Prosolv SMCC has been approved by the Japanese Ministry, Health and Welfare (MHW) on November 26, 2003 and is now available for use in pharmaceutical formulations in Japan. With previous approvals by the US FDA and the European Union regulatory bodies, Prosolv is now approved in all major pharmaceutical markets.
The Japanese launch enables pharmaceutical companies to expand the development of global formulations using Prosolv SMCC without regulatory delay. Prosolv is a high-functionality excipient, an advanced new class of co-processed excipients that perform multiple functions simultaneously for high-quality, rapid tablet formulation.
Prosolv is a patented technology that combines microcrystalline cellulose and colloidal silicon dioxide to produce a portfolio of novel high-functionality excipients. Prosolv SMCC is a multi-functional excipient that delivers excellent flow, compaction and drug dispersion simultaneously to tablet formulations. This enables the industry to develop cost-effective, direct compression formulas that produce distinct, uniquely small tablets with excellent content uniformity.
"The launch of Prosolv in Japan enables our pharmaceutical partners to harmonize global formulation development using our multi-functional product," says Eric Smith, vice president marketing for JRS Pharma. "In addition, Prosolv provides the opportunity to create novel direct compression formulas with excellent content uniformity, compaction and flow, thereby delivering superior medications. We are expecting two Japanese product launches that utilize Prosolv within the next 12 months."
JRS Pharma LP is a wholly owned subsidiary of JRS Pharma GMBH & Co. KG in Germany. JRS produces a unique combination of innovative excipient technologies and products that enable pharmaceutical and biotech companies to develop high-quality tablets and capsules with significant cost savings.