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Claims for Patent: 4,464,394

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Claims for Patent: 4,464,394

Title: Compositions and methods for using 13-cis vitamin A acid compounds
Abstract:Methods for the prophylaxis of certain premalignant conditions and epithelial carcinomas comprising systemically administrating 13-cis vitamin A acid and a suitable pharmaceutical carrier material are described and compositions containing 13-cis Vitamin A acid suitable for systemic administration are disclosed.
Inventor(s): Bollag; Werner (Basel, CH)
Assignee: Hoffmann LaRoche Inc. (Nutley, NJ)
Application Number:06/283,585
Patent Claims: 1. A method of prophylaxis against the development of epithelial carcinomas of the skin, gastrointestinal tract, respiratory tract or genito-urinary tract which comprises enterally administering to persons susceptible to such carcinomas a composition comprising a medicinally inert, pharmaceutically acceptable carrier material and 13-cis vitamin A acid or a pharmaceutically acceptable salt thereof, said composition being administered in an amount sufficient to provide from about 0.05 mg to about 3.0 mg of 13-cis vitamin A acid or its pharmaceutically acceptable salt per kg of body weight per day.

2. A method in accordance with claim 1 wherein said composition additionally contains an antioxidant selected from the group consisting of alpha-tocopherol, N-methyl-.gamma.-tocopherolamine, butylated hydroxyanisole, butylated hydroxytoluene, ethoxyquin and mixtures thereof.

3. The method in accordance with claim 1 wherein the daily amount of 13-cis vitamin A acid administered is from 0.1 mg. to about 1.0 mg. per kilogram of body weight of said person.

4. A method in accordance with claim 1 wherein said composition is administered in the form of pharmaceutical unit dosage, each unit dosage containing from about 5.0 mg. to about 50.0 mg. of 13-cis vitamin A acid or its pharmaceutically acceptable salt.

5. A method in accordance with claim 1 wherein said pharmaceutically acceptable salt is the sodium salt.

6. A method in accordance with claim 1 wherein said carcinomas are those of the skin, bronchi, gastrointestinal tract, genitalia or oral cavity.

7. A method in accordance with claim 6 wherein said composition is administered in the form of pharmaceutical unit dosage, each unit dosage containing from about 5.0 mg. to about 50.0 mg. of 13-cis vitamin A acid or its pharmaceutically acceptable salt.

8. A method in accordance with claim 6 wherein said composition is administered to patients afflicted with a premalignant condition characterized by a propensity to mature into one of said carcinomas.

9. A method in accordance with claim 8 wherein said premalignant condition is bronchogenic disease.

10. A composition in unit dosage form for enteral administration comprising as an active ingredient 13-cis Vitamin A acid or pharmaceutically acceptable salts thereof and a pharmaceutically acceptable carrier suitable for enteral administration, said active ingredient being present in said composition in an amount of from about 5 mg to about 50 mg.

11. The composition of claim 10 wherein said carrier is vegetable oil.

12. The composition of claim 10 wherein said unit dosage form is a tablet, capsule or dragee.

13. The composition of claim 12 wherein said unit dosage form is a capsule.
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