HRP20170529T1 - Proizvodnja sterilnog farmaceutskog brinzolamida - Google Patents
Proizvodnja sterilnog farmaceutskog brinzolamida Download PDFInfo
- Publication number
- HRP20170529T1 HRP20170529T1 HRP20170529TT HRP20170529T HRP20170529T1 HR P20170529 T1 HRP20170529 T1 HR P20170529T1 HR P20170529T T HRP20170529T T HR P20170529TT HR P20170529 T HRP20170529 T HR P20170529T HR P20170529 T1 HRP20170529 T1 HR P20170529T1
- Authority
- HR
- Croatia
- Prior art keywords
- brinzolamide
- sterilization treatment
- gamma radiation
- carried out
- radiation
- Prior art date
Links
- HCRKCZRJWPKOAR-JTQLQIEISA-N brinzolamide Chemical compound CCN[C@H]1CN(CCCOC)S(=O)(=O)C2=C1C=C(S(N)(=O)=O)S2 HCRKCZRJWPKOAR-JTQLQIEISA-N 0.000 title claims 7
- 229960000722 brinzolamide Drugs 0.000 title claims 7
- 230000005855 radiation Effects 0.000 claims 9
- 238000000034 method Methods 0.000 claims 8
- 230000001954 sterilising effect Effects 0.000 claims 7
- 238000004659 sterilization and disinfection Methods 0.000 claims 7
- 239000000843 powder Substances 0.000 claims 5
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims 4
- 239000001307 helium Substances 0.000 claims 3
- 229910052734 helium Inorganic materials 0.000 claims 3
- SWQJXJOGLNCZEY-UHFFFAOYSA-N helium atom Chemical compound [He] SWQJXJOGLNCZEY-UHFFFAOYSA-N 0.000 claims 3
- -1 polyethylene Polymers 0.000 claims 3
- XKRFYHLGVUSROY-UHFFFAOYSA-N Argon Chemical compound [Ar] XKRFYHLGVUSROY-UHFFFAOYSA-N 0.000 claims 2
- 239000004698 Polyethylene Substances 0.000 claims 2
- 239000000463 material Substances 0.000 claims 2
- 229910052757 nitrogen Inorganic materials 0.000 claims 2
- 229920000573 polyethylene Polymers 0.000 claims 2
- 239000004743 Polypropylene Substances 0.000 claims 1
- AZDRQVAHHNSJOQ-UHFFFAOYSA-N alumane Polymers [AlH3] AZDRQVAHHNSJOQ-UHFFFAOYSA-N 0.000 claims 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Polymers [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims 1
- 229910052786 argon Inorganic materials 0.000 claims 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims 1
- 239000011888 foil Substances 0.000 claims 1
- 239000001301 oxygen Substances 0.000 claims 1
- 229910052760 oxygen Inorganic materials 0.000 claims 1
- 229920000728 polyester Polymers 0.000 claims 1
- 229920001155 polypropylene Polymers 0.000 claims 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
- A61L2/0029—Radiation
- A61L2/0035—Gamma radiation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
- A61K31/542—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with heterocyclic ring systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/63—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
- A61K31/635—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/08—Radiation
- A61L2/081—Gamma radiation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
- A61P27/06—Antiglaucoma agents or miotics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/21—Pharmaceuticals, e.g. medicaments, artificial body parts
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Pharmacology & Pharmacy (AREA)
- Molecular Biology (AREA)
- Biomedical Technology (AREA)
- Ophthalmology & Optometry (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Plural Heterocyclic Compounds (AREA)
Claims (8)
1. Postupak pripreme sterilne mase (bulk) praška brinzolamida koji obuhvaća sterilizacijsku obradu brinzolamida terminalnim gama zračenjem naznačeno time što je brinzolamid masa (bulk) praška koja se dalje pakira u zaštićenoj atmosferi gdje se atmosfera koja zamjenjuje okolni zrak odabire između vakuuma, argona, dušika ili helija.
2. Postupak prema zahtjevu 1, gdje se sterilizacijska obrada gama zračenjem provodi u zatvorenoj polietilenskoj vrećici i ovaj spremnik se zatvara u drugu vrećicu napravljenu od materijala visoko nepropusnog za kisik i vlagu.
