Once Daily Formulations Of Tetracyclines

Abstract

Disclosed are once-daily formulations containing tetracyclines, especially doxycycline. Such formulations are useful, for instance, for the treatment of collagenase destructive enzyme-dependent diseases, such as periodontal disease and acne, and acute and chronic inflammatory disease states, such as rosacea and arthritis.

1 . An oral pharmaceutical composition containing a tetracycline, which at a once-daily dosage will give steady state blood levels of the tetracycline of a minimum of about 0.1 μg/ml and a maximum of about 1.0 μg/ml. 
     
     
         2 . The composition of  claim 1 , which at a once-daily dosage will give steady state blood levels of the tetracycline of between about 0.3 μg/ml to about 0.8 μg/ml. 
     
     
         3 . The composition of  claim 1 , wherein the tetracycline is doxycycline. 
     
     
         4 - 7 . (canceled) 
     
     
         8 . The composition of  claim 1 , which is a combination of a component containing a tetracycline in an immediate release (IR) formulation and a second component containing a tetracycline in a delayed release (DR) formulation, wherein the ratio of IR to DR is from about 99:1 to about 70:30. 
     
     
         9 . The composition of  claim 8 , wherein the tetracycline is doxycycline. 
     
     
         10 . The composition of  claim 9 , wherein the ratio of immediate release component to delayed release component is from about 80:20 to about 70:30. 
     
     
         11 . The composition of  claim 9 , wherein the ratio of immediate release component to delayed release component is 75:25. 
     
     
         12 - 17 . (canceled) 
     
     
         18 . An oral pharmaceutical dosage form containing between 25 and 50 mg. of a tetracycline. 
     
     
         19 . The dosage form of  claim 18 , wherein the tetracycline is doxycycline. 
     
     
         20 . The dosage form of  claim 19 , which contains about 40 mg. of doxycycline. 
     
     
         21 . The dosage form of  claim 18 , which is in an immediate release formulation. 
     
     
         22 . The dosage form of  claim 18 , which is a granule, tablet, pellet, powder, sachet, capsule, gel, dispersion or suspension. 
     
     
         23 - 24 . (canceled) 
     
     
         25 . The dosage form of  claim 19 , wherein a portion thereof is of a delayed release formulation, and another portion is of an immediate release formulation. 
     
     
         26 . A method for treating a collagenase dependent disease or condition, and/or acute or chronic inflammatory condition in a mammal, comprising administering a daily dose of a tetracycline composition according to  claim 1  to the mammal, for at least a time sufficient to ameliorate the disease or condition. 
     
     
         27 . The method of  claim 26 , wherein the mammal is a human. 
     
     
         28 . The method of  claim 26 , wherein the disease or condition is selected from periodontal disease, rosacea, acne, dry eye, rheumatoid arthritis, hyperparathyroidism, and diabetes. 
     
     
         29 . The method of  claim 28 , wherein the disease is periodontal disease. 
     
     
         30 . (canceled) 
     
     
         31 . The method of  claim 28 , wherein the condition is rosacea. 
     
     
         32 . (canceled) 
     
     
         33 . The method of  claim 28 , wherein the condition is dry eye. 
     
     
         34 - 48 . (canceled)