US2007077300A1PendingUtilityA1

Oral compositions containing a salivation inducing agent

49
Individually held — no corporate assignee on recordPriority: Sep 30, 2005Filed: Sep 30, 2005Published: Apr 5, 2007
Est. expirySep 30, 2025(expired)· nominal 20-yr term from priority
Inventors:David WynnRonni L. Robinson
A61P 29/00A61K 9/7007A61K 9/0056A61K 36/28A61K 9/282A61K 9/2886A61K 31/4178A61K 9/5078A61K 31/167A61K 9/2068A61K 9/2081A61K 31/4747
49
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Claims

Abstract

Oral dosage forms, and particles used therein, containing salivation inducing agents are disclosed. The salivation agents may be in the core of the dosage form and/or in coatings applied thereto, or alternatively may be within particles and/or the matrix of such dosage forms, in coatings applied to such particles, or on the surface of such coated particles. The particles may be produced into a tablet form, such as a chewable tablet form, that provides for the immediate release of the active ingredient. Other oral dosage forms include thin film strips, gummi, foam tabs, and lozenges.

Claims

exact text as granted — not AI-modified
1 . An oral dosage form comprised of: 
 a) a core; and    b) a coating substantially covering the core,    wherein the coating contains, based upon the total dry weight of the dosage form, from about 0.1 percent to about 10 percent of at least one salivation inducing agent.    
   
   
       2 . The oral dosage form of  claim 1 , wherein the salivation inducing agent is selected from the group consisting of tasteless muscarinic acetylcholine receptor agonists; N,N-disubstituted phenylalkylamines wherein the alkyl has from about 1 to about 8 carbons; spirooxathiolane-quinuclidine; Heliopsis longpipes root; cholinesterase inhibitors; and mixtures thereof.  
   
   
       3 . The oral dosage form of  claim 1 , wherein the salivation inducing agent is selected from the group consisting of pilocarpine; N,N-disubstituted-2-phenylcyclopropylamines; spirooxathiolane-quinuclidine; Heliopsis longpipes root; cholinesterase inhibitors; and mixtures thereof.  
   
   
       4 . The oral dosage form of  claim 1  wherein the salivation inducing agent has a salivation-inducing value of at least about 12%.  
   
   
       5 . The oral dosage form of  claim 1 , wherein the active ingredient is a nonsteroidal anti-inflammatory drug, acetaminophen, pseudoephedrine, phenylpropanolamine, chlorpheniramine, dextromethorphan, diphenhydramine, dimenhydrinate, meclizine, famotidine, loperamide, ranitidine, cimetidine, astemizole, loratadine, desloratadine, fexofenadine, cetirizine, antacids, oxybutynin, methylphenidate, pharmaceutically acceptable salts thereof, metabolites thereof, and mixtures thereof.  
   
   
       6 . The oral dosage form of  claim 1  which meets the USP dissolution specification for immediate release tablets containing the particular active ingredient.  
   
   
       7 . A particle comprising, based upon the total dry weight of the particle: 
 a) a core containing an active ingredient; and    b) a texture masking coating layer substantially covering the core, and    c) from about 0.1% to about 25% of a salivation inducing agent layer substantially covering the texture masking coating layer.    
   
   
       8 . The particle of  claim 7 , wherein the salivation inducing agent is selected from the group consisting of tasteless muscarinic acetylcholine receptor agonists; N,N-disubstituted phenylalkylamines wherein the alkyl has from about 1 to about 8 carbons; spirooxathiolane-quinnuclidine; Heliopsis longpipes root; cholinesterase inhibitors; and mixtures thereof.  
   
   
       9 . The particle of  claim 8 , wherein the salivation inducing agent is pilocarpine; N,N-disubstituted-2-phenylcyclopropylamines; spirooxathiolane-quinuclidine; Heliopsis longpipes root; cholinesterase inhibitors; and mixtures thereof.  
   
   
       10 . The particle of  claim 7  wherein the salivation inducing agent has a salivation-inducing value of at least about 12%.  
   
