ORAL CALCITONIN COMPOSITIONS AND APPLICATIONS THEREOF

摘要

The present invention relates to compositions for the oral delivery of pharmacologically active calcitonin, to methods of synergistically enhancing the biological effects of orally administered calcitonin with D type vitamins and calcium, and to methods of treating and/or preventing disease in mammals, particularly humans, by orally administering calcitonin compositions in accordance with the invention.

主权项

1: An oral pharmaceutical composition which is a fixed combination in the form of a single entity consisting of an oral delivery agent selected from N-{5-chlorosalicyloyl)-8-aminocaprylic acid (5-CNAC), N-(10-[2-hydroxy benzoyl]amino)decanoic acid (SNAD), N-(8-[2-hydroxybenzoyl]amino)caprylic acid (SNAC), and a hydrate, solvate or a salt thereof; 0.1 to 2.5 mg of calcitonin;
a) a D vitamin in an amount of from 200 to 1000 IU, selected from Vitamin D1, Vitamin D2, Vitamin D3, Vitamin D4 and Vitamin D5; and b) a calcium salt in an amount of from 200 to 1000 mg free calcium and at least one of a pH adjuster, a preservative, a flavorant; a taste-masking agent; a fragrance; a humectant; a tonicifier a colorant; a surfactant; a plasticiser; a lubricant; a flow aid; a compression aid; a solubilizer; an excipient; a diluent; a phosphate buffer salt; citric acid, glycol, a dispersing agent, crospovidone, or povidone, wherein said fixed combination in the form of a single entity is in oral unit-dosage form.