Offering solutions to insoluble problems

Following the BSE crisis, the FDA recommended that gelatin be removed from the Generally Regarded As Safe (GRAS) list. This meant that a new, non-animal based soft capsule was required.

For 65 years gelatin has been used to form capsules. In a market worth US$377bn (e414bn), 70% of the capsules are gelatin coated, thus making about 2bn people disenfranchised from taking these tablets on moral, ethnic or religious grounds.

However, the final nail in the gelatin coffin was the BSE crisis, which struck the UK and Europe in the 1990s. As a result the FDA recommended that gelatin be removed from the GRAS list, leaving a market for non-animal based alternatives.

This is where BioProgress, a Cambridge, UK-based, company stepped in. After years of research they developed the XGel film system, the world's first non-gelatin soft capsule process.

The system has both ingestible and non-ingestible uses. The capsules formed can contain liquids, suspensions, pastes or dry powders and the real advantage is that the time taken to produce the capsules is much shorter than that of gelatin capsule production.

The latter also requires a major capital investment, which often means that for many companies it is not economically viable to run their own plant.

encapsulation products

However, the XGel film system means that companies can produce their own encapsulation products. Another advantage is that with around 30 designer films, applications can be tailor-made for the client, and with the film production being dry, packing powders is not a problem.

As Barry Muncaster, chairman and ceo of BioProgress says, 'We developed a new natural material, which can be used to form the shell of soft capsules used for the delivery of cod liver oil and evening primrose oil etc.'

The innovative new material, which can be formed into a role of film in widths far greater than that possible with gelatin, has tremendous advantages to the existing system. 'It is much more reliable in processing speed and it can be produced much wider because the film is preformed and can be very accurate across its entire length,' Muncaster continues.

'It is a dry material, so once the capsule has been made, it can be packaged very quickly compared with the existing [gelatin-based] process, which can take up to 48 hours to dry.

'The whole system also allowed new product development that was never before available with gelatin, which has some limitations because it does not dissolve in cold water.

'We can design some products, which will release the contents in a cold water environment of less than 37°C.'

With regards to physical properties, gelatin is limited to set parameters for moisture content, temperature usage, oxidation properties and dissolution limitations dependant on the gelatin source.

However, because the XGel system uses polymers, which can be modified chemically, the properties required by the customer can be determined as required.

Currently in development, the revolutionary Septum capsule, which contains a film membrane separating two halves of the capsule, is designed to contain two separate active substances in a single capsule, for example, a combination of oils and powders. The capsule can be engineered to dissolve at different times and sites in the digestive system.

The system is waiting to be exploited by pharmaceutical companies looking for better drug delivery systems.

Muncaster also speaks about development in machinery, 'We took the new material and designed a new machinery process to utilise that material.' The resulting machine has a small footprint, and produces savings of up to 50% compared with the standard gelatin process.

Commercialisation

BioProgress has recently sold its first powder fill version of the XGel film system to Farmasierra, one of Spain's largest contract manufacturers for the pharmaceutical industry. It was the first ever sale of any machine capable of producing powder filled non-gelatin capsules.

The company has also sold the first full XGel film system license and XGel film system for liquid products to Peter Black Healthcare, which is the UK's leading producer of vitamin, herb and mineral supplements.

At its production facility in March, Cambridgeshire, BioProgress is completing the commissioning of the first machine to be used by Peter Black.

In another agreement, BioProgress has extended its relationship with Boots Healthcare International (BHI), which will enable new product concepts to enter consumer trials.

'The initial product development with Boots has progressed extremely well and the new product concepts we have developed are now moving to the consumer acceptability trial phase.

'We are in negotiations with Boots to agree the terms of commercialisation of the products on a global basis which, in line with our business model, will include a technology licensing agreement, the design and supply of production machines and the on-going supply of the proprietary film materials necessary to manufacture the new products,' says Graham Hind, md of BioProgress Technology.

This is really how the company works. At the top of an imaginary triangle, the business model is concerned primarily with the intellectual property (IP) aspect. Below that top level the company concentrates on r&d and licences. Finally, underpinning the whole operation are the royalties, the machines and the film design.

intellectual property

However, the essence of BioProgress is the IP that they have built up over the years.

Based on water soluble films, laminates, coatings and engineering processes, this technology has led to a diverse number of operations. Apart from the encapsulation and enrobing systems, the company also has IP rights in disposable and biodegradable products, as well as medical and hospital products.

The latter includes flushable ostomy pouches, while sanitary towels that can be flushed away are a major breakthrough in efforts to reduce landfill waste.

With a strategy of using its knowledge base to develop exclusive product lines and add value to existing mass-market products, while helping to protect the environment, BioProgress Technology is a company with a bright future.