Gallstone dissolution compositions and method

Claim 2

A composition for prevention and treatment of radiolucent gallstones, comprising: (a) a safe and effective amount of a non-absorbable, non-digestible polyol fatty acid polyester wherein the polyol is esterified with at least four fatty acid groups; and (b) a safe and effective amount of a litholytic bile acid.

Claim 3

A composition according to claim 1 wherein the litholytic bile acid is selected from the group consisting of chenodeoxycholic acid, ursodeoxycholic acid, and their pharmaceutically-acceptable salts, and mixtures thereof.

Claim 4

A composition for prevention and treatment of radiolucent gallstones, comprising: (a) a non-absorbable, non-digestible liquid polyol fatty acid polyester wherein the polyol is esterified with at least four fatty acid groups; (b) a safe and effective amount of a litholytic bile acid; and (c) sufficient anti-anal leakage agent to prevent leakage of said liquid polyester through the anal sphincter.

Claim 5

A composition for prevention and treatment of radiolucent gallstones, comprising: (a) a non-absorbable, non-digestible liquid polyol fatty acid polyester wherein the polyol is esterified with at least four fatty acid groups; (b) a safe and effective amount of a litholytic bile acid; and (c) sufficient anti-anal leakage agent to prevent leakage of said liquid polyester through the anal sphincter.

Claim 6

A composition according to claim 3 wherein the litholytic bile acid is selected from the group consisting of chenodeoxycholic acid, ursodeoxycholic acid, and their pharmaceutically-acceptable salts, and mixtures thereof.

Claim 7

A composition according to claim 4 wherein the sucrose fatty acid polyester is a member selected from the group consisting of the hexaoleate, haptaoleate and octaoleate of sucrose, and mixtures thereof.

Claim 8

A composition according to claim 5 which comprises at least about 10% by weight of the anti-anal leakage agent.

Claim 9

A composition for prevention and treatment of radiolucent gallstones, comprising: (a) a non-absorbable, non-digestible liquid polyol fatty acid polyester wherein the polyol is esterified with at least four fatty acid groups; (b) a safe and effective amount of a litholytic biel acid; and (c) sufficient fat-soluble vitamins selected from the group consisting of vitamin A, vitamin D, vitamin E and vitamin K, and mixtures thereof, to prevent abnormally low levels of said fat-soluble vitamins in humans or animals ingesting said composition.

Claim 10

A composition for prevention and treatment of radiolucent gallstones, comprising: (a) a non-absorbable, non-digestible liquid polyol fatty acid polyester wherein the polyol is esterified with at least four fatty acid groups; (b) a safe and effective amount of a litholytic biel acid; and (c) sufficient fat-soluble vitamins selected from the group consisting of vitamin A, vitamin D, vitamin E and vitamin K, and mixtures thereof, to prevent abnormally low levels of said fat-soluble vitamins in humans or animals ingesting said composition.

Claim 11

A composition according to claim 7 wherein the litholytic bile acid is selected from the group consisting of chenodeoxycholic acid, ursodeoxycholic acid, and their pharmaceutically-acceptable salts, and mixtures thereof.

Claim 12

A composition according to claim 8 wherein the polyol fatty acid polyester is selected from the group consisting of sugars and sugar alcohols containing from 4 to 8 hydroxyl groups esterified with fatty acid groups, wherein each fatty acid group has from about 8 to about 22 carbon atoms.

Claim 13

A composition according to claim 9 wherein the polyol fatty acid polyester is sucrose fatty acid polyester.

Claim 14

A composition according to claim 10 wherein the sucrose fatty acid polyester is selected from the group consisting of the hexaoleate, haptaoleate, and octaoleate of sucrose, and mixtures thereof.

Claim 15

A composition according to claim 11 which additionally contains at least about 10% by weight of an anti-anal leakage agent.

Claim 18

A method according to claim 13 wherein the composition administered further comprises a safe and effective amount of a litholytic bile acid.

Claim 19

A method according to claim 13 which further comprises the concurrent administration of a composition comprising a safe and effective amount of a litholytic bile acid.

Claim 20

A method according to claim 14 or 15 wherein the litholytic bile acid is selected from the group consisting of chenodeoxycholic acid, ursodeoxychloic acid, and their pharmaceutically-acceptable salts, and mixtures thereof.

Claim 21

A method according to claim 13, 14, or 15 wherein the polyol fatty acid polyester is selected from the group consisting of sugars and sugar alcohols containing from 4 to 8 hydroxyl groups esterified with fatty acid groups, wherein each fatty acid group has from about 8 to about 22 carbon atoms.

Claim 22

A method according to claim 17 wherein the amount of polyester administered is from about 50 milligrams to about 2 grams polyester per kilogram of body weight per day.

Claim 23

A method according to claim 18 wherein the sucrose fatty acid polyester is selected from the group consisting of the hexaoleate, heptaoleate and octaoleate of sucrose, and mixtures thereof.