Abstract
OPTIMIZATION AND EVALUATION OF FORMULATION FOR pH DEPENDANT SOLUBLE DRONEDARONE HYDROCHLORIDE

K. Ramesh*, B. Chandra Shekar and P. Khadgapathi

ABSTRACT

The brand name of marketed Innovator product for Dronedarone Tablets 400 mg is MULTAQ® (dronedarone) 400 mg tablets, it is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF. The recommended dose is one tablet of 400 mg twice a day with morning and evening meals. Dronedarone hydrochloride is showing pH dependant solubility, the solubility of drug substance is more in the pH range of 3.0 to 5.0. In order to have a bioequivalent generic product to that of marketed Innovator product, it is recommended to have the similar dissolution profiles in FDA recommended dissolution media. The present work was attempted to map the dissolution profiles of Dronedarone from tablet dosage to that of corresponding innovator product (MULTAQ® 400 mg tablets) profiles in FDA recommended dissolution media by optimizing the quantity of granulating fluid (Purified water), concentration of both surfactant (Poloxamer P407) and super disintegrant (Crospovidone). Based on the in vitro dissolution profiles of test product formulation, it was clearly evident that rate of dissolution of Dronedarone from tablet dosage form is showing increasing trend with decreasing concentration of Poloxamer P407 and increasing concentrations of Crospovidone and more over the quantity of purified water is also playing an important role with respect to granulation consistency, disintegration time and in-vitro dissolution profiles.

Keywords: Dronedarone Hydrochloride, Fluid uptake, Poloxamer, Crospovidone, pH dependant solubility, Rate of Dissolution.


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