NIPER says API nano crystal formulation tech will cut drug costs
The new technology, dubbed NanoCrySP, generates the nano-crystals directly as solid powder, rather than as a nano-suspension in liquid. It uses a novel spray-drying-based method that generates solid particles, dispersed in excipients.
“[The technology] does not require use of any specialised equipment which some of the current technologies require. This coupled with the fact that a solid powder is obtained directly would reduce the cost of the nano-crystal based formulation,” explained Arvind Bansal, head of pharmaceutics at NIPER in India.
“This technology is suitable for a wide range of drugs, especially poorly water soluble drugs. They can be developed as tablets, capsules or other solid dosage forms.”
NIPER has entered a licensing agreement for development and commercialisation with Windlas Biotech, an Indian pharmaceutical company, which plans to scale up the technology and establish proof of clinical benefits. They have taken the marketing rights for Europe and the US. NIPER retains ownership of relevant patents.
Nano-crystals are nanometer-sized particles that allow drugs act faster and more efficiently than conventional forms.
Solubility enhancement
More than 60% of drugs are not soluble in water, which prevents their absorption in blood and tissues, leaving most drugs to be excreted without absorption. Formulators can address this by converting drug actives into nano-crystals, which are more readily absorbed as Bansal explained.
“Dissolution enhancement increases the speed which the drug dissolves in water. Reduction in particle size to nanometer size increases the surface area available for dissolving, which increases the dissolution rate. Faster dissolution is important for optimal absorption of orally administered drugs in the intestine."
This idea was backed by bioavailability expert Piera Di Martino from the University of Camerino, Italy who we asked for his view on the NIPER syste.
“This technology permits improved dissolution rate of active ingredients, allowing a faster pharmacological action” Di Martino said, adding that “The most interesting aspect is the possibility of getting very small nanoparticles in solid dispersions.”
However, Di Martin added that the technology must be evaluated case-by-case and in particular all stability tests must be carefully executed.
NIPER has applied for Indian, US and European patents for the technology.
