Method for administering a spill resistant pharmaceutical system

Abstract

A method for administering a spill-resistant pharmaceutical formulation comprises delivery from a squeezable container of a pharmaceutical agent in a suitable vehicle comprising a liquid base and a thickening agent.

1 . A method for administering a pharmaceutically active agent to a patient in need of the pharmaceutically active agent, comprising the step of administering a therapeutically effective amount of the active agent in a pharmaceutical composition comprising an effective amount of a pharmaceutical agent in a suitable vehicle comprising a liquid base and a thickening agent, the formulation consisting of mutually compatible components and having the following properties: 
 an initial viscosity within the range of about 7,500 to about 12,500 cps using a Brookfield Viscometer with a ‘C’ spindle with Helipath movement at a spindle speed of 20 rpm and 20-25 degrees C.,    a viscometric yield value of a semi-solid    a spill resistant consistency permitting the composition to be squeezed by light manual pressure though a channel of about 1-1.5 mm, to spread in a spoon bowl sufficiently quickly for accurate measurement, and to remain in the spoon bowl without spilling for at least about one second and less than about 20 seconds on spoon tilting at 90 degrees, and for at least about 30 seconds upon spoon vibration at a frequency of about 120/minute,    homogeneity such that the components do not separate under conditions of use, and    a storage stability such that the foregoing properties are retained for at least three months of storage at elevated temperature, with viscosity remaining within a range of 50% less to 100% more than the initial viscosity,    wherein said thickening agent comprises components selected from the group consisting of cellulose derivatives in an amount of less than about 2 weight % by volume, and water-soluble carboxyvinyl polymer in an amount less than 1 weight % by volume.    
     
     
         2 . The method of  claim 1  wherein the composition has a viscosity between about 7,500 and about 25,000 cps after storage for three months at a temperature of 40 degrees C. and 75% humidity.  
     
     
         3 . The method of  claim 1  wherein the composition has an initial viscosity of between about 7500 and about 12,500 cps after storage.  
     
     
         4 . The method of  claim 1  wherein the thickening agent is from about 0.25 to less than 1 weight % water-soluble carboxyvinyl polymer.  
     
     
         5 . The method of  claim 1  wherein the liquid base comprises glycerin and sorbitol.  
     
     
         6 . The method of  claim 1  wherein the thickening agent comprises water-soluble carboxyvinyl polymer in an amount of from about 0.25 to about 1.0 weight % by volume.  
     
     
         7 . The method of  claim 1  having a spill-resistant consistency permitting the composition to remain in the spoon bowl without spilling for from about 1 second to about 4 seconds on spoon inversion and on spoon tilting at 90 degrees.  
     
     
         8 . The method of  claim 1  wherein the pharmaceutical agent is selected from the group consisting of an analgesic, non-steroidal anti-inflammatory, antihistamine, cough suppressant, expectorant, bronchodilator, anti-infective, CNS active drug, cardiovascular drug, antineoplastic, cholesterol-lowering drug, anti-emetic, vitamin, mineral supplement and fecal softener.  
     
     
         9 . The method of  claim 1  wherein the pharmaceutical agent is selected from the group consisting of acetaminophen, aspirin, ibuprofen, diphenhydramine, dextromethorphan, guafenesin, pseudoephedrine, carbidopa, levodopa, terfenadine, ranitidine, ciprofloxacin, triazolam, fluconazole, propranolol, acyclovir, fluoxetine, enalapril, diltiazem, lovastatin and a pharmaceutically acceptable salt or ester thereof.  
     
     
         10 . The method of  claim 1  wherein the storage stability extrapolates to at least two years shelf life at room temperature.  
     
     
         11 . The method of  claim 1  wherein the patient is dexterity-impaired.  
     
     
         12 . The method of  claim 1  wherein the patient is selected from the group consisting of young children, the infirm, and elderly adults with motor disabilities.  
     
     
         13 . The method of  claim 1  wherein the patients have tremors.