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Claims for Patent: 6,811,794

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Claims for Patent: 6,811,794

Title: Sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles
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.
Inventor(s): Burnside; Beth A. (Bethesda, MD), Chang; Rong-Kun (Rockville, MD), Guo; Xiaodi (New City, NY)
Assignee: Shire Laboratories, Inc. (Rockville, MD)
Application Number:10/027,349
Patent Claims: 1. 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.

2. 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.

3. 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.

4. The method of claim 3, wherein said at least pH-dependen agent is at least one polymer that swells at a pH in excess of 5.5.

5. The method of claim 4, wherein said at least one polymer that swells at a pH in excess of 5.5 is selected from acrylic acid polymers, sodium alginate, carrageenan, alginic acid, pectin, or sodium carboxymethylcellulose.

6. The method of claim 3, wherein said at least one pH-dependent agent is at least one enteric agent.

7. The method of claim 3, wherein said enteric agent is select from cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, polvinyl acetate phthalate, methacrylic acid copolymers, cellulose acetate trimellitate, hydroxypropyl methylcellulose acetate, succinate, shellac, or zein.

8. 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.

9. 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.

10. The method of claim 9, wherein said at least one polymer at swells at a pH in excess of 5.5 is selected from acrylic acid polymers, sodium alginate, carrageenan, alginic acid, pectin, or sodium carboxymethylcellulose.

11. The method of claim 8, wherein said at least one pH-dependent agent is at least one enteric agent.

12. The method of claim 11, wherein said entetic agent is select from cellulose acetate phthalate, hydroxypropyl methyicellulose phthalate, polvinyl acetate phthalate, methacrylic acid copolymers, cellulose acetate trimellitate, hydroxypropyl methyloellulose acetate, succinate, shellac, or zein.
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