Vcaps Plus HPMC capsules met the target product profile needs of levomilnacripran. With a three-fold lower average moisture content than gelatin capsules, the capsules are less hygroscopic and limit the potential transfer of moisture exposure to the API.
Morristown, NJ (PRWEB) November 04, 2013
Capsugel’s Vcaps® Plus HPMC (hypromellose) capsules are increasingly the preferred capsule option among pharmaceutical companies looking for innovative dosage forms to enhance product performance and improve product stability. Recently, Forest Laboratories, Inc. and Pierre Fabre Laboratories selected Vcaps Plus HPMC capsules for levomilnacipran, a serotonin and norepinephrine reuptake inhibitor recently approved for Major Depressive Disorder by the U.S. Food and Drug Administration.
The companies turned to Capsugel for its industry-leading formulation and encapsulation expertise early in the development of levomilnacipran. The companies required an advanced solution that they could tailor for levomilnacipran’s unique formulation. The collaboration with Capsugel helped pinpoint the right dosage form for the active pharmaceutical ingredient (API) with Vcaps® Plus HPMC and accelerate the process of getting the drug into human clinical trials quickly and, ultimately, to market.
“Many new chemical entities are moisture sensitive. Securing the right dosage form is critical to protecting against moisture transfer between the capsule and the molecule,” said Keith Hutchison, Senior Vice President of R&D at Capsugel. "Vcaps Plus HPMC capsules met the target product profile needs of levomilnacipran. With a three-fold lower average moisture content than gelatin capsules, the capsules are less hygroscopic and limit the potential transfer of moisture exposure to the API, helping to enhance stability.”
Composed of just HPMC and water with no gelling agent, Vcaps® Plus HPMC capsules have a consistent, pH-independent release of API, meaning they offer a more effective option to other HPMC capsules containing gelling systems. Numerous studies have shown that Vcaps Plus HPMC capsules have both good and consistent disintegration and dissolution properties, optimizing product performance. Moreover, they are suitable for moisture-sensitive ingredients, provide product stability and reduce risk of cross-linking.
“Research also shows that Vcaps® Plus HPMC capsules show better performance in terms of filling and rejection rate than traditional HPMC capsules, which contain gelling agents. This provides the potential to reduce drug development timelines,” added Dr. Hutchison.
Capsugel is a global leader in delivering high-quality, innovative dosage forms and solutions to its customers in the health care industry. The company’s Hard Capsule business offers customers the broadest portfolio of gelatin, vegetarian, and other specialized capsule technologies. Capsugel’s Dosage Form Solutions (DFS) business utilizes an array of proprietary technologies and specialized manufacturing capabilities to solve customers’ most pressing product development challenges, including bioavailability enhancement, modified release, abuse deterrence, biotherapeutic processing, and inhalation formulation. The company's fast-to-clinic program streamlines product development from pre-formulation through clinical and commercial supply for finished dosage forms. Headquartered in Morristown, N.J., Capsugel serves more than 4,000 customers in more than 100 countries. For additional information, visit http://www.capsugel.com.
For more information, contact Christina Chnaider at 610-680-6214 or Christina(dot)Chnaider(at)capsugel(dot)com.