Softgel formulation to challenge Abbott drug

The formulation has been developed by drug delivery specialists Banner Pharmacaps, and following today's announcement will be commercialized by JDS Pharmaceuticals, who focus on medication for psychiatric illnesses. The new formulation will offer a version of the anti-convulsant drug, used to treat a variety of seizure disorders associated with bipolar disorder, epilepsy or migraine, based on Banner's patent-pending EnteriCare delivery system. The EnteriCare softgels are not coated, unlike other products on the market, and have a clear outer shell. The technology allows for enteric, site specific drug delivery, and can be used with acid-sensitive compounds or compounds that can cause gastric upset. Banner has designed its EnteriCare product so that the enteric properties are encapsulated within the gelatin shell, which can also be UV-formulated to accommodate photosensitive compounds. One of the main selling points of the new formulation is in terms of patient preference; according to Banner, independent studies have shown that consumers prefer softgels which are perceived as easy to swallow whilst performing better and being able to mask bad tastes or odors. Another advantage of the EnterCare system is that by having the external layer designed as a seamless, single piece, the capsules are tamper evident - particularly important in this current climate of excessive drug counterfeiting. The fact that the capsules are uncoated also removes any risk of flaking or cracking which can be common with other products on the market which sport spray on coatings. The company has several products in development applying the EnteriCare technology to a number of targets, but the company was unable to disclose any further details regarding its development plans. The valproic acid product will be the first formulation using the EnteriCare system to reach the market. The US Food and Drug Administration (FDA) accepted Banner's New Drug Application for its Valproic Acid Delayed Release product back in February, with approval anticipated in October this year. The company is planning to launch the product in early 2008. The current major player that Banner and JDS will be competing with is Abbott, with its drug Depakote, one of the firm's lead products that comes in delayed release and extended release formulations. Although in a different form (a standard tablet as opposed to a softgel capsule), the Banner/JDS product functions the clinically in the same way as Depakote, which generated Abbott $1.2bn from US sales alone in 2006.