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|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)|
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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