Metered-dose inhalations, stability testing

In the US, two separate guidelines have been developed, one covering both metered dose inhalers (MDIs) and dry powder inhalers (DPIs) and one covering nasal sprays, inhalation solutions, and suspensions and inhalation sprays [22, 23], The guidance on MDIs and DPIs is however still in draft form nearly 10 years after being published for comment one of the unresolved issues is the dose content uniformity requirements which are discussed later in this chapter (Section 16.5.4). There are also other sections which would benefit from further discussion, in particular the number and nature of some of the tests that may be expected on stability. 

Stability test Nonpros surized metered dose nasal spray Nasal single use sprays Non-pressurized metered dose inhaler Product for nebulization (single and multiple use)... 

Stability test Pressurized metered dose nasal spray Pressurized metered dose inhaler Dry powder inhaler and nasal powders, device metered Dry powder inhaler pre-metered... 

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