Sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles
AssigneeShire Laboratories, Inc.
InventorsBeth A. Burnside, Rong-Kun Chang, Xiaodi Guo
Life of this patent
Estimating the term…
Abstract
A pharmaceutical composition comprising at least one pharmaceutically active agent that is pH dependent, at least one non-pH dependent sustained release agent, and at least one pH dependent agent that increases the dissolution rate of the at least one pharmaceutically active agent at a pH in excess of 5.5. Such compositions have minimized pH-dependent dissolution profiles or pH-independent dissolution profiles.
Claims12
A pharmaceutical composition, comprising:
- (a) guanfacine;
- (b) hydroxypropyll methylcellulose;
- (c) ammonip methacrylate copolymer;
- (d) microcrystalline cellulose;
- (e) a methacrylic acid copolymer;
- (f) glycejyl behenate;
- (g) fumaric acid;
- (h) lactose monohydrate;
- (i) povidone;
- and
- (j) crospovidope aranulated blend.
A pharmaceutical composition, comprising:
- (a) quanfacine hydrochloride;
- (b) hydroxypropyl methylcellulose;
- (c) ammonio methacrylate copolymer;
- (d) microcrystalline cellulose;
- (e) a methacrylic acid polymer;
- (f) glyceryl behenate;
- (g) fumaric acid;
- (h) lactose monohydrate;
- (i) povidone;
- and
- (j) crospovidone granulated blend.
A method for treating an attention deficit disorder or attention deficit with hyperactivity disorder in a patient, comprising administering to said patient a composition comprising
- (a) at least one pharmaceutically active agent that is pH dependent, said pharmaceutically active agent being quanfacine or quanfacine hydrochloride;
- (b) at least one non-pH dependent sustained release agent selected from the group consisting of ethylcellulose, cellulose acetate, vinyl acetate/vinyl chloride copolymer, acrylate/methacrylate copolymers, polvethylene oxide, hydroxynropyl methylcellulose, carageenan, alginic acid and salts thereof, hvdroxyethyl cellulose, hydroxypropyl cellulose, karaya gum, acacia gum, tragacanth gum, locust bean gum, guar gum, sodium carboxymethyl cellulose, methyl cellulose, beeswax, camauba wax. cetyl alcohol, hydrogenated vegetable oils, and stearyl alcohol;
- and
- (c) at least one pH dependent agent that increases the rate of release of said at least one pharmaceutlcally active apent from a tablet dosage form at a pH in excess of 5.5;
- which is given in an amount effective to treat said attention deficit disorder or attention deficit with hyperactivity disorder in said patient.
A method of reducing the likelihood of side effects associated with the administration of guanfacine, comprising administering to a patient a therapeutically effective amount of a the position comprising
- (a) at least one pharmaceutically active agent that is pH dependent, said pharmaceutically active agent being guanfacine or guanfacine hydrochloride;
- (b) at least one non-pH dependent sustained release agent selected from the group consisting of ethylcellulose, celluipse acetate, vinyl acetate/vinyl chloride copolymers, acrylate/methacrylate copolymers, polyethylene oxide, hydroxynropyl methylcellulose, carageenan, glainic acid and salts thereof, hydroxyethyl cellulose, hydroxypropyl cellulose, karaya gum, acacia gum, tragacanth gum, locust bean gum, guar gum, sodium carboxymethyl cellulose, methyl cellulose, beeswax, carnauba wax, cetyl alcohol, hydrogenated vegetable oils, and stearyl alcohol;
- and
- (c) at least one pH dependent agent that increases the rate of release of said at least one pharmaceutically active agent from a tablet dosage form at a pH in excess of 5.5.
The method of clalm 8, wherein said at least one pH-dependent gent is at least one polymer that swells at a pH In excess of 5.5.
Dependencies are inferred from the claim text.