US5980882A
Expired / Lapsed
US
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Drug-resin complexes stabilized by chelating agents
Assignee: UCB Manufacturing Inc
•
Filing: 1997-04-16
•
Granted: 1999-11-09
•
Expires: 2017-04-16
Abstract
Abstract The invention provides a pharmaceutical composition comprising a drug-resin complex and a chelating agent in which the composition is in the form of a solid or a gel. The invention also provides a method of making such a composition and a method for improving the stability of a pharmaceutical composition.
Inventors
- 👤 Martin L. Eichman
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 18:05
CPC Classifications
A; A61; A61K; A61K47/00; A61K47/06; A61K47/16; A61K47/18; A61K47/183; A61K47/50; A61K47/51; A61K47/56; A61K47/58; A61K47/585; A61K47/69; A61K47/6903; A61K9/00; A61K9/0087; A61K9/0095; A61K9/48; A61K9/50; A61K9/5005; A61K9/5015; A61K9/5021; A61K9/5036; A61K9/5042; A61K9/5047; A61K9/5084
Claims Analysis
Total Claims: 46
Claim 1
Independent Claim
103 words
A pharmaceutical composition comprising a drug-resin complex and a chelating agent, wherein the composition is in the form of a solid or a gel, wherein the chelating agent is present in an amount effective to reduce the amount of degradation of the drug in the drug resin complex by more than 20 percent over twelve months of storage at room temperature relative to an otherwise identical pharmaceutical composition without the chelating agent; wherein the changing agent is selected from EDTA or a salt of EDTA; and wherein the drug in the drug-resin complex is selected from dextromethorphan, codeine, morphine, hydrcodone, pseudoephedrine, or phenylpropanolamine.
Claim 2
Dependent Claim
103 words
A pharmaceutical composition comprising a drug-resin complex and a chelating agent, wherein the composition is in the form of a solid or a gel, wherein the chelating agent is present in an amount effective to reduce the amount of degradation of the drug in the drug resin complex by more than 20 percent over twelve months of storage at room temperature relative to an otherwise identical pharmaceutical composition without the chelating agent; wherein the changing agent is selected from EDTA or a salt of EDTA; and wherein the drug in the drug-resin complex is selected from dextromethorphan, codeine, morphine, hydrcodone, pseudoephedrine, or phenylpropanolamine.
Claim 3
Dependent Claim
17 words
A pharmaceutical composition according to claim 1, wherein the composition is in the form of a solid.
Claim 4
Dependent Claim
19 words
A pharmaceutical composition according to claim 1, wherein the resin in the drug-resin complex is a cationic exchange resin.
Claim 5
Dependent Claim
18 words
A pharmaceutical composition according to claim 3, wherein the resin is a divinylbenzene sulfonic acid cationic exchange resin.
Claim 6
Dependent Claim
20 words
A pharmaceutical composition according to claim 1, wherein the chelating agent is not covalently bound to the drug resin complex.
Claim 7
Dependent Claim
19 words
A pharmaceutical composition according to claim 1, wherein the chelating agent is covalently bound to the drug resin complex.
Claim 8
Dependent Claim
24 words
A pharmaceutical composition according to claim 1, wherein the chelating agent is present in a concentration of from 0.001 to 10 percent by weight.
Claim 9
Dependent Claim
24 words
A pharmaceutical composition according to claim 1, wherein the chelating agent is present in a concentration of from 0.1 to 5 percent by weight.
Claim 10
Dependent Claim
16 words
A pharmaceutical composition according to claim 1, wherein the drug-resin complex comprises a diffusion barrier coating.
Claim 11
Dependent Claim
16 words
A pharmaceutical composition according to claim 9, wherein the diffusion barrier coating is an enteric coating.
Claim 12
Dependent Claim
15 words
A pharmaceutical composition according to claim 1, wherein the drug-resin complex comprises a solvating agent.
Claim 13
Dependent Claim
14 words
A pharmaceutical composition according to claim 11, wherein the solvating agent is polyethylene glycol.
Claim 14
Dependent Claim
20 words
A pharmaceutical composition according to claim 1, wherein the drug-resin complex comprises a solvating agent and a diffusion barrier coating.
Claim 15
Dependent Claim
22 words
A pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is suitable for oral, topical, rectal, vaginal, nasal, or ophthalmic administration.
Claim 16
Dependent Claim
29 words
A pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is in the form of a tablet, a capsule, a powder, a lotion, a cream, or a suppository.
Claim 17
Dependent Claim
16 words
A pharmaceutical composition according to claim 14, wherein the pharmaceutical composition is suitable for oral administration.
