A Discriminatory and Biorelevant Dissolution Test Method for Simvastatin Drug Products
نویسندگان
چکیده
منابع مشابه
A Discriminatory and Biorelevant Dissolution Test Method for Simvastatin Drug Products
Biorelevant in vitro dissolution is a useful technique for qualitative forecasting of the in vivo behavior of a formulation. A biorelevant dissolution medium for simvastatin was developed with a lower concentration of surfactant (0.1% sodium lauryl sulfate, SLS) in the medium as compared with the 0.5% SLS concentration stated in the USP monograph. The slower dissolution rate of simvastatin tabl...
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INTRODUCTION Dissolution testing can play an important role in several areas for drug products as a quality control tool to monitor batch-to-batch consistency of drug release from a dosage form and as an in vitro surrogate for in vivo performance that can guide formulation development and ascertain the need for bioequivalence tests. The possibility of substituting dissolution tests for clinical...
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In this study, a discriminative dissolution method was developed for Cephalexin OD (orally disintegrating) tablets 750mg. The solubility and stability of the cephalexin API was determined in ten different solutions. In that 0.01N HCl, glycine buffer pH 3-0, acetate buffer pH 4.5 and water gave good stability and the solubility. Dissolution profiling of cephalexin OD tablets 750mg of single batc...
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Carvedilol (BCS Class II drug) is a nonselective β-adrenergic blocking agent with α1-blocking activity and it is mainly used in the management of hypertension. Two commercial brands of carvedilol drug, of strength 12.5mg were used for the Invitro dissolution studies. In the present study four dissolution media [pH 1.2 (0.1 N Hcl), pH 4.5 Acetate buffer, pH 6.8 phosphate buffer, and Distilled wa...
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ژورنال
عنوان ژورنال: Dissolution Technologies
سال: 2009
ISSN: 1521-298X
DOI: 10.14227/dt160409p11