Ranbaxy gathers momentum in novel drug delivery

India's Ranbaxy Laboratories has stepped up its efforts to dominate the domestic novel drug delivery system (NDDS) market, in-licensing two new drugs from Europe in as many weeks.

One of the recently acquired products stems from a deal with the Indian arm of French company Ethypharm, the other comes from Netherlands-based Pharma company, Eurodrug Laboratories.

The company already has 30 NDDS products on the market in India and plans to bring in five more by the end of the year.

"The NDDS market is a niche segment that is continuing to grow and we are focusing heavily in this area," Ranbaxy spokesperson, Krishnan Ramalingam, told In-PharmaTechnologist.com.

The recent exclusive licensing deal with Ethypharm is for its novel analgesic drug, Trambax (Tramadol), a tablet that melts rapidly in the mouth without water, allowing it to be used anywhere at any time - of particular value in many parts of India.

This is achieved through Ethypharm's proprietary Flashtab technology, which it is using in several drug applications to make medicines more palatable and easier to swallow.

A Flashtab formulation typically combines Ethypharm's T-Mask taste-masking crystals with specific excipients (such as flavourings) to provide a palatable oral formulation that has the ability to disperse in the mouth in less than 30 seconds.

The technology combines both taste masking and rapid dispersion, is not limited by the particular characteristics of the active ingredient, can handle doses up to 650mg and - claims the company - is less costly to manufacture than other more complex competing systems.

Ethypharm will manufacture the drug using this technology on behalf of Ranbaxy from its Mumbai facility.

While still used in only a minority of oral medicines - with estimated annual sales $1.7bn (€1.5bn) 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.

Other companies offering fast-melt technologies include Cardinal Health with its Zydis system, CIMA Labs (OraSOLV, DuraSOLV) and Eurand (AdvaTab).

Just prior to the Trambax deal, Ranbaxy also inked a deal with Eurodrug Laboratories, for the asthma product Synasma (doxophylline) - a novel xanthine bronchodilator for chronic bronchitis, asthma and chronic obstructive pulmonary disease (COPD).

However the deal is non-exclusive, with Ranbaxy's large Indian rival, Dr Reddy's Laboratories also given permission to market the drug in India, although under a different brand name.

Eurodrug has already been selling the drug in Europe, Latin America and a few Asian countries such as Korea, Philippines and Thailand, before its foray into India.

Synasma is claimed to be superior to currently available xanthine analogues, such as theophylline and aminophylline due to its "unique technology."

However, Ranbaxy did not provide the details of this technology, nor the reason for the superiority of the product, which will be manufactured by Eurodrug in the Netherlands.

"This product will build on the oral asthma franchise of Ranbaxy, and strengthen the company's position in the fast growing Indian asthma segment," said Sanjeev Dani, regional director of Ranbaxy in India and The Middle East.

India has an estimated 15-20m asthmatic patients and the estimated prevalence rate in 5-11 year old children is between 10-15 per cent.

With a growth rate of 14 per cent, as opposed to just 9 per cent globally, the Indian market for respiratory diseases is one of the fastest growing therapeutic segments in India, with asthma drugs accounting for 30 per cent of this market.