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
Physicochemical Characterization SRI’s Pharmaceutical Formulation Design group’s preformulation services include the following physicochemical characterization studies
Back to Pharmaceutical Formulation Design High Throughput Solubility Screening Does your drug candidate have poor solubility or no solubility in water?
If so, High Throughput Solubility (HTS) screening can be the solution. HTS screening is an effective way to screen and identify the co-solvent systems with the desired soluble concentration from a library of co-solvent systems. It is
SRI has developed several levels of HTS screens with hundreds of co-solvent combinations suitable for both Oral and parenteral administration. We have employed this technology for developing formulations for BCS class II - IV type compounds. An exemplary SRI proprietary HTS screen is shown below. In Vitro Drug Permeation Studies Does your drug exhibit poor in vitro permeability? Do you want to know your compound’s permeability characteristics? Do you want to know the best site of intestinal absorption for your drug? If so SRI’s expertise in in vitro permeability studies using Caco-2 cells and Ussing Chambers can help you. Using our state of the art HTS screening and in vitro testing on Ussing Chamber apparatus we can develop formulations for your drug with enhanced permeability. Information obtained can be used to tailor the formulations and target to a specific part of the intestine using one of our several Formulation Development technologies offered at SRI. Back to Pharmaceutical Formulation Design
Dosage/Formulation Development
SRI has capabilities for providing services for coating of capsules and tablets of all sizes ranging from bench to pilot scale. We have experience for coating the following dosage forms for both functional and non functional coating
We can accommodate batch sizes from one gram to kilograms for R & D batches to clinical supplies. Our unique way of coating minicapsules and minitablets is a perfect solution for preparation of enteric coated dosage forms for in vivo studies especially designed for small animals such as rats and rodents. SRI’s Pharmaceutical Formulation Design group also specializes in development of liquid formulations such as:
If required we use our HTS Screening technology for selecting and incorporating the rightful excipients. We use the traditional homogenizers for preparation of emulsions and suspensions and also state of the art Microfluidizer for the development and preparation of stable nano-dispersions, nano-emulsions, microencapsulation in polymers, Solids-in-liquid suspensions etc. SRI has the experience and capability to develop and manufacture semi solid formulations such as the following
Back to Pharmaceutical Formulation Design Alternative Drug Delivery Systems SRI also has expertise in development of alternative or specialized drug delivery systems. We have experience in developing formulations for the following delivery systems.
Back to Pharmaceutical Formulation Design
Contact Us
|
|||||||
About Us 
R&D Divisions Careers Newsroom Contact Us
©2008 SRI International 333 Ravenswood Avenue, Menlo Park, CA 94025-3493
SRI International is an independent, nonprofit corporation. Privacy policy