Quality Assessment and Comparative Study of different Marketed Brands of Metformin

Jain, Akash; Chaudhary, Jasmine; Saini, Anju; Mehan, Navneet

doi:10.5958/0974-360x.2019.00228.2

Cited by 4 publications

(3 citation statements)

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“…The Monsanto Hardness Tester was used to determine the hardness of randomly selected 6 tablets from each formulation. The hardness provide the indication of mechanical resistance against breakage and erosion during packing, transportation and storage ( Jain et al, 2019 ).…”

Section: Methodsmentioning

confidence: 99%

Synthesis of Thiol-Modified Hemicellulose, Its Biocompatibility, Studies, and Appraisal as a Sustained Release Carrier of Ticagrelor

et al. 2021

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Background: Nature has always been considered as the primary source of pharmaceutical ingredients. A variety of hemicelluloses, as well as their modified forms, have been under investigation. Herein, a study was designed to explore the biocompatibility of hemicellulose and its modified form (thiolated hemicellulose) as well as its potential as a pharmaceutical excipient.Method: For thiol modification thiourea was used as the thiol donor, HCl as the catalytic reagent, and methanol was used for washing purposes. Modified polymers were characterized for physicochemical characteristics, including surface morphology, the amorphous or crystalline nature of the particles, modification of polymer by FTIR, and biocompatibilities. For acute oral toxicity study, a single dose of 2 g/kg was administered to albino rats of 200 g average weight (n = 3). Polymers were evaluated as pharmaceutical excipients by preparing compressed tablets of antiplatelet drug (Ticagrelor), followed by various quality control tests, such as swelling index, thickness and diameter, disintegration, and in-vitro drug release.Results: From the results, it was observed that thiol modification has been successfully accomplished as characteristic peaks belonging to –SH group appeared at 2667.7691 cm−1 in FTIR scan. The modified polymer was found safe in the use concentration range, confirming their safe use for in vivo analysis. No significant effect has been observed in the behavior, biological fluid (blood), or on vital organs. Thiolated hemicellulose was found to be an excellent drug retarding polymer as 8 h of dissolution studies showed that 67.08% of the drug has been released.Conclusion: Conclusively, incorporation of thiol moiety made the polymer more mucoadhesive with, and a worthy carrier of, the drug with good biocompatibilities.

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Section: Methodsmentioning

confidence: 99%

Synthesis of Thiol-Modified Hemicellulose, Its Biocompatibility, Studies, and Appraisal as a Sustained Release Carrier of Ticagrelor

et al. 2021

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“…The hardness of six tablets was evaluated using the Monsanto Hardness Tester for their mechanical strength to withstand fracture and erosion during handling [29].…”

Section: Hardnessmentioning

confidence: 99%

Synthesis and characterization of thiol modified beta cyclodextrin, its biocompatible analysis and application as a modified release carrier of ticagrelor

Zaman

Bajwa²,

Saeed³

et al. 2020

Biomed. Mater.

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Thiol modification of beta cyclodextrin (β-CD) was carried out using thiourea, which served as a thiol donor. The chemical reaction was mediated using HCl. Polymer prepared via thiolation was further subjected to physicochemical and biocompatible analysis. Acute oral toxicity and compatibility was determined in albino rats. Furthermore, compressed tablets of ticagrelor (TCG) were prepared using modified and unmodified polymers and evaluated via various quality control tests. Thiolation was successfully achieved and confirmed by the FTIR scan, as a significant corresponding peak was observed at 2692 cm−1 wavenumber, demonstrating the attachment of –SH group. In vivo analysis has confirmed the safe use of β-CD, as none of the vital organs showed any kind of toxic effects. Dissolution studies revealed that Tβ-CD was able to release 96.62% of the drug within 1 h of the study, hence providing an immediate release. Conclusively, a thiol moiety was successfully attached to the polymeric backbone and was found safe to be used as a pharmaceutical excipient.

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“…So, to ensure the safety and reliability of any pharmaceutical dosage form in terms of quality, pharmaceutical companies should maintain the pharmacopoeial standards as prescribed by pharmaceutical regulatory authorities during the manufacturing of the drugs (Patel & Chota, 2011;Caudron et. al., 2008;Jain et. al., 2019).…”

Section: Introductionmentioning

confidence: 99%

Quality assessment of metformin hydrochloride tablets retailed in Lagos, Nigeria

Adepoju-Bello,

Oyawaluja,

Analikwu

2024

njpr

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Background: Metformin is a biguanide antihyperglycemic drug used with diet and exercise for glycemic control in type 2 diabetes mellitus.Objectives: This research aims to compare and analyze different metformin products to ascertain their critical quality parameters. The goal is to ensure that prescribed medicine effectively treats patients and protects the public.Materials and Methods: We evaluated the quality of ten metformin tablet brands in Lagos (Mushin and Surulere area) using official methods to assess weight, hardness, friability, disintegration time, and dissolution. Active ingredient content was also measured.Results: Out of all the tablets tested, only 10 % had weights outside of the official British Pharmacopoeia 2002 limits (not more than two tablets should deviate from ±5% and none of the tablets should deviate by ± I0). The hardness test was passed by all the tablets (A minimum hardness of 4 kgF is a pass), while 80 % passed the friability test (weight loss of ≤ 1 %w/w is a pass). Additionally, all film-coated tablets disintegrated within 30 minutes according to United States Pharmacopoeia/National Formulary 2003 (film-coated tablets disintegrate within 30 minutes). Ninety percent of the tablets passed the dissolution test (drug release within 60 minutes should be between 93 and 103 %) and 90 % of all brands examined passed the assay test for the active ingredient contents. The British Pharmacopoeia 2019 standard was used for the dissolution test.Conclusion: Routine pharmaceutical analysis is essential for the quality of pharmaceutical products and the safety of consumers.

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Quality Assessment and Comparative Study of different Marketed Brands of Metformin

Cited by 4 publications

References 0 publications

Synthesis of Thiol-Modified Hemicellulose, Its Biocompatibility, Studies, and Appraisal as a Sustained Release Carrier of Ticagrelor

Synthesis of Thiol-Modified Hemicellulose, Its Biocompatibility, Studies, and Appraisal as a Sustained Release Carrier of Ticagrelor

Synthesis and characterization of thiol modified beta cyclodextrin, its biocompatible analysis and application as a modified release carrier of ticagrelor

Quality assessment of metformin hydrochloride tablets retailed in Lagos, Nigeria

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