BRPI0517256B8 - método para fabricação de uma forma de dosagem sólida de rápida desintegração - Google Patents

método para fabricação de uma forma de dosagem sólida de rápida desintegração

Info

Publication number
BRPI0517256B8
BRPI0517256B8 BRPI0517256A BRPI0517256A BRPI0517256B8 BR PI0517256 B8 BRPI0517256 B8 BR PI0517256B8 BR PI0517256 A BRPI0517256 A BR PI0517256A BR PI0517256 A BRPI0517256 A BR PI0517256A BR PI0517256 B8 BRPI0517256 B8 BR PI0517256B8
Authority
BR
Brazil
Prior art keywords
solid dosage
water
manufacturing
dosed
dosage form
Prior art date
Application number
BRPI0517256A
Other languages
English (en)
Inventor
Heinz Bauer Kurt
Original Assignee
Pantec Ag
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=34929781&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI0517256(B8) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Pantec Ag filed Critical Pantec Ag
Publication of BRPI0517256A publication Critical patent/BRPI0517256A/pt
Publication of BRPI0517256B1 publication Critical patent/BRPI0517256B1/pt
Publication of BRPI0517256B8 publication Critical patent/BRPI0517256B8/pt

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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61K9/0007—Effervescent
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/10—Laxatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Pain & Pain Management (AREA)
  • Cardiology (AREA)
  • Rheumatology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medicinal Preparation (AREA)
  • Drying Of Solid Materials (AREA)
  • Meat, Egg Or Seafood Products (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

forma de dosagem sólida de rápida desintegração, altamente porosa e seu modo de fabricação compreendendo a preparação de um pó e uma etapa de secagem por congelamento. a presente invenção refere-se a um método de fabricação de formas de dosagem sólidas de rápida desintegração, caracterizado pelo fato de que um ou mais componentes de formação de estrutura em forma em pó sólida misturada são administrados dosadamente em cavidades de moldes ou embalagens de blister, os componentes restantes dissolvidos em água administrados dosadamente e adicionados ao pó para formar uma massa plastificada, molhada, congelada para abaixo de -20°c e água sublimada em alto vácuo. deste modo formas de dosagem sólidas são obteníveis com uma estrutura porosa similar como usualmente resultam de processos de secagem por congelamento, mas o processo exige muito menos água, que significa consideravelmente menos tempo e menos energia.
BRPI0517256A 2004-10-28 2005-10-27 método para fabricação de uma forma de dosagem sólida de rápida desintegração BRPI0517256B8 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP04105381 2004-10-28
PCT/EP2005/055591 WO2006045830A1 (en) 2004-10-28 2005-10-27 A highly porous, fast-disintegrating solid dosage form and its way of manufacturing comprising the preparation of a podwer and a freezedrying step

Publications (3)

Publication Number Publication Date
BRPI0517256A BRPI0517256A (pt) 2008-10-07
BRPI0517256B1 BRPI0517256B1 (pt) 2018-11-21
BRPI0517256B8 true BRPI0517256B8 (pt) 2021-05-25

Family

ID=34929781

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0517256A BRPI0517256B8 (pt) 2004-10-28 2005-10-27 método para fabricação de uma forma de dosagem sólida de rápida desintegração

Country Status (18)

Country Link
US (1) US8802145B2 (pt)
EP (1) EP1804764B1 (pt)
JP (1) JP4980228B2 (pt)
KR (1) KR101379297B1 (pt)
CN (2) CN102631289B (pt)
AT (1) ATE398444T1 (pt)
BR (1) BRPI0517256B8 (pt)
CA (1) CA2585426C (pt)
CY (1) CY1108343T1 (pt)
DE (1) DE602005007624D1 (pt)
DK (1) DK1804764T3 (pt)
ES (1) ES2308566T3 (pt)
HK (1) HK1171364A1 (pt)
IL (1) IL182745A (pt)
PL (1) PL1804764T3 (pt)
PT (1) PT1804764E (pt)
SI (1) SI1804764T1 (pt)
WO (1) WO2006045830A1 (pt)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2359812C (en) 2000-11-20 2004-02-10 The Procter & Gamble Company Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
DE102017104472A1 (de) 2017-03-03 2018-09-06 Nordmark Arzneimittel Gmbh & Co. Kg Schmelztablette enthaltend Burlulipase und daraus hergestellte pharmazeutische Zusammensetzung
CN106666722B (zh) * 2017-03-13 2019-03-22 广州正广生物科技有限公司 一种螺旋藻片及其制备方法
CA3115574A1 (en) 2018-10-15 2020-04-23 Aprecia Pharmaceuticals LLC Method and system for forming a dosage form within a packaging
GB2585414B (en) 2019-02-22 2023-06-14 Catalent Uk Swindon Zydis Ltd Minimizing agglomeration, aeration, and preserving the coating of pharmaceutical compositions comprising ibuprofen
GB2597579B (en) 2019-02-22 2023-04-26 Catalent Uk Swindon Zydis Ltd Minimizing agglomeration of drug particle coating material during storage to stabilize disintegration times of pharmaceutical products
AU2020224375A1 (en) * 2019-02-22 2021-10-14 Catalent U.K. Swindon Zydis Limited Minimizing aeration of suspensions during in-line mixing
AU2020225818A1 (en) 2019-02-22 2021-10-14 Catalent U.K. Swindon Zydis Limited Preserving functionally-coated API particles produced by solventless mixing processes in aqueous suspension
US11672761B2 (en) 2020-11-16 2023-06-13 Orcosa Inc. Rapidly infusing platform and compositions for therapeutic treatment in humans

