Rapid-melt compositions, methods of making same and method of using same

Abstract

A novel rapid-melt composition, including methods of making the same, and methods of using the same for the delivery of prophylactic and therapeutic active materials to a mammal. The rapid-melt compositions are formed by molding or compression, with an additional heating step being preferred.

1 . A rapid melt composition comprising: at least one binder in an amount from about 0.01% to about 70% by weight; a salivating agent in an amount from about 0.05% to about 15% by weight; a diluent/bulking material in an amount from about 10% to about 90% by weight; a lubricant in an amount from about 0.1% to about 5%; and a therapeutically effective amount of a drug, wherein the composition is prepared in the absence of added water; and wherein said drug is selected from the group consisting of: encapsulated glucosamine, chondroitin, encapsulated phenylephrine, encapsulated acetaminophen, encapsulated vitamin C, encapsulated guaifenesin, encapsulated aspirin, calcium carbonate, magnesium hydroxide, or a mixture thereof.  
   
   
       2 . The composition of  claim 1 , wherein the said drug is encapsulated glucosamine HCl and is present at an amount of about 500 mg to 3000 mg.  
   
   
       3 . The composition of  claim 2 , wherein said drug is a combination of glucosamine HCl and chondroitin sulfate, and are present at an amount of about 500 mg to 1500 mg and about 400 mg to 1200 mg, respectively.  
   
   
       4 . The composition of  claim 1 , wherein said drug is acetaminophen and is present at an amount of about 80 mg to about 1000 mg.  
   
   
       5 . The composition of  claim 4 , wherein said composition further comprises phenylephrine HCl, wherein acetaminophen is present at an amount of about 325 mg to about 650 mg and phenylephrine HCl is present at an amount of about 5 mg to 10 mg.  
   
   
       6 . The composition of  claim 1 , wherein said drug is vitamin C, and is present at an amount of about 15 mg to 3000 mg.  
   
   
       7 . The composition of  claim 1 , wherein said drug is guaifenesin, and is present at an amount of about 50 to 600 mg.  
   
   
       8 . The composition of  claim 1 , wherein said drug is aspirin and is present at an amount of about 80 mg.  
   
   
       9 . The composition of  claim 1 , wherein said drug is calcium carbonate and is present at an amount of about 750 mg to 1250 mg.  
   
   
       10 . The composition of  claim 9 , wherein said composition further comprises magnesium hydroxide at an amount of about 150 mg to 400 mg.  
   
   
       11 . The composition of  claim 1 , wherein said drug is phenylephrine HCl and is present at an amount of about 10 mg.  
   
   
       12 . The composition of  claim 7 , wherein said guaifenesin composition is initially formulated into beads, which are optionally compressed into a tablet or caplet.