Minocycline oral dosage forms for the treatment of acne

Abstract

Minocycline oral dosage forms containing a controlled release carrier are useful for the treatment of acne.

What is claimed is: 
     
         1 . A method of treating acne, comprising administering an oral dosage form to a subject in need thereof, wherein said oral dosage form comprises:
 minocycline or a pharmaceutically acceptable salt thereof; and   an amount of a controlled-release carrier composition that is effective to render said oral dosage form pharmacokinetically distinct from MINOCIN® immediate-release minocycline hydrochloride.   
     
     
         2 . The method of  claim 1 , comprising administering the oral dosage form to the subject at a minocycline free base equivalent dosage in the range of about 0.75 mg/kg to about 1.5 mg/kg. 
     
     
         3 . The method of  claim 1 , comprising administering the oral dosage form to the subject on a once-daily basis. 
     
     
         4 . The method of  claim 1 , further comprising reducing at least one adverse side effect as compared to that expected from administering the MINOCIN® immediate-release minocycline hydrochloride. 
     
     
         5 . The method of  claim 4 , wherein reducing at least one adverse side effect comprises reducing the likelihood of experiencing said adverse side effect. 
     
     
         6 . The method of  claim 4 , wherein reducing at least one adverse side effect comprises reducing the magnitude of said adverse side effect. 
     
     
         7 . The method of  claim 4 , wherein reducing at least one adverse side effect comprises reducing the duration of said adverse side effect. 
     
     
         8 . The method of  claim 1 , further comprising informing the subject that the oral dosage form may cause an adverse effect. 
     
     
         9 . The method of  claim 8 , wherein the adverse effect is selected from ear and labyrinth disorders, eye disorders, gastrointestinal disorders, immune system disorders, infections and infestations, laboratory blood abnormalities, metabolism and nutritional disorders, musculoskeletal and connective disorders, nervous system disorders, psychiatric disorders, renal and urinary disorders, reproductive system and breast disorders, respiratory, thoracic and mediastinal disorders, skin and subcutaneous tissue disorders, vascular disorders, pseudomembranous colitis, hepatotoxicity, vasculitis, tissue hyperpigmentation, and anaphylaxis. 
     
     
         10 . The method of  claim 8 , wherein the adverse effect is selected from gastrointestinal disorders, blurred vision, autoimmune syndromes, and adverse renal reactions. 
     
     
         11 . The oral dosage form of  claim 1 , wherein said minocycline salt is minocycline hydrochloride. 
     
     
         12 . The method of  claim 11 , comprising administering the oral dosage form to the subject at a minocycline free base equivalent dosage in the range of about 0.75 mg/kg to about 1.5 mg/kg. 
     
     
         13 . The method of  claim 11 , comprising administering the oral dosage form to the subject on a once-daily basis. 
     
     
         14 . The method of  claim 11 , further comprising reducing at least one adverse side effect as compared to that expected from administering the MINOCIN® immediate-release minocycline hydrochloride. 
     
     
         15 . The method of  claim 14 , wherein reducing at least one adverse side effect comprises reducing the likelihood of experiencing said adverse side effect. 
     
     
         16 . The method of  claim 14 , wherein reducing at least one adverse side effect comprises reducing the magnitude of said adverse side effect. 
     
     
         17 . The method of  claim 14 , wherein reducing at least one adverse side effect comprises reducing the duration of said adverse side effect. 
     
     
         18 . The method of  claim 11 , further comprising informing the subject that the oral dosage form may cause an adverse effect. 
     
     
         19 . The method of  claim 18 , wherein the adverse effect is selected from ear and labyrinth disorders, eye disorders, gastrointestinal disorders, immune system disorders, infections and infestations, laboratory blood abnormalities, metabolism and nutritional disorders, musculoskeletal and connective disorders, nervous system disorders, psychiatric disorders, renal and urinary disorders, reproductive system and breast disorders, respiratory, thoracic and mediastinal disorders, skin and subcutaneous tissue disorders, vascular disorders, pseudomembranous colitis, hepatotoxicity, vasculitis, tissue hyperpigmentation, and anaphylaxis. 
     
     
         20 . The method of  claim 18 , wherein the adverse effect is selected from gastrointestinal disorders, blurred vision, autoimmune syndromes, and adverse renal reactions.