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AR134066A2 - ORAL SUSTAINED-RELEASE COMPOSITION PREPARED BY MOLDING A COMPOSITION COMPRISING CILOSTAZOL - Google Patents

ORAL SUSTAINED-RELEASE COMPOSITION PREPARED BY MOLDING A COMPOSITION COMPRISING CILOSTAZOL

Info

Publication number
AR134066A2
AR134066A2 ARP240102729A ARP240102729A AR134066A2 AR 134066 A2 AR134066 A2 AR 134066A2 AR P240102729 A ARP240102729 A AR P240102729A AR P240102729 A ARP240102729 A AR P240102729A AR 134066 A2 AR134066 A2 AR 134066A2
Authority
AR
Argentina
Prior art keywords
weight
parts
cilostazol
test
released
Prior art date
Application number
ARP240102729A
Other languages
Spanish (es)
Inventor
Youn Woong Choi
Byung Gu Min
Sang Min Cho
Jae Sang Jang
Ji Hyun Choi
Original Assignee
Korea United Pharm Inc
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=57441116&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR134066(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Korea United Pharm Inc filed Critical Korea United Pharm Inc
Publication of AR134066A2 publication Critical patent/AR134066A2/en

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
    • 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
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)

Abstract

Se proporciona una formulación de liberación sostenida oral, en la que la formulación de liberación sostenida de la presente invención exhibe una tasa de disolución inicial apropiada y un perfil de disolución capaz de mantener efectivamente la concentración de fármaco en el cuerpo, de este modo se reduce la generación de efectos secundarios mientras que se mantiene la eficacia de cilostazol aun cuando se toma una vez por día y también mejora el cumplimiento con el fármaco. Reivindicación 1: Una formulación de liberación sostenida oral que se prepara mediante el moldeado de una composición que comprende cilostazol como un ingrediente activo, una mezcla de un polímero hidrófilo y un carbómero como un portador de liberación sostenida, y un agente solubilizante, en la que la formulación de liberación sostenida oral exhibe el siguiente perfil de disolución cuando se somete a una prueba de disolución de acuerdo con el segundo procedimiento de la Prueba de disolución de la Farmacopea de Corea (un procedimiento de paletas) (37 ± 0,5ºC, solución de lauril sulfato de sodio 0,5%, 50 rpm): 1) 20% a 30% del peso total de cilostazol se libera en el punto de tiempo de 2 horas después del inicio de la prueba; 2) 50% a 70% del peso total de cilostazol se libera en el punto de tiempo de 5 horas después del inicio de la prueba; y 3) al menos 85% del peso total de cilostazol se libera en el punto de tiempo de 10 horas después del inicio de la prueba. Reivindicación 14: Una formulación de liberación sostenida oral que se prepara por moldeado de una composición que comprende 100 partes en peso de cilostazol como ingrediente activo, una mezcla de 10 partes en peso a 30 partes en peso de hidroxipropilmetilcelulosa y 3 partes en peso a 10 partes en peso de carbómero como un portador de liberación sostenida, 5 partes en peso a 20 partes en peso de un agente solubilizante, 30 partes en peso a 70 partes en peso de un relleno, 1 parte en peso a 10 partes en peso de un aglutinante, y 2 partes en peso a 10 partes en peso de un lubricante, en la que la formulación de liberación sostenida oral exhibe el siguiente perfil de disolución cuando se somete a una prueba de disolución de acuerdo con el segundo procedimiento de Prueba de disolución de la Farmacopea de Corea (un procedimiento de paletas) (37 ± 0,5ºC, solución de lauril sulfato de sodio 0,5%, 50 rpm): 1) 20% a 30% del peso total de cilostazol se libera en el punto de tiempo de 2 horas después del inicio de la prueba; 2) 50% a 70% del peso total de cilostazol se libera en el punto de tiempo de 5 horas después del inicio de la prueba; y 3) al menos 85% del peso total de cilostazol se libera en el punto de tiempo de 10 horas después del inicio de la prueba.An oral sustained-release formulation is provided, wherein the sustained-release formulation of the present invention exhibits an appropriate initial dissolution rate and a dissolution profile capable of effectively maintaining the drug concentration in the body, thereby reducing the generation of side effects while maintaining the efficacy of cilostazol even when taken once a day and also improving drug compliance. Claim 1: An oral sustained-release formulation prepared by molding a composition comprising cilostazol as an active ingredient, a mixture of a hydrophilic polymer and a carbomer as a sustained-release carrier, and a solubilizing agent, wherein the oral sustained-release formulation exhibits the following dissolution profile when subjected to a dissolution test according to the second procedure of the Korean Pharmacopoeia Dissolution Test (a paddle procedure) (37 ± 0.5°C, 0.5% sodium lauryl sulfate solution, 50 rpm): 1) 20% to 30% of the total weight of cilostazol is released at the time point 2 hours after the start of the test; 2) 50% to 70% of the total weight of cilostazol is released at the time point 5 hours after the start of the test; and 3) at least 85% of the total weight of cilostazol is released at the time point 10 hours after the start of the test. Claim 14: An oral sustained-release formulation prepared by molding a composition comprising 100 parts by weight of cilostazol as the active ingredient, a mixture of 10 parts by weight to 30 parts by weight of hydroxypropyl methylcellulose and 3 parts by weight to 10 parts by weight of carbomer as a sustained-release carrier, 5 parts by weight to 20 parts by weight of a solubilizing agent, 30 parts by weight to 70 parts by weight of a filler, 1 part by weight to 10 parts by weight of a binder, and 2 parts by weight to 10 parts by weight of a lubricant, wherein the oral sustained-release formulation exhibits the following dissolution profile when subjected to a dissolution test according to the second procedure of the Korean Pharmacopoeia Dissolution Test (a paddle procedure) (37 ± 0.5°C, 0.5% sodium lauryl sulfate solution, 50 rpm): 1) 20% to 30% of the total weight of cilostazol is released at the time point 2 hours after the start of the test; 2) 50% to 70% of the total weight of cilostazol is released at the time point 5 hours after the start of the test; and 3) at least 85% of the total weight of cilostazol is released at the time point 10 hours after the start of the test.

