At AAPS PharmSci 360 it was clear that new excipients could be utilized to innovatively solve a range of amorphous dispersion/formulation problems. These new excipients provide significant strategy advances over conventional approaches and although our Improved Pharma scientists utilized a number of novel approaches to prepare amorphous dispersions while at SSCI, these new excipients provide even more innovative strategies. Figure 1 shows the new WR Grace Syloid® and the enhanced dissolution profile this excipient can afford.
In a very interesting paper Dave and co-workers showed that combining Syloid® with a polymer provided even greater dissolution rate enhancement. Kinnari and coworkers also showed that Syloid® was very effective in producing a composition of itraconzazole with signifcantly enhanced dissolution and faster release. Overall, this excipient along with Improved Pharma’s analytical methods provides a new/improved strategy to further enhance dissolution and stabilize amorphous materials. Additionally, Improved Pharma’s PDF Synchrotron methods provide a way to determine the structure of these new materials and enhance the ability to describe these compositions both in regulatory and patent applications.
Figures provided from WR Grace brochure entitled “Syloid XDP Silica Pharmaceutical excipient (https://grace.com/personal-care/en-US/Documents/Syloid%20XDP%20Application%20Note.pdf).
Patel and Dave, AAPS PharmSciTech, Vol. 14, No. 2, June 2013 (# 2013) DOI: 10.1208/s12249-013-9947-z
Kinnari, P., et. al, Int. J. Pharm., 414, 148-156 (2011).