KR102160837B1 - 활성 물질의 연장된 방출을 위한 약제학적 형태 - Google Patents

활성 물질의 연장된 방출을 위한 약제학적 형태 Download PDF

Info

Publication number
KR102160837B1
KR102160837B1 KR1020147036365A KR20147036365A KR102160837B1 KR 102160837 B1 KR102160837 B1 KR 102160837B1 KR 1020147036365 A KR1020147036365 A KR 1020147036365A KR 20147036365 A KR20147036365 A KR 20147036365A KR 102160837 B1 KR102160837 B1 KR 102160837B1
Authority
KR
South Korea
Prior art keywords
pharmaceutical form
active substance
compartment
emulsifier
active
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.)
Active
Application number
KR1020147036365A
Other languages
English (en)
Korean (ko)
Other versions
KR20150041612A (ko
Inventor
게르노트 프란카스
칼 하인츠 프루취클렝크
Original Assignee
헨니그 아르쯔나이미텔 게엠베하 운트 코. 카게
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 헨니그 아르쯔나이미텔 게엠베하 운트 코. 카게 filed Critical 헨니그 아르쯔나이미텔 게엠베하 운트 코. 카게
Publication of KR20150041612A publication Critical patent/KR20150041612A/ko
Application granted granted Critical
Publication of KR102160837B1 publication Critical patent/KR102160837B1/ko
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

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
    • 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
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
KR1020147036365A 2012-06-25 2013-06-24 활성 물질의 연장된 방출을 위한 약제학적 형태 Active KR102160837B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE102012105512.2A DE102012105512A1 (de) 2012-06-25 2012-06-25 Arzneiform zur verlängerten Freisetzung von Wirkstoffen
DE102012105512.2 2012-06-25
PCT/EP2013/063163 WO2014001268A1 (de) 2012-06-25 2013-06-24 Arzneiform zur verlängerten freisetzung von wirkstoffen

Publications (2)

Publication Number Publication Date
KR20150041612A KR20150041612A (ko) 2015-04-16
KR102160837B1 true KR102160837B1 (ko) 2020-09-29

Family

ID=48670585

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020147036365A Active KR102160837B1 (ko) 2012-06-25 2013-06-24 활성 물질의 연장된 방출을 위한 약제학적 형태

Country Status (22)

Country Link
EP (1) EP2863891B1 (https=)
KR (1) KR102160837B1 (https=)
AU (1) AU2013283474B2 (https=)
BR (1) BR112014032583B1 (https=)
CA (1) CA2876294C (https=)
CO (1) CO7240370A2 (https=)
DE (1) DE102012105512A1 (https=)
EA (2) EA035815B1 (https=)
ES (1) ES2817248T3 (https=)
HR (1) HRP20201534T1 (https=)
HU (1) HUE050945T2 (https=)
IL (1) IL236465B (https=)
IN (1) IN2014MN02511A (https=)
LT (1) LT2863891T (https=)
MX (1) MX371143B (https=)
PH (1) PH12014502834B1 (https=)
PL (1) PL2863891T3 (https=)
PT (1) PT2863891T (https=)
RS (1) RS60872B1 (https=)
SI (1) SI2863891T1 (https=)
UA (1) UA116776C2 (https=)
WO (1) WO2014001268A1 (https=)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3042642A1 (en) 2013-08-12 2015-02-19 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US10172797B2 (en) 2013-12-17 2019-01-08 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
HUE043399T2 (hu) 2014-06-26 2019-08-28 Hennig Arzneimittel Gmbh&Co Kg Gyógyszer, különbözõ okokból eredõ szédülés kezelésére
CA2955229C (en) 2014-07-17 2020-03-10 Pharmaceutical Manufacturing Research Services, Inc. Immediate release abuse deterrent liquid fill dosage form
AU2015336065A1 (en) 2014-10-20 2017-05-04 Pharmaceutical Manufacturing Research Services, Inc. Extended release abuse deterrent liquid fill dosage form
KR101625344B1 (ko) * 2015-12-21 2016-06-08 주식회사 유영제약 세레콕시브 및 둘록세틴을 함유하는 약제학적 조성물

