CRED Getting the CMC Dossier Right 2024

05/09/2024

Other Products

• Oral liquids where swallowing solids can be a problem • Accuracy of dosing with devices, compatibility, palatability, preservatives • Transdermal delivery (patches) for prolonged release

• Skin irritancy, adhesion, skin permeation

• Suppositories/Pessaries

• Temperature effects such as melting

The Organisation for Professionals in Regulatory Affairs

13

Local Delivery • Eyedrops (sterile considerations)

• Preservatives or specific design of multi-dose containers, single-use containers • Nasal Sprays • Irritancy to nasal mucosa, damage to nasal cilia, osmotic effect

Image result for nasal pressurized metered dose sprays

Creams and Ointments

•

• Separation of phases, thixotropy and rheology control, absorption

• Tablets / capsules for local effect in colon

The Organisation for Professionals in Regulatory Affairs

14

7