CA2406064A1 - Minimizing adverse experience associated with oxybutynin therapy - Google Patents
Minimizing adverse experience associated with oxybutynin therapy Download PDFInfo
- Publication number
- CA2406064A1 CA2406064A1 CA002406064A CA2406064A CA2406064A1 CA 2406064 A1 CA2406064 A1 CA 2406064A1 CA 002406064 A CA002406064 A CA 002406064A CA 2406064 A CA2406064 A CA 2406064A CA 2406064 A1 CA2406064 A1 CA 2406064A1
- Authority
- CA
- Canada
- Prior art keywords
- composition
- oxybutynin
- desethyloxybutynin
- metabolite
- auc
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
- A61K9/7061—Polyacrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/10—Drugs for disorders of the urinary system of the bladder
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
- A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
Abstract
The present invention provides compositions and methods for administering oxybutynin while minimizing the in-cidence and or severity of adverse drug experiences associated with oxybutynin therapy. In one aspect, these compositions and methods provide a lower plasma concentration of oxybutynin metabolites, such as N-desethyloxybutynin, which is presumed to be contributing at least in part to some of the adverse drug experiences, while maintaining sufficient oxybutynin plasma concentration to benefit a subject with oxybutynin therapy. The invention also provides isomers of oxybutynin and its metabolites that meet these characteristics of minimized incidence and/or severity of adverse drug experiences, and maintenance of beneficial and effective ther-apy for overactive bladder.
Claims (23)
1. A pharmaceutical composition that minimizes an adverse drug experience associated with oxybutynin therapy comprising: oxybutynin, wherein the composition provides a plasma area under the curve (AUC) ratio of oxybutynin to an oxybutynin metabolite of about 0.5:1 to about 5:1.
2. The composition of claim 1, wherein the AUC ratio of oxybutynin to an oxybutynin metabolite is about 0.5:1 to about 2:1.
3. The composition of claim 1, wherein the AUC ratio of oxybutynin to an oxybutynin metabolite is from about 1:1 to about 5:1.
4. The composition of claim l, wherein the AUC ratio of oxybutynin to an oxybutynin metabolite is from about 0.8:1 to about 1.5:1.
5. The composition of claim 1, wherein the oxybutynin in the plasma is (R)-oxybutynin, (S)-oxybutynin, or a combination thereof.
6. The composition of claim 1, wherein the metabolite of oxybutynin is N-desethyloxybutynin.
7. The composition of claim 6, wherein the N-desethyloxybutynin is (R)-N-desethyloxybutynin, (S)-N-desethyloxybutynin, or a combination thereof.
8. The composition of claim 5, wherein the AUC of (R)-oxybutynin to (S)-oxybutynin is about 0.7:1.
9. The composition of claim 7, wherein the AUC of (R)-N-desethyloxybutynin to (R)-oxybutynin is from about 0.4:1 to about 1.6:1.
10. The composition of claim 9, wherein the AUC ratio of (R)-N-desethyloxybutynin to (R)-oxybutynin is about 1:1.
11. The composition of claim 7, wherein the AUC ratio of (R)-N-desethyloxybutynin to (S)-N-desethyloxybutynin about 0.5:1 to about 1.3:1.
12. The composition of claim 7, wherein the AUC ratio of (R)-N-desethyloxybutynin to (S)-N-desethyloxybutynin is about 0.9:1.
13. The composition of claim 1, wherein the metabolite plasma concentration reaches a peak plasma value of less than about 8 ng/ml.
14. The composition of claim 1, wherein the metabolite plasma concentration reaches a peak value of less than about 5 ng/ml.
15. The composition of claim l, wherein the composition is a formulation which is selected from the group consisting of an oral, parenteral, transdermal, inhalant, or implantable composition.
16. The composition of claim 1, wherein the composition is a non-oral composition.
17. The composition of claim l, which is a sustained release composition.
18. The composition of claim 15, wherein the composition is a transdermal composition.
19. The composition of claim 18, further comprising an optional ingredient selected from the group consisting of: a permeation enhancer, an anti-irritant, an adhesion adjuster, or a combination thereof.
20. The method of claim 1, wherein the adverse drug experience is an experience selected from the group consisting of:
gastrointestinal/genitourinary, nervous system, cardiovascular, dermatological, and ophthalmic experiences, or a combination thereof.
gastrointestinal/genitourinary, nervous system, cardiovascular, dermatological, and ophthalmic experiences, or a combination thereof.
21. The method of claim 20, wherein the adverse experience is an anticholinergic adverse experience, or an antimuscarinic adverse experience.
22. An article of manufacture for transdermal application comprising:
a composition as recited in any preceding claim wherein the composition provides, upon administration to a subject, a plasma AUC ratio of oxybutynin to an oxybutynin metabolite as recited in any preceding claim.
a composition as recited in any preceding claim wherein the composition provides, upon administration to a subject, a plasma AUC ratio of oxybutynin to an oxybutynin metabolite as recited in any preceding claim.
23. A method of minimizing an adverse drug experience associated with oxybutynin therapy comprising the step of:
administering a pharmaceutical composition as in any of claims 1-21.
administering a pharmaceutical composition as in any of claims 1-21.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US55971100A | 2000-04-26 | 2000-04-26 | |
US09/559,711 | 2000-04-26 | ||
PCT/US2001/013135 WO2001080796A1 (en) | 2000-04-26 | 2001-04-24 | Minimizing adverse experience associated with oxybutynin therapy |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2406064A1 true CA2406064A1 (en) | 2001-11-01 |
CA2406064C CA2406064C (en) | 2011-03-15 |
Family
ID=24234699
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA2406064A Expired - Lifetime CA2406064C (en) | 2000-04-26 | 2001-04-24 | Minimizing adverse experience associated with oxybutynin therapy |
Country Status (16)
Country | Link |
---|---|
US (6) | US6743441B2 (en) |
EP (3) | EP1992342A1 (en) |
JP (3) | JP2003531157A (en) |
CN (4) | CN101305994A (en) |
AT (1) | ATE488233T1 (en) |
AU (2) | AU2001253782B2 (en) |
BR (1) | BR0110381A (en) |
CA (1) | CA2406064C (en) |
CY (1) | CY1111498T1 (en) |
DE (1) | DE60143477D1 (en) |
DK (1) | DK1280486T3 (en) |
ES (1) | ES2357699T3 (en) |
HK (1) | HK1052287A1 (en) |
MX (2) | MX342305B (en) |
PT (1) | PT1280486E (en) |
WO (1) | WO2001080796A1 (en) |
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2001
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