A stable solid pharmaceutical composition consisting essentially of an effective amount of a salt of formula (II) [structure] together with an alkaline-reacting component maintaining the pH preferably above 8, or a salt with a divalent metal cation; and at least one pharmaceutical excipient; said salt of formula (II) being essentially stable during storage at room temperature for a period of at least 3 years. A process for stabilizing the salt of formula (II). A crystalline salt of formula (II) and a process for preparing said salt.

Claims

32 · 5 independent · depth 4

32 granted claims

›1.independentA stable solid pharmaceutical composition consisting essentially of an effective amount of a salt of formula (II)+25

›2.↳ 1The solid pharmaceutical composition of claim 1 having a pH maintained above 8 by the alkaline-reacting component.d2

›3.↳ 1The solid pharmaceutical composition of claim 1 wherein n is 1 and An +is Li+, Na+or K+.d2+5

›5.↳ 1The solid pharmaceutical composition of claim 1 wherein the salt of formula (II) is a salt of N-ethyl-N-phenyl- 5-chloro- 1,2-dihydro- 4-hydroxy- 1-me…d2

›8.↳ 1The solid pharmaceutical composition of claim 1 wherein the salt of formula (II) is a salt of N-ethyl-N-phenyl- 5-ethyl- 1,2-dihydro- 4-hydroxy- 1-met…d2+2

›13.↳ 1The solid pharmaceutical composition of claim 1 wherein the salt of formula (II) is a lithium or calcium salt of N-ethyl-N-phenyl- 5-chloro- 1,2-dihyd…d2

›14.↳ 1The solid pharmaceutical composition of claim 1 which is in the form of a capsule or a tablet.d2

›15.↳ 1The solid pharmaceutical composition of claim 1 wherein the salt of formula (II) is present in an amount of 0.01 to 10% by weight of the composition.d2

›16.↳ 1The solid pharmaceutical composition of claim 1 wherein the salt of formula (II) is present in an amount of 0.1 to 2% by weight of the composition.d2

›17.↳ 1The solid pharmaceutical composition of claim 1 wherein the alkaline-reacting component is selected from sodium, potassium, calcium and aluminum salts…d2

›18.↳ 1The solid pharmaceutical composition of claim 1 wherein the alkaline-reacting component is present in an amount of 0.1 to 99% by weight of the composi…d2

›19.↳ 1The solid pharmaceutical composition of claim 1 wherein the alkaline-reacting component is present in an amount of 1 to 20% by weight of the compositi…d2

›20.↳ 1The solid pharmaceutical composition of claim 1 wherein the salt with a divalent metal cation is calcium acetate.d2+1

›22.↳ 1The solid pharmaceutical composition of claim 1, wherein the pharmaceutical excipient is selected from solid powdered carriers, binders, disintegrants…d2+4

›27.independentA process for stabilizing a salt of formula (II)

›28.independentA process for stabilizing a salt of formula (II)

›29.independentA process for stabilizing a salt of formula (II)

›30.independentA stable solid pharmaceutical composition comprising an effective amount of a salt of formula (II)+2

Classifications

4 codes

IPC · International Patent Classification

Section C — Chemistry; metallurgy

C07D215/38

USPC · US Patent Classification

546/155546/153546/159

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Pendency

4.2 y

1,516 days filing → grant

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after a restriction

Responses

1 RCE

Examiner

D. Margaret Seaman

art unit 1625 · TC 1600

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Citations: 14 back · 0 forward

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1 priority documents

›Priority documents — 1

Type	Document	Date
related publication	US 20050192315 A1	1 Sep 2005

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