Troikaa Pharmaceuticals is expected get a US patent for new method for delivering the pain killer drug diclofenac through injection, reports said.
Troikaa currently markets its diclofenac injectable product under the brand name Dyanapar AQ in India.
“Troikaa is shortly to get US patent for its Dyanapar AQ 1 ml injections, as proceedings at the USFDA have got over, we are just awaiting certificate and confirmation from them (USFDA),” Troikaa Pharmaceuticals MD Ketan Patel was quoted as saying.
Troikaa Pharma claims that it has introduced diclofenac 75mg / 1ml injection is introduced for the management of acute pain, for the first time in the world.
Diclofenac is a nonsteroidal anti-inflammatory drug which relieves pain and reduces inflammation (swelling). It is used to treat headaches, muscle aches, dental pain, and athletic injuries. It is commonly used to treat the pain, swelling and stiffness associated with arthritis.
Unlike conventional diclofenac, 1ml Dynapar AQ injection of Troikaa can be given to the shoulder muscle (intra-deltoid) as well as I.V infusion.
Multicentric clinical studies have proven the efficacy and safety of 75mg/1ml Diclofenac injections, Troikaa said.
Bioequivalence studies show that Dynapar AQ 1ml injection offers higher bioavailability compared to conventional 3ml Diclofenac injection.
Studies show that majority of intra-gluteal injections may actually be subcutaneous and the rate of absorption is faster when given intra-deltoid rather than intra-gluteal.
Moreover, smaller volume of concentrated solution causes less muscle damage as compared to larger volume of relatively less concentrated solution.
Dynapar AQ 75mg/1ml is indicated in management of acute pain including post-operative pain.
Troikaa sees a huge market for Dynapar AQ injections around the world.
Troikaa has filed patent for Dynapar AQ injections in 99 countries including US.
Dynapar AQ 75mg/1ml received its first Patent from South Africa followed by Myanmar and OAPI region countries.
Proceeding for patent in Israel for this injection is also almost over and it would be received soon, according to Ketan Patel.
Troikaa has also been granted Department of Scientific & Industrial Research (DSIR) National Award for R & D efforts in Industry (2008) Group-1: Physical & Biological Sciences, for developing Dynapar AQ 75mg/1ml – The only 75mg/1ml diclofenac injection.
Headquartered in Ahmedabad, west India, Troikaa mainly focuses on Novel Drug Delivery Systems (NDDS).
Troikaa has filed six patents in various areas of drug delivery.
Troikaa is planning to establish a project under Biotechnology, anti-cancer / hormones and steroids in an area spanning 65 acres land at Sanand District, Ahmedabad, Gujarat.
The company has chalked out plans to invest Rs.141 crores with the object of expanding its manufacturing capacity as well as to set up state-of-the-art facilities for various Novel Drug Delivery Systems.
The company also plans to increase its the domestic sales from the present 750 to about 2000 by the year 2012.
Troikaa will also set up a facility to manufacture biotechnology products.
Troikaa’s R&D centre is accredited by Department of Scientific and Industrial Research (DSIR) affiliated to The Ministry of Science and Technology.
Troikaa has manufacturing facilities at Ahmedabad and Dehradun.