Nucleation of drug delivery balloons to provide improved crystal size and density
First Claim
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1. A method of making a drug delivery balloon having a coating thereon comprising a drug, the balloon made of a balloon material, the drug selected from the group consisting of paclitaxel, paclitaxel analogs and paclitaxel derivatives,wherein the drug has a characteristic amorphous form and a crystalline form comprising:
- a) applying a coating of the drug in the amorphous form to the balloon material, and, subsequent to applying the coating,b) annealing with a solvent vapor the coating which has been applied in step a), the solvent vapor comprising an alcohol, to produce the crystalline form of the drug on the balloon,wherein in the applying step a) the drug coating is applied to a balloon surface that has been nucleated by blooming of a component in the balloon material to the surface thereof, the component crystallizing at the surface of the balloon material as a result of the blooming to induce formation of drug crystals in the annealing step.
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Abstract
Drug delivery balloons have densely packed crystals of small particle size of the drug thereon. An amorphous drug coating is applied to a balloon surface and annealed to provide the crystals. The balloon surface is nucleated to induce formation of drug crystals in the annealing step to provide the crystals in high density with small size.
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Citations
17 Claims
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1. A method of making a drug delivery balloon having a coating thereon comprising a drug, the balloon made of a balloon material, the drug selected from the group consisting of paclitaxel, paclitaxel analogs and paclitaxel derivatives,
wherein the drug has a characteristic amorphous form and a crystalline form comprising: -
a) applying a coating of the drug in the amorphous form to the balloon material, and, subsequent to applying the coating, b) annealing with a solvent vapor the coating which has been applied in step a), the solvent vapor comprising an alcohol, to produce the crystalline form of the drug on the balloon, wherein in the applying step a) the drug coating is applied to a balloon surface that has been nucleated by blooming of a component in the balloon material to the surface thereof, the component crystallizing at the surface of the balloon material as a result of the blooming to induce formation of drug crystals in the annealing step. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A method of making a drug delivery balloon having a coating thereon comprising a drug, the balloon made of a balloon material, the drug selected from the group consisting of paclitaxel, paclitaxel analogs and paclitaxel derivatives, wherein the drug has a characteristic amorphous form and a crystalline form comprising:
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a) applying a coating of the drug in the amorphous form to the balloon material, and, subsequent to applying the coating, b) annealing with a solvent vapor the coating which has been applied in step a), the solvent vapor comprising an alcohol, to produce the crystalline form of the drug on the balloon, wherein in the applying step the drug coating is applied to a balloon surface that has been nucleated by treating the balloon material so as to cause a component from within the balloon material to migrate to the surface of the balloon material, the component crystallizing at the surface of the balloon material and inducing formation of drug crystals in the annealing step.
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Specification