Antares Pharma has announced that it has completed formulation and preclinical activities for its first fast melt oral tablet incorporating a nonsteroidal anti-inflammatory drug (NSAID) using its Easy Tec fast melt technology.
Antares' Easy Tec technology can reduce the manufacturing and packaging costs. The formulation contains excipients already used in marketed products and all are GRAS. As a result no additional toxicity studies are required to support the use of the excipients in a formulation.
Fast-dispersing doses, which are designed to release the active ingredient in the oral cavity without water, are increasingly used by the pharmaceutical industry to deliver a wide range of drugs.
The product, currently named AP-159, is a fast melt based formulation that the company intends to develop in two different dosage strengths similar to conventional tablets in the marketplace. Given once daily, the product is indicated for relief of the signs and symptoms of osteoarthritis. AP-159 is a small tablet that disintegrates in the mouth in less than 15 seconds without requiring water. After the quick disintegration, no aftertaste or residue remains.
The product has been developed for the treatment of osteoarthritis and the company anticipates that its scale-up will be initiated with a US manufacturer in the coming months followed by the relevant bioequivalence studies planned by the fourth quarter of 2005.
"While there are other fast melt technologies available, Easy Tec also offers a simple manufacturing process, which we believe can provide differentiated advantages to Antares Pharma," said Dr Dario Carrara, managing director of Antares Pharma's pharmaceutical and formulation division in Switzerland.
The company said it intends to file an ANDA early in 2006. The fast-melt market is one of the fastest growing sectors of the drug delivery market with industry experts projecting a 20 per cent annual growth rate for the next several years.
This growth is fuelled by the patient demand, with industry-sponsored surveys suggesting that approximately 88 per cent of patients prefer taking medications that incorporate a fast dissolve technology compared to traditional tablets.
Furthermore, a study reported last year found that as many as 40 per cent of all people have difficulty swallowing traditional tablets.
Jack Stover, president and CEO of Antares Pharma, said: "The target market that AP-159 is directed to serve is currently estimated to be in excess of $1 billion (€774 million). We also expect this to be the first of several fast melt drugs to be unveiled by Antares Pharma."