Science

Dissolution Validations

We launched our GI Dissolution method in 2008. This method uses typically 5 mg of API per experiment on the SiriusT3 instrument, and provides information about dissolution rates under conditions of changing pH that mimic conditions in the human gastrointestinal tract. We described the method and provided validation data in:

Gravestock, T. B., K. Comer, J. Frake, E. Judge, S. Ruiz, R. Anal. Methods 2011, 3, 560-567.

Much of the current research at Sirius and our collaboration partners is in the Dissolution area. The development of the GI Dissolution method can be followed in posters available from the Downloads section of this web site.
The story starts in 2008 with GI Dissolution of pure API  in aqueous buffers at four pH values. 
Later posters describe dissolution  of APIs in the presence of FaSSIF, FesSSIF and solubility-enhancing excipients.
Our most recent dissolution results were reported in three posters presented at the AAPS 2012 Annual Meeting, which look at dissolution in the presence of an aqueous buffer plus a lipid introduced at pH 3.9 to simulate the gut’s ability to absorb API in neutral form, dissolution of solid dispersions, and dissolution of pharmaceutical cocrystals.