HRP20191394T1 - Proizvodnja linija za proizvodnju medicinskih proizvoda i proizvodno postrojenje koje sadrži takvu proizvodnu liniju - Google Patents

Proizvodnja linija za proizvodnju medicinskih proizvoda i proizvodno postrojenje koje sadrži takvu proizvodnu liniju Download PDF

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Publication number
HRP20191394T1
HRP20191394T1 HRP20191394T HRP20191394T1 HR P20191394 T1 HRP20191394 T1 HR P20191394T1 HR P20191394 T HRP20191394 T HR P20191394T HR P20191394 T1 HRP20191394 T1 HR P20191394T1
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Croatia
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production line
production
extruder
active ingredient
screw
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English (en)
Inventor
Margerie Victoire De
Donatien Bruggeman
Hans Mayer
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Rondol Ind
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Publication of HRP20191394T1 publication Critical patent/HRP20191394T1/hr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/36—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die
    • B29C48/395—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die using screws surrounded by a cooperating barrel, e.g. single screw extruders
    • B29C48/40—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die using screws surrounded by a cooperating barrel, e.g. single screw extruders using two or more parallel screws or at least two parallel non-intermeshing screws, e.g. twin screw extruders
    • B29C48/402—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die using screws surrounded by a cooperating barrel, e.g. single screw extruders using two or more parallel screws or at least two parallel non-intermeshing screws, e.g. twin screw extruders the screws having intermeshing parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/06—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of pills, lozenges or dragees
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/08—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of suppositories or sticks
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/022—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the choice of material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/14—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the particular extruding conditions, e.g. in a modified atmosphere or by using vibration
    • B29C48/141—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the particular extruding conditions, e.g. in a modified atmosphere or by using vibration extruding in a clean room
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/36—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die
    • B29C48/395—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die using screws surrounded by a cooperating barrel, e.g. single screw extruders
    • B29C48/40—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die using screws surrounded by a cooperating barrel, e.g. single screw extruders using two or more parallel screws or at least two parallel non-intermeshing screws, e.g. twin screw extruders
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/88—Thermal treatment of the stream of extruded material, e.g. cooling
    • B29C48/911—Cooling
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/92—Measuring, controlling or regulating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/20—Extrusion means, e.g. for producing pharmaceutical forms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/40—Heating or cooling means; Combinations thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/40—Heating or cooling means; Combinations thereof
    • A61J2200/42—Heating means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/40—Heating or cooling means; Combinations thereof
    • A61J2200/44—Cooling means
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C2791/00—Shaping characteristics in general
    • B29C2791/004—Shaping under special conditions
    • B29C2791/005—Using a particular environment, e.g. sterile fluids other than air
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/14—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the particular extruding conditions, e.g. in a modified atmosphere or by using vibration
    • B29C48/142—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the particular extruding conditions, e.g. in a modified atmosphere or by using vibration using force fields, e.g. gravity or electrical fields

Claims (13)

