Tablets that incorporate super-disintegrants or excipients that are highly moisture sensitive have previously proved troublesome to coat using traditional methods. Standard coating techniques tend to involve spraying a coating that has been dissolved in liquid, clearly not the best method for tablets that are likely to disintegrate if the moisture content is a little too high.
BioProgress' new technique uses traditional methods to create novel tablet cores with a high disintegration profile that are also easily coated. When combined with the company's TabWrap system, this offers significant improvements over tablets manufactured by existing pharmaceutical production techniques.
The TabWrap system is a totally dry coating process which removes issues surrounding highly soluble tabletting excipients, and novel tablet cores with the thin film coating also allow drugs to be absorbed more rapidly into the blood stream.
The combination of the new formulation with the firm's TabWrap coating process is covered by a series of patents.
TabWrap is a high-speed finishing process for compressed tablets, wrapping the individual pills in an edible film sheet. The firm says that method is particularly suitable for fragile tablet formulations which can chip and damage during the conventional coating process.
The process uses the company's proprietary XGel films in the coating process, which are free of animal derivatives and can be coloured, flavoured and pre-printed. If tablet cores are already embossed with logos or symbols, the TabWrap coating will take up the embossing. The cost of the coating system is less than sugar coating, and while a little more costly than traditional spraying methods it is claimed to be more efficient as it only involves a single-step process rather than separate spraying and drying stages.
Back in December 2006 the company announced that the first novel TabWrap system had been placed into a fully compliant manufacturing facility with INyX Group in the UK. The system is currently undergoing final validation prior to commercial production.
BioProgress has initiated a series of core development projects with external partners, all of which focus on rapid release pain relief products which will be marketed through the company's pharmaceutical products division, Dexo. The company hopes to be able to cash in on the lucrative over-the-counter (OTC) analgesic market, which was worth around $3.1bn (€2.4bn) in 2005 in the US alone.
The products in development will be targeting the US, Japan and Middle Eastern markets, but will also eventually be made available for registration on the European market.
BioProgress is also in a number of discussions with global pharmaceutical companies regarding TabWrap and the firm's formulation techniques, with a view to reformulation of existing brands or incorporating previously unusable molecules.
"We have had a very proactive marketing strategy," BioProgress CDO Steve Martin told In-PharmaTechnologist.com.
"We are in some very interesting and positive discussions at the current stage."
Reformulating their products using BioProgress' novel system would mean there are significant opportunities for pharmaceutical companies in terms of patent enhancement or extensions - the patents covering the TabWrap and novel core formulations themselves stretch through to the mid-2020s. The risk pharmaceutical firms could run by not working with BioProgress in this way, is that the company would be quite able to go ahead with new drug formulations independently, thus potentially threatening other companies' market share.
"We are looking to have the first products launched into the market place by the end of 2007, predominantly in the North American market" said Martin.
Middle East Move
Rumours have been circulating lately regarding plan for BioProgress to expand their presence in the Middle East after their non-animal derived products received significant attention at the Arab Health Exhibition in Dubai this month.
The move would give the firm a foothold in the large and growing potential market in the East Region, and further extend the company's global reach.
"We are clearly looking to build a business on a global basis," Martin told In-PharmaTechnologist.com
"We went to the exhibition to gauge interest, and the response was significantly better than we imagined. We made a clear commercial decision to get our products registered there are soon as we can."