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Formulation Development

SRI can assist in preparing the Chemistry, Manufacturing and Control (CMC) data package needed for an IND by assessing the relevant pharmaceutical physical and chemical aspects of both the drug substance and its formulation or drug product. SRI is very conscious of the cost parameters and regulatory requirements for formulating new drugs, and we look for simple, economical solutions to dosage design challenges. Our staff has extensive industry experience relating to all kinds of dosage forms and has worked with new chemical entities, OTC products, generic products, and line extensions. Protection of proprietary information is routinely incorporated in our procedures.

Preformulation
Our preformulation services include determination of the physico-chemical properties of the compound which includes the following

Dosage/Formulation Development
SRI assists clients with the development of a suitable "First in Human"dosage form in the shortest possible time.  SRI has expertise in the development of pharmaceutical products ranging from standard formulations for oral administration to alternative and novel dosage designs.

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 Dec 1, 2011