Delivery of antipsychotics through an inhalation route
First Claim
1. A condensation aerosol for delivery of a drug selected from the group consisting of olanzapine, trifluoperazine, haloperidol, loxapine, risperidone, clozapine, quetiapine, promazine, thiothixene, chlorpromazine, droperidol, prochlorperazine and fluphenazine,wherein the condensation aerosol is formed by heating a thin layer containing the drug, on a solid support, to produce a vapor of the drug, and condensing the vapor to form a condensation aerosol,characterized by less than 10% drug degradation products by weight, andan MMAD of less than 5 microns.
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Abstract
The present invention relates to the delivery of antipsychotics through an inhalation route. Specifically, it relates to aerosols containing antipsychotics that are used in inhalation therapy. In a method aspect of the present invention, an antipsychotic is delivered to a patient through an inhalation route. The method comprises: a) heating a thin layer of an antipsychotic, on a solid support, to form a vapor; and, b) passing air through the heated vapor to produce aerosol particles having less than 5% antipsychotic drug degradation products. In a kit aspect of the present invention, a kit for delivering an antipsychotic through an inhalation route is provided which comprises: a) a thin film of an antipsychotic and b) a device for dispensing said thin film as a condensation aerosol.
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Citations
70 Claims
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1. A condensation aerosol for delivery of a drug selected from the group consisting of olanzapine, trifluoperazine, haloperidol, loxapine, risperidone, clozapine, quetiapine, promazine, thiothixene, chlorpromazine, droperidol, prochlorperazine and fluphenazine,
wherein the condensation aerosol is formed by heating a thin layer containing the drug, on a solid support, to produce a vapor of the drug, and condensing the vapor to form a condensation aerosol, characterized by less than 10% drug degradation products by weight, and an MMAD of less than 5 microns.
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4. A method of producing a drug selected from the group consisting of olanzapine, trifluoperazine, haloperidol, loxapine, risperidone, clozapine, quetiapine, promazine, thiothixene, chlorpromazine, droperidol, prochlorperazine and fluphenazine, in an aerosol form comprising:
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a. heating a thin layer containing the drug, on a solid support, to produce a vapor of the drug, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 10% drug degradation products by weight, and an MMAD of less than 5 microns. - View Dependent Claims (5, 6, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44)
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45. A condensation aerosol for delivery of olanzapine, wherein the condensation aerosol is formed by heating a thin layer containing olanzapine, on a solid support, to produce a vapor of olanzapine, and condensing the vapor to form a condensation aerosol characterized by less than 5% olanzapine degradation products by weight, and an MMAD of 0.2 to 3 microns.
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46. A condensation aerosol for delivery of trifluoperazine, wherein the condensation aerosol is formed by heating a thin layer containing trifluoperazine, on a solid support, to produce a vapor of trifluoperazine, and condensing the vapor to form a condensation aerosol characterized by less than 5% trifluoperazine degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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47. A condensation aerosol for delivery of haloperidol, wherein the condensation aerosol is formed by heating a thin layer containing haloperidol, on a solid support, to produce a vapor of haloperidol, and condensing the vapor to form a condensation aerosol characterized by less than 5% haloperidol degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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48. A condensation aerosol for delivery of loxapine, wherein the condensation aerosol is formed by heating a thin layer containing loxapine, on a solid support, to produce a vapor of loxapine, and condensing the vapor to form a condensation aerosol characterized by less than 5% loxapine degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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49. A condensation aerosol for delivery of risperidone, wherein the condensation aerosol is formed by heating a thin layer containing risperidone, on a solid support, to produce a vapor of risperidone, and condensing the vapor to form a condensation aerosol characterized by less than 5% risperidone degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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50. A condensation aerosol for delivery of clozapine, wherein the condensation aerosol is formed by heating a thin layer containing clozapine, on a solid support, to produce a vapor of clozapine, and condensing the vapor to form a condensation aerosol characterized by less than 5% clozapine degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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51. A condensation aerosol for delivery of quetiapine, wherein the condensation aerosol is formed by heating a thin layer containing quetiapine, on a solid support, to produce a vapor of quetiapine, and condensing the vapor to form a condensation aerosol characterized by less than 5% quetiapine degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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52. A condensation aerosol for delivery of promazine, wherein the condensation aerosol is formed by heating a thin layer containing promazine, on a solid support, to produce a vapor of promazine, and condensing the vapor to form a condensation aerosol characterized by less than 5% promazine degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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53. A condensation aerosol for delivery of thiothixene, wherein the condensation aerosol is formed by heating a thin layer containing thiothixene, on a solid support, to produce a vapor of thiothixene, and condensing the vapor to form a condensation aerosol characterized by less than 5% thiothixene degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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54. A condensation aerosol for delivery of chlorpromazine, wherein the condensation aerosol is formed by heating a thin layer containing chlorpromazine, on