Method for making a transdermal fentanyl patch with even drug crystal distribution
OwnerSpiros Fotinos, Jerome Langlume +1inventors
InventorsSpiros Fotinos, Jerome Langlume, Jean Paul Caravita
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Abstract
Methods of producing a transdermal delivery patches are described comprising the preparation of a uniform suspension of drug particles. A plasticizer is added to the suspension. A solution of an adhesive is add to the suspension to form a drug suspension in the adhesive mixture. The drug suspension is coated on a release liner and all solvents are evaporated to form a solid drug reservoir layer. A medical device for transdermal administration of a drug can include the solid drug reservoir layer. Suitable drugs include fentanyl and sufentanil.
Claims8
A medical device for transdermal administration of a drug comprising:
- a solid drug reservoir layer formed by the steps of:
- micronizing fentanyl to a particle size of less than about 40 microns;
- dispersing the micronized fentanyl in a first solvent to form a uniform suspension of particles of fentanyl, the first solvent is heptane;
- adding a first plasticizer to the uniform suspension of particles of fentanyl;
- forming an adhesive solution of an adhesive and a second solvent, the second solvent is heptane;
- and where the adhesive consists of a silicone adhesive;
- and
- adding the uniform suspension of particles of fentanyl quantitatively to the adhesive solution to add the particles of fentanyl from the uniform suspension to the adhesive solution, all the particles of fentanyl suspended in the uniform suspension are crystalline particles having a particle size which is not larger than an initial particle size of the fentanyl, wherein when the suspension of particles of fentanyl in the heptane with plasticizer is added to the adhesive solution, the fentanyl particles remain suspended without dissolving.
Dependencies are inferred from the claim text.