US2006004094A1PendingUtilityA1

Composition and method for treating hemorrhoids and/or anorectal disorders

51
Individually held — no corporate assignee on recordPriority: Jul 2, 2004Filed: Jul 2, 2004Published: Jan 5, 2006
Est. expiryJul 2, 2024(expired)· nominal 20-yr term from priority
Inventors:Gary Robert AgisimRichard John KennyMiron Gerard StillEllen Bland GilliamHelen Elizabeth Taylor
A61K 31/24A61K 31/137A61P 9/14A61P 43/00A61K 31/74
51
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Claims

Abstract

The invention provides an oil-in-water emulsion useful in the treatment of anorectal disorders comprising a local anesthetic, vasoconstrictor, glycerin and water, and method of preparation of the emulsion and a method for treating hemorrhoids using the composition of the invention.

Claims

exact text as granted — not AI-modified
1 . A pharmaceutical composition for treating hemorrhoids and/or anorectal disorders, the pharmaceutical composition comprising: 
 an effective amount of a topical anesthetic, an effective amount of a vasoconstrictor, glycerin and water wherein the pharmaceutical composition is an oil-in-water emulsion and wherein the topical anesthetic and the vasoconstrictor are solubilized in the water portion of the oil-in-water emulsion.    
   
   
       2 . The pharmaceutical composition of  claim 1  wherein the ratio of the glycerin amount by weight to the sum of the glycerin amount and water amount by weight is about 20% to about 45%.  
   
   
       3 . The pharmaceutical composition of  claim 2  wherein the sum of the glycerin amount and water amount is at least 50% w/w of the pharmaceutical composition.  
   
   
       4 . The composition of  claim 1 ,  2  or  3  wherein the vasoconstrictor comprises at least one of phenylephrine hydrochloride, ephedrine sulphate, epinephrine, epinephrine hydrochloride and tetrahydrozoline HCl.  
   
   
       5 . The composition of  claim 1 ,  2  or  3  wherein the anesthetic comprises at least one of benzocaine, benzyl alcohol, dibucaine, dibucaine HCl, pramoxine hydrochloride, tetrocaine, tetracaine HCl, diyclonine, and dyclonine HCl.  
   
   
       6 . The composition of  claim 1  further comprising at least one non-ionic emulsifier.  
   
   
       7 . The composition of  claim 6  wherein the at least one non-ionic emulsifier includes an ethoxylated fatty alcohol that is a solid at room temperature.  
   
   
       8 . The composition of  claim 1  further comprising a pH adjusting compound wherein the pH adjusting compound has buffering capacity and wherein the pH is adjusted to less than about pH 6.  
   
   
       9 . The composition of  claim 1  further comprising about 12% w/w to about 18% w/w of a semisolid oleaginous protectant.  
   
   
       10 . The composition of claims  1  further comprising at least one antioxidant.  
   
   
       11 . A pharmaceutical composition for treating hemorrhoids and/or anorectal disorders in humans, the pharmaceutical composition comprising: 
 pramoxine hydrochloride, phenylephrine hydrochloride, glycerin and water wherein the pharmaceutical composition is an oil-in-water emulsion, wherein the pramoxine hydrochloride and phenylephrine hydrochloride are solubilized in the water portion of the oil-in-water emulsion and wherein the ratio of the glycerin amount by weight to the sum of the glycerin amount and water amount by weight is about 20% to about 45%.    
   
   
       12 . The pharmaceutical composition of  claim 11  wherein the sum of the glycerin amount and water amount is at least 50% w/w of the pharmaceutical composition.  
   
   
       13 . The composition of  claim 11  further comprising at least one non-ionic emulsifier.  
   
   
       14 . The composition of  claim 13  wherein the at least one non-ionic emulsifier includes an ethoxylated fatty alcohol that is a solid at room temperature.  
   
   
       15 . The composition of  claim 11  further comprising a pH adjusting compound wherein the pH adjusting compound has buffering capacity and wherein the pH is adjusted to less than about pH 6.  
   
   
       16 . The composition of  claim 11  further comprising about 12% w/w to about 18% w/w of a semisolid oleaginous protectant.  
   
   
       17 . The composition of  claim 11  further comprising at least one antioxidant.  
   
   
       18 . A pharmaceutical composition for treating hemorrhoids and/or anorectal disorders in humans, the pharmaceutical composition comprising about 0.5% w/w to about 3.0% w/w pramoxine hydrochloride, about 0.1% w/w to about 1.0% w/w phenylephrine hydrochloride, glycerin, water, about 0.1% w/w to about 0.3% w/w sodium benzoate, about 12% w/w to about 18% w/w petrolatum, about 0.2% w/w Tenox™, about 0.5% w/w mixed tocopherols, citric acid, and at least one non-ionic emulsifier wherein the pharmaceutical composition is an oil-in-water emulsion, wherein the pramoxine hydrochloride and phenylephrine hydrochloride are solubilized in the water portion of the oil-in-water emulsion, and wherein the ratio of the glycerin amount by weight to the sum of the glycerin amount and water amount by weight is about 20% to about 45%.  
   
   
       19 . The composition of  claim 18  wherein the sum of the glycerin amount and water amount is at least 50% w/w.  
   
   
       20 . The composition of  claim 18  wherein the amount of citric acid is sufficient to adjust the pH to a pH of about 3.5 to about 4.2.  
   
   
       21 . The composition of  claim 18  wherein at least one non-ionic emulsifier includes an ethoxylated fatty alcohol that is a solid at room temperature.  
   
   
       22 . The composition of  claim 18  further comprising about 0.1% w/w to about 2.0% w/w carboxymethylcellulose and about 0.01% w/w to about 1.0% w/w xanthan gum.  
   
   
       23 . A method of preparing a composition for treating hemorrhoids and/or anorectal disorders in humans comprising combining a topical anesthetic, a vasoconstrictor, glycerin and water in such amounts to form an oil-in-water emulsion wherein the topical anesthetic and the vasoconstrictor are solubilized in the water portion of the oil-in-water emulsion, wherein the ratio of the glycerin amount to the sum of the glycerin amount and the water amount by weight is about 20% to about 45%, and wherein the sum of the glycerin amount and the water amount is at least 50% w/w of the pharmaceutical composition.  
   
   
       24 . A method of treating of hemorrhoids and/or anorectal disorders in humans comprising administering to the anorectal region a safe and effective amount of the pharmaceutical composition of  claim 1 ,  11  or  18 .

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