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Dry Powder and Nebulized Aerosol Inhalation of Pharmaceuticals Delivered to Mice Using a Nose-only Exposure System
Published on: April 6, 2017
[The compatibility between packing material and ipratropium bromide aerosol]
Zhi-hua Yue1, Dian-dian Shen, Chang-qin Hu
1National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China.
Yao Xue Xue Bao = Acta Pharmaceutica Sinica
|March 1, 2011
Summary
Inappropriate pharmaceutical packaging can lead to impurities and low drug content in ipratropium bromide aerosol products. Compatibility studies between drug products and packaging materials are crucial for ensuring medication quality and safety.
Area of Science:
- Pharmaceutical Science
- Analytical Chemistry
- Materials Science
Context:
- Ipratropium bromide aerosol products are widely used for respiratory conditions.
- Current analytical methods for drug quality control may lack specificity.
- Drug packaging materials can interact with the formulation, affecting drug quality.
Purpose:
- To identify impurities in ipratropium bromide aerosol products related to packaging materials.
- To investigate the impact of packaging materials on active pharmaceutical ingredient (API) content.
- To highlight the need for improved analytical methods and packaging compatibility studies.
Summary:
- HPLC and LC-MS methods identified packaging-related impurities like antioxygen BHT and 2246 in ipratropium bromide aerosols.
- Leachable additives from packaging can be present at high levels, and API content can be reduced by adsorption and leaking.
- Existing assay methods are often not specific enough to ensure drug quality effectively.
Impact:
- This study emphasizes the critical role of packaging material compatibility in maintaining drug quality and efficacy.
- Findings support the need for stricter regulations regarding pharmaceutical packaging materials.
- The research serves as a pilot study advocating for mandatory compatibility assessments between drugs and their packaging.
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