet of Linagliptin, a DDP-4 Inhibitor

2021 ◽  
Vol 24 (2) ◽  
pp. 168-179
Author(s):  
Tanoy Saha ◽  
Md Mahbubul Alam ◽  
Dilshad Noor Lira ◽  
Abu Shara Shamsur Rouf
Keyword(s):  
Drug Release ◽  
Immediate Release ◽  
Pharmaceutical Journal ◽  
Dosage Forms ◽  
Angle Of Repose ◽  
Drug Dissolution ◽  
Disintegration Time ◽  
Weight Variation ◽  
Tablet Dosage ◽  
Release Tablet

The study aimed to develop and evaluate an immediate-release tablet dosage form of Linagliptin. Different concentrations (ranges 5-10%) of super-disintegrants, Croscarmellose sodium (CCS), and Sodium starch glycolate (SSG) were used to prepare nine tablet dosage forms (F1 to F9) through the direct compression method. The compatibility of the formulations was evaluated by FTIR to reveal any possible drug-excipient interactions and it was proved to be compatible with all formulations. Precompression (bulk density, tapped density, Carr’s index, Hausner’s ratio, and angle of repose) and post-compression parameters (weight variation, hardness, thickness, and friability) were analyzed for all tablets and the results were found satisfactory as well as within limits as per USP guidelines. All the formulated batches (F1 to F9) exhibited disintegration of tablets within 2 minutes, where formulation F9 represented the lowest disintegration time (51±3 sec) which was also found significantly better than the marketed product (310±5 sec). In terms of drug dissolution, 90% of drug release was observed for all nine formulations within 45 minutes and formulation F9 (5% CCS and 5% SSG) illustrated the rapid and highest dissolution rate compared to the marketed one’s, 100% drug release at 20 minutes and 91.77 % drug release at 30 minutes successively. The respective data sets of drug release were mathematically fitted to several kinetic models and for all formulations, drug release pattern obeyed first-order kinetics amongst those, formulation F2 (r2= 0.98), F4 (r2= 0.99), F5 (r2= 0.98), and F9 (r2= 0.97) were found to be best fitted in this kinetic norm. Based on disintegration time and dissolution data comparison to a brand leader market product, F9 was experienced as the best formulation. Furthermore, it was observed that if SSG and CCS were combined, then these two parameters were more improved compared to their separate uses. Thus, incorporation of the optimum amount of super-disintegrants in a formulation showed rapid swelling, faster disintegration as well as ease of dissolution of tablet dosage forms. Bangladesh Pharmaceutical Journal 24(2): 168-179, 2021

scholarly journals Uji Mutu Fisik Metoklopramid HCl Tablet Chewable dengan Variasi Jenis Pengisi sebagai Diluent menggunakan Metode Granulasi Basah

2021 ◽  
Vol 1 (2) ◽  
pp. 76-85
Author(s):  
Umi Latifiana ◽  
Deny Budi Legowo ◽  
Erna Fitriany ◽  
Andri Priyoherianto ◽  
Muhammad Novianto Ainul Huri
Keyword(s):  
New Product ◽  
Wet Granulation ◽  
Test Results ◽  
Quality Test ◽  
Disintegration Time ◽  
Chewable Tablet ◽  
Physical Quality ◽  
Chewable Tablets ◽  
Tablet Hardness

Metoclopramide HCl are used to reduce vomiting and nausea. The availability on the market in the form of tablet, syrup and injection. Patient tend to prefer take drugs by oral use because it was easier. Chewable tablet is the new product as the alternative ways to treatment children and adult patient who had difficulity problem of swallowing drugs. Objectives: This research aims to formulate the chewable metoclopramide HCl tablets using diluent variations to get a better physical quality test. Chewable tablets of metoclopramide HCl are made using diluent variations, they are mannitol, sucrose, lactose. Formula I mannitol, formula II sucrose, and formula III lactose. Chewable tablet preparations are made by the wet granulation method. Data collection was performed on physical characteristics including organoleptic, weight uniformity, uniformity of size, tablet hardness, tablet fragility, disintegration time, metoclopramide HCl levels. Physical quality test results were statistically analyzed to determine the effect of variations in the diluent on the characteristics of chewable tablets. The results of this research have an influence on the physical quality and uniformity of contents of various types of diluent variations between each formulation. In this research, fillers have an important role in the preparation of chewable metoclopramide tablets to determine the physical quality of the tablets and the uniformity of their contents. The variation of diluent that gives better results is mannitol. This is because formulas that use mannitol have uniformity in content that meets the requirements, faster disintegration time, and physical quality of tablets that still meet the requirements, when compared to the first and second formulations. The variation of diluent that gives better results is mannitol.

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