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5-cnac as oral delivery agent for parathyroid hormone fragments5-cnac as oral delivery agent for parathyroid hormone fragments description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20090264367, 5-cnac as oral delivery agent for parathyroid hormone fragments. Brief Patent Description - Full Patent Description - Patent Application Claims
1. Field of the Invention The present invention relates to the oral delivery of parathyroid hormone (PTH). The mammalian parathyroid hormones, e.g. human (hPTH), bovine (bPTH) and porcine (pPTH), are single polypeptide chains of 84 amino acid residues having molecular weights of approximately 9500. Specifically, the present invention relates to PTH fragments incorporating at least the first 28 N-terminal amino acid residues (PTH (1-28)) up to and including the first 41 N-terminal amino acid residues (PTH (1-41)). More particularly, the invention is directed to pharmaceutical compositions for the oral delivery of PTH, said compositions comprising PTH (1-28) to (1-41) and N-(5-chlorosalicyloyl)-8-aminocaprylic acid (5-CNAC). 2. Description of the Related Art PTH studies done in animals and humans with PTH, PTH-related peptides, and PTH analogues have demonstrated its usefulness in increasing bone formation and bone resorption and have prompted interest in its use for the treatment of osteoporosis and related bone disorders. However, the oral delivery of PTH in mammals has proven difficult due, at least in part, to the insufficient stability of PTH in the gastrointestinal tract as well as the inability of PTH to be readily transported through the intestinal walls into the blood stream. U.S. Pat. No. 5,773,647 (the \'647 patent) describes 193 carrier compounds useful for the delivery of active agents, including PTH. One of the carrier compounds expressly described therein is N-(5-chlorosalicyloyl)-8-aminocaprylic acid (5-CNAC) having the formula
Example 2 in Column 6 of the \'647 patent describes the preparation of 11 different dosing compositions some intracolonic (IC) and some oral gavage (PO) each containing parathyroid hormone and a carrier, the carrier being different for each composition. An IC dosing composition was prepared using 5-CNAC as the carrier. Example 3 therein describes in vivo tests carried out dosing male Sprague-Dawley rats with the dosing solutions prepared In Example 2. Blood samples were collected and the serum PTH concentration was quantified for each rat. Surprisingly, it has now been found that 5-CNAC in combination with specific PTH fragments, i.e. PTH fragments incorporating at least the first 28 N-terminal amino acid residues (PTH (1-28)) up to and including the first 41 N-terminal amino acid residues (PTH (1-41)) when orally administered gives unexpectedly high PTH serum levels reactive to other PTHs and other carriers and provide a sharp Cmax allowing for a bone formation effect. Accordingly, the present invention is directed to pharmaceutical compositions suitable for oral delivery of PTH fragments and to methods of administering such compositions. Specifically, the instant invention is directed to a pharmaceutical composition for oral delivery comprising a therapeutically effective amount of a PTH fragment and 5-CNAC, said PTH fragment selected from PTH (1-28) to PTH (1-41). Preferably, the PTH is human parathyroid hormone, hPTH. In another embodiment, the invention is directed to a method for orally administering an effective dose of PTH comprising orally administering to a patient in need of PTH a pharmaceutical composition comprising a therapeutically effective amount of a PTH fragment and 5-CNAC, said PTH fragment selected from PTH (1-28) to PTH (1-41). The invention is also directed to a method of stimulating new bone formation comprising orally administering to a patient in need of new bone formation a pharmaceutical composition comprising a therapeutically effective amount of a PTH fragment and 5-CNAC, said PTH fragment selected from PTH (1-28) to PTH (1-41). In a further embodiment, the invention is directed to a method of treatment or prevention of osteoporosis comprising orally administering to a patient in need of said treatment or prevention a pharmaceutical composition comprising a therapeutically effective amount of a PTH fragment and 5-CNAC, said PTH fragment selected from PTH (1-28) to PTH (1-41). In a still further embodiment, the invention is directed to the use of 5-CNAC for the preparation of a pharmaceutical composition suitable for the oral delivery of PTH fragments selected from PTH (1-28) to PTH (1-41). Further features and advantages of the invention will become apparent from the following detailed description of the invention. Continue reading about 5-cnac as oral delivery agent for parathyroid hormone fragments... Full patent description for 5-cnac as oral delivery agent for parathyroid hormone fragments Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this 5-cnac as oral delivery agent for parathyroid hormone fragments patent application. Patent Applications in related categories: 20090298774 - Bifunctional molecules for inhibiting hiv entry - Disclosed herein are bifunctional molecules which inhibit HIV entry into the target cell. 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