Orodispersible formulations

Abstract

An orodispersible formulation for contraception or hormone replacement therapy containing an estrogen and a progestogen that has sufficient hardness, disintegration time and friability.

What is claimed is: 
     
         1 . A method of oral contraception for a female in need thereof, the method comprising administering to the female an orodispersible solid dosage form comprising ethinyl estradiol, wherein the orodispersible solid dosage form is placed in an oral mucosa and/or on a tongue of the female, and wherein the orodispersible solid dosage form disintegrates in about 30 seconds or less. 
     
     
         2 . The method of  claim 1 , wherein the orodispersible solid dosage form is administered sublingually, buccally, or sublabially. 
     
     
         3 . The method of  claim 1 , wherein the orodispersible solid dosage form is placed on the tongue. 
     
     
         4 . The method of  claim 1 , wherein the orodispersible solid dosage form is administered without water and comes into contact with saliva. 
     
     
         5 . The method of  claim 1 , wherein the orodispersible solid dosage form is administered with water and comes into contact with saliva. 
     
     
         6 . The method of  claim 1 , wherein the orodispersible solid dosage form is not chewed. 
     
     
         7 . The method of  claim 1 , wherein bioavailability of the ethinyl estradiol in the female is increased compared to that from swallowing and/or chewing the orodispersible solid dosage form. 
     
     
         8 . The method of  claim 1 , wherein the administering is performed daily. 
     
     
         9 . The method of  claim 1 , wherein the administering is performed once daily. 
     
     
         10 . The method of  claim 1 , wherein an ethinyl estradiol content in the orodispersible solid dosage form is 0.075% w/w or less of the orodispersible solid dosage form. 
     
     
         11 . The method of  claim 1 , wherein the orodispersible solid dosage form comprises about 2.5 mcg to about 50 mcg of the ethinyl estradiol. 
     
     
         12 . The method of  claim 1 , wherein the orodispersible solid dosage form comprises about 2 mcg to less than about 5 mcg of the ethinyl estradiol. 
     
     
         13 . The method of  claim 1 , wherein the orodispersible solid dosage form is about 70 mg to about 90 mg. 
     
     
         14 . The method of  claim 1 , wherein the orodispersible solid dosage form is capable of being dispensed via a blister pack.