Capsugel's Vcaps Plus HPMC Capsules Enhance Performance for Recently Approved Levomilnacipran
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 FDA.
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 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, optimising 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.
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