Abstract
The purpose of this study was to develop and validate a discriminative dissolution method for the metformin film-coated tablet with immediate release of the active substance that belongs to class III of the Biopharmaceutical Classification System (BCS). Different conditions such as type of dissolution medium, volume of dissolution medium, rotation speed, apparatus, and filter suitability were evaluated. The most discriminative release profile for the metformin film-coated tablet was accomplished by using Apparatus II (paddle) and 1000 mL of phosphate buffer pH 6.8 as the dissolution medium and maintained on 37 ± 0.5°C with a rotation speed of 75 rpm. The quantification of the released active substance was performed by UV/Vis spectrophotometry, at 232 nm. Acceptance criteria for not less than 75% (Q) of the labeled content for 45 minutes were set. The dissolution method was validated according to the current international guidelines using the following parameters: specificity, accuracy, precision, linearity, robustness, and stability of the solutions, found to be meeting the predetermined acceptance criteria. A developed dissolution method has discriminatory power to reflect the characteristics of the medicinal product and is able to distinguish any changes related to quantitative formulation and can be also applied for routine batch testing.
Highlights
Dissolution tests can be used to guide the development of new formulations and to assist in proper formulation selection, to assess the characteristics of the active substance (AS), and to evaluate the batch-to-batch quality and stability of the medicinal product helping in the establishment of shelf life [1,2,3]
Different conditions such as type of dissolution medium, volume of dissolution medium, rotation speed, apparatus, and filter suitability were evaluated. e most discriminative release profile for the metformin film-coated tablet was accomplished by using Apparatus II and 1000 mL of phosphate buffer pH 6.8 as the dissolution medium and maintained on 37 ± 0.5°C with a rotation speed of 75 rpm. e quantification of the released active substance was performed by UV/Vis spectrophotometry, at 232 nm
Metformin hydrochloride (1,1-dimethylbiguanide hydrochloride) is used in the treatment of type 2 diabetes mellitus. e active substance is highly hydrophilic and is classified as class III according to the Biopharmaceutical Classification System (BCS) with high solubility and low permeability. e active substance is ionized at physiological pH
Summary
Dissolution tests can be used to guide the development of new formulations and to assist in proper formulation selection (selection of excipients), to assess the characteristics of the active substance (AS), and to evaluate the batch-to-batch quality and stability of the medicinal product helping in the establishment of shelf life [1,2,3]. It is commonly used as a prediction of the in vivo performance of a medicinal product to provide a basis for achieving in vitro/in vivo correlation and to minimize the need for bioequivalence studies (BE). The dissolution conditions must follow the sink conditions and the quantitation method should be specific, accurate, precise, linear, and robust [7,8,9]
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