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Controlled release pharmaceutical composition useful for the treatment of diseases and conditions affecting metabolism and/or structural integrity of cartilage and/or bone in male comprises strontium salt

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Disciplines
  • Medicine
  • Pharmacology

Abstract

NOVELTY - A controlled release pharmaceutical composition comprises a strontium salt in an amount for once daily oral administration. USE - For the treatment and/or prophylaxis of a cartilage and/or bone disease and/or conditions resulting in a dysregulation of cartilage and/or bone metabolism in a mammal (including human female or male adult (e.g. 20 - at least50 years older female; including female who is of the same age as her age of onset of menopause and female who is at least6 months beyond the onset of menopause, and 20 - at least70 years older male), adolescent and child); such as osteoporosis (also including secondary osteoporosis induced by e.g. endocrine diseases, metabolic causes, nutritional conditions, drug substances and/or disorders of the collagen metabolism), osteoarthritis, osteopectoris, osteopenia, Paget's disease, hypercalcemia of malignancy, periodontal disease, hyperparathyroidism, periarticular erosions in rheumatoid arthritis, osteodystrophy, myositis ossificans, Bechterew's disease, osteolytic lesions produced by bone metastasis, bone pain due to bone metastasis, bone loss due to sex steroid hormone deficiency, bone abnormalities due to steroid hormone treatment, bone abnormalities caused by cancer therapeutics, osteomalacia, Behcet's disease, hyperosteosis, metastatic bone disease, immobilization-induced or glucocorticoid-induced osteopenia or osteopectoris, osteoporosis pseudoglioma syndrome, idiopathic juvenile osteoporosis; for the improvement of fracture healing after traumatic or atraumatic fracture; for the improvement of implant stability; for the maintenance or increase of energy level; for building up or strengthening muscle tissue; for weight gain; for the treatment of a female or male having a bone mineral density (BMD) of greater than 1 SD below the young adult female or male mean respectively, and a female or male having a BMD below the adult female or male mean for women or men of the same age, respectively; and for the treatment of a female or male having a level of specific biomarker of resorption of more than 1 SD above the young adult female or male mean, or above the adult female or male mean for women or mean of the same age, respectively (claimed). ADVANTAGE - The composition is free of side effects due to the hormone replacement therapy with estrogen. The controlled release formulation of strontium further reduces or minimizes the side effects and further achieves a plasma level that is substantially constant during prolonged period of time. The strontium salt is released from the composition in such a manner that the amplitude (difference between peak and nadir) of the plasma concentration relative to the peak level is (less than 40, preferably less than 25, especially less than 15, particularly less than 10)% after the administration of the composition, once daily for (at least 7, preferably at least 14, especially at least 30) days. The composition when tested in an in vitro dissolution test, releases strontium ion (wt.%) not more than 10, not more than 70 and at least70 in the first 30 minutes, first 4 hours and first 14 hours, respectively. DETAILED DESCRIPTION - An INDEPENDENT CLAIM is included for a pharmaceutical composition containing the strontium salt, a drug substance that induces osteoporosis and a carrier.

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