Capsugel wants to standardise lipid formulation tests
The organisation – made up of experts from industry and academia – will conduct research into oral lipid-based drug delivery systems for poorly soluble drugs.
It eventually hopes to develop guidelines to standardise in vitro evaluation methods to support the development of promising new drug candidates; a high proportion of which are tricky to develop because of bioavailability problems.
Speaking to in-PharmaTechnologist.com, the consortium’s chair Hassan Benameur said: “Lipid formulations have been underutilised. This is mainly because the published literature on mechanisms of action, laboratory formulation methods, and development of lipid-based products is limited.”
Benameur, who is also senior director of pharmaceutical sciences at Capsugel said a better knowledge-base will give developers more confidence when using lipid formulations.
“If formulators can predict which drugs will benefit from lipid formulations, and have appropriate tests to optimise formulations before they embark on in vivo experiments, formulators are more likely to consider lipid formulations at an early stage,” he said.
When asked why Capsugel took the arguably unusual move of forging a not-for-profit partnership with would-be rival firms, including Merck KGaA and Sanofi, Benameur told us it is “pre competitive”.
He said sharing the financial load, as well as creating a global consensus within both industry and with the regulators, makes sense for future business.
Sanofi research and development’s (R&D) Ross Blundell, a consortium member, also said: “It is difficult to see that an industrial partner working alone could have achieved the same breadth of data in the same time frame as the consortium.”
The latest findings
The team’s first research paper, set to be published in the Journal of Pharmaceutical Sciences, focuses on standardisation for digestion testing.
Colin Pouton from the Monash University in Melbourne – the working group leader of the Lipid Formulation Classification System Consortium – said: “Our initial findings confirm that using the digestion model is the preferable method for differentiating between formulations.”
However Benameur said there are currently too many methods - different pH's, different formulae for simulated intestinal fluid, different enzyme levels, different volumes and concentrations of materials – which is confusing to developers.
“At present the consortium is focused on establishing the variables that affect the results of in vitro dispersion and digestion tests,” he said. “The consortium will then produce guidelines for performing in vitro dispersion and digestion tests, including suggested standard test specifications and examples of data processing.”
