Use of In vitro Dissolution Testing to Assess Multiple Generic Metformin Tablets

Wong, Sze; Ngo, Suong N.T.

doi:10.9734/jpri/2018/39508

Cited by 3 publications

(4 citation statements)

References 9 publications

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“…3). Nevertheless, Wong and Ngo [32] reported that even if multiple generic MH IR tablets had different dissolution profiles in vitro, the in vivo performance might not likely be diverted to a clinically significant extent. The previous conclusion was in complete accordance with Oyetunde et al [29] who discussed in their study that even if the dissolution performance of BSC class III drug products were found to be relatively slow, they may still have similar in vivo absorption.…”

Section: Beaker Methodsmentioning

confidence: 99%

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Comparative in Vitro Dissolution Study on Metformin Market Products Using Different Dissolution Apparatuses

Hashem

Abdou

Mursi

et al. 2019

Int J Pharm Pharm Sci

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Objective: This study was proposed to evaluate and compare the in vitro dissolution profiles of six Metformin Hydrochloride (MH) market products.Methods: Different dissolution apparatuses (USP apparatus II, IV and beaker method) were used to evaluate the dissolution profiles (in phosphate buffer, pH 6.8) of two immediate release (IR) generic products of Metformin Hydrochloride (MH): Cidophage® 1000 mg (G1, Egyptian market) and Metformin arrow® 1000 mg (G2, French market) with respect to the reference products named Glucophage® 850 mg (R1, Egyptian market and R2, French market). In addition to a generic controlled-release (CR) product; Cidophage Retard® 850 mg (G3) versus the reference product; Glucophage XR® 1000 mg (R3) (both from Egyptian market). Dissolution efficiency (D. E.) and the similarity factor (f2) were calculated. Weight uniformity, hardness, tablet dimensions and MH content were measured. Results:Results of the three apparatuses showed that MH IR products studied (reference and generics) did not meet the 75% USP 30 specifications for MH dissolved at 30 min. For MH CR products, Glucophage XR® did not fulfill the USP release criteria, while Cidophage Retard® did. USP apparatus IV revealed the highest sensitivity and discriminative capability. Conclusion:Generally, MH IR generics (G1 and G2) might be interchangeable with the innovator product (Glucophage®). However, Cidophage Retard® might not be interchangeable with Glucophage XR®.

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Section: Beaker Methodsmentioning

confidence: 99%

“…This may be due to differences in rate and extent of absorption [26], excipients and manufacturing processes [27] or the manufacturing variables such as the mixing effect and granulation procedure [7]. Few studies compared the performance of innovator and generic products of MH in different countries [26,[28][29][30][31][32][33][34][35].…”

Section: Introductionmentioning

confidence: 99%

Comparative in Vitro Dissolution Study on Metformin Market Products Using Different Dissolution Apparatuses

Hashem

Abdou

Mursi

et al. 2019

Int J Pharm Pharm Sci

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“…While bioequivalence testing of generic tablet products against an innovator product is required by regulatory bodies during a process of market authorization, the relative performance of the various generic formulations is not routinely tested 20 .…”

Section: Metforminmentioning

confidence: 99%

Comparative In Vitro Evaluation Of Different Brands Of Metformin Hydrochloride Film Coated Tablets Marketed In Addis Ababa, Ethiopia

Abatea

Temesgen

Nigatu

2020

Asian J Pharm Res Dev

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Metformin hydrochloride is a biguanide class of drug widely used to treat Type 2 diabetes mellitus. Its oral bioavailability is about 50 to 60 % with a half-life of about 3 h. This study focused on evaluation and comparison of the physicochemical properties of different brands of metformin hydrochloride (500mg) film coated tablets available in drug retail outlets in Addis Ababa, Ethiopia. Some different in vitro tests including hardness, weight variation, disintegration time, dissolution study, and assay were conducted as per United States Pharmacopeia. To compare dissolution profiles of the generic products against the innovator product (product A), a model independent method, similarity factor (f2), was also used. Weight variation result showed that all brand fall within the 5% limit from the average which is acceptable. Disintegration time of less than 15 minutes was observed for all brands. The in vitro drug release study results for the products ranged between 82 and 93% release within 30 minutes which is above 80% limit as per the United States Pharmacopeia requirement. The similarity f2 values for generic products ranged from 53 to 75%. Furthermore, assay value of the studied brands varied from 95.60 to 104.37% which was within standard limit (95-105%). It can be concluded that all brands of metformin hydrochloride tablets met pharmacopoeial specification for the tested parameters of physicochemical properties like weight variation, hardness of tablets, disintegration time, drug release study and assay.

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“…the small intestine is the main site of absorption of immediate-release metformin, and little absorption occurs in the stomach and colon (12). Therefore, metformin must have a rapid dissolution rate to increase the contact time of the dissolved drug with the absorption mucosa (13,14). The dissolution test is a physical test that measures the ability of both the pure drug (intrinsic dissolution) and the one contained in a solid pharmaceutical form to dissolve in a given medium under controlled experimental conditions.…”

Section: Gc24mentioning

confidence: 99%

Dissolution Test of Patent and Generic Drugs of Metformin Hydrochloride

Torres-Moreno,

Luque-Ortega,

Torres-Moreno

et al. 2024

Dissolut. Technol.

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Type 2 diabetes is a chronic, multifactorial disease with a genetic predisposition caused by a deficit in the action or secretion of insulin, resulting in hyperglycemia, which is characterized by increased blood glucose levels. Metformin hydrochloride is the most frequently used medication. There is a wide variety of generic metformin products in the Mexican market, and these products can vary in quality depending on the manufacturing process and formulation. The purpose of this study was to assess the dissolution properties of 850-mg immediaterelease metformin hydrochloride tablets from two batches of three different brands available in the Mexican market (in Mexico City): patent Dabex, interchangeable/generic Dinorax, and similar Setebaid. In vitro dissolution studies were performed in accordance with the Pharmacopoeia of the United Mexican States (FEUM). For the titration test, Dinorax exceeded the specifications (95-105%) as well as batch 2 of the Setebaid brand. For the dissolution tests, Dinorax and Setebaid passed but not Dabex. For weight variation, all brands were within the limits of acceptance criteria. The Dabex brand, which is considered a reference by FEUM, did not pass the dissolution test.

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Use of In vitro Dissolution Testing to Assess Multiple Generic Metformin Tablets

Cited by 3 publications

References 9 publications

Comparative in Vitro Dissolution Study on Metformin Market Products Using Different Dissolution Apparatuses

Comparative in Vitro Dissolution Study on Metformin Market Products Using Different Dissolution Apparatuses

Comparative In Vitro Evaluation Of Different Brands Of Metformin Hydrochloride Film Coated Tablets Marketed In Addis Ababa, Ethiopia

Dissolution Test of Patent and Generic Drugs of Metformin Hydrochloride

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