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006099865A2 (de) 2005-03-23 2006-09-28 Hennig Arzneimittel Gmbh & Co. Kg Tablettenförmige retardzubereitung enthaltend cinnarizin und dimenhydrinat gegen schwindel
WO2007056078A2 (en) 2005-11-02 2007-05-18 Cytokinetics, Inc. Certain chemical entities, compositions, and methods
WO2009074609A1 (de) 2007-12-12 2009-06-18 Basf Se Salze von wirkstoffen mit polymeren gegenionen
WO2010142456A1 (en) 2009-06-11 2010-12-16 Photocure Asa Solid compositions comprising 5-aminolevulinic acid
WO2011024029A1 (en) 2009-08-24 2011-03-03 Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi Fast disintegrating dosage forms of cinnarizine and dimenhydrinate combination
WO2012175737A1 (de) 2011-06-24 2012-12-27 Hennig Arzneimittel Gmbh & Co. Kg Wirkstoffmatrix
WO2012175747A1 (de) 2011-06-24 2012-12-27 Hennig Arzneimittel Gmbh & Co. Kg Herstellungsverfahren und arzneiform
WO2013030119A1 (de) 2011-08-29 2013-03-07 Hennig Arzneimittel Gmbh & Co. Kg Darreichungsform mit stabilisierten wirkstoffpartikeln

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9405304D0 (en) * 1994-03-16 1994-04-27 Scherer Ltd R P Delivery systems for hydrophobic drugs
IE80467B1 (en) * 1995-07-03 1998-07-29 Elan Corp Plc Controlled release formulations for poorly soluble drugs
DE69811233T2 (de) * 1997-10-27 2003-11-20 Merck Patent Gmbh Feste lösungen und dispersionen von eines schlecht wasserlöslichen wirkstoffes
US6368622B2 (en) * 1999-01-29 2002-04-09 Abbott Laboratories Process for preparing solid formulations of lipid regulating agents with enhanced dissolution and absorption
US7374779B2 (en) * 1999-02-26 2008-05-20 Lipocine, Inc. Pharmaceutical formulations and systems for improved absorption and multistage release of active agents
ATE500819T1 (de) * 2003-12-31 2011-03-15 Bend Res Inc Stabilisierte pharmazeutische feste zusammensetzungen von arzneimitteln mit geringer löslichkeit, poloxameren und stabilisierenden polymeren
US20050281876A1 (en) * 2004-06-18 2005-12-22 Shun-Por Li Solid dosage form for acid-labile active ingredient
WO2007086078A2 (en) * 2006-01-30 2007-08-02 Panacea Biotec Ltd. Novel pharmaceutical compositions and process of preparation thereof
CN101049309A (zh) * 2006-04-03 2007-10-10 陈茜 桂利嗪滴丸及其制备方法
DK2200588T3 (da) * 2007-09-25 2019-07-01 Solubest Ltd Sammensætninger, som omfatter lipofile aktive forbindelser, og fremgangsmåde til fremstilling deraf

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006099865A2 (de) 2005-03-23 2006-09-28 Hennig Arzneimittel Gmbh & Co. Kg Tablettenförmige retardzubereitung enthaltend cinnarizin und dimenhydrinat gegen schwindel
WO2007056078A2 (en) 2005-11-02 2007-05-18 Cytokinetics, Inc. Certain chemical entities, compositions, and methods
WO2009074609A1 (de) 2007-12-12 2009-06-18 Basf Se Salze von wirkstoffen mit polymeren gegenionen
WO2010142456A1 (en) 2009-06-11 2010-12-16 Photocure Asa Solid compositions comprising 5-aminolevulinic acid
WO2011024029A1 (en) 2009-08-24 2011-03-03 Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi Fast disintegrating dosage forms of cinnarizine and dimenhydrinate combination
WO2012175737A1 (de) 2011-06-24 2012-12-27 Hennig Arzneimittel Gmbh & Co. Kg Wirkstoffmatrix
WO2012175747A1 (de) 2011-06-24 2012-12-27 Hennig Arzneimittel Gmbh & Co. Kg Herstellungsverfahren und arzneiform
WO2013030119A1 (de) 2011-08-29 2013-03-07 Hennig Arzneimittel Gmbh & Co. Kg Darreichungsform mit stabilisierten wirkstoffpartikeln

