Frequently Asked Questions

No, but in Europe they have been approved for use with organic ingredients, allowing the entire finished product to be labeled organic. To learn more about this, please contact your Customer Service Representative.

Yes, Capsugel® Vcaps® plus offer advantages, particularly a lower moisture content, which makes them suitable for hygroscopic and moisture-sensitive drugs and manufacturing processes. Capsugel® Vcaps® Plus HPMC capsules have a 6 to 7% water content, they are ideal for low moisture or moisture sensitive ingredients.

Yes, they have the same dimensional characteristics as Capsugel® Coni-Snap® capsules. They run on same filling machines as all standard capsules.

Yes, a number of new chemical entities have been approved as pharmaceutical products in both the United States and in the European Union. An in-vivo study demonstrates that Capsugel® Vcaps® plus capsules are equivalent to gelatin in terms of human pharmacokinetics profile. Given the unique properties of Capsugel® Vcaps® Plus there is a growing interest from pharmaceutical companies in utilizing this capsule as an alternative to gelatin.

Yes, a print window guide has been developed specifically for Capsugel® Vcaps® Plus capsules.

If variability is noted in-vitro with ionic media, then an in-vivo concern should be suspect as well. Diets like the American breakfast or those in which fruit/fruit juice/vitamin consumption is a part would naturally lend variability in release rates from HPMC capsules that contain gelling aids. Simulated milk fluid is routinely used to compare the ionic strength of a fed state against that of the fasted protocol of the pH 1.2 (USP) protocol. Again high variability exists between the dissolution curve of a product with gelling aids that can occur in-vivo between fed and fasted states. Comparatively, HPMC capsules like Capsugel® Vcaps® Plus which contain no gelling agent or gel promoter, regardless of the pH or the ionic strength of dissolution medium used, show minimal variability. The implication becomes clear for the formulator – a system in which variability all but negated relieves many of the concerns that may occur between the laboratory and the clinic.

Capsugel® Vcaps® Plus capsules have been tested by Capsugel® for more than 5 years at 25° C and 65% RH and has passed all disintegration and dissolution test protocols.

In a study published in the International Journal of Pharmaceutics (2009) the Capsugel® Vcaps® Plus capsules had a 3.29% RSD in weight compared with the first generation capsule with a gelling system which had a 5.45% RSD in weight. Subsequent studies have shown even tighter weights for current production runs.

Capsugel® Vcaps® Plus have been thoroughly tested on all high speed capsule-filling machines and demonstrated excellent machineability performance at maximum speeds with <0.01% rejects.

When evaluating a polymer, there are four primary questions to consider : chemical incompatibility between the active ingredient and/or one of its excipients and gelatin, if the formulation is moistire sensitive, sensitive to oxidation, the region in which the product will be marketed.

Gelatin has been the choice for immediate release formulations for more than 100 years. It opens quickly and is completely dissolved in 20 to 30 minutes. Capsugel® Vcaps® Plus capsules, made from HPMC, need a hydration period in order to pull water into the matrix to allow disintegration to begin.

Indistinguishable from gelatin, more than 200 colors have been formulated. The Capsugel® Vcaps® Plus capsule has a smooth surface and tighter closure than HPMC with gelling agents. Scanning electron photomicrographs of the surface of Capsugel® Vcaps® Plus capsules shows a clean edge and smoother surface than gelatin as well.

The Capsugel® Vcaps® Plus capsules are available in low moisture versions which are shipped in sealed aluminum bags. Special controls on manufacturing are required to provide a low relative humidity manufacturing suite to ensure the capsules do not equilibrate during filling and packaging.

Yes, Capsugel® Vcaps® Plus capsules may be developed with a limited palette of colors. Developed without gelling agents, Capsugel® Vcaps® Plus capsules are manufactured through a proprietary thermogelation process. Due to the natural chemical response of some dyes to heat, Capsugel has developed a validation process to confirm consistency of pre-formulated colors in the two groups. Formulas for these colors are available upon request.

Capsugel® Vcaps® Plus are made from HPMC - hydroxypropylmethylcellulose - a cellulose derived from pine trees. Due to a patented thermogellation manufacturing process, no gelling agents are required in manufacturing to form the capsules. They are considered a second generation vegetarian capsule - because they perform just like gelatin while bringing the benefits of a vegetarian alternative.

