Method and composition for treating or preventing osteoporosis
AssigneeBone Care International, Inc.
InventorsJoyce C. Knutson, Charles W. Bishop, Charles R. Valliere
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Abstract
Method of treating or preventing osteoporosis by administering orally a 1.alpha.-hydroxyprevitamin D. This previtamin D form increases vitamin D blood level without significant risk of hypercalcemia associated with other oral dosing of vitamin D forms. The 1.alpha.-hydroxyprevitamin is compounded into a pharmaceutical composition in combination with a pharmaceutically acceptable excipient.
Claims23
An improved and stabilized previtamin D oral formulation, said formulation comprising a therapeutically effective amount of substantially pure, solvent-free crystalline 1.alpha.-hydroxyprevitamin D which is a 1.alpha.-hydroxyprevitamin D.sub.2, 1.alpha.-hydroxyprevitamin D.sub.3 or a 1.alpha.-hydroxyprevitamin D.sub.4 substantially free of its thermal isomer, and a pharmaceutically acceptable oral formulation carrier, said formulation being capable of administration with less hypercalcemia than oral administration of the same amount of corresponding activated vitamin D.sub.2, D.sub.3 or D.sub.4.
An improved and stabilized previtamin D oral formulation, said formulation comprising a therapeutically effective amount of substantially pure, solvent-free crystalline 1.alpha.,25-dihydroxyprevitamin D.sub.3 substantially free of its thermal isomer, and a pharmaceutically acceptable oral formulation carrier, said effective amount being a daily dosage of about 0.5 .mu.g to about 25 .mu.g, said formulation being capable of administration with less hypercalcemia than oral administration of the same amount of activated vitamin D.sub.3.
A method for treating or preventing osteoporosis in a human being, comprising administering orally to said human being in need thereof an effective amount of 1.alpha.-hydroxyprevitamin D which is a 1.alpha.-hydroxyprevitamin D.sub.2, a 1.alpha.-hydroxyprevitamin D.sub.3 or a 1.alpha.-hydroxyprevitamin D.sub.4, wherein the human being experiences less hypercalcemia than that resulting from oral administration of the same amount of corresponding activated Vitamin D.sub.2, D.sub.3 or D.sub.4, and wherein the 1.alpha.-hydroxyprevitamin D is substantially pure, crystalline solvent-free, stable at room temperature and substantially free of its thermal isomer.
Dependencies are inferred from the claim text.