At Pharmatek, our team of formulation scientists has a comprehensive understanding of injectable drug product development and is skilled at maximizing solubility and stability of our clients’ small molecule and peptide drug candidates. Our priority is to provide safe and robust formulations to meet our clients’ early-stage development goals. We offer a variety of services, tests and product configurations for your injectable drug development needs.

Injectable Dosage Routes:

•Intravenous
•Subcutaneous
•Intramuscular
•Intrathecal

Injectable Dosage Forms:

•Liquid (Aqueous/Cosolvent
•Complexations (Cyclodextrin)
•Lyophilization
•Suspenions

Analytical Services

•Stability indicating HPLC Method Development & Qualifications (Reversed Phase, Ion Exchange)
•Osmolality
•Viscosity
•Injectability
•Clarity
•Thermal Characterization
•Aggregation Analysis by SEC (Peptides)

Charaterization

•Accelerated Stability Studies
•In-Use Stability Studies
•pH Solubility & Stability Assessment
•Solubility & Excipient Compatibility
•Physiochemical Characterization of API
•Hygroscopicity Evaluation
•In-vitro Plasma Compatibility Studies
•Filter Compatibility Assessment
•Adsorption

Development

•Toxicology Formulation Development & Stability Studies with GLP support
•Clinical Formulation Development & Stability Studies
•Container/Closure & Delivery Component Compatibility Studies
•Lyophilization Cycle Development
•Placebo Development
•Lyophilized Powder for Reconstitution
•Autoclave for Terminal Sterilization Studies

Manufacturing Support

•Manufacture of Working Reference Standards
•Manufacturing Process Development
•Scale-Up & Technical Transfer Studies
•cGMP Drug Product Release & Stability Testing
•USP/EP Testing including: pH, Osmolality, Clarity, Volume in Container

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