Enteric Capsules

Through the blend of polymer science and capsule engineering, Lonza 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 capsule technology simplifies drug enteric delivery implementation from early-stage development to commercial manufacturing. The pharmaceutical grades of cellulosic derivatives used in Vcaps® Enteric capsules 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.

PROVEN FUNCTIONALITY

• Improve 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) 
• Achieve 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).

Product Description

• Two-piece hard capsule
• Manufactured with pharmaceutical-grade cellulosic derivatives (HPMC-AS, HPMC)
• Size #0, white opaque standard (other sizes and colors available upon request)

Regulatory Status

• 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.