Solutions for oral dosage

Abstract

Pharmaceutical compositions comprising a vehicle, a solubilizer, and a surfactant are disclosed to be used in conjunction with non-chemotherapeutic active pharmaceutical ingredients which are soluble in water but subject to hydrolysis to some extent. Such non-chemotherapeutic active pharmaceutical ingredients may include amitriptyline, a derivative thereof, or a combination thereof. The pharmaceutical compositions may be administered as an oral solution. Other embodiments are directed towards methods of using and methods of making such formulations.

1 . A pharmaceutical composition in the form of a liquid oral solution comprising amitriptyline or a derivative thereof; a solubilizer; a surfactant; and water. 
     
     
         2 . The pharmaceutical composition of  claim 1 , wherein the non-chemotherapeutic active pharmaceutical ingredient is amitriptyline hydrochloride. 
     
     
         3 . The pharmaceutical composition of  claim 1 , wherein the solubilizer is selected from ethanol, propylene glycol, polyhydric alcohols such as concentrated glycerol, glycerol, polyvinyl alcohol, polyethylene glycol, ethylene glycol, or a combination thereof. 
     
     
         4 . The pharmaceutical composition of  claim 1 , wherein the solubilizer is glycerol. 
     
     
         5 . The pharmaceutical composition of  claim 1 , wherein the surfactant is selected from sorbitan esters, polyethoxylated sorbitan esters, Caprylocaproyl macrogol-8 glycerides, Lauroyl macrogol-32 glycerides, stearoyl macrogol-32 glycerides, polyethoxylated and/or hydroginated castor oil, PEG-40 hydrogenated castor oil, PEG-60 hydrogenated castor oil, PEG-35 castor oil or polyoxyl 35 castor oil, Macrogol (25) cetostearyl ether, polyethoxylated ethers, polyethylene glycol, poloxamer, alpha tocopherol, polyoxyethylene lauryl ether, polyvinyl caprolactam-polyvinylacetate-polyethyleneglycol graft copolymer, PEG-35 castor oil, polyoxyl 35 castor oil, polysorbate 80, or a combination thereof. 
     
     
         6 . The pharmaceutical composition of  claim 1 , wherein the surfactant is polysorbate 80. 
     
     
         7 . The pharmaceutical composition of  claim 1 , wherein the amitriptyline is in an amount of about 1 mg/mL to about 50 mg/mL. 
     
     
         8 . The pharmaceutical composition of  claim 1 , wherein the solubilizer is in an amount of about 0.1% w/v to about 50% w/v. 
     
     
         9 . The pharmaceutical composition of  claim 1 , wherein the surfactant is in an amount of about 0.01% w/v to about 0.5% w/v. 
     
     
         10 . The pharmaceutical composition of  claim 1 , the solubilizer is glycerol, the surfactant is polysorbate 80, and the vehicle is water. 
     
     
         11 . A pharmaceutical composition in liquid solution form comprising a therapeutically effective amount of amitriptyline; about 0.1% w/v to about 50% w/v solubilizer, about 0.01% w/v to about 5% w/v surfactant; and water. 
     
     
         12 . A method of treating a disease or disorder in a subject in need thereof, the method comprising administering a pharmaceutical composition in the form of a liquid oral solution comprising amitriptyline; a solubilizer; a surfactant; and a vehicle. 
     
     
         13 . The method of  claim 12 , wherein the disease or disorder is selected from the group consisting of major depressive disorder, anxiety disorders, attention deficit hyperactivity disorder, bipolar disorder, migraines, nocturnal enuresis, irritable bowel syndrome, neuropathic pain, fibromyalgia, postherpetic neuralgia, insomnia, or a combination thereof.