Pharmaceutics

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 dissociation constants, hygroscopicity, lipophilicity, melting point via differential thermal analysis, water content by Karl Fischer analysis, and salt formation characteristics. We also conduct polymorph studies based on differences in solid phase IR and evaluate solubility profiles under a variety of pH conditions.

We are aware of the extensive amounts of information that are required for preformulation and we can tailor our research to only those pieces of information that are immediately relevant for developing a certain dosage form.

Dosage/Formulation Design
SRI assists clients with the development of pharmaceutical products ranging from standard formulations for oral administration to alternative and novel dosage designs. Dosage forms include:

SRI has particular experience in aerosol drug delivery, including device design, that is especially useful for the development of drugs for respiratory diseases such as asthma and for companies active in gene therapy. We have the expertise to deliver both small and large molecules systematically via aerosol as an alternative to the injections often used for peptides and proteins. SRI has a proprietary position on micronizing proteins and peptides to an appropriate particle size for pulmonary delivery while retaining their activity. We have also developed systems for improving the stability of protein therapeutics, including vaccines. In addition, our many years of research in the field of microencapsulation and biopolymers can be applied to a variety of parenteral and oral systems to permit controlled drug delivery, taste masking or the formulation of prodrugs. Such capabilities allow clients to develop OTC versions of drugs or special formulations for children or the elderly, as potential live extensions.

Contact Us:
Client Services
Biosciences
Phone: 866-451-5998 (toll-free) or 650-859-3000
FAX: 650-859-3041
Email: biosciences@sri.com
     Last Updated Jun 15, 2006