HRP20210268T1 - Postupak gravimetrijskog punjenja čvrstog proizvoda u farmaceutski spremnik u sterilnim uvjetima - Google Patents

Postupak gravimetrijskog punjenja čvrstog proizvoda u farmaceutski spremnik u sterilnim uvjetima Download PDF

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HRP20210268T1
HRP20210268T1 HRP20210268TT HRP20210268T HRP20210268T1 HR P20210268 T1 HRP20210268 T1 HR P20210268T1 HR P20210268T T HRP20210268T T HR P20210268TT HR P20210268 T HRP20210268 T HR P20210268T HR P20210268 T1 HRP20210268 T1 HR P20210268T1
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container
cylinder
solid product
microns
inner cavity
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HRP20210268TT
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Elena Cebadera Miranda
Ibón Gutierro Aduriz
Maria GARCÍA AMO
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Laboratorios Farmacéuticos Rovi, S.A.
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Publication of HRP20210268T1 publication Critical patent/HRP20210268T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07Devices 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
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B1/00Packaging fluent solid material, e.g. powders, granular or loose fibrous material, loose masses of small articles, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B1/30Devices or methods for controlling or determining the quantity or quality or the material fed or filled
    • B65B1/32Devices or methods for controlling or determining the quantity or quality or the material fed or filled by weighing
    • B65B1/34Adjusting weight by trickle feed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/41961,2,4-Triazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B1/00Packaging fluent solid material, e.g. powders, granular or loose fibrous material, loose masses of small articles, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B1/04Methods of, or means for, filling the material into the containers or receptacles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B1/00Packaging fluent solid material, e.g. powders, granular or loose fibrous material, loose masses of small articles, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B1/04Methods of, or means for, filling the material into the containers or receptacles
    • B65B1/06Methods of, or means for, filling the material into the containers or receptacles by gravity flow
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B1/00Packaging fluent solid material, e.g. powders, granular or loose fibrous material, loose masses of small articles, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B1/30Devices or methods for controlling or determining the quantity or quality or the material fed or filled
    • B65B1/32Devices or methods for controlling or determining the quantity or quality or the material fed or filled by weighing
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B31/00Packaging articles or materials under special atmospheric or gaseous conditions; Adding propellants to aerosol containers
    • B65B31/02Filling, closing, or filling and closing, containers or wrappers in chambers maintained under vacuum or superatmospheric pressure or containing a special atmosphere, e.g. of inert gas
    • B65B31/025Filling, closing, or filling and closing, containers or wrappers in chambers maintained under vacuum or superatmospheric pressure or containing a special atmosphere, e.g. of inert gas specially adapted for rigid or semi-rigid containers
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01GWEIGHING
    • G01G15/00Arrangements for check-weighing of materials dispensed into removable containers
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01GWEIGHING
    • G01G15/00Arrangements for check-weighing of materials dispensed into removable containers
    • G01G15/006Arrangements for check-weighing of materials dispensed into removable containers using electrical, electromechanical, or electronic means not covered by G01G15/001, G01G15/02, G01G15/04
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01GWEIGHING
    • G01G17/00Apparatus for or methods of weighing material of special form or property
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes

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  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Quality & Reliability (AREA)
  • Epidemiology (AREA)
  • Dispersion Chemistry (AREA)
  • Basic Packing Technique (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicinal Preparation (AREA)

Claims (19)

