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The InForMED™ Approach to Pharmaceutical Product Development

"InForMED™" is SRI International's novel approach to designing pharmaceutical dosage forms. The proprietary InForMED concept is composed of three main interactive components:

• "In" - The in vitro characterization of the drug substance
• "For" - Formulation design and development
• "MED" - Optimization of the formulation by integrating data on the metabolism, elimination, and distribution of the drug

Each component's approach is described briefly below.

The InForMED process starts with understanding the drug substance. First, the in vitro properties ("In"), including the physical and chemical characterization of the drug, are measured. This involves determining the melting point, crystal habit, particle size, bulk density, polymorphism, and so forth. The chemical characterization involves determining pKa, log P, intrinsic dissolution rate, solubility, pH-solubility, and pH stability profiles. Along with these physicochemical properties, we also screen the compound in vitro, utilizing CaCO2 cells, to determine its permeability characteristics and susceptibility to various metabolizing enzymes. Thus, we rapidly and inexpensively obtain a pharmaceutical profile of the drug.

The second component is formulation design and development ("For"). This step uses the data obtained from the in vitro studies to quickly design a suitable formulation. The in vitro data are also used for insight into the route of administration to be investigated first. During the "For" design phase, we address the potential problem of low solubility, instability, poor absorption, etc. Depending on the problem at hand, appropriate GRAS excipients are selected and formulations developed to overcome the potential problem. During this phase pilot stability studies are conducted under accelerated conditions to narrow down the excipients and formulation specifications.

At the final stage of design phase ("MED"), in vivo pharmacokinetic data such as metabolism, excretion, and distribution are taken into account to optimize the formulation of the drug substance. We use pharmacokinetic and pharmacodynamic studies to refine our understanding of drug substance behavior in vivo to achieve a finely tuned drug product. We optimize the dosage formulation using all the information and insight available to provide an "InForMED" and exquisite final product.

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     Last Updated Mar 19, 2009