초록 ▼

A method for making a transdermal drug delivery device for heat sensitive and volatile drugs is disclosed. The device contains a drug-containing adhesive composite layer having an impermeable backing material laminated to the distal surface thereof and a proximal peelable impermeable backing materia

A method for making a transdermal drug delivery device for heat sensitive and volatile drugs is disclosed. The device contains a drug-containing adhesive composite layer having an impermeable backing material laminated to the distal surface thereof and a proximal peelable impermeable backing material adapted for removal for administering a drug to the skin or mucosa laminated to the proximal surface thereof. The method comprising the steps of providing first and second adhesive laminates each comprising a drug permeable adhesive layer having laminated to one surface one of said backing materials and having the opposing surface exposed. The drug, in gelled form and optionally containing additives such as enhancers and preservatives, is extruded onto at least one exposed surface of the first or second adhesive laminate followed by laminating together the exposed surfaces of the first and second adhesive laminate such that the adhesive layers and gelled drug are combined to form the drug-containing adhesive composite layer having the distal and proximal surfaces covered by the respective backing materials. The adhesives used in making up the laminates may be the same or different provided the drug is compatible with the adhesive. The process is particularly adaptable to the formulation of nicotine-containing patches. Drug delivery devices made according to the disclosed method and a method of using these drug delivery devices are also described.

대표청구항 ▼

A method for making a transdermal or transmucosal drug delivery device including a drug-containing adhesive composite layer consisting essentially of first and second drug permeable adhesive layers containing a drug in gel form, said composite layer having a distal backing material impermeable to sa

A method for making a transdermal or transmucosal drug delivery device including a drug-containing adhesive composite layer consisting essentially of first and second drug permeable adhesive layers containing a drug in gel form, said composite layer having a distal backing material impermeable to said drug laminated to the distal surface of said composite layer and a proximal peelable film which is substantially impermeable to said drug and adapted for removal for administering a drug to the skin or mucosa laminated to the proximal surface of said composite layer, said method comprising the steps of: (a) providing a first adhesive laminate comprising said first adhesive layer having laminated to one surface thereof said distal backing material and having the opposing surface of said first adhesive layer exposed; (b) providing a second adhesive laminate comprising said second adhesive layer having laminated to one surface thereof said proximal peelable film and having the opposing surface of said second adhesive layer exposed; (c) extruding said drug, in gel form, onto at least one exposed surface of said first or second adhesive laminate; and (d) laminating together the exposed surfaces of said first adhesive laminate and said second adhesive laminate, at least one of which contains said extruded gelled drug, such that said first and second adhesive layers and said gelled drug are combined to form said drug-containing adhesive composite layer having said distal backing material covering one surface thereof and said proximal peelable film covering the opposite surface thereof.