Tackling Formulation and Early Development Challenges of CNS Drugs
Avoid Roadblocks in CNS Drug Development
Development of drugs to treat central nervous system (CNS) disorders presents a unique set of challenges, including active pharmaceutical ingredients (APIs) with low solubility, poor bioavailability, or highly potent characteristics.
Altasciences is equipped to handle the formulation, as well as the preclinical, clinical, and commercial development of CNS drugs. Our FDA-registered and inspected cGMP manufacturing and analytical facilities are equipped with:
- DEA manufacturing and analytical license for drug Schedules I to V
- Segregated Grade C and D cleanrooms for the handling of highly potent APIs
- In-house R&D and formulation laboratories for drug product release and ICH stability testing
- Method development for low concentration formulations often used for psychedelics
- cGMP warehouse, including narcotic vaults and cold storage
Our scientific team has expertise with liquid-filled capsules, often the preferred dosage form for CNS drugs. We are also highly skilled in complex formulations and testing of controlled substances, including cannabidiols.
Get in touch to discuss how we can rapidly formulate and advance your CNS drug product to market.
Related Resources
- Webpage: Full Range of Manufacturing and Analytical Solutions
- Video: Handling of Highly Potent APIs and Controlled Substances
- Webpage: An Integrated Solution for Your First-In-Human Trials
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.