CO2020002904A2 - Fabricación de composiciones farmacéuticas - Google Patents

Fabricación de composiciones farmacéuticas

Info

Publication number
CO2020002904A2
CO2020002904A2 CONC2020/0002904A CO2020002904A CO2020002904A2 CO 2020002904 A2 CO2020002904 A2 CO 2020002904A2 CO 2020002904 A CO2020002904 A CO 2020002904A CO 2020002904 A2 CO2020002904 A2 CO 2020002904A2
Authority
CO
Colombia
Prior art keywords
manufacture
pharmaceutical compositions
excipient
pharmaceutical composition
mixing
Prior art date
Application number
CONC2020/0002904A
Other languages
English (en)
Inventor
Robert Rönnback
Josselin Saunier
Original Assignee
Ferring Int Center Sa
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 Ferring Int Center Sa filed Critical Ferring Int Center Sa
Publication of CO2020002904A2 publication Critical patent/CO2020002904A2/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
    • A61K9/08—Solutions
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F23/00—Mixing according to the phases to be mixed, e.g. dispersing or emulsifying
    • B01F23/02—Maintaining the aggregation state of the mixed materials
    • B01F23/024—Maintaining mixed ingredients in movement to prevent separation of the ingredients after mixing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F23/00—Mixing according to the phases to be mixed, e.g. dispersing or emulsifying
    • B01F23/06—Mixing phases by adding a very small quantity of one of the phases or microdosing
    • B01F23/062—Mixing ingredients in very small quantity, adding microingredients or microconcentration, e.g. adding vitamins, minerals, proteins, enzymes, hormones, antibiotics or worm medicines
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F27/00—Mixers with rotary stirring devices in fixed receptacles; Kneaders
    • B01F27/05—Stirrers
    • B01F27/11—Stirrers characterised by the configuration of the stirrers
    • B01F27/114—Helically shaped stirrers, i.e. stirrers comprising a helically shaped band or helically shaped band sections
    • B01F27/1143—Helically shaped stirrers, i.e. stirrers comprising a helically shaped band or helically shaped band sections screw-shaped, e.g. worms
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F27/00—Mixers with rotary stirring devices in fixed receptacles; Kneaders
    • B01F27/60—Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a horizontal or inclined axis
    • B01F27/72—Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a horizontal or inclined axis with helices or sections of helices
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F27/00—Mixers with rotary stirring devices in fixed receptacles; Kneaders
    • B01F27/80—Mixers with rotary stirring devices in fixed receptacles; Kneaders with stirrers rotating about a substantially vertical axis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/80—Mixing plants; Combinations of mixers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/80—Mixing plants; Combinations of mixers
    • B01F33/82—Combinations of dissimilar mixers
    • B01F33/821—Combinations of dissimilar mixers with consecutive receptacles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/80—Mixing plants; Combinations of mixers
    • B01F33/84—Mixing plants with mixing receptacles receiving material dispensed from several component receptacles, e.g. paint tins
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/20—Measuring; Control or regulation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/20—Measuring; Control or regulation
    • B01F35/21—Measuring
    • B01F35/211—Measuring of the operational parameters
    • B01F35/2111—Flow rate
    • B01F35/21111—Mass flow rate
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/20—Measuring; Control or regulation
    • B01F35/21—Measuring
    • B01F35/211—Measuring of the operational parameters
    • B01F35/2117—Weight
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/20—Measuring; Control or regulation
    • B01F35/21—Measuring
    • B01F35/2132—Concentration, pH, pOH, p(ION) or oxygen-demand
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/20—Measuring; Control or regulation
    • B01F35/21—Measuring
    • B01F35/2135—Humidity, e.g. moisture content
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/20—Measuring; Control or regulation
    • B01F35/21—Measuring
    • B01F35/214—Measuring characterised by the means for measuring
    • B01F35/2144—Measuring characterised by the means for measuring using radiation for measuring the parameters of the mixture or components to be mixed
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/20—Measuring; Control or regulation
    • B01F35/22—Control or regulation
    • B01F35/2201—Control or regulation characterised by the type of control technique used
    • B01F35/2203—Controlling the mixing process by feed-forward, i.e. a parameter of the components to be mixed is measured and the feed values are calculated
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/71—Feed mechanisms
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/71—Feed mechanisms
    • B01F35/715—Feeding the components in several steps, e.g. successive steps
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/80—Forming a predetermined ratio of the substances to be mixed
    • B01F35/82—Forming a predetermined ratio of the substances to be mixed by adding a material to be mixed to a mixture in response to a detected feature, e.g. density, radioactivity, consumed power or colour
    • 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