1. Metoda gravimetrijskog punjenja čvrstog proizvoda u posudu (1) koja obuhvaća sljedeće korake: a) dobava posude (1) koju čini tijelo općenito cilindričnih svojstava (2) i koje je u svom gornjem dijelu opremljeno obrubom (3) promjera malo većeg od promjera tijela (2) posude (1), b) umetanje posude (1) u šuplji cilindar (4), čija unutarnja šupljina (5) ima promjer malo veći od promjera tijela (2) posude (1), a koji je opremljen upustom (6) u gornjem dijelu unutarnje šupljine (5), tako da obrub (3) posude (1) nalegne u upust (6) gornjeg područja unutarnje šupljine (5) cilindra, a s područjem obruba (3) posude (1) i upusta (6) gornjeg područja unutarnje šupljine (5) cilindra (4) jedino područje dodira između posude (1) i cilindra (4), tako da posuda (1) ostane visiti u unutarnjoj šupljini (5) cilindra (4) i to tako da joj je gornja površina (7) smještena malo ispod gornje površine (8) cilindra; c) odlaganje cilindra (4) i posude (1) iznad jedinice za vaganje (9) koja je opremljena na svojoj površini za vaganje (10), izbočinom (11) promjera manjeg od promjera unutarnje šupljine (5) cilindra (4) i visine prikladne za podizanje posude (1) na visinu dovoljnu (h) tako da obrub (3) posude više ne dodiruje upust (6) gornjeg područja unutarnje šupljine (5) cilindra (4) ali bez da gornja površina (7) posude (1) prelazi visinu gornje površine (8) cilindra (4), tako da posuda (1) bude potpuno ovješena iznad izbočine (11) postavljene na površini (10) jedinice za vaganje (9) i posljedično njoj leži sva njezina težina; d) pokrivanjem gornje površine (8) cilindra (4) hermetički pomoću poklopca (12) opremljenog otvorom (13) kroz koji je moguće dodati čvrsti proizvod pomoću dozirnog elementa ili mlaznice (14); e) vaganjem posude uz točnost po volji (1) dok je ovješena iznad izbočine (11) postavljene na površini (10) jedinice za vaganje (9) i stavljanjem cijele njezine težine na izbočinu (11), te f) punjenje posude (1) krutim proizvodom kroz otvor (13) poklopca (12), gravimetrijski kontrolirajući količinu proizvoda koji mu se dodaje pomoću jedinice za vaganje (9).
2. Postupak prema patentnom zahtjevu 1, naznačen time, da između posude (1) i cilindra (4) se postavi najmanje jedna čahura koja pokriva posudu (1) konstruirana tako da jamči vertikalnost i ovjes posude (1) unutar unutarnje šupljine (5) cilindra (4) tako da ni posuda (1) niti njezina pokrovna čahura dodiruju unutarnje stjenke cilindra (4).
3. Postupak prema patentnim zahtjevima 1 ili 2, naznačen time, da se koraci od c) do f) ponavljaju višekratno ako se više od jednog čvrstog proizvoda dozira u posudu (1).
4. Postupak prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time što se prethodno, naknadno ili istodobno s bilo kojim od koraka od a) do f) uvodi faza u kojoj se ionizira posuda (1) i/ili cilindar (4) kako bi se neutralizirao njezin elektrostatički naboj.
5. Postupak u skladu s patentnim zahtjevom 4, naznačen time što se faza ionizacije izvodi uvođenjem ionizirajuće šipke, igle ili prstena u posudu (1) i/ili u cilindar (4).
6. Postupak u skladu s patentnim zahtjevima 4 ili 5, naznačen time što se uvodi mlaz komprimiranog zraka ili sterilnog N2 u posudu (1) i/ili cilindar (4) istovremeno s ionizacijom kako bi se pomoglo doziranje i osigurali potrebni sterilni uvjeti.
7. Postupak prema bilo kojem od prethodnih zahtjeva, naznačen time, da se punjenje krutog proizvoda u posudu (1) faze f) izvodi se pomoću beskonačnog vijka, gravimetrijskog dozatora gubitkom težine, opremljenog lijevkom i mlaznicom velike preciznosti, dozatorom s jednim navojem, dozatorom s dva navoja, dozatorom s vibracijskim kanalom ili vibracijskim lijevkom, dozatorom s transportnom trakom ili dozatorom opremljenim sustavom za zbijanje.
8. Postupak u skladu s patentnim zahtjevom 7, naznačen time što je lijevak opremljen mješalicom koja osigurava konstantnu i tekuću opskrbu krutim proizvodom u posudu (1).
9. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je cilindar (4) opremljen mnoštvom unutarnjih šupljina (5), od kojih je svaki sposoban primiti posudu (1)∙
10. Postupak prema zahtjevu 9, naznačen time, da je jedinica vaganje (9) višestruka s ciljem da može vagati više posuda (1) postavljenih u višestruke unutarnje šupljine (5) cilindra (4).
11. Postupak prema bilo kojem od prethodnih zahtjeva, naznačen time, da je posuda (1) štrcaljka, bočica, kapsula, ampula, uređaj za jednu dozu, inhalator, boca, blister karpule, vrećica ili džepovi konstruirani za držanje čvrste tvari.
12. Postupak prema patentnom zahtjevu 11, naznačen time je posuda (1) štrcaljka ili karpula.
13. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je cilindar (4) od metala titana ili čelika, odnosno plastike, kristala, stakla, kamena ili smole.
14. Postupak prema patentnom zahtjevu 13, naznačen time da je posuda (4) opremljena vanjskim obrubom konstruiranim tako da se cilindar (4) može poduprijeti kliještima ili stezaljkama, ili tako da se cilindar (4) može premjestiti šinama dizanjem s jednog mjesta na druga mjesta u jedinici za punjenje.
15. Postupak prema bilo kojem od prethodnih zahtjeva, naznačen time što je izbočina (11) postavljena na površini (10) jedinice za vaganje (9) općenito cilindričnog oblika, a gornja površina ima pretežito ravan ili stožast oblik, odnosno oblik krnjeg stošca.
16. Postupak prema bilo kojem od prethodnih zahtjeva, naznačen time, da kruti proizvod koji se puni u posudu (1) ima sljedeću raspodjelu čestica po njihovoj veličini: - najviše 10% ukupnog volumena odnosi se na čestice koje su pojedinačno manje od 20 mikrona, - najviše 10% ukupnog volumena odnosi se na čestice koje su pojedinačno veće od 230 mikrona i one koje su manje od 140 mikrona, - vrijednost d0.5 je unutar raspona 60-160 mikrona, pri čemu se s d0.5 označava srednja vrijednost veličine čestica koja dijeli populaciju točno na dvije jednake polovice, tako da je 50% populacije iznad ove vrijednosti, a 50% ispod.
17. Postupak prema bilo kojem od prethodnih zahtjeva 1 do 15, naznačen time, da kruti proizvod koji se puni u posudu (1) ima sljedeću raspodjelu čestica po njihovoj veličini: - najviše 10% ukupnog volumena odnosi se na čestice koje su pojedinačno manje od 20 mikrona, - najviše 10% ukupnog volumena odnosi se na čestice koje su pojedinačno veće od 325 mikrona i one koje su manje od 245 mikrona, - vrijednost d0.5 je unutar raspona 100-155 mikrona,
18. Postupak prema patentnim zahtjevima 16 ili 17, naznačen time, da kruti proizvod koji se puni u posudu (1) je jedan iz skupine koju čine risperidon, paliperidon, fentanil, olanzapin, letrozol, aripiprazol, anastrozol, asenapin, brekspiprazol, kariprazin, klozapin, iloperidon, lurasidon, kvetiapin, ziprasidon, uključujući svaki njihov derivat, metabolit ili sol, same ili u kombinaciji.
19. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, koji se izvodi u aseptičnom okruženju u kabinetu s laminarnim protokom zraka.
HRP20210268TT 2017-03-31 2021-02-16 Postupak gravimetrijskog punjenja čvrstog proizvoda u farmaceutski spremnik u sterilnim uvjetima HRP20210268T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
ES201730587A ES2684403B1 (es) 2017-03-31 2017-03-31 Procedimiento para el llenado gravimetrico en condiciones esteriles de solidos en un contenedor farmaceutico y contenedor farmaceutico utilizable en el mismo
PCT/EP2018/056968 WO2018177800A1 (en) 2017-03-31 2018-03-20 Process for the gravimetric filing in sterile conditions of solids in a pharmaceutical container
EP18713593.4A EP3601060B1 (en) 2017-03-31 2018-03-20 Process for the gravimetric filing in sterile conditions of solids in a pharmaceutical container

