As new product development in pharmaceutical research becomes patient targeted and complex, more-and-more products are being delivered by injection than orally. Development of parenteral dosage forms is more difficult than oral formulations. Chemical and physical stability are key considerations, viscosity is critical, and sterility is essential.
Ascendia recognizes the challenge in developing parenteral dosage forms and specializes in offering early-stage development services for these type of projects. A major milestone in a pharmaceutical development project is the “first-in-man” study. For parenteral products reaching this milestone is especially difficult due to the expense of producing clinical trial materials. Ascendia offers small-batch size services for conducting this type of first-in-man study.
We develop and evaluate parenteral formulations for preclinical and early human studies. There are a couple of key considerations for the development of a parenteral pharmaceutical product: the administration route (intravenous, intramuscular, or subcutaneous) and the requirement for a sterile, pyrogen-free dosage form. During development, the formulation is optimized via pH adjustments, co-solvents, complexation, surfactants and combinations of these methods. Different dosage-form concepts can be developed: solutions, suspensions, emulsions, or a lyophilized powder for reconstitution (if stability is an issue).
Ascendia will work with you to put a cGMP batch record and process in place to produce small quantities of your drug product suitable for injection. Typically the dosage form will be in a vial – either as a suspension or lyophilized. Sterility is assured via autoclaving or by aseptic processing if necessary.
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