ARP240102729A 2015-05-29 2024-10-08 ORAL SUSTAINED-RELEASE COMPOSITION PREPARED BY MOLDING A COMPOSITION COMPRISING CILOSTAZOL AR134066A2 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
KR1020150076256A KR101748215B1 (en) 2015-05-29 2015-05-29 Oral sustained-release preparation

Publications (1)

Publication Number Publication Date
AR134066A2 true AR134066A2 (en) 2025-11-26

Family

ID=57441116

Family Applications (2)

Application Number Title Priority Date Filing Date
ARP160101559A AR104811A1 (en) 2015-05-29 2016-05-27 ORAL FORMULATION OF SUSTAINED RELEASE
ARP240102729A AR134066A2 (en) 2015-05-29 2024-10-08 ORAL SUSTAINED-RELEASE COMPOSITION PREPARED BY MOLDING A COMPOSITION COMPRISING CILOSTAZOL

Family Applications Before (1)

Application Number Title Priority Date Filing Date
ARP160101559A AR104811A1 (en) 2015-05-29 2016-05-27 ORAL FORMULATION OF SUSTAINED RELEASE

Country Status (6)

Country Link
KR (1) KR101748215B1 (en)
AR (2) AR104811A1 (en)
PH (1) PH12015000296B1 (en)
RU (1) RU2696870C2 (en)
TW (1) TWI732762B (en)
WO (1) WO2016195154A1 (en)

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EG23951A (en) * 1999-03-25 2008-01-29 Otsuka Pharma Co Ltd Cilostazol preparation
TWI383809B (en) * 2005-06-29 2013-02-01 Otsuka Pharma Co Ltd Orally disintegrating powder comprising cilostazol
KR20070024254A (en) * 2005-08-26 2007-03-02 한국오츠카제약 주식회사 Sustained-release tablet containing cilostazol
EP2481398A4 (en) * 2009-09-23 2013-03-06 Korea United Pharm Inc EXTENDED RELEASE CILOSTAZOL TABLE WITH IMPROVED DELIVERY RATE AND MINIMIZED SIDE EFFECTS
KR101068475B1 (en) * 2009-12-29 2011-09-28 환인제약 주식회사 Sustained release formulation comprising cilostazol and preparation method thereof
KR20130106456A (en) * 2011-04-29 2013-09-30 한국유나이티드제약 주식회사 Composition for controlled release of drug

Also Published As

Publication number Publication date
TW201707688A (en) 2017-03-01
AR104811A1 (en) 2017-08-16
WO2016195154A1 (en) 2016-12-08
TWI732762B (en) 2021-07-11
KR101748215B1 (en) 2017-06-20
PH12015000296A1 (en) 2017-03-13
RU2017140447A3 (en) 2019-07-17
KR20160141253A (en) 2016-12-08
RU2017140447A (en) 2019-07-02
RU2696870C2 (en) 2019-08-07
PH12015000296B1 (en) 2017-03-13

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