AU2019309381A1 - Ready-to-use, terminally sterile packaging for surgical antiseptic and method of use - Google Patents
Ready-to-use, terminally sterile packaging for surgical antiseptic and method of use Download PDFInfo
- Publication number
- AU2019309381A1 AU2019309381A1 AU2019309381A AU2019309381A AU2019309381A1 AU 2019309381 A1 AU2019309381 A1 AU 2019309381A1 AU 2019309381 A AU2019309381 A AU 2019309381A AU 2019309381 A AU2019309381 A AU 2019309381A AU 2019309381 A1 AU2019309381 A1 AU 2019309381A1
- Authority
- AU
- Australia
- Prior art keywords
- iodine
- composition
- povidone
- package
- bottle
- Prior art date
- Legal status (The legal status 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 status listed.)
- Pending
Links
- 230000002421 anti-septic effect Effects 0.000 title claims abstract description 37
- 238000000034 method Methods 0.000 title claims description 17
- 238000004806 packaging method and process Methods 0.000 title description 8
- CPKVUHPKYQGHMW-UHFFFAOYSA-N 1-ethenylpyrrolidin-2-one;molecular iodine Chemical compound II.C=CN1CCCC1=O CPKVUHPKYQGHMW-UHFFFAOYSA-N 0.000 claims abstract description 88
- 229920000153 Povidone-iodine Polymers 0.000 claims abstract description 88
- 229960001621 povidone-iodine Drugs 0.000 claims abstract description 88
- 239000000203 mixture Substances 0.000 claims abstract description 71
- ZCYVEMRRCGMTRW-UHFFFAOYSA-N 7553-56-2 Chemical compound [I] ZCYVEMRRCGMTRW-UHFFFAOYSA-N 0.000 claims abstract description 54
- 229910052740 iodine Inorganic materials 0.000 claims abstract description 54
- 239000011630 iodine Substances 0.000 claims abstract description 54
- XMBWDFGMSWQBCA-UHFFFAOYSA-N hydrogen iodide Chemical compound I XMBWDFGMSWQBCA-UHFFFAOYSA-N 0.000 claims abstract description 25
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 20
- 231100000028 nontoxic concentration Toxicity 0.000 claims abstract description 19
- 239000007975 buffered saline Substances 0.000 claims abstract description 10
- 230000005251 gamma ray Effects 0.000 claims abstract description 7
- 230000005855 radiation Effects 0.000 claims description 24
- 239000000463 material Substances 0.000 claims description 15
- -1 polypropylene Polymers 0.000 claims description 9
- 239000004743 Polypropylene Substances 0.000 claims description 8
- 229920001155 polypropylene Polymers 0.000 claims description 8
- 230000000295 complement effect Effects 0.000 claims description 6
- 239000001488 sodium phosphate Substances 0.000 claims description 5
- 229910000162 sodium phosphate Inorganic materials 0.000 claims description 5
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims description 5
- 238000007865 diluting Methods 0.000 claims description 4
- 230000002378 acidificating effect Effects 0.000 claims description 2
- 206010073306 Exposure to radiation Diseases 0.000 claims 1
- 238000002513 implantation Methods 0.000 claims 1
- PNDPGZBMCMUPRI-UHFFFAOYSA-N iodine Chemical compound II PNDPGZBMCMUPRI-UHFFFAOYSA-N 0.000 abstract description 6
- 239000000243 solution Substances 0.000 description 36
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 17
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 17
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 15
- 229940069328 povidone Drugs 0.000 description 13
- NLKNQRATVPKPDG-UHFFFAOYSA-M potassium iodide Chemical compound [K+].[I-] NLKNQRATVPKPDG-UHFFFAOYSA-M 0.000 description 12
- XMBWDFGMSWQBCA-UHFFFAOYSA-M iodide Chemical compound [I-] XMBWDFGMSWQBCA-UHFFFAOYSA-M 0.000 description 9
- 229940006461 iodide ion Drugs 0.000 description 8
- 230000001954 sterilising effect Effects 0.000 description 7
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 6
- 238000009472 formulation Methods 0.000 description 6
- 238000004659 sterilization and disinfection Methods 0.000 description 6
- 239000000654 additive Substances 0.000 description 5
- 239000011780 sodium chloride Substances 0.000 description 5
- 239000007864 aqueous solution Substances 0.000 description 4
- 238000006243 chemical reaction Methods 0.000 description 4
- 239000000645 desinfectant Substances 0.000 description 4
- 239000004094 surface-active agent Substances 0.000 description 4
- AOBORMOPSGHCAX-UHFFFAOYSA-N Tocophersolan Chemical compound OCCOC(=O)CCC(=O)OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C AOBORMOPSGHCAX-UHFFFAOYSA-N 0.000 description 3
- 238000002835 absorbance Methods 0.000 description 3
- 238000010494 dissociation reaction Methods 0.000 description 3
- 229940113601 irrigation solution Drugs 0.000 description 3
- 239000000047 product Substances 0.000 description 3
- FVAUCKIRQBBSSJ-UHFFFAOYSA-M sodium iodide Chemical compound [Na+].[I-] FVAUCKIRQBBSSJ-UHFFFAOYSA-M 0.000 description 3
- XZXYQEHISUMZAT-UHFFFAOYSA-N 2-[(2-hydroxy-5-methylphenyl)methyl]-4-methylphenol Chemical compound CC1=CC=C(O)C(CC=2C(=CC=C(C)C=2)O)=C1 XZXYQEHISUMZAT-UHFFFAOYSA-N 0.000 description 2
- 206010052428 Wound Diseases 0.000 description 2
- 208000027418 Wounds and injury Diseases 0.000 description 2
- 229940107816 ammonium iodide Drugs 0.000 description 2
- 230000000844 anti-bacterial effect Effects 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 230000007423 decrease Effects 0.000 description 2
