Solid Dosage Form Containing a Taste Masked Active Agent

Abstract

A solid dosage form containing a taste masked active agent is provided. The solid dosage form may be provided as a water soluble film that is disintegrable in the oral cavity to deliver and release the taste masked active agent. The disintegrable film includes at least one water soluble polymer and a taste masked ketoprofen active. Also provided are methods for preparing the solid dosage form and for using the solid dosage to administer an effective dosage of an active agent, such as ketoprofen, into the oral cavity for absorption.

1 - 33 . (canceled) 
     
     
         34 . An orally disintegrable solid dosage form comprising:
 (a) a pharmacologically effective amount of an active agent; and   (b) an edible alkaline agent or base in an amount effective to increase pH of the active agent;   (c) a pharmaceutically acceptable carrier.   
     
     
         35 . The orally disintegrable solid dosage form of  claim 34 , wherein said orally disintegrable solid dosage form is a disintegrable oral tablet. 
     
     
         36 . The orally disintegrable solid dosage form of  claim 34 , wherein said orally disintegrable solid dosage form is a disintegrable oral film. 
     
     
         37 . The orally disintegrable solid form dosage form of  claim 36 , wherein said disintegrable oral film further comprises: (c) at least one water soluble film forming polymer. 
     
     
         38 . The orally disintegrable solid dosage form of  claim 37 , wherein said (c) water soluble film forming polymer is selected from the group consisting of cellulose, alkyl celluloses, substituted alkyl celluloses, salts of substituted alkyl celluloses, polyalkylene oxides, polyalkylene glycols, synthetically or naturally occurring gums, acrylic acid polymers, acrylic acid copolymers, methacrylic acidpolymers, methacrylic acid copolymers, polyacrylamides, carrageanan, pullunan, polyvinyl pyrrolidone, polyvinyl alcohol, alginic acid, salts of alginic acid, carboxyvinyl polymers and mixtures thereof. 
     
     
         39 . The orally disintegrable solid dosage form of  claim 38 , wherein said water soluble film forming polymer is a substituted alkyl cellulose selected from the group consisting of hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose and mixtures thereof. 
     
     
         40 . The orally disintegrable solid dosage form of  claim 39 , wherein said substituted alkyl cellulose polymers are hydroxypropyl methylcellulose polymers. 
     
     
         41 . The orally disintegrable solid dosage form of  claim 34 , wherein said edible alkaline agent is selected from the group consisting of hydroxides, edible bicarbonates, edible carbonates, phosphate buffers, citrate buffers, alkaline amino acids and mixtures thereof. 
     
     
         42 . The orally disintegrable solid dosage form of  claim 34 , wherein said active agent is a non-steroidal anti-inflammatory drug. 
     
     
         43 . The orally disintegrable solid dosage form of  claim 42 , wherein said non-steroidal anti-inflammatory drug is a propionic acid derivative. 
     
     
         44 . A method for analgesic treatment, the treatment of acute tendinitis, the treatment of bursitis, or any combination thereof, the method comprising administering the orally disintegrable solid dosage form of  claim 42 . 
     
     
         45 . A method of administering an orally disintegrable solid dosage form of  claim 34  comprising: (a) providing the orally disintegrable solid dosage form of  claim 34 ; and (b) introducing said orally disintegrable solid dosage form into the oral cavity. 
     
     
         46 . A method for preparing an orally disintegrable solid dosage form comprising forming a mixture of an edible alkaline agent or base, a pharmacologically effective amount of an active agent, and a pharmaceutically acceptable carrier; and forming an orally disintegrable solid dosage form from the mixture. 
     
     
         47 . The method of preparing the orally disintegrable solid dosage form of  claim 46  comprising:
 (a) preparing a mixture comprising an active and a liquid; 
 (b) increasing the pH of the mixture; 
 (c) mixing the mixture with at least one film forming polymer to form a polymer mixture; and 
 (d) forming an orally disintegrable film from the polymer mixture. 
 
     
     
         48 . The method of preparing the orally disintegrable solid dosage form of  claim 47 , wherein said liquid is water. 
     
     
         49 . The method of preparing the orally disintegrable solid dosage form of  claim 47 , comprising increasing the pH of the mixture with a base or with an edible alkaline agent selected from the group consisting of hydroxides, edible bicarbonates, edible carbonates, phosphate buffers, citrate buffers, alkaline amino acids and mixtures thereof. 
     
     
         50 . The method of preparing the orally disintegrable solid dosage form of  claim 49 , wherein said pH of the mixture is increased to a pH of about 5.5 or greater. 
     
     
         51 . The method of preparing the orally disintegrable solid dosage form of  claim 46 , wherein said orally disintegrable solid dosage form is a disintegrable oral tablet. 
     
     
         52 . The method of preparing the orally disintegrable solid dosage form of  claim 46 , wherein said active agent is a non-steroidal anti-inflammatory drug. 
     
     
         53 . The method of preparing the orally disintegrable solid dosage form of  claim 52 , wherein said non-steroidal anti-inflammatory drug is a propionic acid derivative.