Bioequivalence and Bioavailability Forum

Dear all,

We have the formulation of solid dosage form, API is BCS-Class-II and registered formulation.

During processing of the the product we had some physical properties problem, to resolve many experiments carried out by using same excipients which are present in the registered formulation but not resolved. Finally we resolved by adding additional excipeint (1%) which was not present in the formulation. Same excipient was used by many other marketed leaders (formulation) of same molecule. Hence there is no incompatibility issue.

To address this with regulatory authorities (TGA) how we can proceed (with scientific justification).
Justification require: There will not be any impact on Bioavailability/Bioequivalence with addition of the additional excipient which is not present in the registered formulation.

We have done the comparative dissolution studies in release media and compared with previously manufactured batch dissolution data, data is complying there is no difference.

Hope some body can guide in this regard.

Thanks in advance

Rgds,

Srini

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Edit: Category changed. [Helmut]