| Oral administration of calcitonin -> Monitor Keywords |
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Oral administration of calcitoninRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Designated Organic Active Ingredient Containing (doai), Peptide Containing (e.g., Protein, Peptones, Fibrinogen, Etc.) DoaiOral administration of calcitonin description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20060135402, Oral administration of calcitonin. Brief Patent Description - Full Patent Description - Patent Application Claims
FIELD OF THE INVENTION [0001] This invention relates to orally effective pharmaceutical compositions of calcitonin, the administration thereof and treatment of disorders responsive to the action of calcitonin therewith in humans. BACKGROUND OF THE INVENTION [0002] U.S. Pat. Nos. 5,773,647 and 5,866,536, as well as International Application WO 00/59863 disclose pharmaceutical compositions for the oral delivery of calcitonin using modified amino acids as oral delivery agents. Said documents are incorporated herein by reference. Oral delivery agents disclosed include N-(5-chlorosalicyloyl)-8-aminocaprylic acid (5-CNAC), N-(10-[2-hydroxybenzoyl]aminodecanoic acid (SNAD) and N-(8-[2-hydroxybenzoyl]amino)caprylic acid (SNAC), disodium salts and hydrates and solvates thereof. SUMMARY OF THE INVENTION [0003] The present invention is directed to a particular method of orally administering pharmaceutical compositions comprising calcitonin in combination with one or more oral delivery agents, i.e., prior to the consumption of food in humans, and method of treatment of disorders responsive to the action of calcitonin employing such method of administration; also oral solid pharmaceutical compositions with particular ratios of the amount of oral delivery agent to the amount of calcitonin in which the amount of oral delivery agent is decreased. DETAILED DESCRIPTION OF THE INVENTION [0004] Particularly, the present invention is directed to treatment of disorders responsive to the action of calcitonin, which comprises the oral administration to a human host of a pharmaceutical composition comprising calcitonin and an oral delivery agent, said oral administration being in the absence of food, advantageously a short interval prior to the consumption of food, for instance, a short interval before a meal, so as to enhance the oral bioavailability of calcitonin. [0005] Disorders responsive to the action of calcitonin are, e.g., Paget's disease, hypercalcemia and osteoporosis. [0006] The term "about" as used herein denotes both the actual numbers of values cited, as well as a range falling within up to 10% below and above the cited numbers or values. [0007] As used herein, "calcitonin" refers to a class of pharmacological agents used for the treatment of, e.g., Paget's disease, hypercalcemla and osteoporosis, including natural, synthetic or recombinant human, salmon, pig or eel calcitonin. [0008] Preferred is salmon calcitonin (sCT). The calcitonins are commercially available or may be synthesized by known methods. Atypical human dose of sCT is 100 IU (0.018 mg) when administered by injection. [0009] The appropriate oral human dosage will vary depending, e.g., on the age of the subject, the oral formulation and the nature and severity of the condition to be treated. An oral human dose of sCT is typically in the range of about 0.05-5 mg, preferably about 0.1-2.5 mg, when administered in combination with an oral delivery agent. [0010] The oral dosage will also vary depending on the delivery agent and the actual formulation involved. [0011] Suitable oral delivery agents are those described in U.S. Pat. Nos. 5,773,647 and 5,866,536, as well as International Application WO 00/59863, the contents of which are incorporated herein by reference. Specific embodiments thereof are 5-CNAC, SNAD and SNAC, and the disodium salts and hydrates and solvates thereof, such as the ethanol solvates. The disodium salts, monohydrates and ethanol solvates are described in International Application WO 00/59863, including their preparation. [0012] Preferred as oral delivery agent is 5-CNAC, particularly the disodium salt or the hydrate or solvate thereof, such as the ethanol solvate. [0013] Typically, the hydrate or ethanol solvate of, e.g., the disodium salt of 5-CNAC contains about one molecule of water or ethanol per molecule of the oral delivery agent, thus being a monohydrate or monoethanol solvate. [0014] Particularly preferred is 5-CNAC disodium salt, advantageously the monohydrate form thereof. [0015] As used herein "5-CNAC" denotes N-(5-chlorosalicyloyl)-8-aminocaprylic acid. Unless denoted otherwise, the term "disodium salt" used in connection with 5-CNAC refers to the disodium salt in any form. [0016] 5-CNAC is described in U.S. Pat. No. 5,773,647, the contents of which are hereby incorporated by reference, and can be made by methods described therein. The sodium salts and alcohol solvates and hydrates thereof, along with methods for preparing them, are described in WO 00/59863, which is also incorporated herein by reference. Examples 2 and 7 of WO 00/59863 are directed, respectively, to 5-CNAC disodium salt monohydrate and 5-CNAC disodium salt monoethanol solvate. [0017] Surprisingly, it has now been found that the oral administration of a calcitonin formulation, preferably a solid calcitonin formulation comprising calcitonin and an oral delivery agent, at a short interval prior to a meal greatly increases the oral absorption and the systemic bioavailability of calcitonin in comparison to administration with a meal. [0018] The short interval for administration prior to a meal is up to 2 hours, advantageously about 5 minutes to 1 hour, preferably about 5 to 30 minutes, most preferably about 5 to 15 minutes, and as little as about 2-5 minutes or just prior to a meal. [0019] A meal represents particularly a standard meal, namely breakfast, lunch or dinner. [0020] The increase in oral absorption and systemic bloavailability of calcitonin is determined by measuring the plasma concentration of calcitonin achieved after administration of the drug at various intervals prior to a meal and at mealtime. Typically, the plasma concentration is measured at predetermined periods after the administration of the drug so as to determine the maximum plasma concentration (C.sub.max) and the total amount absorbed as determined by the area under the curve (AUC). Continue reading about Oral administration of calcitonin... 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