Basic Info
  • Factory Location: Suzhou

    Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa

  • Sample Provided: no

    Payment Terms: L/L

    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.
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