Inhalation drug products deliver drugs into the lungs by oral inhalation and include inhalation aerosols, inhalation powders, inhalation sprays, inhalation solutions, inhalation suspensions, solutions for inhalation, and drugs for inhalation solutions dosage forms. Nasal drug products deliver drugs into the nasal cavity and include nasal sprays, nasal solutions, nasal aerosols, and nasal powder dosage forms. This chapter does not address nasal products in gel and ointment form.
Drug product tests are divided into two categories: 1) general quality tests (universal tests); and 2) product performance tests. General quality tests assess the integrity of the dosage form, whereas product performance quality tests assess delivery of the drug and other attributes that may relate to in vivo drug performance.
General Quality Tests for Inhalation Drug Products
- Inhalation Aerosol
- Description
- Assay (strength and content uniformity)
- Co-Solvent Content [(e.g., ethanol) if present]
- Elemental Impurities
- Foreign Particulate Matter
- Identification
- Impurities and Degradation Products
- Leachables
- Leak Rate
- Microbial Limits
- Net Fill Weight
- Residual Solvents
- Spray Pattern
- Valve Delivery
- Water Content
Inhalation Solution
- Description
- Assay (strength and content uniformity)
- Assay for Antimicrobial Preservative and Stabilizing Excipients (if present)
- Content Uniformity for Premetered Dosage Forms
- Elemental Impurities
- Foreign Particulate Matter
- Identification
- Impurities and Degradation Products
- Leachables
- Net Fill Weight
- Osmolality, if relevant
- pH
- Residual Solvents
- Sterility
- Viscosity, if relevant
- Weight Loss
Inhalation Suspension
- Description
- Assay (strength and content uniformity)
- Assay for Antimicrobial Preservative and Stabilizing Excipients (if present)
- Content Uniformity for Premetered Dosage Forms
- Elemental Impurities
- Foreign Particulate Matter
- Identification
- Impurities and Degradation Products
- Leachables
- Net Fill Weight
- Osmolality, if relevant
- pH
- Residual Solvents
- Sterility
- Viscosity, if relevant
- Weight Loss
- Primary Particle Size Distribution
Solution for Inhalation
- Description
- Assay (strength and content uniformity)
- Assay for Antimicrobial Preservative and Stabilizing Excipients (if present)
- Content Uniformity for Premetered Dosage Forms
- Elemental Impurities
- Foreign Particulate Matter
- Identification
- Impurities and Degradation Products
- Leachables
- Net Fill Weight
- Osmolality, if relevant
- pH
- Residual Solvents
- Sterility
- Viscosity, if relevant
- Weight Loss
- Clarity and Color of Solution upon Dilution in accordance with the labeling
Drug for Inhalation Solution
- Description
- Reconstitution Time (powder)
- Water Content
- Clarity, color, and completeness of solution within specified time, upon reconstitution
- For all other general quality attributes, refer to the previous Inhalation Solution attributes upon (re)constitution of the drug product
Inhalation Spray
- Description
- Plume Geometry
- For all other general quality attributes, refer to the previous Inhalation Solution attributes
Inhalation Powder
- Description
- Assay (strength and content uniformity)
- Content Uniformity for Premetered Dosage Forms
- Elemental Impurities
- Foreign Particulate Matter
- Identification
- Impurities and Degradation Products
- Leachables
- Microbial Limits
- Net Content (device-metered)
- Residual Solvents
- Water Content
General Quality Tests for Nasal Drug Products
- Nasal Aerosol
- Refer to the above Inhalation Aerosol attributes.
Nasal Spray
- Description
- Assay (strength and content uniformity)
- Assay for Antimicrobial Preservative and Stabilizing Excipients (if present)
- Content Uniformity for Premetered Dosage Forms
- Elemental Impurities
- Foreign Particulate Matter
- Identification
- Impurities and Degradation Products
- Leachables
- Microbial Limits
- Net Fill Weight
- Osmolality
- pH
- Primary Particle Size Distribution (for suspensions)
- Pump Delivery
- Residual Solvents
- Spray Pattern
- Viscosity
Nasal Powder
- Refer to the previous Inhalation Powder quality attributes as applicable.
Nasal Solution
- Description
- Assay (strength and content uniformity)
- Assay for Antimicrobial Preservative and Stabilizing Excipients (if present)
- Elemental Impurities
- Foreign Particulate Matter
- Identification
- Impurities and Degradation Products
- Leachables
- Microbial Limits
- Net Fill Weight
- Osmolality
- pH
- Residual Solvents
- Viscosity
Performance Quality Tests for Inhalation and Nasal Drug Products
- Delivery Dose Uniformity
- Droplet/Particle Size Distribution
- Aerodynamic Particle/Droplet Size Distribution
Reference: USP General Chapter 〈5〉
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