Speaking at AAPS 2009 Ranga Velagaleti, manager of regulatory affairs at BASF, explained the process that led to a response letter for the excipient Solutol HS 15 being issued by the US Food and Drug Administration (FDA) before a drug using it was approved by the agency.
A drug-master file (DMF) for Solutol was submitted to the agency in 1992 but the excipient is yet to be used in a FDA-approved drug. This delay between DMF submission and use is attributed to the excipient’s novelty.
Speaking at the same AAPS presentation Sherry Ku, senior director, pharmaceutical development, Wyeth, explained that the company wanted to work with Solutol.
Ku added that the excipient enhances solubility, which is a problem for many new compounds, and has characteristics that make it more desirable than Cremophor.
However, working with novel excipients is “very problematic”, according to Ku who said that the potential need for extra toxicity studies means pharma prefers to work with ingredients which are listed in a major compendium.
To ease this process Wyeth collaborated with IPEC and BASF to build a case for Solutol. This was based on the Novel Excipient Safety Evaluation Procedure that IPEC developed with input from the FDA, clinical trial data from Wyeth and safety evidence from BASF.
Solutol was the first excipient to go through IPEC’s evaluation procedure. In May 2008, having received all the data and evidence, the FDA informed IPEC that its process was a suitable proxy for an agency review of the excipient.
Following the US Pharmacopeia (USP) published a monograph for the excipient, despite it not yet being used in a drug approved by the FDA.