3. Postupak prema zahtjevu 1, gdje se sterilizacijska obrada gama zračenjem provodi sa zračenjem od 25 kGy.
4. Postupak prema zahtjevu 2, gdje je visoko nepropusni materijal polilaminirani aluminij ili metalizirana folija spojena s poliesterom i polipropilenom ili polietilenom.
5. Postupak prema zahtjevima 1-4, gdje se sterilizacijska obrada gama zračenjem provodi na prašku brinzolamida pakiranom pod vakuumom.
6. Postupak prema zahtjevima 1-4, gdje se sterilizacijska obrada gama zračenjem provodi na prašku brinzolamida pakiranom u atmosferi dušika ili helija.
7. Postupak prema zahtjevima 1-6, gdje se sterilizacijska obrada gama zračenjem provodi na sobnoj temperaturi ili ispod nule do -78°C.
8. Postupak prema zahtjevima 3, 6 i 7, gdje se sterilizacijska obrada gama zračenjem provodi na -78°C, sa zračenjem od 25 kGy i na prašku brinzolamida pakiranom u atmosferi helija.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/IT2012/000136 WO2013168186A1 (en) | 2012-05-09 | 2012-05-09 | Production of sterile active pharmaceutical ingredients |
| EP12728832.2A EP2846845B1 (en) | 2012-05-09 | 2012-05-09 | Production of sterile pharmaceutical brinzolamide |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20170529T1 true HRP20170529T1 (hr) | 2017-06-16 |
Family
ID=46321406
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20170529TT HRP20170529T1 (hr) | 2012-05-09 | 2017-04-03 | Proizvodnja sterilnog farmaceutskog brinzolamida |
Country Status (16)
| Country | Link |
|---|---|
| US (1) | US10953115B2 (hr) |
| EP (1) | EP2846845B1 (hr) |
| JP (1) | JP6122485B2 (hr) |
| KR (1) | KR101966830B1 (hr) |
| CN (1) | CN104487099B (hr) |
| BR (1) | BR112014027885B1 (hr) |
| CA (1) | CA2872336C (hr) |
| EA (1) | EA028596B1 (hr) |
| ES (1) | ES2624250T3 (hr) |
| HR (1) | HRP20170529T1 (hr) |
| HU (1) | HUE034356T2 (hr) |
| IN (1) | IN2014DN09993A (hr) |
| MX (1) | MX349920B (hr) |
| PL (1) | PL2846845T3 (hr) |
| PT (1) | PT2846845T (hr) |
| WO (1) | WO2013168186A1 (hr) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20210145836A1 (en) * | 2012-05-09 | 2021-05-20 | Icrom Spa | Production of sterile active pharmaceutical ingredients |
| PT3411004T (pt) * | 2016-02-05 | 2021-05-11 | Innopharma Inc | Processo de fabrico de um saco de perfusão estável e pronto para utilização para uma formulação sensível à oxidação |
| BE1024110B1 (fr) * | 2016-10-18 | 2017-11-16 | Auxin Surgery Sa | Dispositif, procédé et formulation pour dissection assistée de manière chimique |
| AU2017233581B2 (en) * | 2016-03-14 | 2022-08-04 | Auxin Surgery Sa | Device, method and formulation for chemically assisted dissection |
| DE102017107124A1 (de) * | 2017-04-03 | 2018-10-04 | Ferton Holding S.A. | Pulver zur Reinigung eines inneren Körperteils und/oder eines Implantats, Verfahren zur Herstellung eines solchen Pulvers und geeignete Verwendungen |
| IT202100006794A1 (it) | 2021-03-22 | 2022-09-22 | Icrom Srl | Processo per preparare il verde indocianina |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE2004553B1 (de) | 1970-02-02 | 1971-05-19 | Fa B Braun, 3508 Melsungen | Verfahren zur Herstellung von Leit schienen aus menschlichen oder tierischen Geweben zur Wiederherstellung beschädigter oder zerstörter spezifischer Gewebsteile im menschlichen und tierischen Korper |
