Micronized insulin and micronized insulin analogues prepared under acidic conditions, and methods of manufacturing the same under acidic conditions
First Claim
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1. A method of preparing an inhalable insulin suitable for pulmonary delivery, the method comprising:
- dissolving an insulin raw material in an acidic solution to form a dissolved insulin solution;
titrating the dissolved insulin solution with a buffer solution to form a suspension comprising micronized insulin particles; and
stabilizing the micronized insulin particles after titrating the dissolved insulin solution,wherein the stabilizing of the micronized insulin particles comprises adding a stabilizing agent to the suspension,wherein the stabilizing agent is selected from the group consisting of an alcohol, a ketone, and a mixture thereof,wherein the inhalable insulin suitable for pulmonary delivery comprises the micronized insulin particles, the micronized insulin particles are substantially spherical in shape, and the micronized insulin particles comprise up to 99 vol % particles having a particle size of less than 5 μ
m, based on the total volume of the micronized insulin particles, andwherein the micronized insulin particles consist of insulin.
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Abstract
A method of preparing an inhalable insulin suitable for pulmonary delivery includes: dissolving an insulin raw material in an acidic solution to form a dissolved insulin solution; titrating the dissolved insulin solution with a buffer solution to form a suspension comprising micronized insulin particles; and stabilizing the micronized insulin particles.
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Citations
20 Claims
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1. A method of preparing an inhalable insulin suitable for pulmonary delivery, the method comprising:
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dissolving an insulin raw material in an acidic solution to form a dissolved insulin solution; titrating the dissolved insulin solution with a buffer solution to form a suspension comprising micronized insulin particles; and stabilizing the micronized insulin particles after titrating the dissolved insulin solution, wherein the stabilizing of the micronized insulin particles comprises adding a stabilizing agent to the suspension, wherein the stabilizing agent is selected from the group consisting of an alcohol, a ketone, and a mixture thereof, wherein the inhalable insulin suitable for pulmonary delivery comprises the micronized insulin particles, the micronized insulin particles are substantially spherical in shape, and the micronized insulin particles comprise up to 99 vol % particles having a particle size of less than 5 μ
m, based on the total volume of the micronized insulin particles, andwherein the micronized insulin particles consist of insulin. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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Specification