Soft-chew tablet pharmaceutical formulations

Abstract

A product and process of manufacturing an edible soft-chewable dosage form for the delivery of pharmaceutically active ingredients or nutritional agents orally to an animal or human subject, by forming a granulated soft-chew mass by appropriate mixing and sifting steps, and forming tablets with a compression press. Such soft-chew dosage forms have hardness of less than about two kilopond (2 kp) and friability of less than about one percent (1%) at three-hundred (300) rotations when measured according to the United States Pharmacopeia (USP) test. The process for manufacturing such compressed soft-chew tablets employs compression (tablet) pressing equipment to produce soft-chew tablets of consistent weight and texture.

What is claimed is: 
     
         1 . An edible, semi-plastic tablet formed using a tablet press, said tablet comprising:
 at least one active ingredient;   said tablet having a hardness of less than about two kiloponds (2 kp) when measured on a tablet hardness tester;   said tablet having a friability of less than about one percent (1%) at about one-hundred (100) rotations.   
     
     
         2 . The tablet as claimed in  claim 1 ,
 said tablet having a hardness of less than about one kilopond (1 kp) when measured on a tablet hardness tester.   
     
     
         3 . The tablet as claimed in  claim 3 ,
 said tablet having a hardness of about zero kilopond (0 kp) when measured on a tablet hardness tester.   
     
     
         4 . The tablet as claimed in  claim 1 ,
 said tablet having a friability of less than about one percent (1%) at about two-hundred (200) rotations.   
     
     
         5 . The tablet as claimed in  claim 4 ,
 said tablet having a friability of less than about one percent (1%) at about three-hundred (300) rotations.   
     
     
         6 . The tablet as claimed in  claim 1 ,
 said active ingredient being a pharmaceutical ingredient;   said pharmaceutical ingredient being selected from the group consisting of analgesic agents, anesthetic agents, anthelmintic agents, antibiotics, anti-depressants, antiemetic agents, antifungal agents, antihistamines, antiprotozoal agents, antithyroid agents, appetite stimulants, agents used to treat attention-deficit hyperactivity disorder, cardiovascular agents, corticosteroids, parasiticidal agents, steroids, and combinations thereof.   
     
     
         7 . The tablet as claimed in  claim 6 ,
 said active ingredient being selected from the group consisting of acetaminophen, carprofen, cefpodoxime proxetil, deracoxib, enrofloxacin, ibuprofen,   marbofloxacin, pimobendan, and combinations thereof.   
     
     
         8 . The tablet as claimed in  claim 1 , said tablet further comprising:
 at least one granulation aid ingredient,   at least one intra-granular ingredient, and   at least one extra-granular ingredient.   
     
     
         9 . The tablet as claimed in  claim 8 ,
 said granulation aid ingredient being selected from the group consisting of antioxidants, binding agents, coloring agents, humectants, palatability enhancers, plasticizers, preservatives, texturing agents, and combinations thereof.   
     
     
         10 . The tablet as claimed in  claim 9 ,
 said granulation aid ingredient being selected from the group consisting of brown iron oxide, butylated hydroxyanisole, butylated hydroxytoluene, citric acid, cremophor, glycerin, liquid strawberry flavor, mineral oil, polyethylene glycol, polysorbate, povidone, sorbitol, soybean oil, tartaric acid,  zea mays  oil, and combinations thereof.   
     
     
         12 . The tablet as claimed in  claim 8 ,
 said intra-granular ingredient being selected from the group consisting of binding agents, diluents, disintegrants, flavor agents, oil absorbing agents, palatability enhancers, plasticizers, surfactants, texturing agents, and combinations thereof.   
     
