Soft Chewable Pharmaceutical Products

Abstract

A soft chewable pharmaceutical product for delivery of a pharmaceutically acceptable active ingredient to an animal comprising pamoic acid or a pharmaceutically acceptable salt and a process for the manufacture of such soft chewable pharmaceutical product.

What is claimed is: 
     
         1 . A soft chewable veterinary pharmaceutical product comprising as ingredients,
 pamoic acid or a pharmaceutically acceptable salt thereof, provided that such pamoic acid or pharmaceutically acceptable salt thereof is not an active pharmaceutical ingredient,   one or more active pharmaceutical ingredient,   a liquid component,   a forming agent, and   optionally one or more excipients.   
     
     
         2 . The product according to  claim 1  wherein the product comprises sodium pamoate. 
     
     
         3 . The product according to anyone of  claims 1  to  4  wherein the amount of pamoic acid or the pharmaceutically acceptable salt thereof is between 1.5 and 30% w/w. 
     
     
         4 . The product according to  claim 3  wherein the amount of pamoic acid or the pharmaceutically acceptable salt thereof is between 2 and 5% w/w. 
     
     
         5 . A soft chewable veterinary pharmaceutical product comprising as ingredients,
 a pamoate salt of an active pharmaceutical ingredient, provided that such active pharmaceutical ingredient is not pyrantel pamoate or oxantel pamoate,   optionally one or more other active pharmaceutical ingredients,   a liquid component,   a forming agent,   optionally pamoic acid or a pharmaceutically acceptable salt thereof, and   optionally one or more excipients.   
     
     
         6 . The product according to anyone of  claims 1  to  5 , additionally comprising one or more of the following excipients:
 a filler, 
 a stabilizer component, 
 a flavoring component, and/or 
 a sugar component. 
 
     
     
         7 . The product according to anyone of  claims 1  to  6  wherein the active pharmaceutical ingredient is an isoxazoline compound of Formula (I) 
       
         
           
           
               
               
           
         
         wherein 
         R 1 =halogen, CF 3 , OCF 3 , CN, 
         n=integer from 0 to 3, preferably 1, 2 or 3, 
         R 2 =C 1 -C 3 -haloalkyl, preferably CF 3  or CF 2 Cl, 
         T=5- or 6-membered ring, which is optionally substituted by one or more radicals Y, 
         Y=methyl, halomethyl, halogen, CN, NO 2 , NH 2 —C═S, or two adjacent radicals Y form together a chain, especially a three or four membered chain; 
         Q=X—NR 3 R 4  or a 5-membered N-heteroaryl ring, which is optionally substituted by one or more radicals; 
         X=CH 2 , CH(CH 3 ), CH(CN), CO, CS, 
         R 3 =hydrogen, methyl, haloethyl, halopropyl, halobutyl, methoxymethyl, methoxyethyl, halomethoxymethyl, ethoxymethyl, haloethoxymethyl, propoxymethyl, ethylaminocarbonylmethyl, ethylaminocarbonylethyl, dimethoxyethyl, propynylaminocarbonylmethyl, N-phenyl-N-methyl-amino, haloethylaminocarbonylmethyl, haloethylaminocarbonylethyl, tetrahydrofuryl, methylaminocarbonylmethyl, (N,N-dimethylamino)-carbonylmethyl, propylaminocarbonylmethyl, cyclopropylaminocarbonylmethyl, propenylaminocarbonylmethyl, haloethylaminocarbonylcyclopropyl, 
       
       
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         wherein Z A =hydrogen, halogen, cyano, halomethyl (CF 3 ); 
         R 4 =hydrogen, ethyl, methoxymethyl, halomethoxymethyl, ethoxymethyl, haloethoxymethyl, propoxymethyl, methylcarbonyl, ethylcarbonyl, propylcarbonyl, cyclopropylcarbonyl, methoxycarbonyl, methoxymethylcarbonyl, aminocarbonyl, ethylaminocarbonylmethyl, ethylaminocarbonylethyl, dimethoxyethyl, propynylaminocarbonylmethyl, haloethylaminocarbonylmethyl, cyanomethylaminocarbonylmethyl, or haloethylaminocarbonylethyl; 
         Or R 3  and R 4  together form a substituent selected from the group consisting of: 
       
       
         
           
           
               
               
           
         
         or a salt or solvate thereof. 
       
     
     
         8 . The product according to  claim 7  wherein the active pharmaceutical ingredient is 4-[5-(3,5-Dichlorophenyl)-5-trifluoromethyl-4,5-dihydroisoxazol-3-yl]-2-methyl-N-[(2,2,2-trifluoro-ethylcarbamoyl)-methyl]-benzamide. 
     
     
         9 . The product according to  claim 7  wherein the active pharmaceutical ingredient is 4-[5-[3-Chloro-5-(trifluoromethyl)phenyl]-4,5-dihydro-5-(trifluoromethyl)-3-isoxazolyl]-N-[2-oxo-2-[(2,2,2-trifluoroethyl)amino]ethyl]-1-naphthalenecarboxamide. 
     
     
         10 . The product according to  claim 7  wherein the active pharmaceutical ingredient is 4-[5-(3,5-dichlorophenyl)-5-(trifluoromethyl)-4H-isoxazol-3-yl]-2-methyl-N-(thietan-3-yl)benzamide. 
     
     
         11 . The product according to  claim 7  wherein the active pharmaceutical ingredient is 5-[5-(3,5-Dichlorophenyl)-4,5-dihydro-5-(trifluoromethyl)-3-isoxazolyl]-3-methyl-N-[2-oxo-2-[(2,2,2-trifluoroethyl)amino]ethyl]-2-thiophenecarboxamide. 
     
     
         12 . The product according to anyone of  claims 1  to  11  wherein more than one active pharmaceutical ingredient is present. 
     
     
         13 . The product according to  claim 12  wherein the combination of active pharmaceutical ingredients comprises one or more antiparasitics. 
     
     
         14 . A process for the manufacture of a product according to anyone of  claims 1  to  13  in a forming machine comprising the steps of
 d) mixing the ingredients into a dough, 
 e) filling a mold with dough, and 
 f) removing the dough from the mold, 
 
       wherein in the mixing step a) the pamoic acid or the pharmaceutically acceptable salt thereof is mixed with the other ingredients. 
     
     
         15 . Use of pamoic acid or a pharmaceutically acceptable salt thereof in the process according to  claim 14  to increase lubricity of a product according to  claims 1  to  13  when filling the mold with dough or when removing the dough from the mold or both. 
     
     
         16 . Use according to  claim 16  in a process according to  claim 14 . 
     
     
         17 . Use of the soft chewable veterinary pharmaceutical product according to  claims 1  to  13  in the manufacture of a medicament for controlling a parasitic insect, acarid or nematode infestation of an animal. 
     
     
         18 . A soft chewable veterinary pharmaceutical composition comprising an isoxazoline compound of Formula (I) as defined in  claim 7 ,  8 ,  9 ,  10  or  11  for use in a method of controlling a parasitic insect, acarid or nematode infestation of an animal.