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New nanotech excipient offers cheaper solubility option say scientists

By Gareth MacDonald+

22-Jul-2014
Last updated on 22-Jul-2014 at 12:53 GMT2014-07-22T12:53:13Z

New Uppsalite excipient cheaper than mesoporus silica for formulations
New Uppsalite excipient cheaper than mesoporus silica for formulations

Scientists in Sweden have developed a magnesium carbonate-based excipient they claim is a low-cost nanotech alternative to silica for drugmakers struggling to formulate insoluble APIs.

The new excipient – Upsalite – was created by scientists at Uppsala University who used it to develop a formulation of the painkiller ibuprofen that achieved both higher solubility levels and faster dissolution rates than standard pills according to a new study published in the International Journal of Pharmaceutics .

Maria Stommer, head of the University’s nanotechnology and functional materials department, told in-Pharmatechnologist.com the excipient is dotted with 5nm pores that prevent insoluble active pharmaceutical ingredients (API) from forming crystals and coming out of solution.

When we formulate a poorly soluble drug in these pores they simply do not have a chance to get into an ordered, crystalline arrangement.

It is the crystalline arrangement which is poorly soluble, so by forcing the drug to maintain a disordered arrangement we are forcing them to be in a more soluble form. So in short, it is a physical restriction of movement set forth by the narrow pores.”

The approach is similar to how nanotechnology scientists are using mesoporous silica, however, “this material is right now extremely expensive to produce, which Upsalite is not” according to Professor Stommer.

Spin-out 

Stommer and her colleagues from Uppsala University’s Angstrom Laboratory have set up a spin-out firm – Disruptive Materials – to manufacture and commercialise the new excipient for pharmaceutical industry applications.

She told us that Disruptive has “two different manufacturers, one in Sweden for small batches and one in Lithuania for larger batches. We may need a larger production partner in the near future.”

Disruptive is targeting both drugmakers with insoluble API candidates as well as those interested in developing new formulations of approved drugs according to Stommer, who said the firm is already in talks with potential customers.

Source: International Journal of Pharmaceutics

Volume 472, Issues 1–2 , 10 September 2014, Pages 185–191 DOI: 10.1016/j.ijpharm.2014.06.025

Stabilisation of amorphous ibuprofen in Upsalite, a mesoporous magnesium carbonate, as an approach to increasing the aqueous solubility of poorly soluble drugs

Authors Peng ZhangJohan ForsgrenMaria Stromme

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