Dear Ellie,
The following publication describes a paste formula which was submitted to the FDA for approval:
Description of the Product
According to the RFD, Sucralfate HCI Topical PasteTM is an amorphous hydrogel
paste formed by mixing sucralfate with hydrochloric acid prior to use. The RFD states
that the paste is intended to relieve painL 3 by physical
coverage of oral Bwounds.
According to 51 0(k) K043587, the product is comprised of sucralfate L
5 )of Sucralfate HCI Topical pasteTM to be
"l
prepared at the point of care. C 3
For more information on this preparation, please use the following link:
http://www.fda.gov/downloads/CombinationProducts/JurisdictionalInformation/RFDJurisdictionalDecisions/RedactedDecisionLetters/UCM113797.pdf
Hoping this will be helpful,
Rafik
Transdermal drug delivery is not a trivial matter. Drugs chosen for transdermal delivery are generally quite small molecules that are active at very low doses. Sucralfate just isn't the kind of drug that suggests itself for transdermal delivery.
When applied to a mucous membrane, or indeed an ulcer on a mucous membrane, sucralfate probably doesn't penetrate at all. It would be even less likely to penetrate intact skin. So, why do you want to formulate an ointment or solution containing sucralfate, I wonder? The only way in which you will get it to penetrate would be by seriously disrupting the integrity of the skin with a solvent such as dimethyl sulfoxide or sodium lauryl sulfate. I wouldn't want that doing to my skin!
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