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Claims for Patent: RE34672

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Claims for Patent: RE34672

Title: Pharmaceutical composition containing a stable modification of torasemide
Abstract:The present invention provides a process for the preparation of cystalline torasemide in the pure modification I (monoclinic, space group P2.sub.1 /c, melting point 162.degree. C.) from torasemide of modification II (monoclinic, space group P2/n, melting point 169.degree. C.), wherein a suspension of torasemide of modification II is stirred in water with the addition of a catalytic amount of modification I until the rearrangement is complete. The present invention also provides pharmaceutical compositions containing torasemide of modification I.
Inventor(s): Topfmeier; Fritz (Heidelberg, DE), Lettenbauer; Gustav (Lampertheim, DE)
Assignee: Boehringer Mannheim GmbH (Mannheim, DE)
Application Number:08/043,631
Patent Claims: 1. A diuretic pharmaceutical composition comprising an effective amount of rapidly dissolving .Iadd.stable .Iaddend.crystalline torasemide of pure modification I (monoclinic, space group P2.sub.1 /c, melting point .Badd..[.169.degree. C..]..Baddend. .Iadd.of about 159.degree. C. to about 161.5.degree. C., in prism form.Iaddend.) substantially free of crystalline torasemide of modification II (monoclinic, space group P2/n, melting point .Badd..[.162.degree. C..]..Baddend. .Iadd.of about 157.5.degree. C. to about 160.degree. C., in leaflet form.Iaddend.) and a pharmacologically acceptable carrier, said torasemide of modification I .Iadd.being storage stable in tablet form and .Iaddend.having solubility characteristics such that at least 60% is dissolved in water after 15 minutes, and at least 80% is dissolved in water after 30 minutes.

2. The composition of claim 1 comprising, by weight, approximately:

100 parts of the torasemide of modification I and, as the carrier,

20 parts lactose monohydrate,

77 parts maize starch,

2parts silicon dioxide and,

1 part magnesium stearate.

3. The composition of claim 1 comprising, by weight, approximately:

25parts of the torasemide of modification I and, as the carrier,

605 parts lactose monohydrate,

160 parts maize starch,

6 parts silicon dioxide and

4 parts magnesium stearate. .Iadd.

4. A method of producing a diuretic effect in a patient, said method comprising orally administering to the patient at least one storage-stable table consisting essentially of torasemide of pure modification I (monoclinic, space group P2.sub.1 /c, melting point of about 159.degree. to about 161.5.degree. C., in prism form) and being substantially free of crystalline torasemide of modification II (monoclinic, space group P2/n, melting point of about 157.5.degree. C. to about 160.degree. C., in leaflet form). .Iaddend.
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