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HRP20210268T1 true HRP20210268T1 (hr) 2021-04-02

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Country Link
US (1) US11827391B2 (hr)
EP (1) EP3601060B1 (hr)
JP (1) JP7118090B2 (hr)
KR (1) KR102523435B1 (hr)
CN (1) CN110325447B (hr)
AU (1) AU2018246951B2 (hr)
CA (1) CA3054473A1 (hr)
CL (1) CL2019002278A1 (hr)
CO (1) CO2019009613A2 (hr)
CY (1) CY1123847T1 (hr)
DK (1) DK3601060T3 (hr)
EA (1) EA037881B1 (hr)
ES (2) ES2684403B1 (hr)
GE (1) GEP20217287B (hr)
HR (1) HRP20210268T1 (hr)
HU (1) HUE053083T2 (hr)
IL (1) IL268924B1 (hr)
LT (1) LT3601060T (hr)
MX (1) MX2019011509A (hr)
MY (1) MY194575A (hr)
PL (1) PL3601060T3 (hr)
PT (1) PT3601060T (hr)
SG (1) SG11201907919SA (hr)
SI (1) SI3601060T1 (hr)
UA (1) UA127477C2 (hr)
WO (1) WO2018177800A1 (hr)
ZA (1) ZA201905401B (hr)

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CN114392635A (zh) * 2022-02-28 2022-04-26 稀美资源(广东)有限公司 一种乙醇钽自动恒温收集分装器

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