Patent ID: 11918689
Assignee: TRIS PHARMA, INC.
Field: Pharmaceuticals (Chemistry)
Classification: CPC A | IPC A

Claim 0:
1. An extended release oral clonidine aqueous suspension which provides a once-a-day therapeutic effect for clonidine 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 particle and is in a layer over the clonidine-cation exchange resin complex-matrix particles; wherein the modified release 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 in the matrix comprises about 5% w/w to about 20% w/w of the particles:
wherein the modified release barrier coated clonidine-cation exchange resin complex-matrix particles provide about 70% w/w to about 95% w/w of the total clonidine in the suspension, 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, wherein the immediate release clonidine component(s) provide about 5% w/w to about 30% w/w of the total clonidine in the suspension, as determined based on the amount of clonidine equivalent to clonidine HCl;
and
an aqueous suspension base.