Croscarmellose Sodium Efficiency in the Development of a Generic Capsule Formulation of Piroxicam, Comparable Dissolution Profile to the Innovator Product, Feldene

Abstract

The objective of this study was to evaluate the encapsulation performance of Croscarmellose sodium, a superdisintegrant in a low-dose, poor-solubility drug formulation and the in-vitro dissolution performance of the Piroxicam capsules. Preparation, characterization and evaluation of the effects of the different concentrations of carmellose sodium and the amount of dried starch on in-vitro dissolution of Piroxicam capsules. Piroxicam was chosen for its very low solubility in biological fluids, which result in poor systemic bioavailability after oral administration. Piroxicam can be categorized as Class II drugs according to the Biopharmaceutics Classification System. This drug is poorly water soluble, but once dissolved, it is easily absorbed through the gastro-intestinal membrane. The innovator formula includes lactose as the main filler along with corn starch, sodium lauryl sulphate and magnesium stearate. A 32 full factorial design was applied to investigate the combine effect of 2 formulation variable: Dried starch and Croscarmellose sodium. The systematic formulation approach helped in understanding the effect of formulation processing variables. Percent drug dissolved increased with increase in the level of superdisintegrant. These results show that Croscarmellose sodium can be successfully used to produce Piroxicam capsules AB bioequivalence rated to FELDENE, innovator products.