Development and physicochemical characterization of glucosamine and chondroitin granules

Abstract

Abstract: Osteoarthritis and arthrosis are commonly and severe diseasesin modern society. The life expectancy has increased and, in consequence, the morbility of these pathologies. Glucosamine chlorhydrate and chondroitin sulfate have become alternatives for the treatment of the mentioned diseases. They have few interactions with other drugs and encourage endogenous processes of pain relieve. The objective of the present study was to develop a pharmaceutical product formulate as a granulated of glucosamine/ chondroitin 1500 mg//1200 mg. The product indication is the osteoarthritis treatment. The development processes included the next steps: pre-formulation, analytical method development, and quality control specifications. Three pilot batches were developed and its potencies, pH value, granulometry, appearance, dosage weight and residual moisture were evaluated. It was found that the analyzed products were according with USP 38 specifications. The labeled amount was between 90% -110%, the residual moisture had a value inferior to 2,50 ± 1,3 %. The particle average size was 50mm with a normal distribution of granules sizes, which demonstrated that manufacturing process was reproducible and according with established quality standards.