MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....elastomeric, plastic components or coatings of the container and closure system when in.....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)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...Even slight changes in the formulation, drug substance particle size, valve, or actuator can have a major effect on the.....In MDI products, the container closure system consists of the container, the valve and its components, the actuator, additional.....A vehicle that optimally delivers one drug substance may be inappropriate for delivery of a..
http://www.fda.gov/cder/fdama/difconc.htm (score=75)

...From a product quality perspective, the critical issues are release of drug substance from drug.....Container and Closure System Nasal aerosols usually consist of the formulation, container, valve.....For suspension formulations marketed in more than one strength, we recommend that the drug..
http://www.fda.gov/cder/guidance/5383DFT.doc (score=36)

BA/BE studies for Nasal Aerosols and Nasal Sprays for Local Ac
...product changes in terms of physicochemical characteristics of the drug substance, the.....Nasal aerosols consist of the formulation, container, valve, actuator, dust cap.....from three different batches of the drug substance, different batches of critical excipients..
http://www.fda.gov/cder/guidance/2070dft.pdf (score=36)

Packaging
...If a medicine dropper is incorporated as an integral part of the drug container or closure.....The IND should describe the packaging and labeling used for the drug substance and the dosage.....Complete construction, composition, and description of all component parts of valve closure and container, including valve..
http://www.fda.gov/cder/guidance/package.htm (score=20)

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