The pharmaceutical industry worldover sees big opportunity in the use of novel drug delivery technologies as they strive to make their products easier to administer, more patient friendly, and more effective. This is illustrated by the fact that almost 13 per cent of the current $337 billion global pharmaceutical market is accounted for by sales of products incorporating a drug delivery system.
Currently estimated around US $ 38-40 billion and growing at a pace of 25-30 per cent over the last 5 years, observers feel that nearly 40 per cent of formulations available in the market will have NDDS built on to them by the year 2007.
Going by the trends, it has become evident that controlled release (CR) formulations that, at present, grabs 50 - 60 per cent share of the novel drug delivery will continue to rule the roost in the years to come. Transdermal and transmucosal (buccal) systems are also enjoying prominent positions in drug delivery.
Keeping the lead, delayed release, extended release, sustained release and pulsatile release categories in oral drug delivery segment is the driving force in the Indian pharmaceutical industry as well. However, formulations presented in the novel drug delivery systems are yet to be in vogue here. Cost factor is pointed out as the major hurdle preventing the rapid growth in the NDDS. "Indian market is primarily cost-driven. Here one strip of 10 paracetamol tablets is available for Rs 5. But the same stuff in novel drug delivery can cost ten times more. Naturally, our people will go for the low cost option,'' contends a researcher with a leading NDDS producer from Mumbai.
Physicians' lack of faith in the NDDS formulations made in India was another impeding factor, which hindered the proliferation of these products. "Till recently a good lot of medical practitioners just refused to believe that our sustained release or pulsatile release tablets would work as claimed. But, now the situation has changed, I can say," he explains.
And a good number of firms have already identified NDDS as the future growth area. Cipla , Ranbaxy, Wockhardt, Sun, JB Chemicals, Ajanta Pharma etc have already made considerable progress in this segment. The Mumbai based Cipla Ltd which has zeroed in pulmonary route as one of its specialty areas achieved the unique distinction of launching the first CFC (chloroflurocarbon) free inhalers into the world market. Cipla also filed patents for NDDS of cyclosporin and omeprazole. Not much information is available on this leading NDDS player.
Ranbaxy's technological breakthrough came in 1999 when it licensed a 'Platform Technology' on Gas Powdered Gastric Retention System for Spatial and Temporal Control Delivery, to Bayer AG (Germany), for the development and marketing of once-a-day formulation of ciprofloxacin. The company has developed oral controlled release systems for a number of drugs clarithromycin, didanosine, tamsulosin, pioglitazone + metformin. In addition to the in-house programme, Ranbaxy has also initiated a number of joint research programmes, in India and overseas. Two such collaborative programmes are currently on in UK, one with Strathyde University and another with Vectura, a drug delivery company.
Wockhardt's latest introduction is venlafaxine capsules under the brand name Flavix XR. The company had launched 5 NDDS products in the year 2002. Its focus is on developing NDDS products aimed largely towards developed nations. Though mostly under wraps, the Ahmedabad based Sun Pharma is said be concentrating on lyposomal delivery systems. There are indications that the company may get a couple of NDDS in human trials in the next three years.
Similarly middle level players like JB Chemicals, Kopran Research Laboratories Ltd, Themis, Orchid have been doing research in NDDS for some time now.
So, today, NDDS is a buzzword among local pharmaceutical companies. Whether large or medium, many Indian companies are at some stage of NDDS research. They feel there lie a great possibility in NDDS technologies even in the product patent regime. ``Working on new platform technologies for existing drugs or for those several drugs which are coming off patents in the next few years can well be an excellent area wherein Indian firms can rely on till the environment matures for NCE research,'' avers a senior faculty member associated with a leading university in Mumbai.
At the same time, companies who actively pursue NDDS research should also keep in mind that the task is not going to be easy. MNCs also understand the opportunities in this arena. They come out with NDDS formulation on day one itself as the their patent on the original drug expires, cautions this academic who preferred anonymity.
There is no doubt the road is going to be a perilous one, agrees Pradeep G Surve, General Manager- R&D (Formulations) Unique Pharmaceutical Labs, a division of J B Chemicals & Pharmaceuticals Ltd, Mumbai. ``No doubt we need to do a lot of things. It's not going to be easy. Identifying the right drug and working on the right delivery technology is the challenge. But there's scope for success,'' says he.
JB Chemicals, which has successfully launched ranitidine controlled release tablets in the US and nifedipine sustained release tablets in South Africa and Kazakhstan and currently working on another molecule in cardiovascular segment under its patented technology platform, is very confident about the emerging potential for safer, more convenient and targeted drug delivery systems.
Citing the instance of aspirin, a life saving drug for heart disease which otherwise has a dangerous corrosive side effect on the stomach mucosa, Surve points out how the invaluable drug got rejuvenated in a novel drug delivery platform, ``this highly effective blood thinning medication when enteric coated turned out nothing less than a boon for high risk patients who suffer from chronic heart disease resulting from vascular congestion. In fact it is a new lease of life to such a powerful drug.''
In the coming years, as the drug administration turn more pharmacy-controlled, targeted delivery modalities will inavariably, become the focus. Besides, due to the compulsions arising from a hectic life-styles, people are looking for more convenient and customised medicines than thrice a day pills and needle pricks.
This is exactly where the opportunity lies. Definitely, it is not going to be easy. Identification of prospective entities, application of right technology and establishing it as safe alternative would definitely call for immense effort. But it is rewarding, Surve reaffirms.