Inhalation Drug Forms

Testing expertise to support inhaled therapies and regulatory expectations

Inhalation products are widely used to treat respiratory conditions such as asthma, COPD, and cystic fibrosis, and they are also being developed for systemic therapies. These dosage forms require specialized testing to ensure patient safety and regulatory compliance. 

BA Sciences provides inhalation drug product testing services that address extractables and leachables, stability, and microbiological quality, helping you advance products with confidence. 

Regulatory Considerations for Inhalation Products 

The FDA classifies inhalation products among the highest-risk dosage forms for extractables and leachables (E&L) testing. Careful evaluation of packaging, delivery systems, and long-term stability is essential to demonstrate safety and meet regulatory requirements. 

Inhalation Drug Product Testing Services 

Our laboratory offers a full range of studies to support inhalation product development and release, including: 

Extractables & Leachables Testing 

Studies are conducted for metered dose inhalers (MDIs), dry powder inhalers (DPIs), and soft mist inhalers (SMIs). Testing is aligned with FDA expectations for container-closure systems to evaluate potential leachables from packaging and delivery components. 

Stability Studies 

Programs are designed to support inhalation products with services that include: 

• Assay and impurity method development and validation 
• Routine stability testing at defined timepoints 

Microbiological Testing 

Sterility and microbiological quality of nebulized products are assessed using USP <61> and <62> methods. These studies help confirm compliance with compendial requirements and ensure patient safety. 

Why Work with BA Sciences 

Choosing the right partner for inhalation drug product testing ensures studies are designed, executed, and reported in line with regulatory requirements. BA Sciences offers: 

• Proven experience with MDIs, DPIs, SMIs, and nebulized therapies
• Regulatory alignment with FDA and USP expectations
• Comprehensive program management, from method development to final reporting 
• Laboratory infrastructure designed for high-risk dosage form testing 

With BA Sciences, you gain a trusted partner who delivers reliable data and supports every stage of inhalation product development. 

Ensure Safety and Compliance in Inhaled Therapies 

Reach out to BA Sciences today to explore how we can support your next inhalation program.