Means for creating a mass having structural integrity

Abstract

The present invention relates to a means for creating a mass having structural integrity, including a rapidly disintegratable tablet for administration with or without the use of water. The present invention has a wide variety of different uses and applications. One embodiment is a tablet intended for oral administration. The tablet comprises at least one active ingredient and a mixture of excipients. The excipients provide desired characteristics and physical properties and when the tablet is sintered or heated, excellent tablet binding characteristics are obtained. The tablet is intended primarily for oral administration and dissolves in the presence of water. Also disclosed is a process for the preparation of a rapidly disintegratable tablet for administration with or without the use of water. The process comprising dissolving at least one bulking agent and at least one structural agent in a suitable solvent, wherein the solvent provides high porosity upon drying; spray-drying or dispersing said dissolved mixture to obtain a bead or granulated product; dry blending at least one binding agent, and at least one active ingredient with the bead or granulated product to obtain a preformulation product or adding at least one active ingredient to the preformulation product dissolved or dispersed components before spray-drying or dispersing; compressing the preformulation product; and sintering or heating the preformulation product for a sufficient time and temperature to allow the binding agent to change status or melt and allow the binding agent to resolidify as the temperature is reduced to ambient temperature.

1 . A rapidly disintegratable tablet for administration with or without the use of water, said tablet comprising at least one active ingredient and a mixture of excipients, wherein said excipients provide desired characteristics and physical properties and when the tablet is sintered or heated, excellent tablet binding characteristics are obtained.  
     
     
         2 . The rapidly disintegratable tablet according to  claim 1 , wherein said tablet is intended for oral administration.  
     
     
         3 . The rapidly disintegratable tablet according to  claim 2 , wherein said tablet dissolves in the presence of water.  
     
     
         4 . The rapidly disintegratable tablet according to  claim 3 , wherein said mixture of excipients provide desired mouthfeel characteristics and physical properties when the tablet is sintered.  
     
     
         5 . The rapidly disintegratable tablet according to  claim 1 , wherein said mixture of excipients comprises at least one binding agent.  
     
     
         6 . The rapidly disintegratable tablet according to  claim 5 , wherein said binding agent is polyethylene glycol.  
     
     
         7 . The rapidly disintegratable tablet according to  claim 6 , wherein said polyethylene glycol has a molecular weight of approximately 1,000 to 1 million.  
     
     
         8 . The rapidly disintegratable tablet according to  claim 1 , wherein said mixture of excipients comprises at least one structural agent.  
     
     
         9 . The rapidly disintegratable tablet according to  claim 1 , wherein said structural agent is gelatin.  
     
     
         10 . The rapidly disintegratable tablet according to  claim 9 , wherein said gelatin is fishgelatin.  
     
     
         11 . The rapidly disintegratable tablet according to  claim 1 , wherein said sintering or heating is conducted in the range of approximately 50° C. to 120° C.  
     
     
         12 . The rapidly disintegratable tablet according to  claim 1 , wherein said active substance is selected from the group consisting of antacids, analgesics, anti-inflammatory agents, antibiotics, antiviral agents, antiparasitic agents, laxatives, anorexics, antihistamines, antiasthmatics, bronchodilators, laxatives, antiflatulents, antimigraine agents, sedatives, antihyperactives, antihypertensives, tranquilizers, antidepressants, decongestants, beta blockers, H 2 -antagonists, antitussives, decongestants, alkaloids, ion exchange resins, anti-cholesterolemics, anti-lipid agents, antiarrhythmics, antipyretics, appetite suppressants, expectorants, anti-anxiety agents, anti-ulcer agents, coronary vasodilators, cerebral dilators, peripheral vasodilators, anti-infectious agents, psychotropics, antimanics, neuroleptic agents, central nervous system stimulants, gastrointestinal agents, sedatives, antidiarrheal preparations, anti-anginal drugs, peripheral and brain vasodilators, anti-hypertensive drugs, vasoconstrictors, tranquillizers, antipsychotics, antitumor or anticancer drugs, anticoagulants, antithrombotic drugs, hypnotics, anti-emetics, anti-nausea agents, anti-convulsants, neuromuscular drugs, hyper- and hypoglycemic agents, thyroid and antithyroid preparations, diuretics, antispasmodics, uterine relaxants, antiobesity drugs, anabolic drugs, erythropoietin drugs, hematopoietical agents, uricosuric agents, plant extracts, contrast mediums, cough suppressants, mucolytics or mucoregulators, antiuricemic drugs, immunodepressant drugs, cholesterol lowering agents, hormones, enzymes, drugs acting on the rhythm of the heart, drugs used in the treatment of arterial hypertension, anti-migraine agents, drugs acting on blood coagulability, anti-epileptic agents, muscle relaxants, anti-Parkinson drugs, anorexigenic drugs, vitamins, minerals, dietary supplements, nutritional additives and mixtures thereof.  
     
