Hermes Pharma says it can solve the stability challenges that held back development of lipid-based particle coating techs.
The firm - and partners at Research Center Pharmaceutical Engineering GmbH (RCPE), Innojet Herbert Hüttlin and the Karl Franzens University – want to use lipids to create a new particle coating technology that lacks the shortcomings of traditional polymethacrylate and cellulose-based systems.
Detlev Haack, head of R&D at Hermes Pharma, told in-Pharmatechnologist.com that: "With conventional coating processes there is a 30 per cent dispersion. That means 30 per cent are fine dispersed particles, 70 per cent is water or organic solvent. The latter is just a processing aid. The process then needs to evaporate this water or organic solvent.
"As a result, more energy and time is needed to evaporate the water or organic solvent. With lipids there is no need for processing aids and thus processing times as well as energy consumption can be reduced. We assume that applying the new technology will save more than 50 per cent of the processing time.“
The difficulty is that lipids change physically over time, slowly transforming from porous meta-stable states through which molecules can pass to stable beta form states through which they cannot. This can have serious implications on dissolution according to Haack.
"Modification changes are the reason why the dissolution properties after storage are different than immediately after processing. Immediately after processing the meta stable modifications usually occur, thus the release is quicker than with the stable modifications. The dissolution becomes slower after 2 or 3 months of storage as the stable modification occurs."
As a result while lipid coatings are used in pharmaceutical extended-release applications, and indeed the food industry, to date they have not been successfully applied to orally disintegrating pills, which is precisely what Hermes intends to do.
"Our aim is to achieve immediate dissolution when ingesting the final product. Meta stable modifications can achieve that; stable modifications block the API from being released.“
He explained that Hermes plans to address this issue by either making modifications to the lipids as soon as processing finishes or to develop ways of stabilizing the meta-stable state.
Any technology and processing techniquies developed under the project will be owned by Hermes and offered as part of its contract formulation development business. The firm also plans to apply it to products made by its parent company, Hermes Arzneimittel.
"If a customer wants an orally-disintegrating granule with an API that is very bitter, for example, we will use this new technology to coat the particles in order to mask the bitter taste of the API. Customers also want to have better tasting products which would – without the new coating technology - be too bitter to be marketed successfully. And they want to offer products which their competitors simply do not have.