IN-VITRO QUALITY ANALYSIS OF DIFFERENT BRANDS OF PARACETAMOL TABLET AVAILABLE IN BANGLADESH (original) (raw)
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Quality analysis of different marketed brands of paracetamol available in Bangladesh
International Current Pharmaceutical Journal, 2015
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.
2021
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...
Paracetamol is a widely used non-prescription analgesic and antipyretic medicine. It is one of the most commonly used drugs worldwide with non-prescription sales exceeding 25 thousand million doses per year in the United States of America. 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 among the commercially available tablet brands of paracetamol. To assess the quality, Seven different marketed Paracetamol 500 mg tablet were selected and in-vitro dissolution test, potency, disintegration time was carried out. Other general quality parameters of these tablets like weight variation, hardness, friability were also determined according to established protocols. All the brands comply the requirements of ''United State Pharmacopoeia'' as they showed acceptable weight variation range. Friability of all brands was less than 1%. No significant differences were founding disintegration time as they disintegrated within 5 minutes. In case of dissolution profile all brands showed better dissolution time as they released more than 60% of drug in 40 minute. The hardness of one brand was within the range 6 kg/cm 2 to 10 kg/cm 2. The limitation of the potency must be within 95-105%. All three brands meet this specification. This study suggested that most commercially available Paracetamol tablet in Bangladesh maintain the quality and comply with the USP specifications. It can be concluded that standard quality control parameters always should be maintained not for paracetamol but also for all kinds of medicine for getting better drug products.
International Current Pharmaceutical Journal, 2012
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 table...
Comparative in-vitro analysis of different brands of paracetamol tablets available in Nepal
Journal of coastal life medicine, 2016
Objective: To examine the physico-chemical parameters of commercially available local and multinational brands of paracetamol tablets in Nepal. Methods: Different five paracetamol brands were explored by testing various parameters according to standard methods. The studied parameters included weight variation, friability, disintegration, dissolution and assay. The limits of the official test were referenced from official guidelines of Indian Pharmacopoeia (IP) and British Pharmacopoeia (BP). All brands were tested according to their pharmacopoeial claim and methods for these tests were successfully conducted to find out their qualities. Those methods were economic and authentic. Results: Requirements of weight variation and friability value were complied by all brands. Fifteen minutes of disintegration time were also complied by all the brands according to the BP/IP recommendation for uncoated tablets. All brands showed not less than 80% drug release in 45 min as per BP and not less...
Assessment of in vitro Quality Tests of Paracetamol Brands 500mg in Karachi, Pakistan
Journal of Pharmaceutical Research International
Objective: The main purpose of this study is to perform the quality assessment of three different brands of Paracetamol tablets (500 mg) available in local market of Karachi, Pakistan. Methodology: Several pharmacopeial and non-pharmacopeial tests were applied on selected brands coded as P1, P2 and P3, respectively. A sample of (n = 20) tablets from each coded brand were subjected to pharmacopeial tests such as weight variation, friability, disintegration, assay and dissolution and non- pharmacopeial tests such as hardness, diameter and thickness. Dissolution data were subjected to model dependent and model independent kinetic approaches using Dissolution Data solver. Results: The Average weight in mg, hardness in kg , thickness and diameter in mm of (n=20) tablets of brands P1, P2, and P3 were noted and their standard deviation were calculated which were found to be 520.625mg (± 0.49 mg), 519.53 mg (± 0.472 mg) and 521.20 mg (±0.494mg),7.25(±0.45kg), 7.48(±0.29kg) and 6.64(±0.11kg)...
2018
Paracetamol tablets are popular over the counter (OTC) products among the patients as a good analgesics and the<br> objective of this study was to compare the quality of the Paracetamol tablet formulations those are locally available<br> in rural market of Nagpur. The four popular brands (A, B, C, D) of Paracetamol conventional tablet of 500 mg<br> strength were chosen. The quality of tablet formulations of different brands for various official parameters like<br> friability, weight variation, disintegration time, dissolution and drug assay tests were performed as per the<br> pharmacopeia. The result of all these parameters of different brands was in the pharmacopoeial limits so it could be<br> concluded that marketed pharmaceutical tablets of Paracetamol of these brands are safe, effective and efficacious<br> as well as satisfy quality control limits of pharmacopeia. The objective of the study was to determine the<br> biopharmaceutica...
