Research-backed capsules for dietary supplements

In the nutraceuticals industry, Capsugel has become synonymous with capsules. A 131-year old company based in Morris Plains, New Jersey, Capsugel offers eight patented capsule products that provide 'precision packaging' for small, delicate, and light-sensitive solids, semi-solids or liquids.

A division of Pfizer Inc, the company is a leading provider of two-piece gelatin and vegetarian capsules in particular. "Quality and innovation have been part of our history and are cornerstones of our market leadership worldwide," said Ron Millender, vice president and general manager of Capsugel Americas Region.

Among Capsugel's most recent launches are its new Licaps line — two-piece capsules that are specially designed for use with liquid and semi-solid formulations. Available in hard gelatin and vegetarian capsule options, the capsules are sealed using the company's patented LEMS sealing technology for a non-banded seal.

Responding to growing consumer interest in health, Capsugel has also premiered a line of vegetarian capsules — Vcaps and NPcaps — both of which are preservative-free and which retain all the advantages of standard two-piece capsules. Vcaps capsules, manufactured with HPMC, have a low moisture content, allowing Vcaps to withstand temperature extremes, making it ideal for water-sensitive fills. NPcaps capsules are formulated with pullulan and offer high performance machineability, crystal clear appearance and low-oxygen permeability for oxygen-sensitive formulations.

Beyond just capsules
In addition to its product lines — which are manufactured at 11 facilities around the world — Capsugel offers specialised services to dietary supplements customers, including: investigation and supply of global market information on specific herbal products; technical assistance regarding the selection of raw materials and colourants that meet regulatory requirements; and formulation support.

This segment of the company took a big leap forward last December with the unveiling of a new Americas Region Formulation Center in South Carolina.

"This state-of-the-art facility will service the $21 billion dietary supplement markets in North and South America," said Deborah L Morrison, director of Liquids, Americas Region. "It will distinctively use pharmaceutical-based scientific development protocols to formulate dietary supplement ingredients into a liquid dosage form."

Using proprietary software systems and the latest equipment, formulators will test ingredients (for purity, density and combination compatibility) and analyze formulas (for density, particle size and viscosity) to ensure fast-to-market delivery of the final formulations, including those customised for optimum bioavailability.

The facility is housed at SC Bio, a biotech incubator in South Carolina. The protocols used there are technologies transferred from Capsugel's formulation centre in Colmar, France, which has been operating since 2002. Colmar formulators developed a specially formulated co-Q10 that, in one study, delivers 30 per cent higher bioavailability than other dosage forms.

The protocols will shorten formulation time and facilitate quality manufacturing quickly, Morrison said. "They also will help to produce fast-acting, potent formulations with increased bioavailability — key advantages of encapsulated liquid products that are in ever-growing demand," she said.

The Formulation Center will be important for customers seeking customised Licaps creations, said J Croft Hollingsworth, manager of new product development for Liquids, Americas Region. "We are like an extension of their R & D departments — or in some cases, we can be their primary R & D or formulation resource."

After development and testing is completed, the liquid-fills can be encapsulated at the newly expanded Licaps manufacturing factory on Capsugel's South Carolina campus, the world's largest capsule manufacturing plant.

Capsugel's product line

Most popular brand of two-piece gelatin capsule for Rx and DS industries

All-natural, two-piece non-animal capsule made from pullulan

Two-piece capsules of cellulosic raw materials, eg vegetarian choice

Two-piece gelatin or vegetarian capsule for liquid and semi-solid filling

Two-piece gelatin capsule for double-blind clinical trials

Soft Capsules
Can be manufactured in all sizes, shapes, colours and forms for oral, topical, ophthalmic and vaginal use

Press-Fit® and XPress-Fit™ gelcaps
High-gloss gelatin coating encasing caplet core; offers best qualities of gelatin capsule with density of tablet. Rapid release

Small gelatin capsule for oral dosage to rodents in pre-clinical studies

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