Design of Bi-layer products [Design Issues]

posted by A.Shtaiwi – Jordan, 2020-07-17 12:51 (26 d 16:13 ago) – Posting: # 21732
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Dear All,

Hope you are well,

I want to ask if anyone has experience or knowledge about reference product with following formulation:
2 active ingredients, one found in the immediate release layer and the other in the modified release layer. The Test product has the same composition. If the product is intended to be submitted to Europe, is it required to analyse both active ingredients in all required studies for modified release products (single dose studies under fast and fed conditions and multiple dose study) or should we analyse active ingredient which found in the immediate release layer only in the single dose study (either fasting or fed as per the information stated in the spc of the product) and analyse other active ingredient in all studies.

I have checked the EMEA guideline for modified release products but I just found information about biphasic release product where the same active ingredient is released in immediate and sustained release form.

Thanks

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