Alza Corporation

Philip W Ledger

Michel J Cormier

Alfred A Amkraut

Patricia S Campbell

Jean P Marty

Michel J N Cormier

Joseph B Phipps

Juanita A Johnson

Stella Chao

The invention is directed to a composition and product for use in an electrotransport device. The composition includes an ionized drug, an anti-inflammatory agent and a solvent. Preferably, the anti-inflammatory agent is hydrocortisone or esters thereof, and the solvent is water and a material such as an alcohol, a glycol, a glycerol, a cyclodextrin, a nonionic surfactant and/or mixtures thereof.

Reduction of skin irritation during electrotransport delivery

The invention is directed to a composition and product for use in an electrotransport device. The composition includes an ionized drug, an anti-inflammatory agent and a solvent. Preferably, the anti-inflammatory agent is hydrocortisone or esters thereof, and the solvent is an alcohol, a glycol, a glycerol, a cyclodextrin, a nonionic surfactant or mixtures thereof. The composition preferably further includes a gel matrix that is a swellable, hydrophilic polymer, a water soluble hydrophilic polymer or a solid polymer. A hydrophobic polymer and/or additives may also be included.

An electrotransport drug delivery device which delivers an anti-inflammatory agent in order to reduce skin irritation associated with electrotransport delivery of the drug is provided. The anti-inflammatory agent is selected from hydrocortisone, esters of hydrocortisone and salts thereof.

An electrotransport delivery device utilizing reservoir buffering at a select pH ranges in order to reduce skin irritation and skin resistance is provided. Cathodic reservoirs are buffered to a pH of less than about 4, preferably to a pH in the range of about 2 to 4, while anodic reservoirs are buffered to a pH above about 4, preferably to a pH in the range of about 4 to 10. Another electrotransport delivery device utilizes a potassium sensor to monitor potassium efflux from the skin. Potassium efflux above a certain predetermined level has been found to be a precursor to skin irritation/erythema. Operation of the device is modified (eg, terminated) when the predetermined potassium efflux level is sensed.

Reduction of skin irritation and resistance during electrotransport

The present invention is directed to the transdermal administration of methyl nicotinate and an irritating or sensitizing drug. The invention includes a transdermal drug delivery device comprising a matrix adapted to be placed in irritating/sensitizing drug- and methyl nicotinate-transmitting relation with the skin site. The matrix contains sufficient amounts of irritating/sensitizing drug and of methyl nicotinate, in combination, to continuously administer to the skin for a predetermined period of time the drug to provide an effective therapeutic result. The invention is also directed to a method for either 1) preventing or reducing the irritation caused by an irritating drug or 2) preventing or reducing sensitization from occurring, as well as reducing or eliminating pain and discomfort occurring during the elicitation phase after sensitization has already been induced.

Reduction or prevention of skin irritation or sensitization during

A method and means for reducing sensitization or irritation caused by transdermally delivered drugs, wherein one or more metabolic modulators is coadministered with a sensitizing or irritating drug.

Method for reducing sensitization or irritation in transdermal drug

The present invention provides a method of reducing or preventing skin irritation of a weak base drug by inhibiting the accumulation of the drug in the lysosomes. The drug is irritating to humans, i.e., the drug is susceptible to inducing skin or mucosa irritation in a human when the drug is transdermally administered to the human at a therapeutically effective rate. Irritation reduction or prevention is induced by coadministering to the skin or mucosa of the human:

Reduction or prevention of skin irritation by drugs

The present invention is directed to a method of reducing or preventing skin sensitization by inhibiting the immunological processing of a sensitizing drug as an antigen. The drug is sensitizing to humans, i.e., the drug is susceptible to inducing skin or mucosa sensitization in a human when the drug is transdermally administered to the human at a therapeutically effective rate. Skin sensitization reduction or prevention is induced by coadministering to the skin or mucosa of the human:

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Mountain View, CA, United States of America

Philip W Ledger