Banner Pharmacaps Inc., a company involved in the development of soft gelatin dosage form technology, recently announced that the FDA has granted final approval for the company’s New Drug Application (NDA) for Valproic Acid Delayed Release soft gelatin capsules in the 125 mg, 250 mg, and 500 mg strengths. This drug is approved for use in the treatment of manic episodes associated with bipolar disorder, as monotherapy and adjunctive therapy in multiple seizure types, and for prophylaxis of migraine headaches. It has a similar pharmacokinetic profile to Abbott Laboratories Depakote(R) delayed release tablets. Banner has partnered with Noven Pharmaceuticals, Inc., who will market and sell this product under the brand name of Stavzor(TM) through its Noven Therapeutics subsidiary. Stavzor is the first pharmaceutical product to utilize Banner’s patent-pending EnteriCare(TM) technology. This innovative concept allows for the direct delivery of the active pharmaceutical ingredient without encountering the challenges typical to enteric coated softgels. With EnteriCare, the enteric features reside within the shell; thereby avoiding the propensity of coated softgels to crack and chip, potentially compromising the integrity of the functional coating.
