Providing Optimal Delivery of Your Most Critical and Sensitive Drugs
Developing a new non-animal capsule with low-moisture content that also meets global pharmaceutical standards is one major challenge. Providing batch-to-batch quality and consistency on a commercial scale is another.
Vcaps Plus HPMC (hypromellose) capsules from Capsugel meet both these stringent needs. Thanks to a proprietary capsule-manufacturing process that eliminates the need for gelling agents, the unique performance characteristics of Vcaps Plus HPMC capsules expand the range of applications for two-piece capsules ensuring optimal delivery of your critical drugs.
Capsugel Delivers More than Just Capsules
With a commitment to innovation, Capsugel provides a number of advantages to better ensure the success of your pharmaceutical products.
Extensive global supply capability, to better support scale-up needs,
In-depth experience meeting quality and regulatory requirements worldwide,
Superior quality and process controls, ensuring consistent batch-to-batch performance,
Vcaps Plus hypromellose capsules are fully compatible with the Xcelodose® S precision powder micro-dosing system
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Well Suited for Moisture-Sensitive Formulations
With low moisture content, Vcaps Plus HPMC capsule applications include:
Formulations that contain hygroscopic materials,
including dry powder inhalers.
Formulations with active ingredients that are
moisture sensitive.
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Excellent Machinability & Mechanical Stability
An exclusive capsule design coupled with an elastic polymer structure enables high machine efficiencies.
Extensive field testing on a wide array of capsule filling and blister packaging equipment confirms robust commercial performance.
Vcaps Plus HPMC capsule shells are not affected by moisture. Even in low humidity environments, they maintain their elasticity and ability to resist mechanical breakage.
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Resistant to Cross-Linking
With a well-characterized and stable polymer structure, Vcaps Plus HPMC capsules offer reduced potential for cross-linking. And unlike gelatin, they will not cross-link with aldehydes.
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Reduces Interference with Analytical Assays
With no added gelling agents or ionic gel promoters, Vcaps Plus HPMC capsules can:
Avoid interactions with components of the formulation.
Reduce interference with buffers used for in vitro dissolution studies.
Minimize interactions with dietary components of fed in vivo studies.
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In vitro studies provide dissolution end points that closely
match gelatin capsules across the relevant pH range.
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Gelatin-Like Appearance and Greater Patient Compliance
With an elegant high gloss surface, Vcaps Plus HPMC
capsules appear identical to gelatin, and use a similar
array of colorants including globally-approved iron
oxide pigments.
With no animal-derived components, a wider array
of global dietary needs and preferences are met.
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Quality and Global Regulatory Acceptance
Hypromellose is a well-characterized and stable material that has been successfully used for years in various pharmaceutical applications and in capsules.
Hypromellose (hydroxypropyl methylcellulose) used in Vcaps Plus HPMC capsules complies with USP/NF,
EP and JP standards, and is permitted as a food additive for human consumption in accordance with 21 CFR
172.874 and Regulation (EC) No 1333/2008.
HPMC is included in the US FDA Inactive Ingredients Database, and is generally recognized as a non-toxic
and non-irritant material.
Capsule dietary certifications include Kosher, Halal and Vegetarian Society approved.
Manufactured in accordance with IPEC GMP guidelines, in facilities which are ISO 9001 certified.
Capsugel manufacturing locations have registered Type IV (excipient) Drug Master Files with the US FDA
and Health Canada.
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Capsule Size Information
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