Trazodone composition for once a day administration
Inventors
Gervais, Sonia • Smith, Damon • Rahmouni, Miloud • Contamin, Pauline • Ouzerourou, Rachid • Ma, My Linh • Ferrada, Angela • Soulhi, Fouzia
Assignees
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Publication Number
US-9439866-B2
Publication Date
2016-09-13
Expiration Date
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.
Core Innovation
The disclosed invention relates to a method of treating a sleeping disorder in a person in need thereof by administering a sustained release pharmaceutical composition containing trazodone hydrochloride and a hydrogel. The composition consists essentially of about 15% to about 60% by weight trazodone hydrochloride and about 15% to about 85% by weight of a hydrogel that provides a substantially pH-independent controlled release of the trazodone hydrochloride.
When administered, the composition permits 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. The hydrogel is described as providing substantially pH-independent controlled release, including preferred embodiments with cross-linked high amylose starch and/or hydroxypropyl side chains.
Claims Coverage
The partial content includes one independent claim directed to treating a sleeping disorder using a sustained release composition that combines trazodone hydrochloride with a hydrogel providing substantially pH-independent controlled release. The inventive features are grouped into two features.
Sustained release trazodone hydrochloride with substantially pH-independent hydrogel controlled release
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.
pH-independent release maintaining substantially constant effective plasma concentration
The composition 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.
Overall, claim coverage is centered on a sustained-release composition defined by essential weight ranges of trazodone hydrochloride and a hydrogel engineered for substantially pH-independent controlled release, producing substantially constant effective plasma concentrations in a specified ng/mL range over at least 1 hour to at least 24 hours.
Stated Advantages
Permits pH-independent release of the trazodone hydrochloride.
Maintains 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.
Documented Applications
Treating a sleeping disorder in a person in need thereof.
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