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Systemic drug delivery compositions comprising a polycationi substance
| Details |
Inventors: Illum, Lisbeth;
Assignee: Danbiosyst UK Limited (Nottingham, GB)
Primary Examiner: Azpuru; Carlos A.
Assistant Examiner:
Attorney, Agent or Firm: Arnall Golden & Gregory
A composition for administration to the mucosa comprises a pharmacologically active compound and a polycationic substance. The polycationic substance is preferably DEAE-dextran or chitosan and the pharmacologically active compound is preferably insulin or calcitonin. The composition may be a solution, dispersion, powder or microspheres. Other enhancers, such as lysophosphatidylcholine, can be included if desired. |
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DETAILED DESCRIPTION I claim: 1.
A method of systemically delivering a pharmaceutically effective amount of a pharmacologically active compound to a mammal comprising: administering to a mucosal surface a composition including a pharmacologically active compound in a pharmaceutically effective amount when administered systemically and a polymeric substance having a plurality of cationic groups having a molecular weight of 10,000 or more providing for absorption of the active compound across the mucosal surface of the mammal for systemic distribution of the active compound, wherein the polymeric substance is selected from the group consisting of polycationic carbohydrates, polyaminoacids, polyquaternary compounds, protamine, polyimines, polymers having a cationic DEAE group, polyvinylpyridine, polymethacrylates, polyacrylates, polyoxethanes, polyamidoamines, polythiodiethylamino methylethylene, and poly-p-aminostyrene, and (i) the substance is not a polyamino acid which chelates calcium or magnesium ions, (ii) the composition does not consist of microcapsules coated with DEAE-dextran, (iii) if for administration to gut mucosa, the composition does not consist of the active compound and a solution of DEAE-dextran, and (iv) if in the form of a tablet for retention in the mouth, the composition does not comprise chitosan, and allowing the composition to remain in contact with mucosa for a time sufficient for a pharmaceutically effective amount of the pharmacologically active compound to pass through the mucosa.
2.
The method according to claim 1 wherein the site of administration is selected from the group consisting of nasal mucosa, vaginal mucosa and gut mucosa of said mammal.
3.
The method according to claim 1 wherein the polymeric substance comprises microspheres.
4.
The method according to claim 1 wherein the polymeric substance comprises a solution.
5.
The method according to claim 4 wherein the concentration of the polymeric substance is between about 0.
1% and 15% w/v.
6.
The method according to claim 1 wherein the polymeric substance comprises a dispersion
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