Claim 18
Independent Claim
125 words
A method of making a pharmaceutical composition comprising: (a) combining a drug and an ion exchange resin in a liquid to form a drug-resin complex; (b) adding a chelating agent; and (c) drying the result of step (b) to form a solid or gel pharmaceutical composition, wherein the chelating agent is present in an amount effective to reduce the amount of degradation of the drug in the drug resin complex by more than 20 percent over twelve months of storage at room temperature relative to an otherwise identical pharmaceutical composition without the chelating agent; wherein the chelating agent is selected from EDTA or a salt of EDTA; and wherein the drug in the drug-resin complex is selected from dextromethorphan, codeine, morphine, hydrcodone, pseudoephedrine, or phenylpropanolamine.
Claim 19
Independent Claim
125 words
A method of making a pharmaceutical composition comprising: (a) combining a drug and an ion exchange resin in a liquid to form a drug-resin complex; (b) adding a chelating agent; and (c) drying the result of step (b) to form a solid or gel pharmaceutical composition, wherein the chelating agent is present in an amount effective to reduce the amount of degradation of the drug in the drug resin complex by more than 20 percent over twelve months of storage at room temperature relative to an otherwise identical pharmaceutical composition without the chelating agent; wherein the chelating agent is selected from EDTA or a salt of EDTA; and wherein the drug in the drug-resin complex is selected from dextromethorphan, codeine, morphine, hydrcodone, pseudoephedrine, or phenylpropanolamine.
Claim 20
Independent Claim
138 words
A method of making a pharmaceutical composition comprising: (a) combining a drug and an ion exchange resin in a liquid to form a drug-resin complex; (b) adding a chelating agent; (c) drying the result of step (b) to form a solid; and (d) suspending the result of step (c) in an appropriate liquid to form a liquid pharmaceutical composition, wherein the chelating agent is present in an amount effective to reduce the amount of degradation of the drug in the drug resin complex by more than 20 percent over twelve months of storage at room temperature relative to an otherwise identical pharmaceutical composition without the chelating agents; wherein the chelation agent is selected from EDTA or a salt of EDTA; and wherein the drug in the drug-resin complex is selected from dextromethorphan, codeine, morphine, hydrcodone, pseudoephedrine, or phenylpropanolamine.
Claim 21
Independent Claim
138 words
A method of making a pharmaceutical composition comprising: (a) combining a drug and an ion exchange resin in a liquid to form a drug-resin complex; (b) adding a chelating agent; (c) drying the result of step (b) to form a solid; and (d) suspending the result of step (c) in an appropriate liquid to form a liquid pharmaceutical composition, wherein the chelating agent is present in an amount effective to reduce the amount of degradation of the drug in the drug resin complex by more than 20 percent over twelve months of storage at room temperature relative to an otherwise identical pharmaceutical composition without the chelating agents; wherein the chelation agent is selected from EDTA or a salt of EDTA; and wherein the drug in the drug-resin complex is selected from dextromethorphan, codeine, morphine, hydrcodone, pseudoephedrine, or phenylpropanolamine.
Claim 22
Independent Claim
151 words
A method of making a pharmaceutical composition comprising: (a) combining a drug and an ion exchange resin in a first liquid to form a drug-resin complex; (b) drying the result of step (a) to form a solid; (c) suspending the result of step (b) in an appropriate second liquid, which may be the same or different than the first liquid; and (d) adding a chelating agent, to form a liquid pharmaceutical composition, wherein the chelating agent is present in an amount effective to reduce the amount of degradation of the drug in the drug resin complex by more than 20 percent over twelve months of storage at room temperature relative to an otherwise identical pharmaceutical composition without the chelating agent, wherein the chelating agent is selected from EDTA or a salt of EDTA; and wherein the drug in the drug-resin complex is selected from dextromethorphan, codeine, morphine, hydrcodone, pseudoephedrine or phenylpropanolamine.
Claim 23
Independent Claim
151 words
A method of making a pharmaceutical composition comprising: (a) combining a drug and an ion exchange resin in a first liquid to form a drug-resin complex; (b) drying the result of step (a) to form a solid; (c) suspending the result of step (b) in an appropriate second liquid, which may be the same or different than the first liquid; and (d) adding a chelating agent, to form a liquid pharmaceutical composition, wherein the chelating agent is present in an amount effective to reduce the amount of degradation of the drug in the drug resin complex by more than 20 percent over twelve months of storage at room temperature relative to an otherwise identical pharmaceutical composition without the chelating agent, wherein the chelating agent is selected from EDTA or a salt of EDTA; and wherein the drug in the drug-resin complex is selected from dextromethorphan, codeine, morphine, hydrcodone, pseudoephedrine or phenylpropanolamine.
