Method for reducing sensitization or irritation in transdermal drug delivery and means therefor

Claim 1

A method of reducing human skin sensitization or irritation during transdermal administration of a drug to a human, which drug is susceptible to metabolism by an enzyme in the skin and formation of a sensitizing or irritating drug metabolite when the drug is transdermally administered at a therapeutically effective rate, comprising administering to a selected site on the skin of a human in need thereof: (a) a therapeutically effective amount of the drug, at a therapeutically effective rate over a predetermined period of time; and (b) an effective amount of a metabolic modulator capable of inhibiting the enzyme that metabolizes said drug, at a rate which is capable of inhibiting the metabolism of the drug by the enzyme during the period of time when the drug is transdermally administered, and thereby inhibiting the formation of the sensitizing or irritating drug metabolite.

Claim 2

A method of reducing human skin sensitization or irritation during transdermal administration of a drug to a human, which drug is susceptible to metabolism by an enzyme in the skin and formation of a sensitizing or irritating drug metabolite when the drug is transdermally administered at a therapeutically effective rate, comprising administering to a selected site on the skin of a human in need thereof: (a) a therapeutically effective amount of the drug, at a therapeutically effective rate over a predetermined period of time; and (b) an effective amount of a metabolic modulator capable of inhibiting the enzyme that metabolizes said drug, at a rate which is capable of inhibiting the metabolism of the drug by the enzyme during the period of time when the drug is transdermally administered, and thereby inhibiting the formation of the sensitizing or irritating drug metabolite.

Claim 3

A method of reducing human mucosa sensitization or irritation during transmucosal administration of a drug to a human, which drug is susceptible to metabolism by an enzyme present in the mucosa and formation of a sensitizing or irritating drug metabolite when the drug is transmucosally administered at a therapeutically effective rate, comprising: administering to a selected site on the mucosa of a human in need thereof: (a) a therapeutically effective amount of the drug, at a therapeutically effective rate over a predetermined period of time; and (b) an effective amount of a metabolic modulator capable of inhibiting the enzyme that metabolizes said drug, at a rate which is capable of inhibiting the metabolism of the drug by the enzyme during the period of time when the drug is transmucosally administered and thereby inhibiting the formation of the sensitizing or irritating drug metabolite.

Claim 4

A method of reducing human mucosa sensitization or irritation during transmucosal administration of a drug to a human, which drug is susceptible to metabolism by an enzyme present in the mucosa and formation of a sensitizing or irritating drug metabolite when the drug is transmucosally administered at a therapeutically effective rate, comprising: administering to a selected site on the mucosa of a human in need thereof: (a) a therapeutically effective amount of the drug, at a therapeutically effective rate over a predetermined period of time; and (b) an effective amount of a metabolic modulator capable of inhibiting the enzyme that metabolizes said drug, at a rate which is capable of inhibiting the metabolism of the drug by the enzyme during the period of time when the drug is transmucosally administered and thereby inhibiting the formation of the sensitizing or irritating drug metabolite.