Development of novel drug delivery systems (NDDS) has accelerated to unprecedented levels today, as the need for drugs having enhanced efficacy and reduced toxicity is becoming greater. Competition in the NDDS marketplace can only intensify with a large number of new products and technologies forecast to enter in the days to come.

According to estimates by BCC research, the global market for advanced drug delivery systems will reach about $212.8 billion by 2018. NDDS medications contribute to roughly 5-6 percent of India’s pharma market. However, there is no separate regulatory guidance for NDDS products in India.

For Indian generic firms, NDDS development often grabs the major chunk of their R&D outlay since activity in the drug discovery front is not, usually, a priority area. Compared to drug discovery research, which demands huge investment and time, the cost of developing NDDS-based generic products are far less. Risk of failure with NDDS R&D is small.

Development timeline is also short. Besides, significantly low production cost, low cost scientific man power and less expensive clinical trials also make NDDS an attractive proposition for Indian drug makers. Already, the generic players have launched several NDDS products in the Indian market after successfully developing platform technologies for a variety of therapeutics. Majority of the leading Indian companies currently have NDDS portfolios. 

Sun Pharma made headlines in this space when FDA permitted the company to import unapproved liposomal doxorubicin. The company, which launched paclitaxel injection concentrate for nanodispersion using its proprietary Nanotecton platform technology in India, has capabilities in liposomal products, inhalers, lyophilized injections and nasal sprays.

For oral controlled release drugs Sun uses tech platforms like wrap matrix and gastroretentive innovative delivery (GRID). The company also developed swollen microemulsion and gel free reservoir technology for ophthalmic drugs. The Mumbai-headquartered firm has products including azelastine nasal spray and sumatriptan autoinjector in the U.S. and Europe.

Dr. Reddy’s targets mainly dermatology and neurology segments for its differentiated formulations. Topical products, injectables and oral modified release dosage forms are Dr. Reddy’s research areas for indications like psoriasis and dermatitis. For neurologic conditions such as migraine, epilepsy and Parkinson’s disease, the company focuses on buccal, sublingual, intranasal and injectable delivery.

Though many of them have launched oral dosage forms, Indian companies are keen on ocular and parenteral nano delivery systems. Other than liposomes, nano carrier systems include microspheres, niosomes, micelles, nanoemulsions, nanoparticles and dendrimers.

Even as they try delivery systems unique to each drug, some players lay emphasis on developing formulations with an objective to increase the comfort levels of the patient circumventing invasive administration, minimizing the side effects.

Zydus Cadila Healthcare landed on the scene by launching an indigenously manufactured diclofenac transdermal patch. Once applied, the skin delivery system provides extended pain relief for 24-hours at a stretch, offering a clear edge over thrice daily oral dosage forms of diclofenac with potential risk of gastric irritation.

Torrent Pharmaceuticals claims to be the first to develop once-daily formulations for lamotrigine and nicorandil. Torrent leverages proprietary technologies such as dual retard inlay, compact tablet, gastro retentive system and matrix based SR/ modified release formulations, according to the company website.

India’s fast-emerging NDDS sector has a few pure-play drug delivery systems innovators too.

Troikaa Pharmaceuticals Ltd., located in Ahmedabad, has established itself in the NDDS arena with a painless version of diclofenac injectable, developed on the company’s patented AquaTech technology platform. With NDDS as mainstay, Troikaa has created several other technologies such as Lipisol that enables oily formulation to become water miscible and matrix tech that helps sustained release of small amounts of active ingredient over an extended period of time from the tablet. Troikaa has been granted a patent for a non-aqueous formulation of diclofenac for topical delivery in over 50 countries including the EU and Japan.

Obviously, smaller companies including some CMOs are turning their effort on devising delivery modalities for resolving problems with conventional dosage forms of existing molecules or for improving their bioavailability and safety.

Khandelwal Laboratories, a contract manufacturing company from Mumbai, provides an example. Khandelwal, is working on the areas of colon delivery, brain delivery and osmotically engineered systems controlled delivery to improve efficacy and reduce toxicity mainly for antibiotics, cardiovascular, respiratory and oncology drugs.

Several players have made technology-sharing arrangement with foreign firms. Companies are also actively pursuing collaborations with academic institutions to boost NDDS research.