     
         13 . The rapidly disintegratable tablet according to  claim 12 , wherein said active substance is selected from antacids, analgesics, anti-inflammatory agents, coronary vasodilators, peripheral vasodilators, antibiotics, antiviral agents, antianxiety drugs, central nervous system stimulants, antihistamines, hormones, anti-hypertensive agents, bronchodilators, anti-migraine agents, muscle relaxants, anti-epileptic agents, anti-Parkinson drugs, decongestants, diuretics, hypnotic/sedative drugs and expectorants.  
     
     
         14 . The rapidly disintegratable tablet according to  claim 13 , wherein said active substance is selected from ibuprofen, nitroglycerin, clarithromycin and azithromycin.  
     
     
         15 . A process for the preparation of a rapidly disintegratable tablet for administration with or without the use of water, said process comprising: 
 dissolving at least one bulking agent and at least one structural agent in a suitable solvent, wherein said solvent provides high porosity upon drying;    spray-drying or dispersing said dissolved mixture to obtain a bead or granulated product;    dry blending at least one binding agent, and at least one active ingredient with the bead or granulated product to obtain a preformulation product or adding at least one active ingredient to the solvent or dissolved mixture, or adding said binding agent to the bulking agent and/or structural agent and/or solvent, thus said binding agent and said active ingredient may optionally be added before said spray-drying or dispersing;    optionally compressing said preformulation product to obtain a compressed preformulation product; and    sintering said preformulation product for a sufficient time and temperature to allow the binding agent to change status or melt and allow said binding agent to resolidify as the temperature is reduced to ambient temperature.    
     
     
         16 . The process according to  claim 15 , wherein said bulking agent is selected from the group consisting of sucrose, mannitol, sorbitol, xylose, dextrose, fructose, mannose, calcium carbonate and magnesium carbonate.  
     
     
         17 . The process according to  claim 15 , wherein said structural agent is selected from the group consisting of agar, gelatin, albumen, and chondroitin.  
     
     
         18 . The process according to  claim 17 , wherein said structural agent is gelatin.  
     
     
         19 . The process according to  claim 18 , wherein said gelatin is fish gelatin.  
     
     
         20 . The process according to  claim 15 , wherein said solvent is selected from the group consisting of water, ethyl alcohol, and mixtures thereof.  
     
     
         21 . The process according to  claim 15 , wherein said binding agent is selected from the group consisting of polyethylene glycol, fatty acid alcohols and polypeptides.  
     
     
         22 . The process according to  claim 21 , wherein said binding agent is polyethylene glycol.  
     
     
         23 . The process according to  claim 22 , wherein said polyethylene glycol has a molecular weight of approximately 1,000 to 1 million.  
     
     
         24 . The process according to  claim 15 , wherein said sintering or heating is conducted at approximately 50° C. to 100° C. and for approximately one minute to 12 hours.  
     
     
         25 . The process according to  claim 24 , wherein the sintering or heating is conducted at approximately 90° C. for approximately 10 minutes.  
     
     
         26 . A rapidly disintegratable product comprising at least one active ingredient and a mixture of excipients wherein said excipients provide desired characteristics and physical properties and when the product is sintered or heated, excellent binding characteristics are obtained.  
     
     
         27 . A process for the preparation of a rapidly disintegratable product, said process comprising: 
 dissolving at least one bulking agent and at least one structural agent in a suitable solvent, wherein said solvent provides high porosity upon drying;    spray-drying or dispersing said dissolved mixture to obtain a bead or granulated product;    dry blending at least one binding agent, and at least one active ingredient with the bead or granulated product to obtain a preformulation product or adding at least one active ingredient to the solvent or dissolved mixture, or adding said binding agent to the bulking agent and/or structural agent and/or solvent, thus said binding agent and said active ingredient may optionally be added before said spray-drying or dispersing;    optionally compressing said preformulation product to obtain a compressed preformulation product; and    sintering said preformulation product for a sufficient time and temperature to allow the binding agent to change status or melt and allow said binding agent to resolidify as the temperature is reduced to ambient temperature.