Formulation Development Strategies from Preclinical PK, GLP Toxicology and Phase I, II, III Clinical Trials to Commercial GMP Manufacturing
Exploratory Formulation Suite
Special Considerations for Discovery/Pre-clinical Stages:
- Dose requirements for efficacy, PK and toxicology studies vary
- Routes: IV, PO (solution, suspension, solid), SC, IP, etc.
- Often with poor solubility and low bioavailability
- Quick turnaround time
- Limited amount of material
- Scalability for future development
Dosage form development for new chemical entities, OTC products, generic products, and 505(b)(2) product candidates.
- Tablets
- Capsules, powder-filled
- Capsules, liquid-filled
- Oral solutions and suspensions
- Creams, gels, ointments
- Injectables
- Long lasting parenterals
- Controlled/Sustained release products
- Pellets
- Microspheres
- Lyophilized products
- Animal study materials
Other Standard Pre-Formulation/Formulation Service Packages:
- Excipient Compatibility study
- Solid state properties: particle size, state of hydration, crystal form (third party)
- Dissolution method development and testing
- Solubility in simulated gastric fluid (SGF), Simulated intestinal fluids (SIF) and simulated colon fluids (SCF) in Fasted and Fed state
- Stability studies – short-term, accelerated, forced degradation, ICH photo stability