CA2494015A1 - Antibiotic product, use and formulation thereof - Google Patents

Antibiotic product, use and formulation thereof Download PDF

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Publication number
CA2494015A1
CA2494015A1 CA002494015A CA2494015A CA2494015A1 CA 2494015 A1 CA2494015 A1 CA 2494015A1 CA 002494015 A CA002494015 A CA 002494015A CA 2494015 A CA2494015 A CA 2494015A CA 2494015 A1 CA2494015 A1 CA 2494015A1
Authority
CA
Canada
Prior art keywords
antibiotic
product
host
dosage form
max
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
Application number
CA002494015A
Other languages
French (fr)
Other versions
CA2494015C (en
Inventor
Edward M. Rudnic
James D. Isbister
Donald J. Treacy, Jr.
Sandra E. Wassink
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shionogi Inc
Original Assignee
Individual
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2494015A1 publication Critical patent/CA2494015A1/en
Application granted granted Critical
Publication of CA2494015C publication Critical patent/CA2494015C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/429—Thiazoles condensed with heterocyclic ring systems
    • A61K31/43—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose

Abstract

An antibiotic product is comprised of at least three delayed release dosages forms, each of which has a different release profile, with the Cmax for the antibiotic product being reached in less than about twelve hours.

Claims (14)

1. ~An antibiotic product comprising: a first delayed release antibiotic dosage form, a second delayed release antibiotic dosage form, and a third delayed release antibiotic dosage form, each of said first, second and third delayed release antibiotic dosage forms comprising an antibiotic and a pharmaceutically acceptable carrier, said three dosage forms having different release profiles, said antibiotic product reaching a C max in less than about twelve hours, said antibiotic product being free of an immediate release dosage form.
2. ~The product of Claim 1 wherein the C max for the product is reached no earlier than four hours after administration.
3. ~The product of Claim 2 wherein the product is an oral dosage form.
4. ~The product of Claim 3 wherein the antibiotic released from the second dosage in the form reaches a C max in the serum after C max is reached in the serum for antibiotic released from the first dosage form.
5. ~The product of Claim 4 wherein the antibiotic released from the third dosage form reaches a C max in the serum after the antibiotic released from the second dosage form reaches a C max in the serum.
6. ~The antibiotic product of Claim 1 wherein said antibiotic product includes a total dosage of antibiotic that is effective for a twenty four hour period.
7. ~The product of Claim 1 and further comprising a fourth antibiotic dosage form comprising an antibiotic and a pharmaceutically acceptable carrier, wherein antibiotic released from the fourth dosage form reaches a C max in the serum after C max is achieved in the serum for antibiotic released from each of the first, second and third dosage forms.
8. ~A process for treating a bacterial infection in a host comprising:
administering to a host the antibiotic product of Claim 1.
9. ~A process for treating a bacterial infection in a host comprising:
administering to a host the antibiotic product of Claim 2.
10. ~A process for treating a bacterial infection in a host comprising:
administering to a host the antibiotic product of Claim 3.
11. ~A process for treating a bacterial infection in a host comprising:

administering to a host the antibiotic product of Claim 4.
12. A process for treating a bacterial infection in a host comprising:
administering to a host the antibiotic product of Claim 5.
13. A process for treating a bacterial infection in a host comprising:
administering to a host the antibiotic product of Claim 6.
14. A process for treating a bacterial infection in a host comprising:
administering to a host the antibiotic product of Claim 7.
CA2494015A 2002-08-02 2003-08-01 Antibiotic product, use and formulation thereof Expired - Lifetime CA2494015C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/211,039 US7025989B2 (en) 2000-02-24 2002-08-02 Multiple-delayed released antibiotic product, use and formulation thereof
US10/211,039 2002-08-02
PCT/US2003/024186 WO2004012704A1 (en) 2002-08-02 2003-08-01 Antibiotic product, use and formulation thereof

Publications (2)

Publication Number Publication Date
CA2494015A1 true CA2494015A1 (en) 2004-02-12
CA2494015C CA2494015C (en) 2011-07-19

Family

ID=31494291

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2494015A Expired - Lifetime CA2494015C (en) 2002-08-02 2003-08-01 Antibiotic product, use and formulation thereof

Country Status (6)

Country Link
US (1) US7025989B2 (en)
EP (1) EP1542656A4 (en)
JP (1) JP2006500344A (en)
AU (1) AU2003261339B2 (en)
CA (1) CA2494015C (en)
WO (1) WO2004012704A1 (en)

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Also Published As

Publication number Publication date
US20030104055A1 (en) 2003-06-05
EP1542656A4 (en) 2011-05-25
AU2003261339A1 (en) 2004-02-23
JP2006500344A (en) 2006-01-05
EP1542656A1 (en) 2005-06-22
CA2494015C (en) 2011-07-19
WO2004012704A1 (en) 2004-02-12
AU2003261339B2 (en) 2009-06-11
US7025989B2 (en) 2006-04-11

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