UK-based Stanelco says it has developed a starch-based alternative to gelatine hardshell capsules that could also offer cost benefits for dietary supplement makers.
Gelatine, an animal derived material, is becoming less favoured as a delivery form owing to a rise in the number of vegetarians and concerns about possible contamination of animal-derived materials with transmissible spongiform encepahlopathies (TSEs), the infectious agent behind mad cow disease and its human equivalent Creutzfeldt-Jakob disease.
In addition, the natural water bound in gelatine makes it a less thanideal medium for moisture-sensitive active pharmaceutical ingredients (APIs).
Pharmaceutical, vitamin and supplement ingredient makers are increasingly offering formulations without gelatine to meet market demand but many of these are more expensive than the standard gelatine variants.
The main alternative to gelatine hardshell capsules is HPMC (hydroxypropyl methyl cellulose), a synthetic material with a significantly higher cost base than gelatine. One of the leading manufacturers of this type of hard capsule is Pfizer subsidiary Capsugel with its VCaps range, while other players include Scherer, Shionogi Qualicaps, and Su Heung.
Starch-based capsules have been developed in the past - notably by Capsugel in the 1980s - but success has been limited as the capsules could not be filled on industry-standard equipment. Capsugel commissioned bespoke machines from Bosch for its offering.
In contrast, Stanelco maintains that both its starch-based material and the manufacturing process offer the prospect of lower unit costs of production than even gelatine capsules.
Gelatine capsule shells are currently made using a dip moulding process followed by a slow drying process, which injection moulded starch-based alternatives do not require. They are ready for filling immediately following manufacture.
Starch-based hard-shell capsules also offer greater resilience to humidity and heat than gelatine and allow for easy filling since they are non-static.
The product, in development for five years, still needs to get regulatory approval before the product can be consumed by humans but the firm is now looking to join up with third parties to optimise formulations and develop the route to market.
"We believe that the world market for hard capsules is significantly larger than that for soft capsules with many billions of hard capsules produced annually," said Stanelco.
The product was created by subsidiary Adept Polymers - which developed the new polymer blend along with recently acquired Biotec Holding - and partner Carclo Technical Plastics, working on the capsule.
Stanelco's subsidiary, Aquasol Limited, filed for patent protection for the new hardshell capsule in 1999. The patent, which is jointly owned with Carclo, is proceeding to grant in various territories.
The design of the capsule also offers tamper evident and novel dissolution features as well as the possibility of multi-compartments.
Other companies developing and selling alternatives to gelatine capsules have tended to focus on the soft capsule end of the market. They include BioProgress of the UK which has a range of cellulose-based soft capsules based on its XGel film technology, Cardinal Health with its seaweed-based VegiCaps soft capsule range, and Banner Pharmacaps' EcoCaps, which are also made from seaweed.
External links to companies or organisations mentioned in thisstory: