Ion Exchange Resin Treated to Control Swelling

• US 20070148239A1
• Filed: 02/14/2007
• Published: 06/28/2007
• Est. Priority Date: 09/13/2005
• Status: Active Grant

• Current Assignee: Coating Place, Inc.
• Original Assignee: Coating Place, Inc.
• Inventors: Hall, Harlan, Madsen, J.
• Granted Patent: US 8,883,213 B2
• Time in Patent Office: Days
• US Class Current: 424/470
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/192 having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid cannabinoids A61K31/658
• CPC Class Codes: A61K 47/585 Ion exchange resins, e.g. polystyrene sulfonic acid resin
• CPC Class Codes: A61K 9/0095 Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006
• CPC Class Codes: A61K 9/146 with organic macromolecular compounds
• CPC Class Codes: A61P 11/02 Nasal agents, e.g. decongestants
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

The present invention provides a method and composition are provided for loading one or more drugs in a solution onto one or more ion exchange resin particles to form a drug-loaded resin particle. The drug-loaded resin particle is a sustained-release coated layered pharmaceutical drug-ion exchange resin having a one or more pharmaceutically active drugs applied directly to a non-equilibrated ion exchange resin to form a drug-resin complex. The drug-resin complex then coated is shelf stable.

Claims

1. A sustained-release coated pharmaceutical drug-ion exchange resin composition comprising:

a coating applied to a pharmaceutically active drug applied directly to a non-equilibrated ion exchange resin to form a coated drug-resin complex, wherein the coated drug-resin complex is shelf stable.

2. The composition of claim 1, further comprising the addition of one or more sugar alcohols to the non-equilibrated ion exchange resin.

3. The composition of claim 2, wherein the one or more sugar alcohols comprise mannitol, sorbitol, xylitol, maltitol, lactitol, 1,3-dihydroxypropane, inositol glucose, sucrose or combinations and mixtures thereof.

4. The composition of claim 3, wherein the one or more sugar alcohols comprises between about 0.01% and about 10% sorbitol by weight.

5. The composition of claim 1, wherein the non-equilibrated ion exchange resin comprises a sulfonic acid cation exchange resin.

6. The composition of claim 1, wherein the non-equilibrated ion exchange resin comprises dipropylene glycol diallyl ether, polyglycol diallyl ether, triethylene glycol divinyl ether, hydroquinone diallyl ether, tetraallyloxyethanoyl, vinyl ether, vinyl acetate, vinyl butylbenzoate, crotonic acid, polyfunctional alcohol, tetraethylene glycol diacrylate, triallylamine, trimethylolpropane diallyl ether, methylenebisacrylamide, divinylbenzene, phthalic, sulphonphthalic acid, ethylene glycol, polymethyl siloxane α

, γ

-hydroxypropyl or combinations thereof.

7. The composition of claim 1, wherein the pharmaceutically active drug comprises narcotic analgesics, sympathomimetics, antitussives, analgesics antiemetics, anticholinergics, muscle relaxants, bronchodilators, antibiotics, antidepressants, antiasthmatics, antineoplastics, antiepileptics, cardiovascular agents, mixtures and combinations thereof.

8. The composition of claim 1, wherein the pharmaceutically active drug comprises codeine, dihydrocodeine, hydromorphone, morphine, pentazocine, propoxyphene, norephedrine, pseudoephedrine, phenylephrine, gauifenesin dextromethorphan, aspirin, tramadol, metoclopramide, atropine, ipratropium bromide, scopolamine, cyclobenzaprine, papaverine, salbutamol, terbutaline and theophylline, amoxycillin, ampicillin, azlocillin, bacampicillin, cefamandole, cefonicid, cefotaxime, cefotetan, cefoxitin, ceftriaxone, mezlocillin, piperacillin, bupropion, nomifensine, nortriptyline, cromolyn, tamoxifen, valproic acid and phenvtoin, propranolol mixtures and combinations thereof.

9. The composition of claim 1, wherein the coated drug-resin complex comprises a solution, a suspension, a cream, an ointment, a lotion, a capsule, a caplet, a softgel, a gelcap, a tablet, a suppository, an enema, an elixir, a syrup, an emulsion, a film, a granule, a gum, an insert, a jelly, a foam, a paste, a pastille, a pellet, a spray, a troche, a lozenge, a disk, a magma, a poultice, a wafer or combinations thereof.

10. A method of forming a sustained-release coated pharmaceutical drug-ion exchange resin composition comprising the step of:

applying a pharmaceutically active drug directly to a non-equilibrated ion exchange resin to form a drug-resin complex; and

applying a coating to the drug-resin complex, wherein the drug-resin complex is shelf stable.

