SC I O. Inhaled Products

Formulated Preparations: Specific Monographs

The following policy applies to BP monographs for inhaled products. BP monographs contribute to the safety and efficacy of inhaled products through the provision of quality specifications in line with current best practices and test methodology.

1. Alignment of BP terminology and test methodology with those used in the European Pharmacopoeia (Ph. Eur.)

a. Titles for BP monographs for inhaled products should use the relevant European Directorate for the Quality of Medicines and Healthcare (EDQM) full Standard Term for the dosage form, with the BP legacy title included as a subsidiary title for revised monographs.

b. The requirements should be consistent with those specified in the Ph. Eur.

2. Alignment of BP monographs for inhaled products with the Ph. Eur. general monographs for Preparations for Inhalation and Pharmaceutical Preparations.

a. Fine Particle Dose No tests for Fine Particle Dose tests will be included for specific BP finished inhaled product monographs under this revised policy, but a Production statement indicating that a test and limits should be agreed with the competent authority will be included in line with the Preparations for Inhalation General Monograph (with the exception of nebuliser preparations).

b. Uniformity of delivered dose The Uniformity of delivered dose test should be aligned with the Ph. Eur. General Monograph for Preparations for Inhalation and should be included in BP monographs for inhaled products with the exception of preparations intended for nebulisation.

c. Uniformity requirements for nebuliser preparations Appropriate Uniformity of content tests should be included in BP finished product monographs for preparations intended for nebulisation, to harmonise with the specifications of available products.

d. Assay An appropriate Assay (content of active requirement) for all BP monographs for inhaled product monographs is required. The type of Assay included in the monograph should follow the approach taken by the innovator product and the other established products in order to ensure a consistent approach. This is particularly important for preparations that are not intended for nebulisation. Where the average of the results of the Uniformity of delivered dose are used as an Assay, the content limits should be aligned with the Preparations for Inhalation general monograph, to harmonise with the specifications of licensed products.

3. Preparations for Inhalation of the British Pharmacopoeia This general monograph will be omitted for a future BP publication and suitable validated alternative methodology for the Content of active ingredient on actuation of the valve test will be established for existing product monographs when available. The Content of active ingredient on actuation of the valve test methodology from this general monograph will be moved to an Appendix and a cross-reference to this Appendix will be included in finished product monographs until alternative Assay methodology becomes available.

4. Water If control of water content has been shown to be important during product development, a requirement to determine water content should be included in a Production statement in BP monographs for inhaled products, which are not intended for nebulisation, to harmonise with the methodology and specifications used for established products.

5. Labelling With the exception of nebuliser preparations, where appropriate, Labelling statements should be added to BP monographs for finished inhaled products to reflect the label claim of the licensed products in terms of either the pre-metered dose, the metered dose or the delivered dose, as appropriate.

6. Inhalation Powder, Pre-Metered Where the expression “the pre-metered unit is loaded into a dry-powder inhaler to generate an aerosol” appears in individual BP monographs for Inhalation Powders, Pre-Metered, the term “pre-metered unit” refers to the single-dose pre-metered dosage unit, consisting of one or more powders of (a) solid active substance(s), presented in a suitable pharmaceutical form other than a hard capsule. The pre-metered unit is loaded into a dry powder inhaler to generate an aerosol.