Drug-Delivery Technologies for Controlled Release Score With Manufacturers

Dr. Warren Levy of Unigene Laboratories featured in a piece regarding drug delivery mechanisms

The picture for drug-delivery technologies that alter an oral solid’s pharmacokinetics—primarily controlled- (or -extended) release technologies, but including fast-dissolve, taste-masking, enteric coatings and “abuse/misuse deterrent”—is looking fairly bright these days. One of the drivers has been the longstanding search for ways to convert injected drugs into pills or tablets. Controlled release (CR) has traditionally been a desirable option for brand owners looking to extend the patent life of their products, and while that still occurs, the trickle of drugs that have used these delivery enhancements for other reasons is turning into a steady flow.

In the past year, FDA has approved a number of these drugs, across diverse therapeutic classes:
-Last month, Acorda Therapeutics (Hawthorne, NY) announced availability of Ampyra (dalfampridine), a potassium channel blocker indicated for improving the walking ability of multiple sclerosis patients. The drug, an extended-release tablet, uses the MXDAS technology of Elan Drug Technologies (King of Prussia, PA), and consists of a hydrophilic matrix that controls the uptake of the drug in the gastrointestinal tract. While this is the first commercially approved application of MXDAS, Elan has been involved in the commercialization of a dozen other products featuring its family of drug-delivery technologies since 2000.

-In February, Labopharm Inc. (Laval, QC) won FDA approval for Olpetro (trazodone hydrochloride), an antidepressant formulated with the company’s Contramid CR technology. Contramid also figures in Labopharm’s previous FDA approval, for the analgesic Ryzolt (tramadol), marketed in partnership with Purdue Pharma.

-Last August, Eurand (Amsterdam, Netherlands; US HQ in Philadelphia) won approval for Zenpep (pancrelipase), a delayed-release enzyme indicated for cystic fibrosis and pancreatic conditions (Pharmaceutical Commerce, Jan/Feb, p. 9). It is the first proprietary product from Eurand, which offers several types of CR technology, including the Minitabs formulation used in Zenpep.

-Last October, Unigene Laboratories (Boonton, NJ) licensed its Phase III development product, oral calcitonin, to a newly formed venture, Tarsa Therapeutics, in which it will retain partial ownership. Calcitonin, indicated for treating osteoporosis, is a peptide normally administered by injection or intranasally; Unigene has a formulation with an enteric coating to get the drug past the stomach, and an “absorption enhancer” to facilitate uptake.

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Photo Credit: M. Bartosch
Source: Pharmaceutical Commerce