Dear Helen,
Having dealt with this for many years, you want to avoid at all costs
using a novel excipient, which in Europe is defined as one not
previously used in medicinal products. GRAS and US status have very
little if any influence. Although there is a mention of cosmetic use
being useful for topical excipients, in practice it has almost no
influence, unfortunately. However, if a material is authorised for
food use in Europe, this is usually enough for use as an excipient in
medicinal products.
There is no one solution. A good starting point is the Handbook of
Pharmaceutical Excipients, now in the third edition, a joint UK/US
publication (see
<http://www.aphanet.org/news/3rdhndbk.html>http://www.aphanet.org/news/3rdhndbk.html).
If your intended excipient is included here, the WHO limits, max
daily allowance, etc. will be referenced.
One will also need to be very careful regarding claims for enhanced
bioavailability etc. France used to have a category of 'special
excipients' for these, but in general one needs to be very careful
about specifying the function of the excipient to ensure that it
retains its regulatory classification as an excipient without
straying into active substance territory.
Naturally I know one or two experienced consultants within PAREXEL
who would be happy to assist you -- feel free to give me a call
anytime.
Kind Regards,
Pete
Pete Lassoff, Pharm.D.
Associate Director
Worldwide Regulatory Affairs
PAREXEL International Ltd.
River Court, 50 Oxford Road
Denham, Uxbridge, Middlesex
UB9 4DL, UK
Tel: +44 1895 614427
Fax: +44 1895 614375
Mobile: +44 7740 899 222
<mailto:Peter.Lassoff@PAREXEL.com>mailto:Peter.Lassoff@PAREXEL.com
<http://www.PAREXEL.com/>http://www.PAREXEL.com/
-----Original Message-----
From: Ryan, Helen [<mailto:HRyan@ElanCorp.com>mailto:HRyan@ElanCorp.com]
Sent: 02 May 2001 17:26
To: RegAffairs
Subject: Use Of Novel Pharmaceutical Excipients
Importance: High
I am regularly asked by my colleagues in R&D whether or not a compound can
be used as an excipient in a clinical trial formulation. Although I am
obviously aware of the usual US routes such as the GRAS List and EUFA Data
Base how do I get information such as:
Is a particular material approved for use in pharmaceutical products for
oral administration to humans in (a) Europe and (b) the US? i.e. What data
base does one use? Inactive ingredients guide? WHO recommended dose ?
Another??
Where do I go to get details such as maximum allowable daily limits
In some instances an excipient could also possess what some could class as
minor pharmacological activity (e.g. enhance drug substance solubility)
depending on the proposed daily loading.
Could anyone recommend a good regulatory consultant who has experience in
dealing with both US and European Regulatory Agencies where a client may
have been asking similar questions.
Helen
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