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 Pharmaceutical quality of seven brands of diclofenac tablet on the Saudi market

2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Muhammad M. Hammami ◽  
Reem AlSwayeh ◽  
Rajaa F. Hussein
Keyword(s):  
Active Substance ◽  
Diclofenac Sodium ◽  
Quality Criteria ◽  
Immediate Release ◽  
United States Pharmacopoeia ◽  
Pharmaceutical Quality ◽  
Weight Variation ◽  
Variation Range ◽  
Enteric Coated

Abstract Objective We previously reported the pharmaceutical quality of eight brands of 50 mg enteric-coated diclofenac sodium tablet available on the Saudi market. Here, we assess the quality of reference (R1) and four generic (G1–G4) brands of 50 mg immediate-release diclofenac potassium tablet and of reference (R2) and generic (G5) brands of 100 mg sustained-release diclofenac sodium tablet. Results Weight variation (range as % difference from mean), active substance content (mean (SD) as % difference from label), breaking force [mean (SD)], and friability (as % weight loss) were 95–104% and 99–102%, 100.9% (3.4%) and 105.6 (4.2%), 12.2 (1.3) and 12.9 (1.8) kg, and 0.0014% and 0.0012%, for R1 and R2, respectively. For G1-G5, they were ≤ ± 2%, 98.8% (2.7%) to 109.2% (3.8%), 6.4 (0.6) to 13.3 (1.0) kg, and 0.0007% to 0.0261%, respectively. R1 and G1-G4 disintegrated within 04:50–17:20 min: seconds and released a mean of 89–100% of label active substance content by 60 min in buffer (pH 6.8). R2 and G5 did not disintegrate or dissolve in 0.1 N HCl for 2 h, disintegrated in buffer (pH 6.8) in 01:58–02:15 h: minutes, and fulfilled dissolution criteria (pH 7.5) for both United States Pharmacopoeia test-1 and test-2. Thus all seven brands met pre-specified quality criteria.

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 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 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 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 study of quality control parameters of three different brands of azithromycin tablets

2017 ◽  
Vol 6 (7) ◽  
pp. 1572
Author(s):  
Rashmi Singh ◽  
Monika Saxena ◽  
Deeksha Sahay ◽  
Sujata Singh
Keyword(s):  
In Vitro Study ◽  
Quality Parameters ◽  
Pharmaceutical Companies ◽  
Dissolution Profile ◽  
Test Procedures ◽  
Disintegration Time ◽  
Weight Variation ◽  
Quality Control Parameters ◽  
Standard Value

Background: Azithromycin, being a very important antibiotic, is manufactured by different pharmaceutical companies and available in numerous brands. Therefore, it requires a quantitative evaluation and assessment of tablets chemical, physical and bioavailability properties.Methods: The physicochemical quality pararametrs like weight variation, size, hardness, friability, disintegration time and dissolution profile of three brands of azithromycin tablets were assessed by performing various test procedures according to established methods.Results: The different brands of tablets showed very slight variations in weight and size, not exceeding more than 5% of standard value. Similarly, hardness of all the brands was less than 5kg/f and friability ranged from 0.2 to 0.5%. All the brands tested disintegrated in <6 minutes and all the brands released >75% of the active ingredient within 45 minutes.Conclusions: All the physiochemical quality parameters of three brands of azithromycin tablets were found to be within the pharmacopeial specifications therefore all the brands were pharmaceutically and chemically equivalent and can be freely interchanged.

scholarly journals A Comparative Study on In-vitro Quality Control Parameters of Different Brands of Loratadine Tablets Commercially Available in Bangladesh

2021 ◽  
pp. 50-58
Author(s):  
Rosy Fatema ◽  
Sumaiya Khan ◽  
A. S. M. Roknuzzaman ◽  
Ramisa Anjum ◽  
Nishat Jahan
Keyword(s):  
Research Work ◽  
Drug Market ◽  
Quality Standard ◽  
In Vitro Dissolution ◽  
Active Principle ◽  
Dissolution Profile ◽  
Disintegration Time ◽  
Weight Variation ◽  
Local Companies

Loratadine, a second generation H1-receptor antagonist, works by blocking the action of histamine and is widely prescribed for itching, runny nose, watery eyes, and sneezing from "hay fever" and other allergic conditions. To ensure quality the main requirements for a medicinal product are safety, potency, efficacy and stability. This research work aimed to compare and assess the quality levels of different local brands of loratadine tablets available in the drug market of Bangladesh. Six different brands of loratadine 10 mg tablet manufactured by the local companies were used for the analysis. The evaluation was performed through the determination of weight variation, hardness, friability, percent potency, disintegration time, and dissolution profile in accordance with USP-NF specifications. All brands showed acceptable weight variation and % friability. The percent potency for tested samples by UV method ranges from 97.02%-108%, showing none of the brands contains less than 90% of the active principle as per the specification. The result of the physical and chemical studies, such as in-vitro dissolution, disintegration, hardness, etc., has been found to differ but lie within the specified limit. After analyzing the data obtained from the tests, it can be claimed that loratadine 10 mg tablets manufactured and marketed by several local companies in Bangladesh meet the quality standard required to achieve the desired therapeutic outcomes.

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 Formulation and Evaluation of Loperamide HCl Oro Dispersible Tablets

2020 ◽  
Vol 13 (5) ◽  
pp. 100
Author(s):  
Blasco Alejandro ◽  
Torrado Guillermo ◽  
Peña M Ángeles
Keyword(s):  
In Vitro Dissolution ◽  
Dissolution Profile ◽  
Biomedical Sciences ◽  
Disintegration Time ◽  
Weight Variation ◽  
Orally Disintegrating Tablets ◽  
Wetting Time ◽  
Percentage Of Water Absorption ◽  
Hostile Environments

This work proposes the design of novel oral disintegrating tablets (ODTs) of loperamide HCl with special emphasis on disintegration and dissolution studies. The main goal was augmenting the adherence to treatment of diseases which happen with diarrhea in soldiers who are exposed to diverse kinds of hostile environments. Optimized orally disintegrating tablets were prepared by the direct compression method from galenic development to the industrial scale technique, thanks to strategic and support actions between the Spanish Army Force Lab and the Department of Biomedical Sciences (UAH). The results show that loperamide HCl ODT offers a rapid beginning of action and improvement in the bioavailability of poorly absorbed drugs. The manufactured ODTs complied with the pharmacopeia guidelines regarding hardness, weight variation, thickness, friability, drug content, wetting time, percentage of water absorption, disintegration time, and in vitro dissolution profile. Drug compatibility with excipients was checked by DSC, FTIR, and SEM studies.

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