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Oral peptide pharmaceutical dosage form and method of production
 
   
Document Number
US Patent 7316819
Issued Date
January 8, 2008
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Inventors
Crotts; George (Kintnersvill, PA)
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Abstract
A pharmaceutical composition for oral delivery of a peptide is in the form of a lamination having at least two layers. The first layer of the lamination includes at least one pharmaceutically acceptable pH-lowering agent. The second layer includes a therapeutically effective amount of the peptide. The composition also includes at least one absorption enhancer effective to promote bioavailability of the peptide, which is preferably in the second layer, and an enteric coating surrounding the lamination. In a preferred dosage form of a tablet, a water-soluble coating is applied between the lamination and enteric coating which substantially prevents contact between the pH-lowering agent and the enteric coating. In a preferred embodiment, the peptide is salmon calcitonin, the pH-lowering agent is citric acid, and the absorption enhancer is lauroyl l-carnitine.
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Number of Claims:
30
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Published
January 8, 2008
Application Number
10/094,306
Filed
March 7, 2002
US Classification
424/464   424/465 424/490 424/491
Int'l Classification
A61K   9/20   (20060101)   A61K   9/16   (20060101)  
Examiner
Parent Case
This application claims priority benefit of provisional application Ser. No. 60/274,317 filed Mar. 8, 2001.
USPTO Field of Search
424/464   424/451   424/490  
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