Italian drug delivery specialist Eurand has made a foray into the market for fast-melt oral tablets that dissolve quickly in the mouth without chewing or the need for water.
Eurand believes that AdvaTab offers advantages over rival fast-dissolving technologies, such as R P Scherer's Zydis, the current market leader, CIMA Labs' OraSolv and DuraSolv and Ethypharm's Flashtab system. The company has launched the delivery technology, called AdvaTab, six months after acquiring it from Japan's Kyowa Hakko Kogyo.
Gearóid Faherty, Eurand's chief executive, said: "this technology is different from the competition in that while it offers a first class fast-melt tablet in terms of speed of disintegration, it is both easy to produce and more robust". The significance of this, he added, is that AdvaTabs are strong enough to be packed in a broader range of package types, including not only push-through blister packs but also bottles.
The advance that has made this possible is that AdvaTab incorporates a proprietary external lubrication system, unlike traditional tablets that use internal lubrication. Eurand's technology means that 10-30 times less lubricant is used because competing technologies disperse lubricant on the inside and the surface of the tablets, which can decrease tablet hardness. Another benefit, according to the company, is that the tablet does not contain water-resistant bonds between particles that can hinder disintegration.
Faherty noted that there is also potential to expand the range of active pharmaceutical ingredients that can be delivered in fast-melt formulations if AdvaTab is combined with its proprietary taste-masking technology Microcaps. The difficulties associated with masking the unpleasant taste of many drugs have been a primary reason for restricting the uptake of fast-dissolve tablets, according to market research company Pharma Concepts.
While still used in only a minority of oral medicines - with estimated annual sales $1.7 billion (€1.5m) in 2002 - fast-melt delivery is experiencing 40 per cent growth a year as companies turn to it to differentiate their products in the marketplace.
Recent product introductions that have exploited the technology include Johnson & Johnson's Risperdal M-Tab (risperidone), a new formulation designed to improve treatment compliance in schizophrenics, and Schering-Plough's Clarinex RediTab (desloratadine). In the latter case, launch of the fast-melt formulation was a defensive strategy in response to the loss of patent protection on the drug and its subsequent switch to over-the-counter status.