Claim 24
Dependent Claim
125 words
A pharmaceutical composition prepared by the process of: (a) combining a drug and an ion exchange resin in a liquid to form a drug-resin complex; (b) adding a chelating agent; and (c) drying the result of step (b) to form a solid or gel pharmaceutical composition, wherein the chelating agent is present in an amount effective to reduce the amount of degradation of the drug in the drug resin complex by more than 20 percent over twelve months of storage at room temperature relative to an otherwise identical pharmaceutical composition without the chelating agent; wherein the chelating agent is selected from EDTA or a salt of EDTA; and wherein the drug in the drug-resin complex is selected from dextromethorphan, codeine, morphine, hydrcodone, pseudephedrine, or phenylpropanolamine.
Claim 25
Dependent Claim
125 words
A pharmaceutical composition prepared by the process of: (a) combining a drug and an ion exchange resin in a liquid to form a drug-resin complex; (b) adding a chelating agent; and (c) drying the result of step (b) to form a solid or gel pharmaceutical composition, wherein the chelating agent is present in an amount effective to reduce the amount of degradation of the drug in the drug resin complex by more than 20 percent over twelve months of storage at room temperature relative to an otherwise identical pharmaceutical composition without the chelating agent; wherein the chelating agent is selected from EDTA or a salt of EDTA; and wherein the drug in the drug-resin complex is selected from dextromethorphan, codeine, morphine, hydrcodone, pseudephedrine, or phenylpropanolamine.
Claim 26
Dependent Claim
138 words
A pharmaceutical composition prepared by the process of: (a) combining a drug and an ion exchange resin in a liquid to form a drug-resin complex; (b) adding a chelating agent; (c) drying the result of step (b) to form a solid; and (d) suspending the result of step (c) in an appropriate liquid to form a liquid pharmaceutical composition, wherein the chelating agent is present in an amount effective to reduce the amount of degradation of the drug in the drug resin complex by more than 20 percent over twelve months of storage at room temperature relative to an otherwise identical pharmaceutical composition without the chelating agent; wherein the chelating element is selected from EDTA or a salt of EDTA; and wherein the drug in the drug-resin complex is selected from dextromethorphan, codeine, morphine, hydrcodone, pseudoephedrine, or phenylpropanolamine.
Claim 27
Dependent Claim
138 words
A pharmaceutical composition prepared by the process of: (a) combining a drug and an ion exchange resin in a liquid to form a drug-resin complex; (b) adding a chelating agent; (c) drying the result of step (b) to form a solid; and (d) suspending the result of step (c) in an appropriate liquid to form a liquid pharmaceutical composition, wherein the chelating agent is present in an amount effective to reduce the amount of degradation of the drug in the drug resin complex by more than 20 percent over twelve months of storage at room temperature relative to an otherwise identical pharmaceutical composition without the chelating agent; wherein the chelating element is selected from EDTA or a salt of EDTA; and wherein the drug in the drug-resin complex is selected from dextromethorphan, codeine, morphine, hydrcodone, pseudoephedrine, or phenylpropanolamine.
Claim 28
Dependent Claim
151 words
A pharmaceutical composition prepared by the process of: (a) combining a drug and an ion exchange resin in a first liquid to form a drug-resin complex; (b) drying the result of step (a) to form a solid; (c) suspending the result of step (b) in an appropriate second liquid, which may be the same or different than the first liquid; and (d) adding a chelating agent, to form a liquid pharmaceutical composition, wherein the chelating agent is present in an amount effective to reduce the amount of degradation of the drug in the drug resin complex by more than 20 percent over twelve months of storage at room temperature relative to an otherwise identical pharmaceutical composition without the chelating agent; wherein the chelating agent is selected from EDTA or a salt of EDTA; and wherein the drug in the drug-resin complex is selected from dextromethorphan, codeine, morphine, hydrcodone, pseudoephedrine, or phenylpropanolamine.
Claim 29
Dependent Claim
151 words
A pharmaceutical composition prepared by the process of: (a) combining a drug and an ion exchange resin in a first liquid to form a drug-resin complex; (b) drying the result of step (a) to form a solid; (c) suspending the result of step (b) in an appropriate second liquid, which may be the same or different than the first liquid; and (d) adding a chelating agent, to form a liquid pharmaceutical composition, wherein the chelating agent is present in an amount effective to reduce the amount of degradation of the drug in the drug resin complex by more than 20 percent over twelve months of storage at room temperature relative to an otherwise identical pharmaceutical composition without the chelating agent; wherein the chelating agent is selected from EDTA or a salt of EDTA; and wherein the drug in the drug-resin complex is selected from dextromethorphan, codeine, morphine, hydrcodone, pseudoephedrine, or phenylpropanolamine.