| US6071904A (en) * | 1996-12-11 | 2000-06-06 | Alcon Laboratories, Inc. | Process for manufacturing ophthalmic suspensions |
| US20030095890A1 (en) | 2001-09-24 | 2003-05-22 | Shirley Miekka | Methods for sterilizing biological materials containing non-aqueous solvents |
| MX2007014480A (es) * | 2005-05-19 | 2008-04-22 | Albiorex Llc | Esterilizacion terminal de productos de colageno inyectables. |
| MX2008014283A (es) | 2006-05-09 | 2008-11-18 | Astrazeneca Ab | Formulacion parental la cual comprende un inhibidor de bomba de protones esterilizado en su recipiente final por radiacion de ionizacion. |
| CN107007581A (zh) * | 2006-08-24 | 2017-08-04 | 田纳西大学研究基金会 | 取代的n‑酰基苯胺及其使用方法 |
| GB0626021D0 (en) | 2006-12-29 | 2007-02-07 | Insense Ltd | The stabilisation of proteins |
| CA2697160A1 (en) * | 2007-08-21 | 2009-02-26 | Harbor Biosciences, Inc. | Stabilized therapeutic compositions and formulations |
| EP2394637A1 (en) * | 2010-05-21 | 2011-12-14 | Zaklady Farmaceutyczne Polpharma SA | Process for obtaining sterile brinzolamide suspensions |
-
2012
- 2012-05-09 MX MX2014013238A patent/MX349920B/es active IP Right Grant
- 2012-05-09 ES ES12728832.2T patent/ES2624250T3/es active Active
- 2012-05-09 EP EP12728832.2A patent/EP2846845B1/en active Active
- 2012-05-09 US US14/398,912 patent/US10953115B2/en active Active
- 2012-05-09 PT PT127288322T patent/PT2846845T/pt unknown
- 2012-05-09 HU HUE12728832A patent/HUE034356T2/en unknown
- 2012-05-09 BR BR112014027885-7A patent/BR112014027885B1/pt active IP Right Grant
- 2012-05-09 CN CN201280073019.8A patent/CN104487099B/zh active Active
- 2012-05-09 JP JP2015510945A patent/JP6122485B2/ja active Active
- 2012-05-09 WO PCT/IT2012/000136 patent/WO2013168186A1/en active Application Filing
- 2012-05-09 KR KR1020147033573A patent/KR101966830B1/ko active IP Right Grant
- 2012-05-09 EA EA201491845A patent/EA028596B1/ru unknown
- 2012-05-09 IN IN9993DEN2014 patent/IN2014DN09993A/en unknown
- 2012-05-09 PL PL12728832T patent/PL2846845T3/pl unknown
- 2012-05-09 CA CA2872336A patent/CA2872336C/en active Active
-
2017
- 2017-04-03 HR HRP20170529TT patent/HRP20170529T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| BR112014027885A2 (pt) | 2017-06-27 |
| KR101966830B1 (ko) | 2019-04-08 |
| US10953115B2 (en) | 2021-03-23 |
| KR20150024821A (ko) | 2015-03-09 |
| EP2846845B1 (en) | 2017-03-01 |
| PT2846845T (pt) | 2017-06-02 |
| CA2872336C (en) | 2019-08-13 |
| CN104487099A (zh) | 2015-04-01 |
| ES2624250T3 (es) | 2017-07-13 |
| CA2872336A1 (en) | 2013-11-14 |
| BR112014027885B1 (pt) | 2022-07-26 |
| EA028596B1 (ru) | 2017-12-29 |
| EA201491845A1 (ru) | 2015-02-27 |
| JP6122485B2 (ja) | 2017-04-26 |
| EP2846845A1 (en) | 2015-03-18 |
| WO2013168186A1 (en) | 2013-11-14 |
| MX2014013238A (es) | 2015-04-08 |
| US20150141412A1 (en) | 2015-05-21 |
| MX349920B (es) | 2017-08-21 |
| HUE034356T2 (en) | 2018-02-28 |
| PL2846845T3 (pl) | 2017-07-31 |
| CN104487099B (zh) | 2017-06-20 |
| IN2014DN09993A (hr) | 2015-08-14 |
| JP2015523327A (ja) | 2015-08-13 |
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