They are made of just two components: plant-based HPMC and water. They are a globally acceptable primary vegetarian capsule, and in Europe they are suitable for use with organic ingredients. Capsugel® Vcaps® Plus capsules have Kosher and Vegetarian society certifications.

  • Globally - Accepted premium vegetarian capsule
  • Organic friendly - Suitable in EU for use with organic ingredients
  • Vegetarian - Approved by the “Vegetarian Society”
  • Kosher / Halal
  • Non-GMO
  • Vegan* - Approved by the "Vegetarian Society"

*Please note: Empty transparent and colored capsules are vegan certified. Empty capsules containing the colorant carmine are not vegan certified. Imprinted empty capsules are vegan certified if imprinted with shellac free ink.

Capsules are available in 10 sizes ranging from 000, 00el, 00, 0el, 0 1, 2, 3, 4 and 5. They are also available in Capsugel® DBcaps® sizes AAel, AA and A. The Vegetarian Licaps® capsules design is also available for Capsugel® Vcaps® Plus. The internal and external sizes are the same as gelatin. They are available in Capsugel® Coni-Snap® sprinkle capsule as well.

Cross-linking of gelatin is the alteration of gelatin such that the shell disintegrates slower and releases the formulation slower as a result. It can come in the form of internal cross-linking which occasionally results when the capsules experience high heat and humidity. The second form is called ‘external cross-linking’ and is due from exposure to an external agent like aldehydes, peroxides and sulfanic acids which chemically alter the gelatin. Even a small amount of aldehydes and peroxides have been found to exist in some commonly used excipients. Often the addition of enzymes to the dissolution media of internally cross-linked gelatin can resolve the issue just as in vivo the natural enzyme content of the gastrointestinal tract would. But externally cross-linked gelatin capsules may become significantly altered and enzyme addition to the dissolution media may not resolve the issue. Here, chemical incompatibility may point to need for an alternative polymer to gelatin. Dissolution studies show that HPMC is not affected by either internal or external cross-linking.

HPMC stands for hydroxypropylmethylcellulose and has been widely used as tablet and capsule excipient and capsule polymer for more than 15 years. Additionally, HPMC products are Kosher, Vegetarian-society and Vegan* certified.

*Please note: Empty transparent and colored capsules are vegan certified. Empty capsules containing the colorant carmine are not vegan certified. Imprinted empty capsules are vegan certified if imprinted with shellac free ink.

The first generation HPMC capsules developed were manufactured by a process similar to gelatin in which a hot solution of HPMC is made and cold stainless steel pins are used to dip into the polymer bath. In order to produce HPMC capsules this way, a gelling agent and gelling promotion agent are needed to provide the film formation. HPMC is not self-gelling like gelatin. The added gelling agent combines individual strands of HPMC into longer polymer chains. These large strands are net negative (anionaically) charged which requires the use of a gel promoter like potassium chloride to balance the charge and make even larger chains that have enough size to deposit on the cold stainless steel pins.

As customers globally tested the first generation HPMC capsules and experienced the variability, it was clear an alternative process was needed in which gelling systems were not used. That was the genesis of Capsugel® Vcaps® Plus which was created through a proprietary manufacturing process that eliminated the need of either a gelling agent or gel promoter – only HPMC and water. Capsugel® Vcaps® Plus are free from variability related to either pH value or ionic strength of the dissolution media.

Gelatin capsules are dried to 13 to 16% moisture—the ideal content for robust performance. Capsugel® Vcaps® Plus HPMC capsules have a 6 to 7% water content. Recommended storage conditions for both gelatin and Capsugel® Vcaps® Plus are 35 – 65% relative humidity where ambient temperature is 15°C to 25°C. But Vcaps® Plus capsules have a wider window to work within—suitable in RH conditions of 10 to 70%. This applies especially well for hygroscopic compounds which remove moisture from the shell to the formulation and for products sometimes subjected to temporary temperature excursions.

Capsugel® Vcaps® Plus capsules offer the same great vegetarian benefits of Capsugel® Vcaps® capsules with beautiful branding due to their luster and color options. There are nine sizes available: 000 - 00 - 00el - 0el - 0 - 1 - 2 - 3 - 4. To have further information about Capsugel® Vcaps® plus size don't hesitate to visit: Capsugel® Vcaps® Plus Size Information

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