Excipient tools cut tabletting costs

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Related tags: Pharmacology

BioInnovators, a USA-based consultancy serving the pharmaceutical
and biotech industries, has developed a new set of tools designed
to help pharmaceutical and dietary supplement companies understand
and improve cost and time efficiencies in the development and
manufacturing of tablets.

BioInnovators, a USA-based consultancy serving the pharmaceutical and biotech industries, has developed a new set of tools designed to help pharmaceutical and dietary supplement companies understand and improve cost and time efficiencies in the development and manufacturing of tablets.

The tool suite, called Excipio Economics, is the fruit of a collaboration with JRS Pharma LP, formerly the excipient business of US firm Penwest but which was acquired by Germany's J Rettenmaier & Sohne GmbH in February of this year.

Excipio Economics assesses the economic impact of a new generation of high-functionality excipients, compared to conventional excipients, across the complete formulation and manufacturing processes, and provides tools for integrating economic and technical criteria into excipient and process selection.

"Excipio Economics is a valuable aid that can help pharmaceutical companies face increased pressures to lower drug costs, speed the time to market and improve drug performance,"​ said BioInnovators' Matthew Heil. He said the consultancy has already used the approach to quantify the advantages of new high-functionality excipients, such as JRS Pharma's ProSolv SMCC, a patented formulation of microcrystalline cellulose and colloidal silicon dioxide, and found that it can have "a significant effect on development and commercial manufacturing costs. We believe that Excipio Economics can effectively bridge the gap between R&D and manufacturing, and integrate formulation and economic considerations with those of commercial manufacturing decisions."

As an example, one tool in the suite is the Excipio Economics Value Optimization (EEVO) model, an interactive computer simulation that inputs a company's data and produces an integrated analysis of tablet development metrics across multiple processes. The EEVO model measures how choices in formulation can affect cost, productivity and the bottom line, and facilitates the planning and decision-making of tablet development from the earliest stage.

The application of Excipio Economics in the formulation of a New Chemical Entity with difficult formulation characteristics was able to demonstrate the impact of using ProSolv SMCC in place of rival excipients. After 15 formulations were tested without success, the ProSolv SMCC formulation reduced friability and flow problems and met all other target specifications using only two excipients, compared to five in traditional formulations. The benefits were an 80 per cent reduction in time for formulation selection, minimisation of active consumed during development, flow properties suitable for high speed tableting, reduced tablet cost of 17 per cent and reduction in disintegration time, according to BioInnovators.

"Coupling these benefits with an anticipated ease of scale up for commercial manufacturing should lead to an earlier entry to market,"​ commented the consultancy.

Related topics: Processing

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