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 pharmaceutical formulation for oral administration, comprising a pharmaceutical agent in a vehicle comprising a liquid base and a thickening agent, the formulation consisting of mutually compatible components, 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, and wherein the formulation exhibits spill-resistant characteristics. 
   
   
       2 . The pharmaceutical formulation of  claim 1 , wherein the formulation exhibits an initial viscosity within the range of about 2,500 cps to about 75,000 cps. 
   
   
       3 . The pharmaceutical formulation of  claim 2 , wherein the formulation exhibits the following characteristics:
 a viscometric yield value of a semi-solid;   a spill resistant consistency permitting the formulation to be squeezed by light manual pressure through a channel of about 1 to about 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, and for at least about 30 seconds upon spoon vibration;   homogeneity wherein the components do not separate under conditions of use; and   storage stability.   
   
   
       4 . The pharmaceutical formulation of  claim 1 , wherein the liquid base comprises components selected from the group consisting of polyethylene glycol, propylene glycol, glycerin, sorbitol, water and combinations. 
   
   
       5 . The pharmaceutical formulation of  claim 1 , wherein the water-soluble carboxyvinyl polymer is carbomer. 
   
   
       6 . The pharmaceutical formulation of  claim 5 , wherein the carbomer is Carbopol 974. 
   
   
       7 . The pharmaceutical formulation 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. 
   
   
       8 . The pharmaceutical formulation of  claim 7 , wherein the pharmaceutical agent is acetaminophen or a pharmaceutically acceptable salt or ester thereof. 
   
   
       9 . The pharmaceutical formulation of  claim 8 , wherein the carboxyvinyl polymer is carbomer and the liquid base comprises polyethylene glycol. 
   
   
       10 . The pharmaceutical formulation of  claim 7 , wherein the pharmaceutical agent is ibuprofen or a pharmaceutically acceptable salt or ester thereof. 
   
   
       11 . The pharmaceutical formulation of  claim 7 , wherein the pharmaceutical agent is diphenhydramine or a pharmaceutically acceptable salt or ester thereof. 
   
   
       12 . The pharmaceutical formulation of  claim 11 , wherein the carboxyvinyl polymer is carbomer and the liquid base comprises polyethylene glycol. 
   
   
       13 . The pharmaceutical formulation of  claim 1 , wherein the liquid base comprises from about 30% to about 50% (w/w) glycerin. 
   
   
       14 . A pharmaceutical formulation for oral administration, comprising a pharmaceutical agent in a vehicle comprising a liquid base and a thickening agent, the formulation consisting of mutually compatible components, 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, the formulation having the following properties:
 an initial viscosity within the range of about 2,500 cps to about 75,000 cps;   a viscometric yield value of a semi-solid;   a spill resistant consistency permitting the formulation to be squeezed by light manual pressure through a channel of about 1 to about 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, and for at least about 30 seconds upon spoon vibration;   homogeneity wherein the components do not separate under conditions of use; and   storage stability.   
   
   
       15 . The pharmaceutical formulation of  claim 14 , wherein the liquid base comprises components selected from the group consisting of polyethylene glycol, propylene glycol, glycerin, sorbitol, water and combinations. 
   
   
       16 . The pharmaceutical formulation of  claim 14 , wherein the water-soluble carboxyvinyl polymer is carbomer. 
   
   
       17 . The pharmaceutical formulation of  claim 14 , 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. 
   
   
       18 . The pharmaceutical formulation of  claim 17 , wherein the pharmaceutical agent is acetaminophen or a pharmaceutically acceptable salt or ester thereof. 
   
   
       19 . The pharmaceutical formulation of  claim 18 , wherein the carboxyvinyl polymer is carbomer and the liquid base comprises polyethylene glycol. 
   
   
       20 . The pharmaceutical formulation of  claim 17 , wherein the pharmaceutical agent is ibuprofen or a pharmaceutically acceptable salt or ester thereof. 
   
   
       21 . The pharmaceutical formulation of  claim 17 , wherein the pharmaceutical agent is diphenhydramine or a pharmaceutically acceptable salt or ester thereof. 
   
   
       22 . The pharmaceutical formulation of  claim 21 , wherein the carboxyvinyl polymer is carbomer and the liquid base comprises polyethylene glycol. 
   
   
       23 . A spill-resistant pharmaceutical formulation for oral administration, comprising an effective amount of a pharmaceutical agent in a suitable vehicle comprising a liquid base comprising from about 30% to about 50% glycerin, and a thickening agent, the formulation consisting of mutually compatible components and having the following properties:
 an initially viscosity within the range of about 2,500 to about 75,000 cps using a Brookfield Viscometer with a ‘C’ spindle with Helipath movement at a spindle speed of 20 rpm and 20-25° C.,   a viscometric yield value of a semi-solid,   a spill resistant consistency permitting the formulation to be squeezed by light manual pressure through a channel of about 1 to about 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, and for at least about 30 seconds upon spoon vibration;   homogeneity wherein the components do not separate under conditions of use; and   storage stability.   
   
   
       24 . The pharmaceutical formulation of  claim 23 , wherein said thickening agent comprises components selected from the group consisting of cellulose derivatives in an amount of from about 0.9 to 2.5 weight %, and water-soluble carboxyvinyl polymer in an amount less than 1 weight % by volume. 
   
   
       25 . The pharmaceutical formulation of  claim 23 , comprising cellulose derivatives in an amount less than 2 weight %.