Drug Formulation Development
SRI Biosciences has the experience and expertise to solve challenging formulation and drug delivery problems. We address 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 types of dosage forms and has worked with new chemical entities, OTC products, generic products, and line extensions. Protection of proprietary information is routinely incorporated into our procedures.
We start with an understanding of the bulk drug’s physical and chemical properties then screen the compound to determine its permeability characteristics and susceptibility to metabolizing enzymes.
Once the pharmaceutical profile of the drug has been determined, the appropriate route of administration can be identified and designed. Excipients are selected to overcome potential problems in manufacturing and stability, and to address factors impacting delivery issues such as solubility and absorption.
Bench studies are then performed on pilot batches to establish excipient compatibility and dosage form specifications. The final formulation design is optimized to take into account the pharmacokinetic properties of absorption, distribution, metabolism, and excretion.
Dosage forms include solutions, capsules, tablets, emulsions, suspensions, and semisolids. We have developed spray-dried, microencapsulated, and microfluidized formulations. We have also developed specialized alternative drug delivery systems such as bioadhesive nasal gels, biodegradable implants, enteric-coated capsules and tablets, topical gels, and multiparticulate systems.
