Pills that stay longer – upto 24 hours in the stomach –to increase thier time of absorption for prolonged efficacy may soon hit Indian markets.
Sun Pharma, one of the leading Indian pharma companies, is currently developing pills that could stay longer in the bowel.
For this purpose, Sun is developing two technologies i.e Gastro Retentive Innovative Device (GRID) and Wrap Matrix System to address the problems related to controlled release drugs with absorption window.
GRID technology will make the drug to stay in the stomach for the 8 hours. The main advantages of the technology are (i) improve bioavailability of drugs with narrow zone of absorption in GI tract (ii) Floats instantaneously, Swells upto 8 times its initial volume (iii) Maintains physical integrity (iv) Flexible and soft (v) Different types of release profiles possible (vi) Once – a day dosing improves patient compliance.
Sun has used the technology with Baclofen extend release capsules named Baclofen GRS capsules.
It conducted 19 studies for comparative bioavailability and observations of food effect on 388 healthy volunteers and 108 patients in Indian.
It completed Phase III trials, registered product and marketing the drug in Indian market. For US market, it filed IND and received approval from the US FDA for drug.
The company initiated phase III trials, randomized, placebo controlled efficacy tests in 300 patients in USA and also planning to do label safety study test & PK study test on 100 patients.
Other than Baclofen GRS capsules, SPARC is also developing few more drugs with this technology.
Wrap Matrix System is another technology developed by Sun that will make drugs stay even longer – 16 to 24 hours in the stomach.
The key advantages of the technology are (i) Once-a-day dosing (ii)Ability to handle products with higher daily dose (iii) Suitable for drugs with very high solubility (iv) No residual drug in dosage form on evacuation (v) Minimal food effect and (vi) Difficult to reproduce bioequivalence using any other formulation technology.
Sun is developing drugs in six therapies with using this technology such as antiepileptic, antihypertensive, cardiovascular, Skeletal, CNS and anticancer.
Sun’s antiepileptic drug is in Phase II studies in Indian market and expects to file IND with US FDA in Q1 FY’12.
Sun is also working on antihypertensive, cardiovascular, CNS and anticancer therapies using the same technology platform.
Another way of drug delivery Sun Pharma is working for is nanoparticle technology. The company is developing anticancer drugs using this technology.
Generally, the Anticancer Injectables that are used to kill cancer forming cells will kill both cancer forming cells and normal cells too. So this technology is used target only cancer forming cells.
The advantages of technology is it can delivers higher dose without increased adverse event profile.
The company is developing two drugs paclitaxel injection and docetaxel injection using this technology.
Paclitaxel injection using nanoparticle technology achieved 30% higher drug concentration in tumor tissues compared to conventional paclitaxel. The infusion time of the drug is short (30 min) compared to Abraxane injection.
Abraxane injection is used to treat breast cancer manufactured by Abraxis BioScience and marketed by Biocon in India. For Indian market, it planning to initiate Phase II/III studies in Q FY’11.
Dicetaxel injection using nano technology safe to dose up to 7.5 times higher than the conventional docetaxel injection.
The company initiated phase I studies in solid tumor patients in India. For US market, planning to meet US FDA in the current fiscal for Pre-IND meeting.
Sun is developing two injections Goserelin Depot Injection and Octreotide depot injection using this Biogradable technology for treating chronic segment.
In some diseases of chronic segment, the drug levels should be maintained around the clock in the human body.
For this purpose, large molecules (polymers) will be added to drugs. For infusion doctors need to use large size of needle. This will gives inconvenient to patients.
Goserelin is a LHRH analogue used for the treatment of hormone dependant tumours such as prostate cancer, breast cancer & endometriosis. For Indian market, clinical trails are started from April 2010.
Octreotide depot injection is launched in India and planning to file IND in Q1 FY’12 for US market.
Sun Pharma Advanced Research Company (SPARC) made these announcements at an analysts’ meet conducted in Mumbai, recently.