MDI and DPI Drug Products
...The guidance sets forth information that should be provided to ensure continuing drug.....container and closure system as a result of direct contact with the formulation of the MDI.....stem orifice of the valve, the vapor pressure in the container, and the nature of the..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

...Container and Closure System Nasal aerosols usually consist of the formulation, container, valve, actuator, dust.....Release of the drug from the drug product produces droplet or drug particle sizes and distribution patterns.....From a product quality perspective, the critical issues are release of drug substance from drug product and..
http://www.fda.gov/cder/guidance/5383DFT.doc (score=83)

BA/BE studies for Nasal Aerosols and Nasal Sprays for Local Ac
...information that pertains to the identity, strength,quality, purity, and potency of a drug.....Nasal aerosols consist of the formulation, container, valve, actuator, dust cap.....affect the BA of the drug product as a result of different solubilities and/or rates of..
http://www.fda.gov/cder/guidance/2070dft.pdf (score=82)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...A sophisticated formulation of the drug product is required to ensure dosing accuracy and reproducibility, and.....The aerosol dispenser consists primarily of a metal or glass container, a valve assembly, and an.....A sophisticated formulation of the drug product is required to ensure dosing accuracy and reproducibility, and the..
http://www.fda.gov/cder/fdama/difconc.htm (score=66)

Packaging
...If there is a need for interchangeability of container/closure materials for the drug product from one composition or supplier of a.....Complete construction, composition, and description of all component parts of valve closure and container, including valve.....The identity of the source and a description of the formulation(s), process(es), and..
http://www.fda.gov/cder/guidance/package.htm (score=39)

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