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Claims for Patent: 5,997,848

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Claims for Patent: 5,997,848

Title: Methods and compositions for pulmonary delivery of insulin
Abstract:Systemic delivery of insulin to a mammalian host is accomplished by inhalation of a dry powder of insulin. It has been found that dry insulin powders are rapidly absorbed through the alveolar regions of the lungs.
Inventor(s): Patton; John S. (San Carlos, CA), Foster; Linda (Sunnyvale, CA), Platz; Robert M. (Half Moon Bay, CA)
Assignee: Inhale Therapeutic Systems (San Carlos, CA)
Application Number:08/821,493
Patent Claims: 1. A method for delivering insulin into blood circulation of a patient, said method comprising:

providing from 1 to 4 individual dry powder insulin dosages having from a total weight of from 0.5 mg to 15 mg of insulin;

dispersing each of the dry powder insulin doses individually into a gas stream to form dry insulin aerosols; and

inhaling each of the dry powder insulin aerosols into an alveolar region of the patient's lungs;

wherein the dry insulin powder dissolves in a fluid lining of the alveolar region of the lungs and is systemically absorbed into patient blood circulation.

2. A method as in claim 1, wherein the insulin is substantially free from penetration enhancers.

3. A method as in claim 1, wherein each dose contains from 0.5 mg to 10 mg of insulin.

4. A method as in claim 3, wherein the powder carrier comprises a carbohydrate, organic salt, amino acid, peptide, or protein.

5. A method as in claim 1, wherein the insulin dry powder comprises particles having an average size below 10 .mu.m.

6. A method as in claim 1, wherein the dry powder comprises individual particles including both insulin and a carrier material.

7. A method as in claim 1, wherein the insulin is present in the individual particles at from 5% to 99% by weight.
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