New USP Chapter on Inhalation Drug Products

Recommendation

27/28 June 2023
Heidelberg, Germany

Dissolution Testing
Development / Quality Control and in vivo Relevance

In the Pharmacopeial Forum 39/1 from January/February 2013, a draft can be found of a new general chapter <5> on "Inhalation" and "Nasal Drug Products". Now, the general chapter has been revised in order to take into consideration the comments made on the first edition of the revised chapter.

Currently, the following chapters have been revised or re-written:

<601> - Aerosol, Nasal Sprays, MDIs and DPIs
<602> - Propellants
<603> - Topical Aerosols
<604> - Leak Rate
 
The drafts of these texts have also been published in the Pharmacopeial Forum 39/1. Performance tests for inhalation drug products are described in general chapter <601> whereas chapter <5> deals with general quality aspects.

Inhalation drug products release a drug substance into the lungs through oral inhalation, either with aerosols, powders, sprays, solutions or suspension-related dosage forms. Each of this dosage form has its own description in chapter <5>.

General quality tests for inhalation aerosols include among others:

• Identification
• Assay
• Impurities and Degradation Products
• Water Content
• Foreign Particulate Matter
• Extractables
• Spray Pattern
• Microbial Limit
• Alcohol Content (where applicable)
• Net Fill Weight
• Leak Rate

For the other dosage forms (powders, sprays, suspension, etc) some additional quality criteria are listed. However, regarding performance quality tests it is always referred to the new general chapter <601>.

You can find the complete article in the online edition of the Pharmacopeial Forum.