Drug Formulation & Drug Delivery
An important strategic focus of the Pharmaceutical Research Institute is development of state-of-the-art drug formulation and drug delivery units that will facilitate drug development for pharmaceutical and biotechnology organizations. These units will function as a resource partner for pharmaceutical and biotech industries operating under the Food and Drug Administration's current Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
Through these units, PRI-Albany will conduct pre-clinical testing and clinical trials to develop drugs for transitioning to industrial manufacture.
PRI-Albany focuses on drug formulation and stability testing leading to clinical trials, with the potential of discovering new strategies to treat current and emerging disease states. Following is a summary of the services PRI-Albany will provide when these units are fully functioning:
- Novel dosage forms, including sterile products, tablets, capsules, topical preparations and non-conventional products such as semi-solid or sustained-release preparations
- Products to enhance drug solubility, improve bioavailability, enhance drug stability, target tissue delivery and treat specific patient populations
- In vitro evaluation of stability and release properties for formulations
Clinical Dosage Forms Manufacturing
- Pilot- and production-scale batches of pharmaceutical dosage forms will be manufactured, packaged, labeled and shipped
- Bulk drug substances and manufactured products will be evaluated following USP requirements in compliance with GMP recommendations for quality control and assurance
- Long-term stability studies of the manufactured products will be conducted
- Verify chemical structure and compound purity
- Develop and validate analytical methods to quantitate drugs in formulations or biological samples
- Conduct drug stability determinations and other preformulation studies
- Evaluate pharmaceutical dosage forms following USP requirements