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|Title:||Crystalline form of a vitamin D analogue|
|Abstract:||The present invention relates to calcipotriol hydrate--a new crystalline form of calcipotriol--with superior technical properties and with superior stability.|
|Inventor(s):||Hansen; Erik Torngaard (Fredensborg, DK), Rastrup Andersen; Niels Smidt (Vanl.o slashed.se, DK), Ringborg; Lene Hoffmeyer (Br.o slashed.nsh.o slashed.j, DK)|
|Assignee:||Leo Pharmaceutical Products Ltd. (Ballerup, DE)|
1. Calcipotriol monohydrate characterized by its storage stability at 40.degree. C. after 12 months, its ready wettability and wet ball milling characteristics.
2. Pharmaceutical composition containing the compound of claim 1.
3. Pharmaceutical composition according to claim 2 which is a cream.
4. Pharmaceutical composition according to claim 2 which is a gel.
5. Pharmaceutical composition according to any one of claim 4, with a content of the active component of 1-100 .mu.g/g of the composition.
6. The method of preparing calcipotriol monohydrate which comprises dissolving calcipotriol in organic solvent and then adding water to the resulting solution to precipitate the hydrate, said hydrate being characterized by its storage stability at 40.degree. C., its ready wettability and wet ball milling characteristics.
7. In the preparation of a gel formulation which involves wet ball milling a calcipotriol component and adding the wet milled calcipotriol component to a gel base, the improvement which comprises wet milling calcipotriol hydrate as said component and using this wet milled hydrate for addition to said gel base, said hydrate being characterized by its storage stability at 40.degree. C. after 12 months, its ready wettability and wet ball milling characteristics.
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