     
         13 . The tablet as claimed in  claim 12 ,
 said intra-granular ingredient being selected from the group consisting of beef flavor, calcium carboxymethylcellulose, calcium sulfate dihydrate, carnauba wax, croscarmellose sodium, lactose, lactose monohydrate, mannitol, microcrystalline cellulose, polycarbophil, polyethylene glycol, pregelatinized corn starch, silicified microcrystalline cellulose, sodium carboxymethylcellulose, sodium lauryl sulfate, soluplus, sucralose, xylitol, and combinations thereof.   
     
     
         14 . The tablet as claimed in  claim 8 ,
 said extra-granular ingredient being selected from the group consisting of binding agents, diluents, disintegrants, flavor agents, oil absorbing agents, palatability enhancers, plasticizers, surfactants, texturing agents, and combinations thereof.   
     
     
         15 . The tablet as claimed in  claim 14 ,
 said extra-granular ingredient being selected from the group consisting of beef flavor, calcium carboxymethylcellulose, calcium sulfate dihydrate, croscarmellose sodium, lactose, lactose monohydrate, maltodextrin, poly(ethylene) oxide, polyethylene glycol, pregelatinized corn starch, silicified microcrystalline cellulose, sodium carboxymethylcellulose, sodium lauryl sulfate, sucralose, xylitol, and combinations thereof.   
     
     
         16 . The tablet as claimed in  claim 8 ,
 said granulation aid ingredient being present at a concentration of more than about ten percent (10%) by weight based on the total weight of the tablet.   
     
     
         17 . The tablet as claimed in  claim 16 ,
 said granulation aid ingredient being present at a concentration from more than about ten percent (10%) to about fifty percent (50%) by weight based on the total weight of the tablet.   
     
     
         18 . The tablet as claimed in  claim 8 ,
 said intra-granular ingredient being present at a concentration of more than about fifteen percent (15%) by weight based on the total weight of the tablet.   
     
     
         19 . The tablet as claimed in  claim 18 ,
 said intra-granular ingredient being present at a concentration from more than about fifteen percent (15%) to about seventy-five percent (75%) by weight based on the total weight of the tablet.   
     
     
         20 . The tablet as claimed in  claim 8 ,
 said extra-granular ingredient being present at a concentration of more than about five percent (5%) by weight based on the total weight of the tablet.   
     
     
         21 . The tablet as claimed in  claim 20 ,
 said extra-granular ingredient being present at a concentration from more than about five percent (5%) to about fifty percent (50%) by weight based on the total weight of the tablet.   
     
     
         22 . The tablet as claimed in  claim 1 , said tablet further comprising:
 at least one flow aid ingredient;   said at least one flow aid ingredient being selected from the group consisting of colloidal silicon dioxide, magnesium stearate, stearic acid, sodium lauryl sulfate, sodium stearyl fumarate, talc, and combinations thereof.   
     
     
         23 . The tablet as claimed in  claim 1 ,
 said active ingredient being present at a concentration of more than about one one-hundredth percent (0.01%) by weight based on the total weight of the tablet.   
     
     
         24 . The tablet as claimed in  claim 23 ,
 said active ingredient being present at a concentration from more than about one one-hundredth percent (0.01%) to about fifty percent (50%) by weight based on the total weight of the tablet.   
     
     
         25 . An edible, semi-plastic tablet formed using a tablet press, said tablet comprising:
 at least one active ingredient;   said tablet having a weight of more than about three-hundred milligrams (300 mg);   said tablet having a hardness of less than about one kilopond (1 kp) when measured on a tablet hardness tester;   said tablet having a friability of less than about one percent (1%) at about one-hundred (100) rotations.   
     
     
         26 . A process for manufacture of an edible, semi-plastic tablet unit dosage form for the oral administration of an active ingredient comprising the steps of:
 (a) combining said active ingredient with at least one ingredient to form a soft-chew mass; and   (b) compressing said soft-chew mass using a tablet press to form a tablet, wherein said tablet has a hardness of less than about two kiloponds (2 kp) when measured on a tablet hardness tester, and a friability of less than about one percent (1%) at about one-hundred (100) rotations.