BioProgress unveils FastWrap technology for rapid tablet disintegration

The FastWrap system combines the TabWrap process with the company's patented novel tablet core technology to create coated tablets that can rapidly disintegrate and dissolve, allowing for a faster onset of action. The FastWrap technology can also be used to manufacture film-flavoured orally disintegrating tablets, BioProgress says. The new applications reflect a diversification strategy for TabWrap that has also seen the technology extended to enteric coating, as EntWrap. These initiatives address what BioProgress saw as the limited functionality of the TabWrap platform, which involves wrapping tablets individually in the company's XGEL edible cellulose films. BioProgress announced earlier this year that it had developed novel tablet cores with a high disintegration profile that were easily coated using the TabWrap finishing process. As standard coating techniques tend to involve spraying on a coating that has been dissolved in liquid, they have run into problems with tablets that incorporate highly moisture-sensitive super-disintegrants or excipients. The TabWrap system, on the other hand, is a completely dry coating process. The current worldwide market for orally disintegrating tablets stands at more than $700 million (€514.8 million) and is growing at 31 per cent per annum, BioProgress notes. The FastWrap system is aimed at the over-the-counter drug (OTC) sector - specifically analgesics and cough/cold products - where speed and onset of action are key. Global sales of OTC analgesics and cough/cold remedies are estimated at $6.2 billion and $10.5 billion respectively. The FastWrap technology was developed in response to requests from new clients, but BioProgress also intends to use the system to differentiate its own products, particularly within the US market. Meanwhile, the company has embarked on the final process qualification programme for TabWrap, which has been placed with INyX Group, a specialty pharmaceutical company with niche drug-delivery technologies, at its manufacturing facility near Manchester, UK. The system has been shown to operate within its technical specification, producing 100,000 tablets per hour. New variants of XGEL film have also been developed, lending "further differential advantages to certain products utilising the TabWrap system",​ BioProgress said. The company remains on target to manufacture TabWrap-enhanced tablets for launch by the end of this year. These products will debut in the US market, targeting analgesic indications, BioProgress noted, adding that the (undisclosed) molecule in question has a US sales value of $1.4 billion (Datamonitor estimates for 2007) and "offers a unique competitive advantage over the leading brand, which accounts for 14.1 per cent of the total market".​ The company plans to launch a FastWrap version of this product as a line extension in 2008. BioProgress also provided an update on two of its other enabling technologies, Soluleaves and SoluPol. The former is used to produce a range of polymer-based oral delivery films that incorporate active ingredients, colours and flavours. The films can be designed either to dissolve rapidly on contact with saliva or to adhere to mucous membranes, so that the film releases the active ingredient slowly. New products based on the Soluleaves suite of technologies will be launched during the second quarter of this year, BioProgress said. These will include non-regulated products to be channelled through the sales and marketing subsidiary Dexo, as well as US launches of a local anaesthetic for sore mouths and a Soluleaves thin strip. The latter will be marketed under the Accuhist (phenylephrine hydrochloride) allergy brand with BioProgress' US partner Tiber Laboratories. The UK company recently completed an agreement with Tiber for the thin strip version of Accuhist, under which Dexo will also be responsible for sales and promotion of Accuhist Pediatric Drops, Accuhist PDX Drops, and Accuhist DM Drops throughout the US. Other new applications of the Soluleaves platform include a prescription-only line extension of the Ah-Chew (phenylephrine) decongestant brand, which BioProgress' US division will launch in time for the 2007 cough/cold season; and a patented smoking cessation product incorporating a fast-release stabilised oral film strip. The company expects to complete partnership discussions for this latter product "in the very near term". ​​The SoluPol platform was launched in October 2006. It uses soluble muco-adhesive polymer combinations and mixing technologies, similar to those applied to dried active ingredients in the Soluleaves and WaferTab technologies, as a vehicle for low-volume buccal delivery of actives where dose titration is essential (e.g., in paediatric or geriatric patients). According to BioProgress, the soluble polymers not only make the drug available at the site of delivery but can enhance taste-masking and improve stability. Three such formulations are now in pre-registration development, one in partnership and two involving products already marketed by Dexo. One of the Dexo products is an analgesic with a current market value of $1.3 billion and significant market share in Italy, Germany and the US, BioProgress said. Regulatory filings are expected during the second half of 2007.The other Dexo product incorporating the SoluPol technology is in the gastro-intestinal category. In this case, approval filings are expected by year-end.