   
       11 . The particle of  claim 7 , wherein the active ingredient is a nonsteroidal anti-inflammatory drug, acetaminophen, pseudoephedrine, phenylpropanolamine, chlorpheniramine, dextromethorphan, diphenhydramine, dimenhydrinate, meclizine, famotidine, loperamide, ranitidine, cimetidine, astemizole, loratadine, desloratadine, fexofenadine, cetirizine, antacids, oxybutynin, methylphenidate, pharmaceutically acceptable salts thereof, metabolites thereof, and mixtures thereof.  
   
   
       12 . The particle of  claim 7 , wherein the particle meets the USP dissolution specification for immediate release tablets containing the particular active ingredient.  
   
   
       13 . A chewable tablet comprised of the particles of  claim 7 .  
   
   
       14 . An oral dosage form comprised of, based upon the total dry weight of the dosage form, from about 0.1% to about 10% of a salivation inducing agent, wherein the dosage form is selected from the group consisting of a chewable tablet, thin film strip, foam tab, and gummi.  
   
   
       15 . The oral dosage form of  claim 14 , wherein the salivation inducing agent is selected from the group consisting of tasteless muscarinic acetylcholine receptor agonists; N,N-disubstituted phenylalkylamines wherein the alkyl has from about 1 to about 8 carbons; spirooxathiolane-quinnuclidine; Heliopsis longpipes root; cholinesterase inhibitors; and mixtures thereof.  
   
   
       16 . The oral dosage form of  claim 15 , wherein the salivation inducing agent is selected from the group consisting of pilocarpine; N,N-disubstituted-2-phenylcyclopropylamines; spirooxathiolane-quinuclidine; Heliopsis longpipes root; cholinesterase inhibitors; and mixtures thereof.  
   
   
       17 . The oral dosage form of  claim 14  wherein the salivation inducing agent has a salivation-inducing value of at least about 12%.  
   
   
       18 . The oral dosage form of  claim 14 , wherein the active ingredient is a nonsteroidal anti-inflammatory drug, acetaminophen, pseudoephedrine, phenylpropanolamine, chlorpheniramine, dextromethorphan, diphenhydramine, dimenhydrinate, meclizine, famotidine, loperamide, ranitidine, cimetidine, astemizole, loratadine, desloratadine, fexofenadine, cetirizine, antacids, oxybutynin, methylphenidate, pharmaceutically acceptable salts thereof, metabolites thereof, and mixtures thereof.  
   
   
       19 . The oral dosage form of  claim 14 , wherein the dosage form meets the USP dissolution specification for immediate release tablets containing the particular active ingredient.  
   
   
       20 . A particle comprising, based upon the total dry weight of the particle: 
 a) a core containing an active ingredient; and    b) a coating substantially covering the core, said coating comprised of from about 0.1% to about 25% of a salivation inducing agent.    
   
   
       21 . The particle of  claim 20 , wherein the salivation inducing agent is selected from the group consisting of tasteless muscarinic acetylcholine receptor agonists; N,N-disubstituted phenylalkylamines wherein the alkyl has from about 1 to about 8 carbons; spirooxathiolane-quinnuclidine; Heliopsis longpipes root; cholinesterase inhibitors; and mixtures thereof.  
   
   
       22 . The particle of  claim 21 , wherein the salivation inducing agent is selected from the group consisting of pilocarpine; N,N-disubstituted-2-phenylcyclopropylamines; spirooxathiolane-quinuclidine; Heliopsis longpipes root; cholinesterase inhibitors; and mixtures thereof.  
   
   
       23 . The particle of  claim 20 , wherein the active ingredient is a nonsteroidal anti-inflammatory drug, acetaminophen, pseudoephedrine, phenylpropanolamine, chlorpheniramine, dextromethorphan, diphenhydramine, dimenhydrinate, meclizine, famotidine, loperamide, ranitidine, cimetidine, astemizole, loratadine, desloratadine, fexofenadine, cetirizine, antacids, oxybutynin, methylphenidate, pharmaceutically acceptable salts thereof, metabolites thereof, and mixtures thereof.  
   
   
       24 . A chewable tablet comprised of the particles of  claim 20.

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