White Paper: API And Dosage Development
Published May 2021
Abstract:
Active pharmaceutical ingredient (API) are the substance(s) in pharmaceutical drugs that are responsible for the beneficial health effects experienced by consumers. Some key factors that drive API selection are crystallinity, polymorphism, solubility, density, stability, particle size distribution, density, development stage, and need.
This white paper explores:
- API Form Development
- Dosage Form Development
- Dosage Forms
- Regulatory
Keywords: API, API form development, dosage form, pharmaceutical drugs, oral immediate release, oral controlled release, topical and transdermals, sterile liquids, powders, injectable drugs, lyophilized formulations, inhalants, formulation services, batch manufacture, process optimization, eCTD, critical quality attributes, orphan drug, regulations
Click here to view White paper: API And Dosage Development