11. The method of claim 10, further comprising contacting the non-equilibrated ion exchange resin with between about 0.01% and 10% by weight of one or more sugar alcohols, based on the combined weight of the sugar alcohol and the non-equilibrated ion exchange resin.

12. The method of claim 11, wherein the one or more sugar alcohols comprise an aqueous solution.

13. The method of claim 12, wherein the one or more sugar alcohols comprise mannitol, sorbitol, xylitol, maltitol, lactitol, 1,3-dihydroxypropane, inositol glucose, sucrose, mixtures and combinations thereof.

14. The method of claim 10, wherein the non-equilibrated ion exchange resin comprises a sulfonic acid cationic exchange resin particles.

15. The method of claim 10, wherein the non-equilibrated ion exchange resin comprises dipropylene glycol diallyl ether, polyglycol diallyl ether, triethylene glycol divinyl ether, hydroquinone diallyl ether, tetraallyloxyethanoyl, vinyl ether, vinyl acetate, vinyl butylbenzoate, crotonic acid, polyfunctional alcohol, tetraethylene glycol diacrylate, triallylamine, trimethylolpropane diallyl ether, methylenebisacrylamide, divinylbenzene, phthalic, sulphonphthalic acid, ethylene glycol, polymethyl siloxane α

, γ

-hydroxypropyl or combination thereof.

16. The method of claim 10, wherein the pharmaceutically active drug comprises narcotic analgesics, sympathomimetics, antitussives, analgesics antiemetics, anticholinergics, muscle relaxants, bronchodilators, antibiotics, antidepressants, antiasthmatics, antineoplastics, antiepileptics, cardiovascular agents, mixtures and combinations thereof.

17. The composition of claim 10, wherein the pharmaceutically active drug comprises codeine, dihydrocodeine, hydromorphone, morphine, pentazocine, propoxyphene, norephedrine, pseudoephedrine, dextromethorphan, phenylephrine, gauifenesin, aspirin, tramadol, metoclopramide, atropine, ipratropium bromide, scopolamine, cyclobenzaprine, papaverine, salbutamol, terbutaline and theophylline, amoxycillin, ampicillin, azlocillin, bacampicillin, cefamandole, cefonicid, cefotaxime, cefotetan, cefoxitin, ceftriaxone, mezlocillin, piperacillin, bupropion, nomifensine, nortriptyline, cromolyn, tamoxifen, valproic acid and phenvtoin, propranolol mixtures and combinations thereof.

18. A pharmaceutical composition made according to the method of claim 10.

19. A sustained-release coated layered pharmaceutical drug-ion exchange resin composition comprising:

a first pharmaceutically active drug applied directly to a non-equilibrated ion exchange resin to form a first drug-resin complex;

one or more second pharmaceutically active drugs applied directly to the first drug-resin complex to form a layered-drug-resin complex; and

a coating applied to the layered-drug-resin complex, wherein the layered-drug-resin complex is shelf stable.

20. The composition of claim 19, wherein the ion exchange resin comprises dipropylene glycol diallyl ether, polyglycol diallyl ether, triethylene glycol divinyl ether, hydroquinone diallyl ether, tetraallyloxyethanoyl, vinyl ether, vinyl acetate, vinyl butylbenzoate, crotonic acid, polyfunctional alcohol, tetraethylene glycol diacrylate, triallylamine, trimethylolpropane diallyl ether, methylenebisacrylamide, divinylbenzene, phthalic, sulphonphthalic acid, ethylene glycol, polymethyl siloxane α

, γ

-hydroxypropyl or combinations thereof.

21. The composition of claim 19, wherein the first pharmaceutically active drug and each of the one or more second pharmaceutically active drugs independently comprise codeine, dihydrocodeine, hydromorphone, morphine, pentazocine, propoxyphene, norephedrine, pseudoephedrine, phenylephrine, gauifenesin, dextromethorphan, aspirin, tramadol, metoclopramide, atropine, ipratropium bromide, scopolamine, cyclobenzaprine, papaverine, salbutamol, terbutaline and theophylline, amoxycillin, ampicillin, azlocillin, bacampicillin, cefamandole, cefonicid, cefotaxime, cefotetan, cefoxitin, ceftriaxone, mezlocillin, piperacillin, bupropion, nomifensine, nortriptyline, cromolyn, tamoxifen, valproic acid and phenvtoin, propranolol mixtures and combinations thereof.