Landscapes

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

Abstract

La presente divulgación divulga un proceso para la fabricación continua de una composición farmacéutica líquida, comprendiendo el proceso proporcionar una unidad de mezcla, introducir una sustancia terapéutica y un excipiente líquido en la unidad de mezcla, operar esta última mezclando la sustancia y el excipiente obteniendo una composición farmacéutica líquida, descargar la composición en una unidad de contención.
CONC2020/0002904A 2017-09-18 2020-03-12 Fabricación de composiciones farmacéuticas CO2020002904A2 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP17191652 2017-09-18
PCT/EP2018/075034 WO2019053247A1 (en) 2017-09-18 2018-09-17 MANUFACTURE OF PHARMACEUTICAL COMPOSITIONS

Publications (1)

Publication Number Publication Date
CO2020002904A2 true CO2020002904A2 (es) 2020-05-29

Family

ID=59914324

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2020/0002904A CO2020002904A2 (es) 2017-09-18 2020-03-12 Fabricación de composiciones farmacéuticas

Country Status (21)

Country Link
US (1) US12263246B2 (es)
EP (1) EP3684335A1 (es)
JP (1) JP7291127B2 (es)
KR (1) KR102586260B1 (es)
CN (1) CN111372571B (es)
AR (1) AR112818A1 (es)
AU (1) AU2018332076B2 (es)
BR (1) BR112020004952A2 (es)
CL (1) CL2020000643A1 (es)
CO (1) CO2020002904A2 (es)
EA (1) EA039921B1 (es)
IL (1) IL273259B2 (es)
JO (1) JOP20200058A1 (es)
MX (1) MX2020002779A (es)
PH (1) PH12020500525A1 (es)
SG (1) SG11202002168SA (es)
TN (1) TN2020000047A1 (es)
TW (1) TWI775943B (es)
UA (1) UA127186C2 (es)
WO (1) WO2019053247A1 (es)
ZA (1) ZA202001544B (es)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114901794B (zh) 2019-11-15 2026-05-01 隆萨有限公司 用于生产接种物的过程和系统
US12145112B2 (en) * 2020-11-04 2024-11-19 Saudi Arabian Oil Company Methods and systems for the generation of stable oil-in-water or water-in-oil emulsion for enhanced oil recovery
CN112569848B (zh) * 2020-12-16 2022-11-15 安徽惠泽农业科技有限公司 一种多组份复合肥调制处理装置及复合肥生产工艺
US11850619B2 (en) * 2021-03-15 2023-12-26 The Boeing Company Robot end effector for dispensing an extrudable substance
US11583886B2 (en) * 2021-03-15 2023-02-21 The Boeing Company Robot end effector with rotating barrel for dispensing an extrudable substance
US11583876B2 (en) * 2021-03-15 2023-02-21 The Boeing Company Positive displacement end effector with multiple cartridges
AU2023356697A1 (en) * 2022-10-07 2025-05-22 Genzyme Corporation Product formulation in biological manufacturing
JP2024119355A (ja) * 2023-02-22 2024-09-03 株式会社日立ハイテクソリューションズ 生産プロセス制御方法およびシステム

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Also Published As

Publication number Publication date
AU2018332076A1 (en) 2020-04-02
EP3684335A1 (en) 2020-07-29
BR112020004952A2 (pt) 2020-09-15
UA127186C2 (uk) 2023-05-31
CN111372571B (zh) 2022-11-18
KR102586260B1 (ko) 2023-10-06
AU2018332076B2 (en) 2024-10-17
JOP20200058A1 (ar) 2020-03-11
EA202090508A1 (ru) 2020-07-06
TWI775943B (zh) 2022-09-01
CL2020000643A1 (es) 2020-09-11
IL273259A (en) 2020-04-30
CN111372571A (zh) 2020-07-03
IL273259B1 (en) 2024-11-01
WO2019053247A1 (en) 2019-03-21
JP2020534288A (ja) 2020-11-26
SG11202002168SA (en) 2020-04-29
US12263246B2 (en) 2025-04-01
TN2020000047A1 (en) 2021-10-04
TW201919557A (zh) 2019-06-01
EA039921B1 (ru) 2022-03-28
ZA202001544B (en) 2021-10-27
CA3075689A1 (en) 2019-03-21
IL273259B2 (en) 2025-03-01
AR112818A1 (es) 2019-12-18
MX2020002779A (es) 2020-11-06
JP7291127B2 (ja) 2023-06-14
KR20200065002A (ko) 2020-06-08
US20200222319A1 (en) 2020-07-16
PH12020500525A1 (en) 2021-05-10

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