Considerations in Developing Complex Parenteral Formulations

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Parenteral formulations are broadly characterized as sterile solutions, suspensions, emulsions, and powders for reconstitution for injection or infusion; they are administered directly to subjects, entering the systemic circulation and typically providing rapid onset of action in comparison to orally administered products. Small-volume parenteral products are generally presented in vials or ready-to-use pre-filled syringes, providing ease-of-use in the clinical setting or for patient self-administration. The path to delivering these stable, apparently simple solution, suspension, or emulsion formulations is multi-faceted and requires a constant focus on key control measures through pre-formulation development to commercialization.

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