Khandelwal stabilise nanoparticle formulation

The technology has been used to create a silver-nano gel for the topical treatment of burns, diabetic ulcers and bedsores.

In an interview at CPhI, Gururaj Mutalik, DGM-projects and business development at Khandelwal, and Dr K Paknikar, scientist-in-charge at the Agharkar Centre for Nanobioscience, outlined the technology and business prospects.

Paknikar explained that nanoparticles suffer from instability, which leads to them conglomerating and hinders formulation. Khandelwal’s technology uses bio-molecules to stabilise the formulation, which prevents the particles aggregating but does not affect the products safety of efficacy.

The resulting gel has potent antimicrobial activity across a broad range of pathogens, which find it very difficult to develop resistance, according to Paknikar. Khandelwal’s silver-nano gel is effective at 3.15 parts per million.

The product has completed Phase III trials and gained approval from the Central Drugs Standard Control Organisation (CDSCO). Having found a partner the product is now due to launch in India in the next month.

Mutalik said India represents a $30m market but Khandelwal are already eyeing the US, which they believe to be ten times as large. Marketing partners are being sought in the US, with the company hoping to launch the product in six months time.

Beyond this Khandelwal is hoping to expand the range of skin ailments that its technology can be used to treat to capture a larger proportion of the Indian skin market, which Mutalik believes is worth $350m.

Paknikar said that using silver nanoparticles in conjunction with antibiotics gives a synergistic effect and this is now an area of research Khandelwal is pursuing. Preclinical research of the treatment of burns is underway, with less than 20 per cent burns leaving very little scaring.

Burns and wounds represent a $170m market in India but the company’s big ambition is to develop an acne treatment. Mutalik described the market as “massive​” and was positive about the prospects of Khandelwal’s acne treatment, which is currently in preclinical.

Success in the acne market would elevate Khandelwal to a new level, with sales of prescription topical acne products totaling $1.4bn in 2004, according to IMS Health.