Under the agreement, SoluBest will develop a dosage form for testing in pilot clinical trials, as well as scaling up the production process to industrial scale. From there Dr Reddy’s will take over the remaining clinical program, regulatory aspects, production and marketing.
SoluBest’s Solumer platform was developed by the Israel-based drug delivery firm to combat solubility issues; something CEO Amir Zalcenstein describes as “one of the most pressing problems in drug delivery.”
According to him, around 40 per cent of marketed drugs are considered poorly water soluble, and an estimated 70 per cent of new chemical entities (NCEs) entering drug development programs lack the aqueous solubility to allow proficient gastrointestinal absorption.
Zalcenstein told in-PharmaTechnologist that the technology works to create therapeutic formulations by interweaving drug nano-crystallites with FDA-approved polymer compounds.
Once inside the body, these formulations disintegrate into colloidal dispersions. The tiny surface area of the disordered interwoven crystallites helps enhance dissolution of the drug, he said.
Enhanced drug solubility
“Enhanced solubility means that more of the drug is available for uptake in the gut,” said Zalcenstein, adding, “By enhancing the solubility we in fact increase the number of drug molecules in solution that are free to pass through into the GI membrane and taken into the bloodstream.
This notion has been backed up by independent researchers in India who report in the ‘International Journal of Nanoparticles’ that producing nanoscopic crystals of a pharmaceutical product can allow medication to be absorbed by the gut even if the drug is not soluble in water.
Unlike other platforms for improving drug solubility, SoluBest claims the Solumer technology boastsfast turnaround times,allowing a feasibility trial to be completed in less than four weeks. Furthermore, the technology uses standard spray drying equipment, and therefore requires no increase in the manufacturing footprint.
“We’re seeing a lot of competition in the solubility enhancement market, but at the same time demand is growing exponentially. With more and more new compounds in discovery, the problem of insolubility is becoming ever more acute,” said Zalcenstein.
“We hope this deal will increase SoluBest’s long term recognition in the industry, and will bolster our short to medium term deal flow,” he added.
SoluBest has been working to raise $1.5m (€1.1m), and aims to bring this sum up to $2m (€1.4m). The money will go towards enhancing in-house capabilities, and developing SoluBest’s product pipeline, though initially “[SoluBest] intends to establish a profitable drug delivery business,” said Zalcenstein.
Source: International Journal of Nanoparticles
Volume 3, 2010, Pages 280-296
“Physico-Chemical evaluation of gymnemic acids nanocrystals”
Author: R. Ravichandran