Pharmaceutical combined preparation and its use in the treatment of gynaecological disorders

Abstract

The invention relates to a pharmaceutical combined preparation of LHRH analogues and anti-oestrogens having tissue-selective oestrogen activity and also to its use for the treatment of gynaecological disorders, especially for the treatment of endometrioses and myomas.

1 . Pharmaceutical combined preparation comprising two active ingredients one of which is an LHRH analogue or a combination of LHRH analogues and the other of which is an anti-oestrogen having tissue-selective oestrogenic activity.  
     
     
         2 . Combined preparation according to  claim 1 , characterised in that the LHRH analogue is an LHRH agonist or an LHRH antagonist.  
     
     
         3 . Combined preparation according to  claim 1  or  2 , characterised in that the LHRH analogue is selected from the group of compounds Leuprorelin, Cetrorelix, Buserelin, Antide, Ac-D-Nal-D-Cpa-D-Pal-Ser-Tyr-D-Cit-Leu-Lys(Mor)-D-Ala-NH 2 , Ramorelix, Zoladex and derivatives thereof.  
     
     
         4 . Combined preparation according to any one of  claims 1  to  3 , characterised in that the LHRH analogue or the combination of LHRH analogues is orally bioavailable.  
     
     
         5 . Combined preparation according to any one of  claims 1  to  4 , characterised in that the LHRH analogue is a non-peptidergic LHRH agonist or antagonist.  
     
     
         6 . Combined preparation according to any one of  claims 1  to  5 , characterised in that the anti-oestrogen is selected from the group of compounds Raloxifen, Droloxifen, Centchroman and derivatives thereof.  
     
     
         7 . Combined preparation according to any one of  claims 1  to  6 , characterised in that the anti-oestrogen is of the Raloxifen type.  
     
     
         8 . Combined preparation according to any one of  claims 1  to  7 , characterised in that the two active ingredients are in separate forms of administration.  
     
     
         9 . Combined preparation according to any one of  claims 1  to  7 , characterised in that the two active ingredients are in joint forms of administration.  
     
     
         10 . Process for the manufacture of a pharmaceutical combined preparation, characterised in that an LHRH analogue or a combination of LHRH analogues and an anti-oestrogen having tissue-selective activity are formulated with customary pharmaceutical carriers, excipients and/or additives, separately from one another or together.  
     
     
         11 . Process according to  claim 10 , characterised in that the LHRH analogue or the combination of LHRH analogues and the anti-oestrogen having tissue-selective activity are formulated separately from one another.  
     
     
         12 . Process according to  claim 10 , characterised in that the LHRH analogue or the combination of LHRH analogues and the anti-oestrogen having tissue-selective activity are formulated together.  
     
     
         13 . The use of an LHRH analogue or a combination of LHRH analogues, and of an anti-oestrogen having tissue-selective oestrogenic activity, for the treatment of gynaecological disorders, especially for the treatment of endometrioses and myomas.  
     
     
         14 . Use according to  claim 13 , characterised in that LHRH analogue and anti-oestrogen are administered simultaneously and/or in chronological sequence.  
     
     
         15 . Packaging unit comprising two spatially separately packaged active ingredients, one of which is an LHRH analogue or a combination of LHRH analogues and the other of which is an anti-oestrogen having tissue-selective oestrogenic activity, and comprising as third component an information leaflet on the simultaneous and/or chronologically sequential administration of the forms of administration.