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

Author(s):  
Azhar Danish Khan

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.

2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Muhammad M. Hammami ◽  
Rajaa F. Hussein ◽  
Reem AlSwayeh ◽  
Syed N. Alvi

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.


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 ◽  
...  

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


2021 ◽  
Vol 16 (2) ◽  
pp. 111-117
Author(s):  
B.B. Mohammed ◽  
E.J. John ◽  
G.T. Abdulsalam ◽  
K.P. Bahago

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.


2018 ◽  
Vol 96 (9) ◽  
pp. 826-832
Author(s):  
A. I. Dolgushina ◽  
M. I. Karpov ◽  
Olga V. Serousova ◽  
V. V. Osipova ◽  
A. F. Vasilenko ◽  
...  

A number of epidemiological studies have shown the Association of migraine with peptic ulcer disease (JB), however, the processes underlying the pathogenesis and features of the course of these diseases have not been fully studied. Material and methods. A comprehensive examination of the gastrointestinal tract was performed in 114 patients with migraine. Focused on the major clinical and psychological characteristics of patients depending on the availability of gastroduodenopathies, especially pain therapy and serotonin levels in the blood serum. Results. In 18.4% of patients with migraine, regardless of its type, erosive and ulcerative lesions of the stomach and duodenum were detected. In patients with chronic migraine, gastric ULCER developed more often (PF =0.022), the clinical features of the combination of migraine and ULCER were more pronounced intensity of abdominal pain and heartburn. High (5 or more times a week) frequency of nonsteroidal anti-inflammatory drugs (NSAIDs) was an important ulcerogenic factor in patients with migraine. Serotoninergic hypofunction can be discussed as a mechanism that determines the comorbid relationship of migraine and JB. The combination of migraine with NSA contributed to the formation of a more severe course of migraine. In assessing the quality of life indicators of all scales in such patients were lower . Gastropathy can be considered as an additional factor of migraine chronization, requiring appropriate therapeutic interventions to improve the quality of life of patients.


Author(s):  
Mahfuza Rahman ◽  
Khurshida Akter ◽  
Md. Shahin Sarker ◽  
Jinat Fatema Sharna ◽  
Mir Imam Ibne Wahed

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.


2021 ◽  
Vol 2 (1) ◽  
pp. 20-25
Author(s):  
F.M. Yushau ◽  
◽  
S. Awwalu ◽  
A. Musa

Background: Metformin tablets are oral anti hyperglycaemic agents that are used as the first line agent in the management of type 2 diabetes mellitus. The proliferation of many brands of metformin tablets in the market has led to availability of different types; some of which may be substandard or counterfeit. Thus, the need to determine the quality of the various brands marketed in Zaria. Objective: To compare the quality of different brands of metformin tablets that are available in Zaria using British pharmacopoeia standards. Method: Seven brands of metformin tablet (500 mg) were randomly sampled from various community pharmacies within Zaria and analysed with respect to identification, weight variation, friability, disintegration time, dissolution and drug content assay using Pharmacopoeial standards. Results: Except for the dissolution and assay tests, the results of all the other parameters for the various brands were within the Pharmacopoeial limits. The percentage content of metformin in brand 2 was 89.90 % which is outside the official range (95 – 105 %). Furthermore, only 70.61, 75.34 and 70.58 % of metformin dissolved from brands 2, 4 and 7 respectively, after 30 minutes of the dissolution test. Conclusion: It can be concluded that of the seven brands evaluated, only four brands are interchangeable with each other and can be substitutes of each other.


2021 ◽  
Vol 11 (1) ◽  
pp. 60-64
Author(s):  
Rishabh Bindal ◽  
Arpna Indurkhya

Due to more versatility and comfort, mouth dissolving tablets are the most advanced type of oral solid dosage forms. Compared to conventional tablets, it increases the effectiveness of APIs by dissolving within a minute in the oral cavity after contact with less saliva, without chewing and without the need for water for administration. Mouth Dissolving Tablets of Ketorolac tromethamine were prepared by direct compression method using various superdisintegrants like crospovidone, Croscarmellose sodium, and Sodium starch glycolate in different concentrations. Prepared tablets were evaluated for hardness, friability, weight variation, disintegration time, wetting time and in vitro drug release. Results of pre-compression and post-compression studies of all formulations were found within the standard limits. The tablets of all the batches were found to release more than 80% of drug in 5 minutes, which is the desired quality of mouth dissolving tablets that helps in faster absorption of the drug and quick onset of therapeutic effect. The the order of dissolution of various disintegrants was found to be Crospovidone˃ SSG˃ CCS. There was no significant variation in drug content of drug during stability studies for selected batch F3 in accelerated conditions over three months. It was concluded from the study that fast release of Ketorolac tromethamine from formulation F3 may reduce onset of drug action with better patient compliance. Keywords: Crospovidone, Croscarmellose sodium, Ketorolac tromethamine, Mouth dissolving tablets, Sodium starch glycolate, superdisintegrants.


Author(s):  
Md. Emran Hossain ◽  
Sukria Hossain ◽  
Md. Shahin Sarker ◽  
Mst. Mahfuza Rahman ◽  
Mir Imam Ibne Wahed

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.


Author(s):  
Abdulmajed Alsaifi ◽  
Ali Alyahawi

Paracetamol or acetaminophen is active metabolites of phenacitin. It is a widely used over-the-counter analgesic and antipyretic. Chemically, it is 4-hydroxy acetanilide (acetaminophen). Paracetamol is approved for reducing fever in people of all ages. It is commonly used for the relief of headaches, other minor aches and pains, and is a major ingredient in numerous cold and flu remedies. Many different brands and dosage forms of paracetamol are available in Yemeni market that places health practitioners in a dilemma of drug substitution in case of non-availability of a particular brand. The aim of the present study was to evaluate the quality control of four brands of paracetamol tablets (500 mg) marketed and commonly prescribed in Yemeni market. The results and findings of the present study will be interpreted and discussed. Four brands of paracetamol tablets (500 mg) were purchased from the retail pharmacy outlets and their pharmaceutical quality were assessed by using in-vitro tests according to USP and BP standards and unofficial standards as recommended by the manufacturers. The assessment of tablets included the evaluation of uniformity of weight, hardens, friability, disintegration time, dissolution test as well as assay content by UV spectrophotometric method. All brands passed USP and BP standards in- vitro quality control tests prescribed for the tablets except hardens test but all  products were satisfactory for hardness. The results indicated that the overall quality of all tested paracetamol tablets brands was satisfactory as they met the requirements of the official and unofficial quality control tests.  


2018 ◽  
Vol 13 (2) ◽  
pp. 79
Author(s):  
Bassam Abduh Ali ◽  
Mohammed Gameel Al-haddad ◽  
Abdullah Ahmed Areqi

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.


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