Also Published As

Publication number Publication date
AU2013283474B2 (en) 2017-12-14
PL2863891T3 (pl) 2021-01-25
CO7240370A2 (es) 2015-04-17
MX371143B (es) 2020-01-20
EP2863891A1 (de) 2015-04-29
UA116776C2 (uk) 2018-05-10
EA035815B1 (ru) 2020-08-14
IN2014MN02511A (https=) 2015-07-17
HUE050945T2 (hu) 2021-01-28
HRP20201534T1 (hr) 2021-02-19
EA028064B1 (ru) 2017-10-31
BR112014032583A2 (pt) 2017-06-27
EP2863891B1 (de) 2020-08-26
AU2013283474A1 (en) 2015-01-29
KR20150041612A (ko) 2015-04-16
SI2863891T1 (sl) 2020-11-30
IL236465B (en) 2020-06-30
LT2863891T (lt) 2020-12-10
WO2014001268A1 (de) 2014-01-03
ES2817248T3 (es) 2021-04-06
CA2876294A1 (en) 2014-01-03
BR112014032583B1 (pt) 2022-05-17
RS60872B1 (sr) 2020-11-30
CA2876294C (en) 2020-09-08
EA201500043A1 (ru) 2015-09-30
PH12014502834A1 (en) 2015-02-02
BR112014032583A8 (pt) 2021-06-22
PH12014502834B1 (en) 2019-12-04
PT2863891T (pt) 2020-09-25
MX2014015642A (es) 2015-08-05
EA201792143A1 (ru) 2018-05-31
DE102012105512A1 (de) 2014-04-24
IL236465A0 (en) 2015-02-26

Similar Documents

Publication Publication Date Title
KR102160837B1 (ko) 활성 물질의 연장된 방출을 위한 약제학적 형태
CN101277684B (zh) 至少一种活性成分改善释放的微粒及含有该微粒的口服药物剂型
KR20230093401A (ko) 붕해가 개선된 경구용 고형 제제 조성물 및 이의 제조 방법
US11839684B2 (en) Mucoadhesive pharmaceutical composition and preparation method therefor
TW200529803A (en) Extrusion process for forming chemically stable drug multiparticulates
JP2015078182A (ja) 速崩壊性圧縮成型物及びその製法
JP2011157348A (ja) 崩壊性高強度球状粒子組成物
DK2346493T3 (en) Multiparticle-shaped tablets and processes for their preparation
CN1878542A (zh) 非片剂化的、可咀嚼的单独剂量给药剂型
JP2024128041A (ja) 錠剤及び錠剤の製造方法
KR102220130B1 (ko) 유효 성분 조합물의 변형 방출을 위한 모놀리식 투여형
JP2016504349A (ja) 溶融押出された放出制御用薬学組成物、およびこれを含む経口用製剤
EA025128B1 (ru) Лекарственная форма для целевого высвобождения активных веществ
WO2012175737A1 (de) Wirkstoffmatrix
WO2012175747A1 (de) Herstellungsverfahren und arzneiform
US20230201124A1 (en) Lubricant for pharmaceuticals and nutraceuticals

Legal Events

Date Code Title Description
PA0105 International application

St.27 status event code: A-0-1-A10-A15-nap-PA0105

T11-X000 Administrative time limit extension requested

St.27 status event code: U-3-3-T10-T11-oth-X000

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

PG1501 Laying open of application

St.27 status event code: A-1-1-Q10-Q12-nap-PG1501

R17-X000 Change to representative recorded

St.27 status event code: A-3-3-R10-R17-oth-X000

E13-X000 Pre-grant limitation requested

St.27 status event code: A-2-3-E10-E13-lim-X000

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

A201 Request for examination
PA0201 Request for examination

St.27 status event code: A-1-2-D10-D11-exm-PA0201

E902 Notification of reason for refusal
PE0902 Notice of grounds for rejection

St.27 status event code: A-1-2-D10-D21-exm-PE0902

T11-X000 Administrative time limit extension requested

St.27 status event code: U-3-3-T10-T11-oth-X000

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

E701 Decision to grant or registration of patent right
PE0701 Decision of registration

St.27 status event code: A-1-2-D10-D22-exm-PE0701

GRNT Written decision to grant
PR0701 Registration of establishment

St.27 status event code: A-2-4-F10-F11-exm-PR0701

PR1002 Payment of registration fee

St.27 status event code: A-2-2-U10-U12-oth-PR1002

Fee payment year number: 1

PG1601 Publication of registration

St.27 status event code: A-4-4-Q10-Q13-nap-PG1601

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 4

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 5

PR1001 Payment of annual fee

St.27 status event code: A-4-4-U10-U11-oth-PR1001

Fee payment year number: 6

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U11-OTH-PR1001 (AS PROVIDED BY THE NATIONAL OFFICE)

Year of fee payment: 6