Through the blend of polymer science and capsule engineering, Capsugel has developed a line of functional capsules that provides the industry with a viable alternative to achieve enteric protection and delayed release without functional (enteric) coating. Intrinsically enteric capsule technologies are key product design and development tools within the Capsugel targeted delivery technology suite, and can be coupled with a range of additional enabling technologies to meet the bioavailability and pharmacokinetic profile required for your drug product.
Vcaps® Enteric Capsules is a fully compliant capsule technology that simplifies drug enteric delivery implementation from early-stage development to commercial manufacturing. The pharmaceutical grades of cellulosic derivatives used in Vcaps® Enteric capsules are approved and have extensive market precedence for use in providing enteric protection. Vcaps® Enteric capsules have been evaluated in-vitro and in-vivo across a number of compounds, which has proven full compliance with relevant European, Japanese and US Pharmacopeia monographs.
Vcaps® Enteric Capsules have a number of potential applications in terms of functionality, use in product development tools, and as branding and intellectual property considerations.
- Improving tolerability of API’s that cause gastric-irritation
- API protection against degradation in the gastric environment (formulation-dependent, typically APIs with low to moderate acid sensitivity)
- Achieving delayed or targeted release in the small intestine
A Unique Technology
As a proprietary technology – and a viable alternative to enteric coating in the pharmaceutical industry – our intrinsically enteric capsule technologies offer potential product differentiation, life cycle management, and intellectual property opportunities.
Tool for Rapid Product Development
Vcaps® Enteric capsules can be utilized to greatly simplify and accelerate prototype development and rapid in-vivo testing of products requiring targeted delivery to the upper GI tract:
- Eliminate coating system preparation and application steps
- Rapid screening and optimization of enteric performance
- Remove dependency of enteric functionality with process variability
- Obviate need for process development of the enteric coating step, process scale-up and validation
By removing the need for enteric coating, intrinsically enteric capsule technologies also offer tremendous potential in early-stage product development, and can be utilized to greatly simplify formulation and process development, as well as scale-up and validation. Independent analysis has indicated that more than nine months of savings in Phase III readiness may be achievable by eliminating development, scale-up and validation steps associated with enteric coating (H2 Pharma Consulting, 2014).
- Two-piece hard capsule
- Manufactured with pharmaceutical-grade cellulosic derivatives (HPMCAS, HPMC)
- Size #0, white opaque standard (other sizes and colors available upon request)
- Contains commercial polymers used in coating and other pharmaceutical applications for more than 20 years.
- Complies with relevant European, Japanese and US Pharmacopeia monographs.
Water content – less than 6%
- Storage recommendations: 15–25ºC & 35–65%RH, in moisture-tight packaging.
- Robust performance over time and ICH conditions.