Dear Tom
Based on my experience, you can develop your formulation using any flavor, not necessarily approved for a sublingual tablet. You can also use powder instead of oil. However, for the quantity to be used, you must refer to the FDA's Inactive Ingredient database and can use the highest quantity approved in any oral sold dosage form per day (again not necessarily sublingual). You can also refer to the USP-NF for the list of monograph listed flavoring agents and can use any of the flavors in your formulation.
Also note that FDA's Guidance for Industry: Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients is to be referred only when you are using a novel/ new excipient. If you are using an excipient/ flavoring agent already in use/ listed at FDA Inactive Ingredient Database/ listed in the monograph, there is no need to perform testing as per FDA guidance on safety evaluation of excipients. Again, you must have the data on compatibility studies of your excipient/flavoring agent with other components in the formulation.
Hope I was able to answer your query!
Best Regards
Sharry
------------------------------
Sharry Arora
Novartis Pharmaceuticals
Hyderabad
India
------------------------------
Original Message:
Sent: 28-Aug-2017 12:40
From: Tom Stothoff
Subject: Flavor excipients
My company is developing a sublingual tablet and trying to identify a flavor to mask the bad taste. My thought was to review FDA's Inactive Ingredient database and hopefully find an approved sublingual tablet using our preferred flavor of choice at an equal or greater amount than what we intend to use, but I was unsuccessful.
1. Is there a way to determine what flavors are approved for sublingual use? From what I can tell, you have to search each individual flavor to see if it's been used in an approved sublingual product.
2. What if the flavor is approved in another dosage form, but not sublingual tablet?
3. If we are to use a peppermint does it have to be the exact quality already used for sublingual administration or can it be any peppermint quality listed? For example, is it acceptable to use a powder instead of oil?
4. If we are to use a new flavor type (eg. Lemon) or quality (powder instead of oil), not yet approved for sublingual (but approved for another route of administration), what, if any, testing is required for introducing in a sublingual formulation? Would we need to conduct all studies listed in FDA's Guidance for Industry: Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients?
5. Does it make sense to contact the FDA review division to confirm what is required or is discussing at a Pre-IND meeting more appropriate?
Note the product is intended for single use administration (one time only).
Thanks to all for any feedback or advice on how to proceed.
Tom
Chicago