Pharmaceutical composition for transdermal administration
First Claim
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1. Pharmaceutical composition for transdermal administration, comprising:
- a) optionally, a polymeric release matrix capable of forming a flexible film after drying, selected from the group consisting of cellulose polymers and cellulose copolymers,b) an active principlec) 15 to 30% of the weight of the composition of a promoter of transcutaneous absorption of the active principled) 44 to 84.9% of the weight of the composition of a physiologically acceptable non-aqueous solvent appropriate to dissolve the active principle, the transcutaneous absorption promoter and, if present, the release matrix and be rapidly removed by evaporation on contact with the skin,the transcutaneous absorption promoter being selected from the group consisting of;
an aliphatic fatty acid ester which is soluble in the physiologically acceptable non-aqueous solvent and is of general formula;
##STR2## in which R is selected from the group consisting of a linear or branched C2 -C17 alkyl or alkenyl group and a linear or branched C2 -C17 alkyl or alkenyl group substituted with a radical selected from the group consisting of hydroxyl, carboxy and C1 -C4 acyloxy group and R1 is selected from the group consisting of a linear or branched C3 -C8 alkyl group and a linear or branched C3 -C8 alkyl group substituted with one or two hydroxyl groups, or R1 represents a group --CH2 --CH2 --O--(CH2)2 --O--CH2 -CH3, the aliphatic fatty acid ester containing a minimum of 10 carbon atoms and a maximum of 2 hydroxyl groupsan aliphatic fatty alcohol which is soluble in the physiologically acceptable non-aqueous solvent and is of general formula;
space="preserve" listing-type="equation">R.sub.2 --OH II in which R2 represents a C10 -C20 alkyl group.
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Abstract
The invention concerns a pharmaceutical composition for transdermal administration, characterized in that it comprises:
a) optionally, a polymeric release matrix capable of forming a flexible film after drying, chosen from cellulose polymers or copolymers or vinylpyrrolidone/vinyl acetate copolymers
b) an active principle
c) a promoter of transcutaneous absorption of the active principle
d) a physiologically acceptable non-aqueous solvent capable of dissolving the release matrix, the active principle and the transcutaneous absorption promoter and also capable of being rapidly removed by evaporation on contact with the skin.
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Citations
35 Claims
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1. Pharmaceutical composition for transdermal administration, comprising:
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a) optionally, a polymeric release matrix capable of forming a flexible film after drying, selected from the group consisting of cellulose polymers and cellulose copolymers, b) an active principle c) 15 to 30% of the weight of the composition of a promoter of transcutaneous absorption of the active principle d) 44 to 84.9% of the weight of the composition of a physiologically acceptable non-aqueous solvent appropriate to dissolve the active principle, the transcutaneous absorption promoter and, if present, the release matrix and be rapidly removed by evaporation on contact with the skin, the transcutaneous absorption promoter being selected from the group consisting of; an aliphatic fatty acid ester which is soluble in the physiologically acceptable non-aqueous solvent and is of general formula;
##STR2## in which R is selected from the group consisting of a linear or branched C2 -C17 alkyl or alkenyl group and a linear or branched C2 -C17 alkyl or alkenyl group substituted with a radical selected from the group consisting of hydroxyl, carboxy and C1 -C4 acyloxy group and R1 is selected from the group consisting of a linear or branched C3 -C8 alkyl group and a linear or branched C3 -C8 alkyl group substituted with one or two hydroxyl groups, or R1 represents a group --CH2 --CH2 --O--(CH2)2 --O--CH2 -CH3, the aliphatic fatty acid ester containing a minimum of 10 carbon atoms and a maximum of 2 hydroxyl groupsan aliphatic fatty alcohol which is soluble in the physiologically acceptable non-aqueous solvent and is of general formula;
space="preserve" listing-type="equation">R.sub.2 --OH IIin which R2 represents a C10 -C20 alkyl group. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
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27. Matrix for a pharmaceutical composition intended for transdermal administration, comprising:
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a) a polymeric matrix, for the release of an active principle, capable of forming a flexible film after drying, selected from the group consisting of cellulose polymers and cellulose copolymers b) 15 to 30% of the weight of the composition of a promoter of transcutaneous absorption of the active principle c) 44 to 84.9% of the weight of the composition of a physiologically acceptable non-aqueous solvent appropriate to dissolve the active principles, the transcutaneous absorption promoter and, if present, the release matrix and be rapidly removed by evaporation on contact with the skin, the transcutaneous absorption promoter being selected from the group consisting of; an aliphatic fatty acid ester which is soluble in the physiologically acceptable non-aqueous solvent and is of general formula;
##STR3## in which R is selected from the group consisting of a linear or branched C2 -C17 alkyl or alkenyl group and a linear or branched C2 -C17 alkyl or alkenyl group substituted with a radical selected from the group consisting of hydroxyl, carboxy and C1 -C4 acyloxy group and R1 is selected from the group consisting of a linear or branched C3 -C8 alkyl group and a linear or branched C3 -C8 alkyl group substituted with one or two hydroxyl groups, or R1 represents a group --CH2 --CH2 --O--(CH2)2 --O--CH2 -CH3, the aliphatic fatty acid ester containing a minimum of 10 carbon atoms and a maximum of 2 hydroxyl groupsan aliphatic fatty alcohol which is soluble in the physiologically acceptable non-aqueous solvent and is of general formula;
space="preserve" listing-type="equation">R.sub.2 --OH IIin which R2 represents a C10 -C20 alkyl group. - View Dependent Claims (28, 29, 30, 31, 32, 33, 34, 35)
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Specification
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Current AssigneeSanofi
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Original AssigneeSanofi
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InventorsIllel, Brigitte, Saunal, Henry
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Primary Examiner(s)Webman, Edward J.
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Application NumberUS08/930,004Time in Patent Office762 DaysField of Search424/487, 424/488, 424/443, 424/447-449, 602/39, 602/904, 514/947, 604/304US Class Current424/449CPC Class CodesA61K 31/551 having two nitrogen atoms, ...A61K 9/2846 Poly(meth)acrylatesA61K 9/2866 Cellulose; Cellulose deriva...A61K 9/2886 having two or more differen...A61K 9/7015 Drug-containing film-formin...A61P 25/00 Drugs for disorders of the ...Y10S 602/904 Film-forming bandage material
