S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at
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 doxoru-bicin. The company, which launched pa-clitaxel injection concentrate for nanodis-persion 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 gastrore-tentive innovative delivery (GRID). The
company also developed swollen micro-emulsion and gel free reservoir technology
for ophthalmic drugs. The Mumbai-head-quartered 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, nio-somes, micelles, nanoemulsions, nanopar-ticles 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 manu-
factured 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. CP
Growing NDDS Portfolios
Generic drugs on novel delivery platforms