Pulse Pharmaceuticals gets regulatory approval for nano-carrier Vitamin D3 formulation
Hyderabad, Aug 20 (TNT): Indian pharmaceutical company Pulse Pharmaceuticals on Thursday said it has received regulatory approval for its Nano-Carrier Entrapped Vitamin D3 Oral Dispersion, marking a major milestone in the company’s nanomedicine drug-delivery research.
The company said the approval followed scientific evaluation of its nanocarrier technology for Vitamin D3 delivery and described it as probably the first such approval globally.
Clinical studies conducted by the company showed 50-60 per cent higher serum Vitamin D levels with the nano-carrier entrapped Vitamin D3 oral dispersion compared to conventional formulations, it said.
Pulse Pharmaceuticals said it has been working on nanopharmaceutical drug delivery since 2010 and its proprietary “Aqueol” platform is designed to deliver lipophilic compounds in water-based mediums.
The company said its nanotechnology platforms are aimed at improving drug bioavailability, tolerability and overall patient experience.
Beyond Vitamin D3, Pulse is applying its platforms to essential nutrients such as Vitamin K2-7, Vitamin B12 and iron, as well as commonly used medicines including paracetamol, diclofenac and ibuprofen.
On the intellectual property front, Pulse currently holds five granted patents in India, the United States, Russia, Mexico and Australia.
An EU patent for its Aqueol technology is in the final stages of approval, while patents for four other proprietary platforms have been filed across seven major countries.
The company is also working on filing three more patents.
Pulse said it is expanding its commercial reach across India, Southeast Asia, Africa, the Middle East, Russia-CIS and Latin America, besides pursuing strategic collaborations in the US and Europe.
Pulse Pharmaceuticals Founder and Managing Director K V Rambabu said the company’s focus was on identifying unmet needs in drug delivery and developing practical solutions that could make a meaningful difference to patients.
“India has demonstrated its ability to become the pharmacy of the world. The next opportunity is to become a stronger source of pharmaceutical innovation for the world,” he said.
Pulse Pharmaceuticals is an innovation-driven Indian company focused on developing novel drug-delivery systems for molecules that face limitations in conventional formulations, according to the company.
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