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