Dosage Form for Hormonal Contraception

Abstract

A dosage form for hormonal contraception containing a specific number of gestagen-containing daily units A and a specific number of gestagen-containing daily units B for uninterrupted, daily, oral administration of daily units A and then immediately subsequently of daily units B, wherein the daily units A in each case contain at most 200 μg of folic acid and the daily units B contain >200 μg up to the maximum permissible amount of folic acid for women.

What is claimed is: 
     
         1 . A dosage form for hormonal contraception consisting of at least 21 hormone-containing daily units A and of 7 to 3 hormone-containing daily units B, the hormone component of each daily unit A and B, respectively, consists solely of a gestagen, for uninterrupted daily, oral administration of the hormone-containing daily units A, immediately followed by uninterrupted daily, oral administration of the hormone-containing daily units B to women, wherein
 each of the hormone-containing daily units A contains folic acid in a daily amount of 5 μg up to the minimum effective daily amount for women,   each of the hormone-containing daily units B contains folic acid in a daily amount of more than 200 μg up to the maximum permissible amount of folic acid for women, and   both the hormone-containing daily units A and B each have a gestagen content which at least corresponds to the ovulation inhibition dose of the gestagen.   
     
     
         2 . A dosage form according to  claim 1 , wherein each of the hormone-containing daily units B contains more than 200 μg and up to 5 mg of folic acid. 
     
     
         3 . A dosage form according to  claim 1 , wherein each of the hormone-containing daily units A contains the same amount of folic acid, and each of the hormone-containing daily units B likewise contains the same amount of folic acid. 
     
     
         4 . A dosage form according to  claim 1 , wherein the maximum number of hormone-containing daily units A is sufficient for uninterrupted administration for at least one year, and the number of hormone-containing daily units B corresponds to administration for 3 to 7 days. 
     
     
         5 . A dosage form according to  claim 4 , wherein the number of hormone-containing daily units A is sufficient for uninterrupted daily administration for two years. 
     
     
         6 . A dosage form according to  claim 4 , wherein the number of hormone-containing daily units A is sufficient for uninterrupted daily administration for one year. 
     
     
         7 . A dosage form according to  claim 1 , wherein said dosage form comprises 21 to 25 hormone-containing daily units A and 7 to 3 hormone-containing daily units B. 
     
     
         8 . A dosage form according to  claim 1 , wherein said dosage form comprises 42 to 52 hormone-containing daily units A and 7 to 3 hormone-containing daily units B. 
     
     
         9 . A dosage form according to  claim 1 , wherein said dosage form comprises 77 to 193 hormone-containing daily units A and 7 to 3 hormone-containing daily units B. 
     
     
         10 . A dosage form according to  claim 1 , wherein the gestagen content up is up to 150% above the ovulation inhibition dose of the gestagen. 
     
     
         11 . A dosage form according to  claim 1 , wherein both the hormone-containing daily units A and the hormone-containing daily units B each comprise the same amount of gestagen. 
     
     
         12 . A dosage form according to  claim 1 , wherein each of the hormone-containing daily units A and B contains a gestagen selected from the group consisting of norethisterone, norethisterone acetate, norethisterone enantate, norgestimate, norgestrel, levonorgestrel, gestodene, hydroxyprogesterone caproate, medroxyprogesterone acetate, megestrol acetate, lynestrenol, cyproterone acetate, drospirenone, dienogest, desogestrel, progesterone, dydrogesterone, medrogestone, ethynodiol or ethynodiol diacetate, promegestone, nomegestrol acetate, trimegestone, etonogestrel, norelgestromin, norethynodrel and tibolone. 
     
     
         13 . A dosage form according to  claim 12 , wherein each hormone-containing daily unit A or B contains the gestagen in an amount of: 
       
         
           
                 
                 
                 
               
                     
                 
                   0.5 to 2.0 
                   mg 
                   norethisterone, norethisterone acetate; 
                 
                   0.1 to 0.25 
                   mg 
                   norgestimate; 
                 
                   0.3 to 2.0 
                   mg 
                   norgestrel; 
                 
                   0.06 to 0.15 
                   mg 
                   levonorgestrel; 
                 
                   0.03 to 0.12 
                   mg 
                   gestodene; 
                 
                   10 to 800 
                   mg 
                   hydroxyprogesterone caproate; 
                 
                   5.0 to 40 
                   mg 
                   medroxyprogesterone acetate; 
                 
                   1.0 to 10 
                   mg 
                   megestrol acetate; 
                 
                   0.8 to 3 
                   mg 
                   lynestrenol; 
                 
                   1.0 to 10 
                   mg 
                   cyproterone acetate; 
                 
                   1.0 to 10 
                   mg 
                   drospirenone; 
                 
                   1.0 to 10 
                   mg 
                   dienogest; 
                 
                   400 to 2000 
                   mg 
                   progesterone; 
                 
                   5 to 50 
                   mg 
                   dydrogesterone; 
                 
                   0.06 to 0.20 
                   mg 
                   desogestrel; 
                 
                   2 to 30 
                   mg 
                   medrogestone; 
                 
                   0.4 to 3 
                   mg 
                   ethynodiol, ethynodiol diacetate; 
                 
                   0.5 to 10 
                   mg 
                   promegestone; 
                 
                   0.5 to 10 
                   mg 
                   nomegestrol acetate; 
                 
                   0.1 to 10 
                   mg 
                   trimegestone; 
                 
                   0.1 to 2 
                   mg 
                   etonogestrel; 
                 
                   0.1 to 2 
                   mg 
                   norelgestromin; 
                 
                   0.3 to 3 
                   mg 
                   norethynodrel; or 
                 
                   1 to 10 
                   mg 
                   tibolone. 
                 
                     
                 
             
                
               
               
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
                
               
            
           
         
       
     
     
         14 . A dosage form according to  claim 1 , wherein each of the daily units A and B is in the form of a tablet. 
     
     
         15 . A kit containing at least one dosage form for hormonal contraception according to  claim 1 . 
     
     
         16 . A kit according to  claim 15 , wherein the kit contains a plurality of said dosage forms.