Crystalline form of the sodium salt of...

Organic compounds -- part of the class 532-570 series – Organic compounds – Heterocyclic carbon compounds containing a hetero ring...

Reexamination Certificate

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C514S089000

Reexamination Certificate

active

10531877

ABSTRACT:
The present invention relates to a crystalline, hydrated form of the sodium salt of 3-pyridyl-1-hydroxyethylidene-1,1-bisphosphonic acid. The hydrate contains from 6.4 up to 22 weight % of sodium and 15 up to 23 weight % of crystalline water if the sodium content is lower than 7.5 weight %, based on the whole molecule, or 4.5 up to 18 weight % of crystalline water if the sodium content is equal to or higher than 13 weight %, based on the anhydrous substance. Due to stability in humid environments, the hydrate is useful as an active substance for the treatment of diseases associated with bone resorption disorders.

REFERENCES:
patent: 2006/0148762 (2006-07-01), Richter et al.
patent: 01/56983 (2001-08-01), None
patent: 03/086355 (2003-10-01), None
Gossman, William L. et al.: “Three hydrates of the bisphosphonate risedronate, consisting of one molecular and two ionic structures”, Acta Crystallographica Section C, vol. C59, pp. m33-m36, Jan. 11, 2003.
Kushida, K.: “Sodium risedronate hydrate”, Rinsho To Yakubutsu Chiryo, vol. 21, No. 10, pp. 1040-1041, 2002. XP001157194.
Redman-Furey, Nancy L. et al.: “Thermoanalytical Characterization of the Hydration States of Risedronate”, Proceedings of the NATAS Annual Conference on Thermal Analysis and Applications, No. 30th, pp. 733-738, Sep. 21-22, 2002. XP009024613.
U.S. Appl. No. 10/590,694, filed Aug. 25, 2006, Richter et al.

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