Glipizide compositions
First Claim
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1. A composition comprising:
- (a) nanoparticles of spray-dried glipizide or a salt thereof, wherein the glipizide nanoparticles have an effective average particle size of less than 2000 nm; and
(b) at least one surface stabilizer adsorbed on the surface of the glipizide nanoparticles;
wherein;
(i) the surface stabilizer is free of intermolecular cross-linkages;
(ii) the glipizide nanoparticles or a salt thereof is present in an amount of from about 99.5% to about 0.001%, by weight, based on the total combined weight of the glipizide nanoparticles or a salt thereof and at least one surface stabilizer, not including other excipients;
(iii) the at least one surface stabilizer is present in an amount of from about 0.5% to about 99.999% by weight, based on the total combined dry weight of the glipizide nanoparticles or a salt thereof and at least one surface stabilizer, not including other excipients;
(iv) upon administration to a mammal, the glipizide nanoparticles redisperse such that the nanoparticles have an effective average particle size of less than 2 microns; and
(v) the composition exhibits a Cmax which is at least 50% greater than the Cmax exhibited by a non-nanoparticulate glipizide composition when administered at the same dosage.
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Abstract
The present invention is directed to nanoparticulate compositions comprising glipizide. The glipizide particles of the composition preferably have an effective average particle size of less than about 2 microns.
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Citations
49 Claims
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1. A composition comprising:
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(a) nanoparticles of spray-dried glipizide or a salt thereof, wherein the glipizide nanoparticles have an effective average particle size of less than 2000 nm; and (b) at least one surface stabilizer adsorbed on the surface of the glipizide nanoparticles; wherein; (i) the surface stabilizer is free of intermolecular cross-linkages; (ii) the glipizide nanoparticles or a salt thereof is present in an amount of from about 99.5% to about 0.001%, by weight, based on the total combined weight of the glipizide nanoparticles or a salt thereof and at least one surface stabilizer, not including other excipients; (iii) the at least one surface stabilizer is present in an amount of from about 0.5% to about 99.999% by weight, based on the total combined dry weight of the glipizide nanoparticles or a salt thereof and at least one surface stabilizer, not including other excipients; (iv) upon administration to a mammal, the glipizide nanoparticles redisperse such that the nanoparticles have an effective average particle size of less than 2 microns; and (v) the composition exhibits a Cmax which is at least 50% greater than the Cmax exhibited by a non-nanoparticulate glipizide composition when administered at the same dosage. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 46, 47, 48, 49)
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26. A method of treating diabetes in a subject in need thereof comprising administering to the subject an effective amount of a composition comprising:
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(a) nanoparticles of a spray-dried glipizide or a salt thereof, wherein the glipizide nanoparticles have an effective average particle size of less than 2000 nm; and (b) at least one surface stabilizer adsorbed on the surface of the glipizide nanoparticles, wherein; (i) the surface stabilizer is free of intermolecular cross-linkages; (ii) the nanoparticle glipizide or a salt thereof is present in an amount of from about 99.5% to about 0.001%, by weight, based on the total combined weight of the nanoparticle glipizide or a salt thereof and at least one surface stabilizer, not including other excipients; (iii) the at least one surface stabilizer is present in an amount of from about 0.5% to about 99.999% by weight, based on the total combined dry weight of the nanoparticle glipizide or a salt thereof and at least one surface stabilizer, not including other excipients; (iv) upon administration to a mammal, the glipizide nanoparticles redisperse such that the nanoparticles have an effective average particle size of less than 2 microns; and (v) the composition exhibits a Cmax which is at least 50% greater than the Cmax exhibited by a non-nanoparticulate glipizide composition when administered at the same dosage. - View Dependent Claims (27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45)
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Specification