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Each formulation is unique, just as each drug candidate is unique. At Pharmatek, formulation projects start with a strategic formulation plan. The formulation strategy is the result of a thorough analysis of the preformulation data report, the intended manufacturing process, any patient compliance issues and the strategic goals of the company.
At Pharmatek, our team of formulation scientists has a comprehensive understanding of both solid oral drug product development & injectable drug product development. We understand that certain candidates present specific challenges such as low bioavailability, poor solubility and/or permeability and poor physical stability. Formulation development can be helpful in overcoming many of these issues. Our priority is to always provide a safe and robust formulation to meet our clients' early-stage development goals.
Execution of the formulation strategy utilizes a logical, data driven approach:
- Pre-formulation solubility and stability evaluations
- Comprehensive excipient screening
- Prototype development
- Formulation optimization and finalization
- Supporting documentation and data package
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- Parenteral formulations: toxicology formulation development & stability studies with GLP support, placebo development, liquid in a vial, powder in a vial for reconstitution, lyophilized powder for reconstitution
- Oral formulations: solutions, suspensions, emulsions, capsules, tablets, coated capsules or tablets (for non-rodent species)
Note: All formulation development techniques can be applied to both non-potent and highly-potent/cytotoxic compounds
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Formulation development is often seen as a black box. At Pharmatek, it's a science. Our logical, data-driven approach to formulation development gives your compound the best chance at success and provides our clients the most efficient, straightforward process for manufacturing their compound. |
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