This service program supports the development and manufacture, of a wide variety of pharmaceutical dosage formulations, including tablets, capsules, semi-solid preparations, injectibles, and sustained-release products. If requested, manufacturing can be done under GMP.
Main Areas of Focus
- To fill specific gaps in an investigator’s drug development plan as they advance their product towards clinical investigation
- To help investigators obtain data to get additional funding
- To help with prospective partnerships
- To help getting regulatory permission to continue
- Characterization of physical and chemical properties of bulk drug substances targeted for formulation development
- Formulation development to enhance drug solubility, improve bioavailability, enhance drug stability, deliver to target tissues, and treat specific patient populations
- Stability and release properties of formulations in analytical and in vitro assays
- Long-term stability studies of manufactured formulations
- Formulations can be manufactured, packaged, labeled, and shipped under GMP guidelines.
Investigators seeking these services receive no funding from NIAID, but instead receive products or information generated by NIAID-funded contractors on their behalf.
Who Can Use This Resource
- Product must be defined and of known chemical structure
- Investigator must have preliminary data to support the continued development of product