Complex formulation for preventing or treating osteoporosis which comprises solid dispersion of vitamin d or its derivative and bisphosphonate

Abstract

The present invention relates to a solid dispersion comprising vitamin D or a derivative thereof and a cyclodextrin; a complex formulation for the prevention or treatment of osteophorosis, which comprises said solid dispersion and a bisphosphonate; and a method for preparing said complex formulation. The complex formulation of the present invention comprising vitamin D or a derivative thereof and a bisphosphonate can maintain a constant therapeutic level of vitamin D or a derivative thereof through its improved drug stability, while enhancing the patient compliance by minimizing inconvenience and adverse effects when administered to patients. Therefore, the complex formulation of the present invention can be advantageously used for preventing and treating osteophorosis.

Description

Technical field

[0001] The present invention relates to a solid dispersion comprising vitamin D or a derivative thereof and cyclodextrin, a composite preparation for preventing or treating osteoporosis comprising the solid dispersion and a bisphosphonate, and the preparation of the composite preparation Methods. Background technique

[0002] Osteoporosis is a metabolic bone disease in which bone mineral density (BMD) is reduced and bone microstructure is destroyed, leading to an increased risk of fractures. Osteoporosis can be caused by some congenital factors, menopause, hyperthyroidism, hyperparathyroidism, chronic renal failure, or administration of glucocorticoid drugs, and it is most common in postmenopausal women with estrogen deficiency. The increase in osteoclast resorption far exceeds the bone formation of osteoblasts and reduces intestinal calcium absorption, which leads to a rapid decrease in BMD.

[0003] In the treatment of osteoporosis, bisphosphonates that reduce b...

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