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MX2016009347A - Proceso para la reconstitucion de una forma solida de una composicion farmaceutica. - Google Patents

Proceso para la reconstitucion de una forma solida de una composicion farmaceutica.

Info

Publication number
MX2016009347A
MX2016009347A MX2016009347A MX2016009347A MX2016009347A MX 2016009347 A MX2016009347 A MX 2016009347A MX 2016009347 A MX2016009347 A MX 2016009347A MX 2016009347 A MX2016009347 A MX 2016009347A MX 2016009347 A MX2016009347 A MX 2016009347A
Authority
MX
Mexico
Prior art keywords
pressure
pharmaceutical composition
solid form
reconstitution
container
Prior art date
Application number
MX2016009347A
Other languages
English (en)
Inventor
Payet-Burin Xavier
Original Assignee
Ucb Biopharma Sprl
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=50033446&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MX2016009347(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ucb Biopharma Sprl filed Critical Ucb Biopharma Sprl
Publication of MX2016009347A publication Critical patent/MX2016009347A/es

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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • 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
    • A61K9/08—Solutions
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F29/00—Mixers with rotating receptacles
    • B01F29/60—Mixers with rotating receptacles rotating about a horizontal or inclined axis, e.g. drum mixers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F2101/00—Mixing characterised by the nature of the mixed materials or by the application field
    • B01F2101/22—Mixing of ingredients for pharmaceutical or medical compositions
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F2101/00—Mixing characterised by the nature of the mixed materials or by the application field
    • B01F2101/2202—Mixing compositions or mixers in the medical or veterinary field

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

La invención se relaciona con un proceso para la reconstitución de una forma sólida de una composición farmacéutica que comprende los siguientes pasos sucesivos: (i) proporcionar la forma sólida de la composición farmacéutica en un recipiente sellado, siendo la presión dentro del recipiente una presión inicial (pi) comprendida entre 0.5 Pa y 1.2 x 105 Pa; (ii) introducir en un primer punto del tiempo (t0) el disolvente en el recipiente sellado y mantener la presión resultante (Pr) dentro del recipiente durante un tiempo controlado ?t1; y (iii) en un segundo punto del tiempo (t2) incrementar la presión dentro del recipiente a una presión controlada (p2) mayor que la presión resultante (Pr) hasta la reconstitución completa.
MX2016009347A 2014-01-20 2015-01-20 Proceso para la reconstitucion de una forma solida de una composicion farmaceutica. MX2016009347A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP14305070 2014-01-20
PCT/EP2015/050988 WO2015107214A1 (en) 2014-01-20 2015-01-20 Process for reconstitution of a solid form of a pharmaceutical composition

Publications (1)

Publication Number Publication Date
MX2016009347A true MX2016009347A (es) 2017-02-02

Family

ID=50033446

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2016009347A MX2016009347A (es) 2014-01-20 2015-01-20 Proceso para la reconstitucion de una forma solida de una composicion farmaceutica.

Country Status (15)

Country Link
US (1) US10376467B2 (es)
EP (1) EP3096743B1 (es)
JP (1) JP6397933B2 (es)
KR (1) KR102325240B1 (es)
CN (1) CN106163501B (es)
AU (1) AU2015207464B2 (es)
BR (1) BR112016016690A2 (es)
CA (1) CA2936721C (es)
CL (1) CL2016001801A1 (es)
ES (1) ES2916825T3 (es)
IL (1) IL246619A0 (es)
MX (1) MX2016009347A (es)
RU (1) RU2016133973A (es)
SG (1) SG11201605862WA (es)
WO (1) WO2015107214A1 (es)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2960646A1 (en) * 2014-06-27 2015-12-30 F. Hoffmann-La Roche AG Method for determining whether reconstitution of a solution in a container is completed
MX2019007433A (es) 2016-12-22 2019-08-16 Genentech Inc Metodos y formulaciones para reducir el tiempo de reconstitucion de los polipeptidos liofilizados.
WO2021041319A1 (en) * 2019-08-29 2021-03-04 Eli Lilly And Company Crystalline forms of a cd73 inhibitor
SMT202400434T1 (it) 2020-12-23 2025-01-14 Tolmar International Ltd Sistemi e metodi per gruppi valvole per siringhe di miscelazione
USD1029245S1 (en) 2022-06-22 2024-05-28 Tolmar International Limited Syringe connector

