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.....may have an effect on the quality and purity of valve components and, ultimately, 983..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...In MDI products, the container closure system consists of the container, the valve and its components, the actuator.....Even slight changes in the formulation, drug substance particle size, valve, or actuator can.....A vehicle that optimally delivers one drug substance may be inappropriate for delivery of a..
http://www.fda.gov/cder/fdama/difconc.htm (score=60)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...In MDIs, the container and closure system consists of the container, the actuator, the valve and its components, and any additional.....Preferential interaction of the suspended drug substance with the various internal container.....The performance of the valve and its compatibility with other drug product components should be thoroughly investigated before..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=22)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...In MDIs, the container and closure system consists of the container, the actuator, the valve and its components, and any additional.....Preferential interaction of the suspended drug substance with the various internal container.....The performance of the valve and its compatibility with other drug product components should be thoroughly investigated before..
http://www.fda.gov/cder/guidance/2180dft.htm (score=22)

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