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 3 2 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.
Highlights
Over the past decades, pharmaceuticals have made a major contribution in improving the health status of patients
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
Summary
Pharmaceuticals have made a major contribution in improving the health status of patients. Since generic drug products are usually marketed at substantially lower prices than the original brand-name products and with the rising cost of healthcare; development of generics is an attractive option to healthcare providers and governments [2]. A Generic drug product [3,4,5] is considered to be “essentially similar” or bioequivalent to an innovator (brand name) drug product. Bioequivalence implies that a generic drug product is essentially identical to the innovator drug (reference) drug product in term of active ingredient, strength, dosage form, route of administration, quality, safety, efficacy, performance characteristics and therapeutic effects. Generic drug product development may or may not use a different approach and strategy compared to that used to develop branded drug product containing a new chemical entity
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