CA2148823A1 - Sustained Release Microsphere Preparation Containing Antipsychotic Drug and Production Process Thereof - Google Patents

Sustained Release Microsphere Preparation Containing Antipsychotic Drug and Production Process Thereof

Info

Publication number
CA2148823A1
CA2148823A1 CA2148823A CA2148823A CA2148823A1 CA 2148823 A1 CA2148823 A1 CA 2148823A1 CA 2148823 A CA2148823 A CA 2148823A CA 2148823 A CA2148823 A CA 2148823A CA 2148823 A1 CA2148823 A1 CA 2148823A1
Authority
CA
Canada
Prior art keywords
sustained release
antipsychotic drug
microsphere preparation
release microsphere
administration
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
CA2148823A
Other languages
French (fr)
Other versions
CA2148823C (en
Inventor
Shigemi Kino
Tomonori Osajima
Hiroaki Mizuta
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.)
Welfide Corp
Original Assignee
Welfide Corporation
Shigemi Kino
Tomonori Osajima
Hiroaki Mizuta
Yoshitomi Pharmaceutical Industries Ltd.
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=18255017&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2148823(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Welfide Corporation, Shigemi Kino, Tomonori Osajima, Hiroaki Mizuta, Yoshitomi Pharmaceutical Industries Ltd. filed Critical Welfide Corporation
Publication of CA2148823A1 publication Critical patent/CA2148823A1/en
Application granted granted Critical
Publication of CA2148823C publication Critical patent/CA2148823C/en
Anticipated expiration legal-status Critical
Expired - Fee Related 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
    • A61K9/14—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
    • 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)
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4515—Non condensed piperidines, e.g. piperocaine having a butyrophenone group in position 1, e.g. haloperidol
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • 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
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole

Landscapes

  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Manufacturing Of Micro-Capsules (AREA)

Abstract

A sustained release microsphere preparation which is produced by including a hydrophobic antipsychotic drug such as bromperidol, haloperidol or the like into a base composed of a high molecular weight polymer having in vivo histocompatibility such as polylactic acid, poly(lactic-co-glycolic)acid or the like, and a process for the production thereof.
When a long-term administration is required, desired pharmacological effects can be obtained by one injection per 1 to 8 weeks, in stead of daily administration. As the result, considerable improvement in compliance at the time of maintenance therapy can be expected. Also, since a high molecular weight polymer having in vivo histocompatibility is used, surgical operations such as embedding and the like are not required at all, and subcutaneous and intramuscular administrations can be made easily absolutely in the same manner as the case of conventional suspension injections so that recovery of the material is not required. In addition, resistance and pain at the time of administration are small.
CA002148823A 1992-11-17 1993-11-15 Sustained release microsphere preparation containing antipsychotic drug and production process thereof Expired - Fee Related CA2148823C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP4-332441 1992-11-17
JP33244192 1992-11-17

Publications (2)

Publication Number Publication Date
CA2148823A1 true CA2148823A1 (en) 1994-05-26
CA2148823C CA2148823C (en) 1999-03-09

Family

ID=18255017

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002148823A Expired - Fee Related CA2148823C (en) 1992-11-17 1993-11-15 Sustained release microsphere preparation containing antipsychotic drug and production process thereof

Country Status (11)

Country Link
US (2) US5656299A (en)
EP (1) EP0669128B1 (en)
KR (1) KR100333115B1 (en)
AT (1) ATE188375T1 (en)
CA (1) CA2148823C (en)
DE (2) DE69327542T2 (en)
DK (1) DK0669128T3 (en)
ES (1) ES2077547T3 (en)
GR (2) GR960300020T1 (en)
PT (1) PT669128E (en)
WO (1) WO1994010982A1 (en)

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Also Published As

Publication number Publication date
EP0669128A1 (en) 1995-08-30
US5656299A (en) 1997-08-12
GR960300020T1 (en) 1996-03-31
ES2077547T1 (en) 1995-12-01
EP0669128B1 (en) 2000-01-05
WO1994010982A1 (en) 1994-05-26
ATE188375T1 (en) 2000-01-15
DE669128T1 (en) 1996-03-14
ES2077547T3 (en) 2000-06-16
PT669128E (en) 2000-06-30
DK0669128T3 (en) 2000-06-19
DE69327542D1 (en) 2000-02-10
KR100333115B1 (en) 2002-12-02
CA2148823C (en) 1999-03-09
US5871778A (en) 1999-02-16
GR3033016T3 (en) 2000-08-31
EP0669128A4 (en) 1996-09-25
DE69327542T2 (en) 2000-07-06
KR950703936A (en) 1995-11-17

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