Silica-Based Drug Delivery Solutions

Grace and Formac engaged in a multiyear strategic partnership with the mission to provide the pharmaceutical industry with an innovative and powerful delivery technology.

Formac has evolved into the world’s leading center for the formulation of poorly soluble APIs with mesoporous silica. The specific and cutting-edge expertise of Formac is now complemented with the experience of Grace, he number one manufacturer of silica worldwide.

Estimates are that around 40% of drugs on the market and 90% of those in discovery pipelines exhibit poor aqueous solubility. The inherent low and variable oral bioavailability of poorly soluble active pharmaceutical ingredients (APIs) presents an important challenge to drug development.

Our unique drug delivery technology is based on the adsorption of poorly soluble APIs on hydrophilic mesoporous silica materials. Through solvent based techniques, the API can be deposited in the internal mesopore system of the silica material. The interactions between a hydrophobic API and a hydrophilic silica material are typically very weak and easily disrupted upon contact with aqueous media. Desorption of the API from the silica surface upon contact with the gastrointestinal fluids is associated with the generation of API concentrations that are not achievable by dissolution of the crystalline form, thereby creating a driving force for absorption.

The rate at which the drug is presented to the gastrointestinal environment can be tightly controlled, by judiciously modifying the pore size and particle size of the silica material. The superior physical stability of these mesoporous silica based formulations, together with the generic applicability of the technology and the formulation flexibility that results from the ability to fine-tune the silica materials, offers unprecedented advantages for the delivery of poorly soluble APIs.