1. Proizvodna linija (12) za proizvodnju medicinskih proizvoda koji sadrže barem jedan aktivni sastojak, te proizvodna linija (12) sadrži ekstruder (20), za proizvodnju ekstrudata iz aktivnog sastojka i najmanje jednog ekscipijenta namijenjenog stvaranju inkapsulirajućeg matriksa aktivnog sastojka, te rashladni element (24) za hlađenje ekstrudata na izlazu iz ekstrudera (20), te ekstruder (20) sadrži cijev (30) i najmanje dva paralelna vijka (32) smještena u cijevi (30) i međusobno se prožimaju radi miješanja ili svakog aktivnog sastojka ili svakog ekscipijenta, naznačena time što je cijev (30) orijentirana uglavnom okomito.
2. Proizvodna linija (12) prema patentnom zahtjevu 1, naznačena time što je tlocrtna površina koju zauzima proizvodna linija (12) manja od 0,5 m2.
3. Proizvodna linija (12) prema patentnom zahtjevu 1 ili 2, naznačena time što sadrži daljinski upravljački terminal (92) za kontrolu ekstrudera (20) i bežični komunikacijski uređaj (94) za razmjenu podataka između ekstrudera (20) i upravljačkog terminala (92).
4. Proizvodna linija (12) u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što rashladni element (24) uključuje omotač (64) koji definira prolaz (66) za ekstrudat i koji ima najmanje jedan kanal za vođenje (68) za usmjeravanje rashladne tekućine oko prolaza (66).
5. Proizvodna linija (12) prema patentnom zahtjevu 4, naznačena time što je rashladni element (24) smješten ispod cijevi (30).
6. Proizvodna linija (12) prema patentnom zahtjevu 4 ili 5, naznačena time što je prolaz (66) orijentiran uglavnom okomito.
7. Proizvodna linija (12) u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što sadrži okvir (28) koji podupire ekstruder (20) i mehanizam za pomicanje (70) za pomicanje cijevi (30) u odnosu na okvir (28) uzduž uglavnom okomitog smjera.
8. Proizvodna linija (12) u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što je svaki vijak (32) izdužen uzduž određene osi, te ekstruder (20) obuhvaća pogonski uređaj (33) za rotiranje svakog vijka (32) oko njegove osi, te pogonski uređaj (33) i svaki vijak (32) sadrže komplementarne surađujuće elemente (49, 54) za reverzibilno pričvršćivanje svakog vijka (32) na pogonski uređaj (33), navedeni surađujući elementi (49, 54) su prikladni za sprječavanje, kada je vijak (32) učvršćen, pomaka navedenog vijka (32) duž njegove osi u odnosu na cijev (30).
9. Proizvodna linija (10) za proizvodnju medicinskih proizvoda koji sadrže najmanje jedan aktivni sastojak, navedeno proizvodno postrojenje (10) obuhvaća čistu prostoriju (14) u kojoj se proizvode medicinski proizvodi, naznačena time što proizvodno postrojenje (10) sadržava proizvodnu liniju (12) u skladu s bilo kojim od prethodnih patentnih zahtjeva za proizvodnju navedenih medicinskih proizvoda, pri čemu se ekstruder (20) postavlja u čistu prostoriju (14).
10. Proizvodna linija (10) prema patentnom zahtjevu 9, naznačena time što sadrži uređaj za opskrbu (16) za opskrbu ekstrudera (20) s praškastom smjesom koja sadrži aktivni sastojak ili svaki aktivni sastojak i ekscipijent ili svaki ekscipijent, navedeni uređaj za opskrbu (16) sadrži otvor (86) za prihvat smjese u prahu smješten izvan čiste prostorije (14).
11. Proizvodna linija (10) prema patentnom zahtjevu 9 ili 10, naznačena time što sadrži kontrolni sustav (18) za kontrolu proizvodne linije (12), pri čemu se navedeni kontrolni sustav (18) postavlja izvan čiste prostorije (14).
12. Postupak za proizvodnju medicinskog proizvoda, naznačen time što se medicinski proizvod koji sadrži najmanje jedan aktivni sastojak proizvodi korištenjem proizvodne linije u skladu s bilo kojim od patentnih zahtjeva 1 do 8.
13. Postupak za proizvodnju medicinskog proizvoda prema patentnom zahtjevu 12, naznačen time što sadrži opskrbu proizvodne linije (12) s praškastom smjesom koja sadrži aktivni sastojak ili svaki aktivni sastojak, topljenje sastojaka smjese u prahu u ekstruderu (20), miješanje ovih komponenti pod djelovanjem vijaka (32), pomoću vijaka (32) za pokretanje tih pomiješanih komponenata prema izlazu iz ekstrudera (20), kroz koji one odlaze u obliku ekstrudata, te hlađenje ekstrudata pomoću rashladnog elementa (24).
HRP20191394 2015-06-23 2019-08-01 Proizvodnja linija za proizvodnju medicinskih proizvoda i proizvodno postrojenje koje sadrži takvu proizvodnu liniju HRP20191394T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR1555783A FR3037789A1 (fr) 2015-06-23 2015-06-23 Ligne de production pour la production de medicaments, et installation de production comprenant une telle ligne de production
PCT/EP2016/064539 WO2016207279A1 (fr) 2015-06-23 2016-06-23 Ligne de production pour la production de médicaments, et installation de production comprenant une telle ligne de production
EP16733396.2A EP3313353B1 (fr) 2015-06-23 2016-06-23 Ligne de production pour la production de médicaments, et installation de production comprenant une telle ligne de production

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HRP20191394T1 true HRP20191394T1 (hr) 2019-11-01

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HRP20191394 HRP20191394T1 (hr) 2015-06-23 2019-08-01 Proizvodnja linija za proizvodnju medicinskih proizvoda i proizvodno postrojenje koje sadrži takvu proizvodnu liniju

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US (1) US10945923B2 (hr)
EP (1) EP3313353B1 (hr)
JP (1) JP2018527044A (hr)
KR (1) KR20180055760A (hr)
CN (1) CN108200765A (hr)
CA (1) CA2987913C (hr)
CR (1) CR20170585A (hr)
DK (1) DK3313353T3 (hr)
ES (1) ES2740198T3 (hr)
FR (1) FR3037789A1 (hr)
HR (1) HRP20191394T1 (hr)
HU (1) HUE045470T2 (hr)
IL (1) IL256429B (hr)
MX (1) MX2017016698A (hr)
PL (1) PL3313353T3 (hr)
PT (1) PT3313353T (hr)
WO (1) WO2016207279A1 (hr)

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PL3313353T3 (pl) 2019-11-29
CN108200765A (zh) 2018-06-22
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CA2987913A1 (fr) 2016-12-29
IL256429A (en) 2018-02-28
US10945923B2 (en) 2021-03-16
EP3313353A1 (fr) 2018-05-02
HUE045470T2 (hu) 2019-12-30
JP2018527044A (ja) 2018-09-20
CR20170585A (es) 2018-08-06
ES2740198T3 (es) 2020-02-05
EP3313353B1 (fr) 2019-05-01
MX2017016698A (es) 2018-11-09
WO2016207279A1 (fr) 2016-12-29
FR3037789A1 (fr) 2016-12-30
CA2987913C (fr) 2023-10-17
US20180185244A1 (en) 2018-07-05
KR20180055760A (ko) 2018-05-25

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