Claim 30
Independent Claim
92 words
A method for improving the stability of a pharmaceutical composition that contains a drug-resin complex comprising adding a chelating agent in an amount effective to reduce the rate of degradation of the drug in the drug-resin complex by more than 20 percent over twelve months of storage at room temperature relative to an otherwise identical pharmaceutical composition without the chelating agent; wherein the chelating agent is selected from EDTA or a salt of EDTA; and wherein the drug in the drug-resin complex is selected from dextromethorphan, codeine, morphine, hydrocodone, pseudoephedrine, or phenylpropanolamine.
Claim 31
Independent Claim
92 words
A method for improving the stability of a pharmaceutical composition that contains a drug-resin complex comprising adding a chelating agent in an amount effective to reduce the rate of degradation of the drug in the drug-resin complex by more than 20 percent over twelve months of storage at room temperature relative to an otherwise identical pharmaceutical composition without the chelating agent; wherein the chelating agent is selected from EDTA or a salt of EDTA; and wherein the drug in the drug-resin complex is selected from dextromethorphan, codeine, morphine, hydrocodone, pseudoephedrine, or phenylpropanolamine.
Claim 32
Dependent Claim
12 words
A method according to claim 23, wherein the composition is a solid.
Claim 33
Dependent Claim
12 words
A method according to claim 23, wherein the composition is a gel.
Claim 34
Dependent Claim
12 words
A method according to claim 23, wherein the composition is a suspension.
Claim 35
Independent Claim
130 words
A method for administering a drug to a patient in need thereof, comprising: (a) providing a pharmaceutical composition that contains a drug-resin complex that contains the drug; (b) adding a chelating agent; (c) storing the combination of step (b); and (d) subsequently administering the combination of step (b) to the patient, wherein the chelating agent is present in an amount effective to reduce the amount of degradation of the drug in the drug resin complex by more than 20 percent over twelve months of storage at room temperature relative to an otherwise identical pharmaceutical composition without the chelating agent; wherein the chelating agent is selected from EDTA or a salt of EDTA; and wherein the drug in the drug-resin complex is selected from dextromethorphan, codeine, morphine, hydrocodone, pseudoephedrine, or phenylpropanolamine.
Claim 36
Independent Claim
130 words
A method for administering a drug to a patient in need thereof, comprising: (a) providing a pharmaceutical composition that contains a drug-resin complex that contains the drug; (b) adding a chelating agent; (c) storing the combination of step (b); and (d) subsequently administering the combination of step (b) to the patient, wherein the chelating agent is present in an amount effective to reduce the amount of degradation of the drug in the drug resin complex by more than 20 percent over twelve months of storage at room temperature relative to an otherwise identical pharmaceutical composition without the chelating agent; wherein the chelating agent is selected from EDTA or a salt of EDTA; and wherein the drug in the drug-resin complex is selected from dextromethorphan, codeine, morphine, hydrocodone, pseudoephedrine, or phenylpropanolamine.
Claim 37
Dependent Claim
16 words
A pharmaceutical composition according to claim 1, wherein the drug in the drug-resin complex is dextromethorphan.
Claim 38
Dependent Claim
16 words
A pharmaceutical composition according to claim 1, wherein the drug in the drug-resin complex is codeine.
Claim 39
Dependent Claim
15 words
A method according to claim 17, wherein the drug in the drug-resin complex is dextromethorphan.
Claim 40
Dependent Claim
15 words
A method according to claim 17, wherein the drug in the drug-resin complex is codeine.
Claim 41
Dependent Claim
15 words
A method according to claim 17, wherein the drug in the drug-resin complex is dextromethorphan.
Claim 42
Dependent Claim
15 words
A method according to claim 18, wherein the drug in the drug-resin complex is codeine.
Claim 43
Dependent Claim
15 words
A method according to claim 19, wherein the drug in the drug-resin complex is dextromethorphan.
Claim 44
Dependent Claim
15 words
A method according to claim 19, wherein the drug in the drug-resin complex is codeine.
Claim 45
Dependent Claim
15 words
A method according to claim 23, wherein the drug in the drug-resin complex is dextromethorphan.
Claim 46
Dependent Claim
15 words
A method according to claim 23, wherein the drug in the drug-resin complex is codeine.
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| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
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| 3.5 Years (Year 4) | 2002-11-08 | 2003-05-10 | 2003-11-09 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2006-11-08 | 2007-05-10 | 2007-11-09 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2010-11-08 | 2011-05-10 | 2011-11-09 | $7700.00 | Window Closed / Lapsed |