Hello,
I have been searching for updated regulatory guidelines for new surfactants to be used in pharmaceutical applications (focusing on safety and efficacy aspects).
I found the " Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients" FDA guidance document. Would you kindly provide me with some other relevant regulatory documents (FDA, EMA, ICH,..)?
Thanks in advance!
Ruba
Greetings Ruba Ismail,
I think you have to mention what type of formulation you are using and where is the site you are willing to deliver the active ingredient at, as your question is general which make it difficult to give you the resources you are searching for. The formulation and the site of delivery will make you decide which particular surfactant you will use, then to focus on the regulatory guidelines related to it to make it easier for you. As well as, to make it make your question more visible. (Just a suggestion)
Here are some resources (Hope it helps):
Article Bridging the Gap: Academia, Industry and FDA Convergence for...
Article Exploration of Fulvic acid as a functional excipient in line...
Article Contemporary Formulation Development for Inhaled Pharmaceuticals
Sincerely,
Omar ElFar
Thanks Omar Elfar for your answer.
However, I am looking for some regulations by one of the abovementioned regulatory bodies on the requirements of surfactants to be used in oral, pulmonary, topical, etc... drug delivery systems. So not looking for a specific formulation or so, but need the general requirements in case we are developing surfactants to be included in pharmaceutical formulations.
Best,
Ruba
Hi Ruba,
The FDA Inactive Ingredient Database is always a good starting point when looking at new excipients to see if they are already approved for pharmaceutical use via the same or an alternate route of administration.
Also see: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-excipients-dossier-application-marketing-authorisation-medicinal-product-revision-2_en.pdf
Hello Michael Hinchcliffe,
Thanks for your answer. I am actually searching for some general guidelines that describe the characteristics of surfactants to have the potential to be approved for each route of administration by EMA, FDA .... This EMA document can be helpful, thanks again.
Best,
Ruba
- Badges
- Science topic
- Similar topics
- Chemistry
- Pharmacology
- Pharmaceuticals