Inhalation Drug Forms

Inhalation drug forms encompass drug forms where the route of administration is inhalation through the nose and mouth.  The mechanism of action of the drug product will take place throughout the inhalation pathway, including the mouth, nose, throat, and lungs.  The drug product will take the form of atomized droplets or fine dry powder particles, which can be inhaled by the patient. 

Inhalation drug forms are used to treat a wide range of respiratory diseases.  The most common include asthma and chronic obstructive pulmonary disorder (COPD).  Other treatments include cystic fibrosis, diabetes, influenza, Parkinson’s disease, Schizophrenia, lung inflammation, and symptoms of the common cold.  The inhalation route offers an efficient route administration by conferring high pulmonary drug concentrations with low systemic drug concentrations and minimal side effects. 

While there are benefits to the inhalation route of administration, directly treating the lung organ does present risk.  Inhalation drug forms are considered the highest risk drug forms1 by the FDA with regards to evaluating the packaging for Extractables & Leachables.  BA Sciences has extensive experience performing testing on Inhalation Drug products, and meeting the expectations of regulatory authorities. 

Tests that we offer include:

  • Extractables & Leachables Testing: BA Sciences has experience performing E&L studies for all forms of inhalation drug products including Metered Dose Inhalers (MDIs), dry powder inhalers (DPIs) and soft mist inhalers (SMIs). 
  • Stability Studies: BA Sciences can design and perform stability studies for inhalation drug products, including:
    • Assay and Impurity methods development and validation
    • Routine stability testing
  • Microbiology: BA Sciences commonly performs sterility testing on nebulized drug products, following compendial methods such as USP <61> and <62>2,3.

References

  1. FDA Guidance for Industry-Container Closure Systems for Packaging Human Drugs and Biologics, May 1999.
  2. United States Pharmacopeia <61>, Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests.
  3. United States Pharmacopeia <62>, Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms.

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