CRED Getting the CMC Dossier Right 2024

05/09/2024

Tablets/Capsules – Key Considerations

• Low dose – Active ingredient physical properties have little impact on quality of tablet except particle size to ensure dose uniformity • High dose – Active ingredient properties such as bulk density, flowability and compressibility could become critical • Low solubility may require surfactant in formulation and controlled small particle size • Immediate release or modified release (delayed, gastro-resistant, prolonged, extended, controlled etc) • Packaging – mostly about protecting product rather than compatibility and interactions

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Parenteral Dosage Forms

• Active ingredient in a simple liquid vehicle (e.g. 0.9% NaCl ), sterilised for direct administration into body tissues • Use of additives must be justified (e.g. solubilisers and preservatives) • Free from particulates, non-irritant and preferably iso-osmotic with respect to blood/plasma

• Devices may be required (self-injectors/pens/pumps)

• Bolus (small volume) or Infusions (large volume)

• Prolonged or delayed release possible (suspensions, oily vehicles, liposomes)

The Organisation for Professionals in Regulatory Affairs

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