Port Harcourt Medical Journal, 2008
Background: Studies have shown an increase in the usage of generic drug products from multiple sources. These generic drugs are expected to satisfy similar established standards as the original or innovator brands. Aim: To assess the standards and interchangeability of six common brands of paracetamol (acetaminophen) tablet generics marketed in Nigeria. Methods: The biopharmaceutical parameters, weight uniformity and assay of active : ingredients were carried out according to established methods. The dissolution rates and disintegration times were determined in simulated gastric fluid (SGF) and simulated intestinal fluid (SIF) without enzymes. A variation of the concept of dissolution efficiency (DE), known as predicted availability equivalent (PAE), was used to predict the likely in vivobioavailability. Results: All the brands complied with specifications for the weight uniformity, friability, disintegration time and assay of active ingredient tests. In the dissolution efficiency determination, all the brands released more in SGF than SIF. Conclusion: The study showed that all the six brands of paracetamol tablet tested are interchangeable with one another and thus could be prescribed one in place of the other. This would lead to the reduction in the cost of treatment, increased drug availability and an enhanced patients compliance in the use of acetaminophen tablets.
2017
This paper reports a study has been designed to formulate and to offer a comparison of various parameters of combination dose of Paracetamol (500 mg) and Ibuprofen (200 mg). A combined solid dosage form of Paracetamol (500mg) and Ibuprofen (200mg) is formulated and tested by analytical parameters.We use Nuromol (Paracetamol 500 mg and Ibuprofen 200 mg; Reckitt Benckiser Healthcare, UK) as a vendor drug for the purpose to cure from mild to moderately severe pain as a new combination dosage regimen in Bangladesh. Initially combined dosage regimen was prepared using six different formulas and formulated drugs are tested for checking all parameters as with supplied reference drugs. The assay is carried out by employing HPLC system with UV detection at 222 nm.There after each formulation had been subjected to preformulation and postformulation studies. The tablet mass is evaluated by assessing various compressional parameter such as angle of repose, bulk density, tapped density, Hausner's ratio and compressibility index. All the results are met the specifications and this results indicated that this new formulation have good flow properties. Various kinetic models were employed for the application of in vitro release profile assessment. The hardness of the tablet is found 4.3 to 6 kg, friability of the tablet is found 0.25 to 0.63%, disintegration time for the core tablet and the coated tablet are found 40 seconds and 1.30 seconds respectively. The results also show that the presence of active components in the formulated tablets are 100.31% Paracetamol and 101.12% Ibuprofen. We observed the potencies of the Paracetamol are 103.36% and 99.29% for Ibuprofen. All results of post formulation parameters were according to pharmacopoeias and within acceptable range. Based on fundamental comparative behavior of drug dissolution it can be concluded that release profile of all six batches under investigation was compatible with reference drug. In this present study as the newly formulated combination dosages regimen has met all the acceptance criteria and complied with the pharmacopoeial specifications and reference standard this formulation can be adapted as commercial preparation in Bangladesh for treatment of mild to moderately severe pain for post-operative patients.
Background: Acetaminophen is a widely used over-the-counter analgesic, antipyretic and a mild anti-inflammatory drug. It exerts its anti-pyretic and mild anti-inflammatory effects in several, not yet confirmed, mechanisms.It is classified as a non-steroidal anti-inflammatory drug (NSAID) by some sources and not as an NSAID by others. Objective: The purpose of this research work was to determine the quality controlparameters of four different brands of paracetamol tablet manufactured by local firms, according to pharmacopoeia specification. Method:Paracetamol tablet manufactured by four local manufacturers were taken from the market and weredetermined by the quality control parameters including weight variation, hardness, friability and disintegration test. The tablets used were from EPHAR,APF,CADILA and JULPHAR pharmaceutical manufacturers. The tablets were evaluated tocheck if they comply with the specifications of pharmacopoeia. Result: All the tablets of all the brands met with the specifications of pharmacopoeia. Conclusion: Various results were obtained from the test and compared with the specification. The tablets met with the specification and, hence, it can be concluded that the tablets had thedesired and optimum therapeutic efficacy. Recommendation: GMP must be implemented by all pharmaceutical firms. The availability of ingredients and equipment must be ensured before planning to do similar article.