Successful FDA inspection of Alpex Pharma cGMP

Alpex Pharma was inspected for cGMP regulations in August 2015, and the outcome once more was satisfactory. There was...

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ODT (Orally Disintegrating Tablet)

ODT - Fast Melt Technology Overview

ODT (Orally Disintegrating Tablet)

Advanced patented technology based on:
wet granulation
of drug and excipients in a fluid bed granulator; moisture control during the process and in the manufacturing area; tabletting and packaging.

Simple, inexpensive formulation and manufacturing process and  tablets robust enough to be shipped overseas in bulk for final packaging to be completed in the US.

High drug loading: from a few micrograms up to 400-500 mg per tablet.

Effective taste masking and wide application.
Ability to incorporate modified release components: allow for controlled release of the drug according to a desired PK profile.

Patent Protection: The fast melt patent issued in the US in 2000, and is pending in other countries