In pressurised Metered Dose Inhalers (pMDIs) pharmaceutical parameters have a significant impact on efficacy and safety. Therefore, the pharmaceutical properties must be well characterised in order to apply for a marketing authorisation. In addition to the general requirements for pharmaceutical documentation, special requirements must be met.

In the European Community, they are covered by the subsequent current guidelines:

• Note for Guidance on Requirements for Pharmaceutical Documentation for Pressurised Metered Dose Inhalation Products (CPMP/QWP/2845/02)
• Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation (1997 European guide to Good Manufacturing Practise Annex 10)
• European Pharmacopoeia 4: 2.9.18. Preparations for Inhalation: Aerodynamic assessment of fine particles
• European Pharmacopoeia 4: Preparations for Inhalation (Inhalanda)
• European Pharmacopoeia 4: Pressurised Pharmaceutical Preparations

Using CTD structure the presented essay summarises the specific requirements for pMDIs given by the current European guidelines. The following CTD sections are addressed:

3.2.S.4 Control of Drug Substance
3.2.P.2 Pharmaceutical Development
3.2.P.3 Manufacture
3.2.P.4 Control of Excipients
3.2.P.5 Control of Drug Product
    3.2.P.5.1 Specification
    3.2.P.5.2 Analytical Procedure
    3.2.P.5.6 Justification of Specification
3.2.P.7 Container Closure System
3.2.P.8. Stability

The five specific guidelines for pMDIs provide very helpful support for the applicant. In a compressed format they summarise the essential information which must be assessed for the marketing authorisation.

Some issues, such as the requirements for primary packaging material, may be addressed more detailed. For other issues, such as the determination of the fine particle dose, two inconsistent regulations exist in the European Pharmacopoeia and the Note for Guidance on Requirements for Pharmaceutical Documentation for Pressurised Metered Dose Inhalation Products.

Therefore, the knowledge of the legal status of the current European guidelines is very important for the applicant.

The guidelines provide very helpful support for the filing of an application for Marketing Authorisation for a pMDI. Nevertheless, it is difficult to apply for such a marketing authorisation with the knowledge of the current guidelines only. To meet all legal requirements, a fundamental experience with pMDIs is advantageous for the applicant.

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