GELATIN CHALLENGES CONTAINING A HIGH DOSE ACETAMINOPHESION SOLUTION

摘要

A method is disclosed for increasing the solubility of acetaminophen alone or in combination with antihistamines, antitussives, decongestants, and expectorants to form a clear solution for encapsulation into a softgel. The acetaminophen is solubilized alone or in combination with the above ingredients by mixing with polyethylene glycol, propylene glycol, water, polyvinylpyrrolidone and potassium (or sodium) acetate. This invention increases the solubility of the acetaminophen to obtain the same size softgel for a 325 mg dose as is presently available for a 250 mg dose softgel product. The disclosed solvent system is useful because it provides for a highly concentrated solution of acetaminophen capable of encapsulation in a small enough capsule to permit easy swallowing.