Module 3 - Strategic case studies in practice

Table 2 Typical Suitability Considerations for Common Classes of Drug Products (This table is a general guide, and is not comprehensive. See sections III.C through III.H for a more detailed discussion.)

SUITABILITY a

Route of Administration/ Dosage Form

Drug Performance/ Delivery

Protection Compatibility

Safety

Inhalation Aerosols and Solutions, Nasal Sprays Inhalation Powders Injections, Injectable Suspensions b Sterile Powders and Powders for Injection Ophthalmic Solutions and Suspensions Topical Solutions and Suspensions, and Topical and Lingual Aerosols Topical Powders Oral Solutions and Suspensions Topical Delivery Systems

L, S, M, W, G Case 1c

Case 1s

Case 1d

L, W, M Case 3c

Case 5s

Case 1d

L, S, M, G Case 1c

Case 2s

Case 2d

L, M, W Case 2c

Case 2s

Case 2d

L, S, M, G Case 1c

Case 2s

Case 2d

L, S

Case 1c

Case 3s

Case 1d

L, S, M Case 1c

Case 3s

Case 2d

L, M, W Case 3c

Case 4s

Case 3d

L, S, M Case 1c

Case 3s

Case 2d

Oral Powders

L, W Case 2c

Case 3s

Case 3d

Oral Tablets and Oral (Hard and Soft Gelatin)

L, W Case 3c

Case 4s

Case 3d

Capsules If there is a special performance function built into the drug product (e.g., counter cap), it a is of importance for any dosage form/route of administration to show that the container closure system performs that function properly. For definition of the term suspension , see footnote a to Table 1. b

Explanation of Codes in Table 2:

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