The Japanese regulatory authority has approved the JRS Pharma's ProSolv excipient - designed to make it easier and cheaper to make high-quality tablets - for use in pharmaceutical formulations.
ProSolv SMCC has already been approved in the US and Europe, and the Japanese registration accounts for another of the world's major pharmaceutical markets. Importantly, this means that companies can develop a common ProSolv-based product for use across all the major world markets.
The ProSolv range combines microcrystalline cellulose and colloidal silicon dioxide in a portfolio of high-functionality excipients. ProSolv SMCC is a multi-function excipient designed to improve flow, compaction and drug dispersion of tablet formulations. The excipient also allows companies to make very small tablets that are easier to swallow.
Eric Smith, vice president of marketing at JRS Pharma, said that the company is expecting two Japanese product launches that utilize ProSolv within the next 12 months.