Vcaps® Plus capsules developed without gelling agents provide HPMC capsules with improved physical and operational features to match the needs of the pharmaceutical industry. A new in-vivo study demonstrates that Vcaps Plus capsules are equivalent to gelatin in terms of human pharmacokinetics profile, making them an excellent alternative to gelatin or traditional hypromellose (HPMC) for optimizing delivery, performance and stability of OTC, NCEs and off-patent products.
Polymer science and engineering have opened a new era of functional development, which offers the potential for selecting the right capsule for different APIs. The newest HPMC capsules, Vcaps Plus, represents a unique and valuable contribution—they dissolve quickly and predictably at different pH levels and are independent of cations or other food components. Under these conditions, they perform like gelatin. They also offer additional advantages, particularly a lower moisture content, which makes them suitable for hygroscopic and moisture-sensitive drugs and manufacturing processes. HPMC capsules are inert and robust against cross-linking or the effects of extreme storage conditions. They show excellent mechanical properties for manufacturing and come from a renewable, plant-based resource that’s accepted by the global regulatory community. Vcaps Plus capsules have the appearance and performance of gelatin and provide important new options to scientists around the world.
Secondary gelling agents and ionic gel promoters – used by some other HPMC capsules – may slow down release of active ingredients. Capsugel’s Vcaps Plus HPMC capsules are made through a proprietary manufacturing process that eliminates the need for gelling systems. They disintegrate and release their contents independent of pH and ionic strength of the test media.
The non-animal components of the Vcaps Plus HPMC capsule polymer are accepted for pharmaceutical use in all major global markets. TSE certification is not needed, reducing the resources required for regulatory filings and international shipping and customs documentation.
Vcaps Plus HPMC capsules are approved by the Vegetarian Society, non-GMO Project verified and are Kosher and Halal certified addressing important requirements for patients and consumers alike. That is because Vcaps Plus capsules are manufactured in accordance with IPEC’s (International Pharmaceutical Excipient Council) Good Manufacturing Practice (GMP) Guide for Bulk Pharmaceutical Excipients, in facilities which are ISO 9001 certified. Their gelatin-like appearance and shiny surface help to reinforce the commonly held consumer attitude that capsules are easy to swallow1.
Vcaps Plus capsules have lower weight variations than first generation HPMC capsules and a weight-range profile that more closely mimics that of a gelatin capsule. Electron micrographs of Vcaps Plus capsules show that they have a smooth and even surface, which suggest higher quality performance in manufacturing2. They have been thoroughly tested on a variety of high-speed capsule filling machines and demonstrate excellent performance with fewer than 0.01% rejects. In a recent review of more than 30 filling operations across a range of intermittent motion, continuous motion and semi-automatic machines, the Vcaps Plus capsules had an average yield rate of 99.86%, with a range from 99.782% to 100.0%.
[1] BAS 117 – Capsugel Library – 1000 Patients Give Their Opinion on the Capsule
[2] Performance qualification of a New Hypromellose Capsule, Part 1. Comparative Evaluation of Physical, Mechanical and Processability Quality Attributes of Vcaps Plus, Quali-V and Gelatin Capsules. M. Sherry Ku, et a. International Journal of Pharmaceutics, 6 Nov 2009 (epub: 6 Nov 2009), ISSN: 183-3476
Vcaps® Plus capsules - Proven colors for pharmaceutical and/or Health and Nutrition products