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Last Updated: March 28, 2024

Details for Patent: 9,439,866


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Title:Trazodone composition for once a day administration
Abstract: The invention relates to a once a day formulation of trazodone or a trazodone derivative. The formulation contains trazodone or a trazodone derivative and a controlled release excipient so that, once administered orally, the trazodone or the trazodone derivative is maintained at a therapeutic plasma concentration from at least 1 hour to at least 24 hours after initial administration. After administration, the initial therapeutic action takes effect within the first hour and lasts at least about 24 hours. This therapeutic effect remains relatively and substantially stable for the remaining period of 24 hours. The formulations can be used for treating depression and/or sleeping disorders.
Inventor(s): Gervais; Sonia (Laval, CA), Smith; Damon (Saint-Laurent, CA), Rahmouni; Miloud (Pierrefonds, CA), Contamin; Pauline (Magny en Vexin, FR), Ouzerourou; Rachid (Anjou, CA), Ma; My Linh (Saint-Laurent, CA), Ferrada; Angela (Montreal, CA), Soulhi; Fouzia (Dollard-des-Ormeaux, CA)
Assignee: Angelini Pharma, Inc. (Gaithersburg, MD)
Filing Date:Sep 28, 2010
Application Number:12/892,454
Claims:1. A method of treating a sleeping disorder in a person in need thereof, the method comprising administering to the person a sustained release pharmaceutical composition consisting essentially of: from about 15% to about 60% by weight trazodone hydrochloride, and from about 15% to about 85% by weight of a hydrogel that provides a substantially pH-independent controlled release of the trazodone hydrochloride, wherein the composition, when administered to the person, permits a pH-independent release of the trazodone hydrochloride so as to maintain a substantially constant effective plasma concentration between about 50 ng/mL and about 3000 ng/mL from at least about one hour to at least about 24 hour after initial administration.

2. The method according to claim 1, wherein the plasma concentration is effective at treating the sleep disorder in the person.

3. The method according to claim 1, wherein the amount of trazodone hydrochloride is 150 mg.

4. The method according to claim 3, wherein the plasma concentration of trazodone hydrochloride achieved one hour after ingestion is between about 150 ng/mL and about 500 ng/mL.

5. The method according to claim 1, wherein the amount of trazodone hydrochloride is 300 mg.

6. The method according to claim 5, wherein the plasma concentration of trazodone hydrochloride achieved one hour after ingestion is between about 300 ng/mL and about 1000 ng/mL.

7. The method according to claim 1, wherein the percent amount of trazodone hydrochloride is from about 20% to about 50% by weight of the composition, and the amount of hydrogel is from about 20% to about 50% by weight of the composition.

8. The method according to claim 7, wherein the percent amount of trazodone hydrochloride is from about 35% to 50% by weight of the composition, and the amount of hydrogel is from about 15% to about 50% by weight of the composition.

9. The method according to claim 1, wherein the hydrogel is a cross-linked high amylose starch.

10. The method according to claim 9, wherein the amount of the cross-linked high amylose starch is between about 65% and 75% by weight amylose and is cross-linked with phosphorus oxychloride.

11. The method according to claim 1, wherein the hydrogel is a cross-linked high amylose starch with hydroxypropyl side chains.

12. The method according to claim 11, wherein the cross-linked high amylose starch is gelatinized.

13. The method according to claim 1, wherein the person is a human.

14. The method according to claim 1, wherein the composition is in the form of a tablet.

15. The method according to claim 1, wherein the composition is in the form of a caplet.

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