Noven Pharmaceuticals, Inc.

Key Pharmaceuticals, Inc.

Steven Sablotsky

Jesus Miranda

Ronald E Laprade

Joseph A Gentile

John M Questel

Juan A Mantelle

David P Kanios

Cheryl M Gentile

James A Thompson

Dorothy J Leeson

The method of adjusting the saturation concentration of a drug in a transdermal composition for application to the dermis, which comprises mixing polymers having differing solubility parameters, so as to modulate the delivery of the drug. This results in the ability to achieve a predetermined permeation rate of the drug into and through the dermis. In one embodiment, a dermal composition of the present invention comprises a drug, an acrylate polymer, and a polysiloxane. The dermal compositions can be produced by a variety of methods known in the preparation of drug-containing adhesive preparations, including the mixing of the polymers, drug, and additional ingredients in solution, followed by removal of the processing solvents. The method and composition of this invention permit selectable loading of the drug into the dermal formulation and adjustment of the delivery rate of the drug from the composition through the dermis, while maintaining acceptable shear, tack, and peel adhesive properties.

Solubility parameter based drug delivery system and method for altering drug saturation concentration

A blend of at least two polymers, or at least one polymer and a soluble polyvinylpyrrolidone, in combination with a drug provides a pressure-sensitive adhesive composition for a transdermal drug delivery system in which the drug is delivered from the pressure-sensitive adhesive composition and through dermis when the pressure-sensitive adhesive composition is in contact with human skin. According to the invention, soluble polyvinylpyrrolidone can be used to prevent crystallization of the drug, without affecting the rate of drug delivery from the pressure-sensitive adhesive composition.

Solubility parameter based drug delivery system and method for altering

Compositions for topical application comprising a therapeutically effective amount of a pharmaceutical agent(s), a pharmaceutically acceptable bioadhesive carrier, a solvent for the pharmaceutical agent(s) in the carrier and a clay, and methods of administering the pharmaceutical agents to a mammal are disclosed.

Compositions and methods for topical administration of pharmaceutically

A method of increasing the adhesiveness of a shaped pressure sensitive adhesive, comprising adding an adhesiveness and drug release increasing amount of a clay to said adhesive prior to casting of the adhesive. A dermal composition comprising a drug, a pressure sensitive adhesive, an adhesiveness increasing amount of a clay and a solvent. A dermal composition comprising a drug, a multipolymer of ethylene vinyl acetate, an acrylic polymer, a natural or synthetic rubber and a clay, along with optional ingredients known for use in transdermal drug delivery systems.

Method and device for the release of drugs to the skin

Disclosed is a method and apparatus for forming a transdermal drug delivery device from a multilayer web comprised of a backing layer, a drug-containing pressure sensitive adhesive layer, and a release layer or liner in which cutting is progressively achieved along a line coplanar with the axes of a cutting roller and anvil roller counter-rotating in proximity to each other. In one embodiment, cutting is achieved completely through the web about the periphery of the transdermal drug delivery device, while simultaneously achieving a scoring only of the release liner without penetration of the pressure sensitive adhesive layer or backing layer. In an alternate embodiment there are two arrangements of rollers. A first arrangement has a cutting edge for scoring the web. After scoring, the web is passed to a second arrangement for cutting through the web to result in the transdermal drug delivery device.

Method for forming a transdermal drug device

Apparatus for forming a transdermal drug device

An adhesive bilayer transdermal dosage system capable of sustained release of a pharmaceutically active drug to the skin of a human patient having a first component layer which is a pharmaceutically active drug-containing essentially planar sheet of an at least partially cross-linked acrylic adhesive. The planar sheet is formed of a flexible self-supporting cross-linked acrylate of sufficient adhesivity, durability and strength whereby intimate diffusional contact with the skin of the patient is maintained for a period of at least about 24 hours without destruction of the physical integrity of the sheet. The sheet is capable of retaining, dispersed therein, sufficient pharmaceutically active drug to deliver to the skin a pharmaceutically effective amount of the drug over a 24-hour period without dissolution of the at least partially crosss-linked acrylic adhesive. The system also contains a second component layer intimately adhered to one side of the first component layer. The second component layer is resistant to the passage of the pharmaceutically active drug from the first component layer. Methods for making the first component layer and dosage system are also disclosed.

Adhesive transdermal dosage layer

A one step method and apparatus for forming a pressure sensitive adhesive transdermal drug device having a scored release liner which comprises positioning a web containing the release liner using a cutting die having a first cutting element designed to completely cut through the web to form the device and a second cutting element designed to cut only the release liner.

One-step method for forming a pressure-sensitive adhesive transdermal

A composition comprising a flexible backing for a transdermal drug preparation with a water vapor transmission rate about equal to or in excess of that of ethylene vinyl alcohol copolymer, namely equal to or in excess of, at one mil thickness, of about 2 to 4 grams and more preferably in excess of 6 grams per 24 hours per 100 square inches at 40.degree. C. and 90% relative humidity and an oxygen transmission rate equal to or less than ethylene vinyl alcohol copolymer, namely at one mil thickness equal to or less than about 0.01 to 0.1 cubic centimeters per 100 square inches measured over 24 hours at 1 atmospheric pressure, 20.degree. C. and 65% relative humidity.

Breathable backing

A dermal composition comprising a drug, a multipolymer of ethylene-vinyl acetate, an acrylic polymer, and optionally one or more monomers, a natural or synthetic rubber and a tackifying agent. The ratio of the multipolymer to the rubber is, respectively, about 1:1 to about 10:1 and more preferably, 1:1 to 5:1 and more preferably 3:1. The dermal composition can optionally contain a crosslinking agent, tackifiers, penetration enhancers and other ingredients known for use in adhesives for the transdermal delivery of drugs. The dermal compositions can be produced by a variety of methods known in the preparation of drug containing adhesive preparations including the homogenous mixing of the multipolymer, drug and optional crosslinking agent and additional ingredients in solution or suspension or emulsion followed by removal of excess solvent.

Growing community of inventors

Miami, FL, United States of America

Steven Sablotsky