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4741900A (en) 1982-11-16 1988-05-03 Cytogen Corporation Antibody-metal ion complexes
US4543101A (en) * 1984-03-28 1985-09-24 Adria Laboratories, Inc. Valve device to aid in reconstituting injectable powders
GB8720833D0 (en) 1987-09-04 1987-10-14 Celltech Ltd Recombinant dna product
US6307026B1 (en) 1992-12-10 2001-10-23 Celltech Limited Humanized antibodies directed against A33 antigen
FR2716640B1 (fr) 1994-02-28 1996-05-03 Procedes Machines Speciales Dispositif de centrage et de blocage d'une pièce en vue de son rodage à l'aide d'un rodoir à expansion.
KR100546726B1 (ko) * 1996-06-04 2006-10-24 소시에떼 더 콘세이유 더 레세르세 에 다플리까띠옹 시엔띠피끄, 에스.아.에스. 주사제를제조하는방법및장치
GB9625640D0 (en) 1996-12-10 1997-01-29 Celltech Therapeutics Ltd Biological products
US6358236B1 (en) * 1998-08-06 2002-03-19 Baxter International Inc. Device for reconstituting medicaments for injection
DE10211227A1 (de) * 2002-03-13 2003-10-02 Aventis Behring Gmbh Verfahren zur Rekonstitution von Iyophilisierten Proteinen
GB0303337D0 (en) 2003-02-13 2003-03-19 Celltech R&D Ltd Biological products
EP2995331B1 (en) 2004-09-10 2018-09-05 Becton, Dickinson and Company Reconstituting infusion device and method of reconstituting medicament
US7523946B2 (en) * 2005-06-20 2009-04-28 Xerox Corporation Expandable chuck
US9309316B2 (en) * 2005-12-20 2016-04-12 Bristol-Myers Squibb Company Stable subcutaneous protein formulations and uses thereof
PL2242479T3 (pl) * 2007-12-28 2012-02-29 Baxalta Inc Filtracja białek z zastosowaniem przeciwciśnienia
US20110155620A1 (en) * 2009-12-30 2011-06-30 Baxter International Inc. Rapid reconstitution for lyophilized-pharmaceutical suspensions
IN2014DN05901A (es) 2011-12-29 2015-06-05 Omrix Biopharmaceuticals Ltd
US9731076B2 (en) * 2012-06-29 2017-08-15 Ethicon, Inc. Multi-compartment pre-filled mixing syringes with bypass

Also Published As

Publication number Publication date
US10376467B2 (en) 2019-08-13
IL246619A0 (en) 2016-08-31
US20160331682A1 (en) 2016-11-17
JP2017505339A (ja) 2017-02-16
RU2016133973A (ru) 2018-03-05
RU2016133973A3 (es) 2018-07-11
KR20160135176A (ko) 2016-11-25
CN106163501B (zh) 2019-05-31
EP3096743A1 (en) 2016-11-30
WO2015107214A1 (en) 2015-07-23
JP6397933B2 (ja) 2018-09-26
AU2015207464B2 (en) 2019-10-03
KR102325240B1 (ko) 2021-11-11
CA2936721A1 (en) 2015-07-23
CA2936721C (en) 2021-12-14
ES2916825T3 (es) 2022-07-06
SG11201605862WA (en) 2016-08-30
AU2015207464A1 (en) 2016-07-28
BR112016016690A2 (pt) 2018-03-20
CL2016001801A1 (es) 2017-05-05
CN106163501A (zh) 2016-11-23
EP3096743B1 (en) 2022-02-16

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