Solutol HS15 as a Novel Excipient - Pharmaceutical Technology

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Solutol HS15 as a Novel Excipient
The authors present an update to the Wyeth/BASF experience with the IPEC Novel Excipient Safety Evaluation Procedure.


Pharmaceutical Technology
pp. 108-110

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,
. 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.

References

1. FDA, IIG: Frequently Asked Questions, http://www.fda.gov/, January 2010.

2. C.J. Greene et al., US Patent 5,179,122 (1993).

3. Hardling et al., "The Development of Captisol for Use in Parenteral Drug Products," presented at Central Research in Symposium of Pharmaceutical Application of Cyclodextrin, Groton, CT, June-July 1997.

4. Drug Label Information,
, accessed Oct. 1, 2010.

5. FDA, Guidance for Industry: Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (Rockville, MD, May 2005).

6. EMA CHMP, Note for Guidance on Excipients, Antioxidants and Antimicrobial Preservatives in the Dossier for Application for Marketing Authorization of a Medicinal Product (EMA, Brussels, 2003).

7. M.S. Ku, Bullet. Techn. Gattefosse 99, 89 (2006).

8. M.S. Ku, AAPS Jrnl. 10 (1), 208–212 (2008).

9. C.A. Lipinsky et al., Adv. Drug Delivery Rev., 23 (1–3), 3–25 (1997).

10. S. Ku, "Why and How Does a Pharmaceutical Company Take the Risk to Use a Novel Excipient?" presented at AAPS, Los Angeles, CA, November 2009, and at Excipient Fest, Puerto Rico, May 2010.

11. C. Demerlis et al., Pharm. Technol., 33(11), 72–82 (2009).

12. R. Velagaleti. "Excipient Innovation and Regulatory Acceptance for Use in Drug Products–Solubilizer Solutol HS15 Case Study," presented atAA PS, Los Angeles, CA, November 2009.

13. R. Velagaleti., "Excipients for Future–Discovery and Regulatory Journey to Market," presented at Excipient Fest, Puerto Rico, May 2010.


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