For an MDI, is leak-test a stability parameter ?

v9991

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#1
While establishing the product stability of a metered dose inhaler, would you consider leak-test to be part of stability program?

My suggestion, is that it is to be considered as part of stability program...(because, the formula assumes that the rate-of-leak (as measured at T0 time point) is constant; )

If it is not part of normal stability program; the leak test need to be established a part of design-verification of device. (simulate all the stress-conditions of product shelf life)
 
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Ronen E

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#2
While establishing the product stability of a metered dose inhaler, would you consider leak-test to be part of stability program?

My suggestion, is that it is to be considered as part of stability program...(because, the formula assumes that the rate-of-leak (as measured at T0 time point) is constant; )

If it is not part of normal stability program; the leak test need to be established a part of design-verification of device. (simulate all the stress-conditions of product shelf life)
Hi,

I'm not 100% sure what are your concerns, but anyway -

If you develop a device that you suspect is subject to a leak mechanism (as a normal characteristic or as a failure mode), and the leak creates a concern over you device's performance, then yes, you probably should, as part of your design verification / shelf-life studies, establish the leak characteristic under typical and extreme shelf-life and use-life stresses;

If on top of that you are also concerned with the stability of a drug that is supposed to work with your device, and you suspect that this stability is affected by the above characterized leak mechanism, then in my opinion it would make sense to test this stability under the worst-case leak scenario over the entire applicable product life (device / drug / shelf / use etc.).

Cheers,
Ronen.
 
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v9991

Trusted Information Resource
#3
here's specific reference citing the need for establishing leak test over stability...

The leak rate test is important in stability studies because it may provide information on pressure loss and may predict, at subsequent test stations, failures in testing for dose content uniformity through container life (see section III.F.1.j). It should be noted, however, that leak rates are not necessarily constant over time.
4.2.1.16 Performance after temperature cycling (CTD 3.2.P.2.4)
A study should be conducted to determine the effect of temperature cycling on the performance of the product. Containers should be stored in various orientations and cycled between recommended storage conditions and a temperature below freezing (0°C). For suspensions, cycling between the
recommended storage conditions and a high temperature (e.g., 40°C) should be considered, and may be combined with the low temperature cycling study. Storage time should be at least 24 hours under each condition, and containers should be stored under each condition at least five times. The containers should be examined visually for any obvious defects, and tests such as leak rate, weight loss, delivered dose uniformity, fine particle mass, related substances and moisture content should be performed. Any changes from initial results should be assessed for their significance.
when there is point of decision, where ther's difference in expertise... it all comes down to references...:eek:
 

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