New USP monograph
BASF approached the United States Pharmacopeia (USP) for consideration of an official National Formulary (NF) monograph for Solutol HS15 on the following grounds: the FDA review of Solutol HS15's safety data under IPEC's excipient safety
evaluation program; the excipient's monograph status in the European Pharmacopoeia and its use in approved drugs in countries outside the US; the excipient's EMA safety evaluation and its approval to be used
as an excipient in veterinary drugs. As part of their procedure, USP contacted the FDA Compendial Operations office. Based
on FDA's feedback, USP asked BASF to submit materials for monograph development. Efforts by BASF and the USP monograph development
group led to the publication of an official polyoxyl 15 hydroxystearate (Solutol HS15) NF monograph in USP 33–NF 28, Reissue Official Oct. 1, 2010 (11–13).
Conclusion
The need for novel excipients, especially solubilizers, is growing throughout the pharmaceutical industry because pipeline
compounds have shifted toward lower solubility in the advent of high-throughput screening during discovery. The successful
use of a novel excipient can only arise from a close partnership between the supplier (i.e., excipient manufacturer) and the
user (i.e., pharmaceutical company). Using Solutol HS15, the IPEC Novel Safety Evaluation Procedure has proved to provide
a venue for verification of regulatory acceptability of novel excipients before late-phase clinical trials and NDA filing.
The authors therefore encourage additional excipient innovation and novel excipient use by drug product manufacturers.
Acknowledgments
The authors would like to thank Ms. Catherine Sheehan, USP, and Mr. Nigel Langley, BASF, for their review and suggestions
for the manuscript. The authors would also like to acknowledge Ms. Fran Donahue and Dr. Jay Goldring (both former Wyeth employees),
and Drs. Bernhard Fussnegger and Christian Becker of BASF for their contributions to the Solutol HS15 IPEC novel-excipient
safety assessment, and USP's Dr. Hong Wong for assistance with monograph development.
Sherry Ku, PhD,* is president and CSO of TWI Anchen Pharma in Tapei, Taiwan, kus_98@yahoo.com
. Ranga Velagaleti, PhD, is manager, regulatory affairs, North America, Pharma Ingredients and Services, BASF, 100 Campus Drive, Florham Park, NJ
07932.
*To whom all correspondence should be addressed.
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