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Claims for Patent: RE39706

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Claims for Patent: RE39706

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 (Hundested, DK), Andersen; Niels Smidt Rastrup (Vanlose, DK), Ringborg; Lene Hoffmeyer (Bronshoj, DK)
Assignee: Leo Pharma A/S (Ballerup, DK)
Application Number:10/986,575
Patent Claims: 1. Calcipotriol monohydrate characterized by its storage stability at 40.degree. C. after 12 months, its ready wettability and .Iadd.its suitability for .Iaddend.wet ball milling .[.characteristics.]. .

2. Pharmaceutical composition containing the .[.compound.]. .Iadd.calcipotriol monohydrate .Iaddend.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 .Iadd.comprising calcipotriol monohydrate .Iaddend.according to any one of .[.claim 4.]. .Iadd.claims 2-4 and a pharmaceutically acceptable vehicle.Iaddend., with a content of the .[.active component of.]. .Iadd.calcipotriol monohydrate being .Iaddend.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 .Iadd.its suitability for .Iaddend.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 .Iadd.its suitability for .Iaddend.wet ball milling .[.characteristics.]. .

.Iadd.8. Calcipotriol monohydrate according to claim 1, wherein said monohydrate exhibits an infrared spectrum which comprises the following characteristic lines based on the potassium bromide technique: 1455(m), 1442(m), 1330(w), 1290(m), 1210(m), 1085(m), 907(m), 895(m) and 573(w) cm.sup.-1, respectively..Iaddend.

.Iadd.9. Calcipotriol monohydrate according to claim 1 or 8, wherein said monohydrate exhibits a solid state CPMAS .sup.13C NMR spectrum which comprises the following resonances: 147.9, 146.5, 134.8, 130.3, 129.0, 126.5, 116.0, 109.4, 75.5, 68.2, 67.2, 56.9, 55.2, 47.8, 47.5, 42.9, 42.0, 41.3, 30.7, 28.9, 25.6, 23.1, 22.6, 19.5, 14.6, 6.2 and 1.9 ppm, respectively..Iaddend.

.Iadd.10. A pharmaceutical composition according to claim 2, wherein said monohydrate exhibits an infrared spectrum which comprises the following characteristic lines based on the potassium bromide technique: 1455(m), 1442(m), 1330(w), 1290(m), 1210(m), 1085(m), 907(m), 895(m) and 573(w) cm.sup.-1, respectively..Iaddend.

.Iadd.11. A pharmaceutical composition according to claim 2 or 10, wherein said monohydrate exhibits a solid state CPMAS .sup.13C NMR spectrum which comprises the following resonances: 147.9, 146.5, 134.8, 130.3, 129.0, 126.5, 116.0, 109.4, 75.5, 68.2, 67.2, 56.9, 55.2, 47.8, 47.5, 42.9, 42.0, 41.3, 30.7, 28.9, 25.6, 23.1, 22.6, 19.5, 14.6, 6.2 and 1.9 ppm, respectively..Iaddend.

.Iadd.12. Pharmaceutical composition according to claim 2 which is an ointment..Iaddend.

.Iadd.13. Pharmaceutical composition according to claim 2 which is a lotion..Iaddend.

.Iadd.14. Pharmaceutical composition according to claim 2 which is a solution..Iaddend.

.Iadd.15. Pharmaceutical composition according to claim 2 which is a suspension..Iaddend.

.Iadd.16. Pharmaceutical composition comprising calcipotriol monohydrate according to claim 12 and a pharmaceutically acceptable vehicle, with a content of the calcipotriol monohydrate being 1-100 .mu.g/g of the composition..Iaddend.

.Iadd.17. Pharmaceutical composition comprising calcipotriol monohydrate according to claim 13 and a pharmaceutically acceptable vehicle, with a content of the calcipotriol monohydrate being 1-100 .mu.g/g of the composition..Iaddend.

.Iadd.18. Pharmaceutical composition comprising calcipotriol monohydrate according to claim 14 and a pharmaceutically acceptable vehicle, with a content of the calcipotriol monohydrate being 1-100 .mu.g/g of the composition..Iaddend.

.Iadd.19. Pharmaceutical composition comprising calcipotriol monohydrate according to claim 15 and a pharmaceutically acceptable vehicle, with a content of the calcipotriol monohydrate being 1-100 .mu.g/g of the composition..Iaddend.
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