a solid support, to produce a vapor of chlorpromazine, and condensing the vapor to form a condensation aerosol characterized by less than 5% chlorpromazine degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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55. A condensation aerosol for delivery of droperidol, wherein the condensation aerosol is formed by heating a thin layer containing droperidol, on a solid support, to produce a vapor of droperidol, and condensing the vapor to form a condensation aerosol characterized by less than 5% droperidol degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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56. A condensation aerosol for delivery of prochlorperazine, wherein the condensation aerosol is formed by heating a thin layer containing prochlorperazine, on a solid support, to produce a vapor of prochlorperazine, and condensing the vapor to form a condensation aerosol characterized by less than 5% prochlorperazine degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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57. A condensation aerosol for delivery of fluphenazine, wherein the condensation aerosol is formed by heating a thin layer containing fluphenazine, on a solid support, to produce a vapor of fluphenazine, and condensing the vapor to form a condensation aerosol characterized by less than 5% fluphenazine degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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58. A method of producing olanzapine in an aerosol form comprising:
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a. heating a thin layer containing olanzapine, on a solid support, to produce a vapor of olanzapine, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% olanzapine degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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59. A method of producing trifluoperazine in an aerosol form comprising:
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a. heating a thin layer containing trifluoperazine, on a solid support, to produce a vapor of trifluoperazine, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% trifluoperazine degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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60. A method of producing haloperidol in an aerosol form comprising:
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a. heating a thin layer containing haloperidol, on a solid support, to produce a vapor of haloperidol, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% haloperidol degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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61. A method of producing loxapine in an aerosol form comprising:
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a. heating a thin layer containing loxapine, on a solid support, to produce a vapor of loxapine, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% loxapine degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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62. A method of producing risperidone in an aerosol form comprising:
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a. heating a thin layer containing risperidone, on a solid support, to produce a vapor of risperidone, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% risperidone degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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63. A method of producing clozapine in an aerosol form comprising:
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a. heating a thin layer containing clozapine, on a solid support, to produce a vapor of clozapine, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% clozapine degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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64. A method of producing quetiapine in an aerosol form comprising:
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a. heating a thin layer containing quetiapine, on a solid support, to produce a vapor of quetiapine, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% quetiapine degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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65. A method of producing promazine in an aerosol form comprising:
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a. heating a thin layer containing promazine, on a solid support, to produce a vapor of promazine, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% promazine degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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66. A method of producing thiothixene in an aerosol form comprising:
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a. heating a thin layer containing thiothixene, on a solid support, to produce a vapor of thiothixene, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% thiothixene degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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67. A method of producing chlorpromazine in an aerosol form comprising:
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a. heating a thin layer containing chlorpromazine, on a solid support, to produce a vapor of chlorpromazine, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% chlorpromazine degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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68. A method of producing droperidol in an aerosol form comprising:
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a. heating a thin layer containing droperidol, on a solid support, to produce a vapor of droperidol, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% droperidol degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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69. A method of producing prochlorperazine in an aerosol form comprising:
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a. heating a thin layer containing prochlorperazine, on a solid support, to produce a vapor of prochlorperazine, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% prochlorperazine degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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70. A method of producing fluphenazine in an aerosol form comprising:
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a. heating a thin layer containing fluphenazine, on a solid support, to produce a vapor of fluphenazine, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% fluphenazine degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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Specification