MDIs formulation [Regulatives / Guidelines]

posted by Mahesh M – India, 2014-12-12 07:57 (4213 d 12:22 ago) – Posting: # 14059
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Hi ElMaestro,

Thanks for your responce.

❝ Especially when multiple inhalations are needed. A 30sec interval between any two inhalations adds some reassurance and is likely good for the efficacy.


do you have any reference for the same?


As you will see when you start the study 30secs is not a lot in practice.

We have to mention dosing procedure in protocol and if we not mention about 30 sec gap between two puffs, regulatory agency may ask for the same (means not follow the SPC with regards of dosing instruction)

please share your thoughts on that.

Regards

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