Compositions and methods for administration to subjects with dysphagia

Abstract

Provided are novel methods and compositions for administration of pharmaceuticals to subjects with dysphagia. Pharmaceuticals are associated with beads and administered with food, beverage or cosmetic to provide ease of administration to subjects with dysphagia. Environmental indicators are associated with beads for Quality Assurance.

1 - 118 . (canceled) 
     
     
         119 . A composition comprising an active pharmaceutical ingredient formed into one or more beads and a colored layer and an outer layer, wherein the one or more beads comprise a first surface, wherein the colored layer is positioned on the outside of the first surface, wherein the colored layer comprises a second surface that is exposed when an outer layer or layers positioned outside the first and second surfaces is degraded by environmental conditions. 
     
     
         120 . The composition of  claim 119 , wherein the outer layer is a polymeric chemical. 
     
     
         121 . The composition of  claim 120 , wherein the polymeric chemical degrades due to solubilization, exposing the colored layer underneath. 
     
     
         122 . The composition of  claim 121 , wherein the solubilization occurs after a duration when the composition is mixed with food or beverage, exposing the colored layer underneath. 
     
     
         123 . The composition of  claim 119 , wherein the one or more beads are between 50 and 200 μm in diameter. 
     
     
         124 . The composition of  claim 123 , wherein the one or more beads are between 50 and 100 μm in diameter. 
     
     
         125 . The composition of  claim 119 , wherein the one or more beads have an average diameter of between 50 and 1000 μm in diameter. 
     
     
         126 . The composition of  claim 125 , wherein the one or more beads have an average diameter of between 50 and 300 μm in diameter. 
     
     
         127 . The composition of  claim 119 , wherein the active pharmaceutical ingredient is selected from the group consisting of nifedipine, metoprolol succinate, isosorbide mononitrate, furosemide, hydrochlorothiazide, diltiazem, verapamil, digoxin, enalapril, lisinopril, ramipril, amlodipine, theophylline, ferrous fumarate and gluconate, atorvastatin, rosuvastatin, levothyroxine, metformin, potassium chloride, trazodone, carbidopa/levodopa, gabapentin, carbamazepine, bupropion, olanzapine, chlorpromazine, valproic acid, clarithromycin, azithromycin, ciprofloxacin, amoxicillin, naproxen sodium, prednisone, acetaminophen, ibuprofen and ranitidine. 
     
     
         128 . The composition of  claim 120 , wherein polymeric chemical degrades above a certain temperature, exposing the colored layer underneath. 
     
     
         129 . The composition of  claim 128 , wherein the polymeric chemical degrades at or below 10° C. 
     
     
         130 . The composition of  claim 128 , wherein the polymeric chemical degrades at or below 0° C. 
     
     
         131 . The composition of  claim 120 , wherein polymeric chemical degrades below a certain temperature, exposing the colored layer underneath. 
     
     
         132 . The composition of  claim 131 , wherein the polymeric chemical degrades at or above 30° C. 
     
     
         133 . The composition of  claim 131 , wherein the polymeric chemical degrades at or above 50° C. 
     
     
         134 . The composition of  claim 120 , wherein the polymeric chemical degrades when exposed to low pH, exposing the colored layer underneath. 
     
     
         135 . The composition of  claim 134 , wherein the low pH is below about 8.0. 
     
     
         136 . The composition of  claim 134 , wherein the low pH is below about 6.5. 
     
     
         137 . The composition of  claim 120 , wherein the polymeric chemical degrades when exposed to high pH, exposing the colored layer underneath. 
     
     
         138 . The composition of  claim 137 , wherein the high pH is above about 6.0. 
     
     
         139 . The composition of  claim 137 , wherein the high pH is above about 7.5. 
     
     
         140 . The composition of  claim 119 , wherein the composition is formulated to alleviate difficulty swallowing in a subject in need thereof. 
     
     
         141 . The composition of  claim 119 , wherein the subject in need thereof suffers from dysphagia. 
     
     
         142 . The composition of  claim 119 , wherein the composition is formulated to be safe and efficacious when administered to the subject in food, beverage or cosmetic. 
     
     
         143 . The composition of  claim 119 , wherein the mouthfeel of the food, beverage or cosmetic is not substantially changed from food, beverage or cosmetic not comprising the composition in the subject in need thereof. 
     
     
         144 . The composition of  claim 119 , wherein the taste of the food, beverage or cosmetic is not substantially changed from food, beverage or cosmetic not comprising the composition to the subject in need thereof. 
     
     
         145 . The composition of  claim 119 , wherein the smell of the food, beverage or cosmetic is not substantially changed from food, beverage or cosmetic not comprising the composition to the subject in need thereof. 
     
     
         146 . A method of making a dosage form comprising adding the composition of  claim 119  to a food, beverage or cosmetic. 
     
     
         147 . A method of administering an active pharmaceutical ingredient to a subject with difficulty swallowing comprising administering the composition of  claim 119  in food, beverage or cosmetic.