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US 12,576,032 B2Granted
Liquid clonidine extended release composition
AssigneeTris Pharma, Inc.
InventorGrishma Patel
Life of this patent
Estimating the term…
Abstract
An oral clonidine dosage unit providing a twenty-four hour extended release profile following a single dose administration is provided. The dosage unit comprises a pharmaceutically effective amount of a coated complex comprising clonidine bound to a cationic exchange resin, which is characterized by a twenty-four hour release profile. Dosage units may also provide an immediate release component.
Claims32
A method for treating attention deficit hyperactivity disorder comprising administering to a subject a single dosage of an extended release oral clonidine aqueous suspension comprising:
- (A) a pharmaceutically effective amount of modified release barrier coated clonidine—cation exchange resin complex—matrix particles, wherein the particles each comprise clonidine bound to a cationic exchange resin in a matrix comprising a hydrophilic polymer or co-polymer, wherein the modified release barrier coating comprises 50% w/w to about 80% w/w of the clonidine—cation exchange resin complex—matrix particle based on particle weight prior to barrier coating and is in a layer over the clonidine—cation exchange resin complex—matrix particles;
- wherein the barrier coating comprises a pH-independent, water-insoluble polymer and a plasticizer and provides modified release to the clonidine in the barrier coated particles wherein the hydrophilic polymer or co-polymer in the matrix comprises about 5% w/w to about 20% w/w of the clonidine—cation exchange resin complex—matrix particles based on weight prior to the barrier coating;
- wherein at least about 70% w/w to about 95% w/w of the clonidine in the suspension is provided by the modified release barrier coated clonidine—cation exchange resin complex—matrix particles, as determined based on the amount of clonidine equivalent to clonidine HCl;
- (B) an immediate release clonidine component(s) comprising (1) an immediate release clonidine—cation exchange resin complex or (2) (a) an immediate release clonidine—cation exchange resin complex and (b) clonidine uncomplexed to an ion exchange resin, a pharmaceutically acceptable salt of clonidine uncomplexed to an ion exchange resin, or a combination thereof;
- and
- an aqueous suspension base.
3 more elements
A method for treating attention deficit hyperactivity disorder once a day comprising administering to a subject a single dose of an extended release oral clonidine aqueous suspension comprising:
- (A) a pharmaceutically effective amount of modified release barrier coated clonidine—cation exchange resin complex—matrix particles, wherein the particles each comprise clonidine bound to a cationic exchange resin in a matrix comprising a hydrophilic polymer or co-polymer, wherein the modified release barrier coating comprises 50% w/w to about 80% w/w of the clonidine—cation exchange resin complex—matrix particle based on particle weight prior to the barrier coating and, the modified release coating is in a layer over the clonidine—cation exchange resin complex—matrix particles;
- wherein the barrier coating comprises a pH-independent, water-insoluble polymer and a plasticizer and provides modified release to the clonidine in the barrier coated particles wherein the hydrophilic polymer or co-polymer in the matrix comprises about 3% w/w to about 20% w/w of the clonidine—cation exchange resin complex—matrix particle based on weight prior to the barrier coating;
- wherein about 70% w/w to about 95% w/w clonidine in the suspension is provided by the modified release barrier coated clonidine—cation exchange resin complex—matrix particles, as determined based on the amount of clonidine equivalent to clonidine HCI;
- (B) about 5% w/w to about 30% w/w clonidine in the suspension in an immediate release form, the immediate release form comprising an immediate release clonidine—cation exchange resin complex, clonidine uncomplexed to an ion exchange resin, and a pharmaceutically acceptable salt of clonidine uncomplexed to an ion exchange resin, as determined based on the amount of clonidine equivalent to clonidine HCl;
- and
- an aqueous suspension base.
3 more elements
A method for treating attention deficit hyperactivity disorder once a day comprising administering to a subject a single dose of an extended release oral clonidine aqueous suspension comprising:
- (A) a pharmaceutically effective amount of modified release barrier coated clonidine—cation exchange resin complex—matrix particles, wherein the particles each comprise clonidine bound to a cationic exchange resin in a matrix comprising a hydrophilic polymer or co-polymer which comprises about 3% w/w to about 20% w/w of the particles, wherein the modified release barrier coating is about 50% w/w to about 80% w/w of the clonidine—cation exchange resin complex—matrix particle based on particle weight prior to barrier coating and the barrier coating is in a layer over the clonidine—cation exchange resin complex-matrix particles and comprises a pH-independent, water-insoluble polymer and a plasticizer;
- wherein about 90% w/w of the clonidine in the suspension is provided by the modified release barrier coated clonidine—cation exchange resin complex—matrix particles, as determined based on the amount of clonidine equivalent to clonidine HCl;
- (B) about 10% w/w of the clonidine in the suspension in an immediate release form, the immediate release form comprising an immediate release clonidine-cation exchange resin complex, clonidine uncomplexed to an ion exchange resin, and a pharmaceutically acceptable salt of clonidine uncomplexed to an ion exchange resin, as determined based on the amount of clonidine equivalent to clonidine HCl;
- and
- an aqueous suspension base.
2 more elements
Dependencies are inferred from the claim text.