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2246013A1 (de) * 1972-09-20 1974-03-28 Boehringer Mannheim Gmbh Verfahren zur herstellung von poroesen tabletten
GB1548022A (en) * 1976-10-06 1979-07-04 Wyeth John & Brother Ltd Pharmaceutial dosage forms
CA1097233A (en) * 1977-07-20 1981-03-10 George K. E. Gregory Packages
ATE24964T1 (de) * 1981-12-11 1987-01-15 Wyeth John & Brother Ltd Verfahren zur herstellung von festen formgegenstaenden.
US5178878A (en) * 1989-10-02 1993-01-12 Cima Labs, Inc. Effervescent dosage form with microparticles
US5654003A (en) * 1992-03-05 1997-08-05 Fuisz Technologies Ltd. Process and apparatus for making tablets and tablets made therefrom
JPH0948726A (ja) 1995-08-07 1997-02-18 Tanabe Seiyaku Co Ltd 口腔内速崩壊性製剤およびその製法
US20010014340A1 (en) * 1996-06-14 2001-08-16 Motohiro Ohta Intrabuccally rapidly disintegrating tablet
US5976577A (en) 1997-07-11 1999-11-02 Rp Scherer Corporation Process for preparing fast dispersing solid oral dosage form
US6010719A (en) * 1997-09-16 2000-01-04 Universiteit Gent Freeze-dried disintegrating tablets
GB9904629D0 (en) * 1999-03-02 1999-04-21 Danbiosyst Uk Oral drug delivery system
DE19931708A1 (de) * 1999-07-08 2001-01-18 Bayer Ag Verfahren zur Herstellung schnell zerfallender, fester pharmazeutischer Zubereitungen
CA2380449A1 (en) * 1999-08-17 2001-02-22 Novartis Consumer Health S.A. Rapidly dissolving dosage form and process for making same
EP1166655A1 (en) * 2000-06-19 2002-01-02 Société des Produits Nestlé S.A. A shelf-stable or chilled foam product and a process for its preparation
CN1290525A (zh) * 2000-10-10 2001-04-11 北京万全阳光医药科技有限公司 冷冻干燥的扎来普隆速溶口服组合物
US6509040B1 (en) * 2001-06-22 2003-01-21 R.P. Scherer Corporation Fast dispersing dosage forms essentially free of mammalian gelatin
CN1197556C (zh) * 2003-02-12 2005-04-20 刘智 一种防治放疗、化疗呕吐的口腔快速崩解片剂及制备方法
US20050036977A1 (en) 2003-08-11 2005-02-17 Dilip Gole Taste-masked resinate and preparation thereof

Also Published As

Publication number Publication date
EP1804764B1 (en) 2008-06-18
KR101379297B1 (ko) 2014-04-10
US8802145B2 (en) 2014-08-12
CY1108343T1 (el) 2014-02-12
ES2308566T3 (es) 2008-12-01
EP1804764A1 (en) 2007-07-11
BRPI0517256A (pt) 2008-10-07
IL182745A0 (en) 2007-07-24
IL182745A (en) 2010-06-30
JP2008517979A (ja) 2008-05-29
US20090062241A1 (en) 2009-03-05
WO2006045830A1 (en) 2006-05-04
CN102631289A (zh) 2012-08-15
SI1804764T1 (sl) 2008-10-31
PL1804764T3 (pl) 2008-11-28
DK1804764T3 (da) 2008-09-29
JP4980228B2 (ja) 2012-07-18
HK1171364A1 (zh) 2013-03-28
KR20070069179A (ko) 2007-07-02
DE602005007624D1 (de) 2008-07-31
CA2585426A1 (en) 2006-05-04
CN102631289B (zh) 2016-05-04
ATE398444T1 (de) 2008-07-15
PT1804764E (pt) 2008-09-11
CA2585426C (en) 2013-05-14
BRPI0517256B1 (pt) 2018-11-21
CN101065105A (zh) 2007-10-31

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B06I Publication of requirement cancelled [chapter 6.9 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 21/11/2018, OBSERVADAS AS CONDICOES LEGAIS.

B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 27/10/2005 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF

B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

Free format text: REFERENTE A 17A ANUIDADE.

B24J Lapse because of non-payment of annual fees (definitively: art 78 iv lpi, resolution 113/2013 art. 12)

Free format text: EM VIRTUDE DA EXTINCAO PUBLICADA NA RPI 2694 DE 23-08-2022 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDA A EXTINCAO DA PATENTE E SEUS CERTIFICADOS, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.