- 239000012895 dilution Substances 0.000 description 2
- 238000010790 dilution Methods 0.000 description 2
- 230000005593 dissociations Effects 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 239000000546 pharmaceutical excipient Substances 0.000 description 2
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 230000009467 reduction Effects 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 230000000699 topical effect Effects 0.000 description 2
- 241000589513 Burkholderia cepacia Species 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 1
- 229920003081 Povidone K 30 Polymers 0.000 description 1
- 238000000862 absorption spectrum Methods 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000003139 buffering effect Effects 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 239000007857 degradation product Substances 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 230000000249 desinfective effect Effects 0.000 description 1
- LOKCTEFSRHRXRJ-UHFFFAOYSA-I dipotassium trisodium dihydrogen phosphate hydrogen phosphate dichloride Chemical compound P(=O)(O)(O)[O-].[K+].P(=O)(O)([O-])[O-].[Na+].[Na+].[Cl-].[K+].[Cl-].[Na+] LOKCTEFSRHRXRJ-UHFFFAOYSA-I 0.000 description 1
- 208000018459 dissociative disease Diseases 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 229910000043 hydrogen iodide Inorganic materials 0.000 description 1
- 230000001771 impaired effect Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000002736 nonionic surfactant Substances 0.000 description 1
- 239000000820 nonprescription drug Substances 0.000 description 1
- 231100000252 nontoxic Toxicity 0.000 description 1
- 230000003000 nontoxic effect Effects 0.000 description 1
- 244000039328 opportunistic pathogen Species 0.000 description 1
- 239000002953 phosphate buffered saline Substances 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 235000009518 sodium iodide Nutrition 0.000 description 1
- 239000007779 soft material Substances 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 241000894007 species Species 0.000 description 1
- 238000002798 spectrophotometry method Methods 0.000 description 1
- 239000008174 sterile solution Substances 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 230000009466 transformation Effects 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/18—Iodine; Compounds thereof
-
- 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
- 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
- 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
- A61L2202/10—Apparatus features
- A61L2202/18—Aseptic storing means
- A61L2202/181—Flexible packaging means, e.g. permeable membranes, paper
-
- 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
-
- 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
- A61L2202/23—Containers, e.g. vials, bottles, syringes, mail
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Molecular Biology (AREA)
- Inorganic Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Containers Having Bodies Formed In One Piece (AREA)
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201862702863P | 2018-07-24 | 2018-07-24 | |
| US62/702,863 | 2018-07-24 | ||
| US201862703830P | 2018-07-26 | 2018-07-26 | |
| US62/703,830 | 2018-07-26 | ||
| PCT/US2019/043288 WO2020023666A1 (fr) | 2018-07-24 | 2019-07-24 | Emballage prêt à l'emploi, stérile aux extrémités pour antiseptique chirurgical et procédé d'utilisation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AU2019309381A1 true AU2019309381A1 (en) | 2021-02-18 |
Family
ID=69181193
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2019309381A Pending AU2019309381A1 (en) | 2018-07-24 | 2019-07-24 | Ready-to-use, terminally sterile packaging for surgical antiseptic and method of use |
Country Status (5)
| Country | Link |
|---|---|
| EP (1) | EP3826688A4 (fr) |
| JP (2) | JP2021532182A (fr) |
| AU (1) | AU2019309381A1 (fr) |
| CA (1) | CA3107304A1 (fr) |
| WO (1) | WO2020023666A1 (fr) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP7521721B2 (ja) * | 2019-08-18 | 2024-07-24 | アイビュー セラピューティクス，インコーポレイテッド | 希釈ポビドンヨード製剤を含む安定した医薬品 |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3911107A (en) * | 1972-12-18 | 1975-10-07 | Flow Pharma Inc | Iodine composition and dissipating solution |
| US4427631A (en) * | 1982-05-27 | 1984-01-24 | Euroceltique, S.A. | Povidone irradiation |
| US6096216A (en) * | 1994-06-09 | 2000-08-01 | American National Red Cross | Iodinated matrices for disinfecting biological fluids |
| DE69606713T2 (de) * | 1995-08-29 | 2000-08-03 | Exxon Chemical Patents, Inc. | Strahlungsbeständiges polypropylen und daraus herstellbare gegenstände |
| US6488665B1 (en) * | 1997-04-08 | 2002-12-03 | Allegiance Corporation | Antimicrobial alcohol gel pre-operative skin-preparation delivery system |
| DE19918324A1 (de) * | 1999-04-22 | 2000-10-26 | Mann Gerhard Chem Pharm Fab | Pharmazeutische Zusammensetzung wirksam gegen durch Bakterien, Viren, Pilze, Hefen und Protozoen verursachte Krankheitszustände |
| JP2010100533A (ja) * | 2008-10-21 | 2010-05-06 | Agurisu:Kk | 電子線滅菌用消毒液及び消毒液収容キット |
| TWI556845B (zh) * | 2008-12-30 | 2016-11-11 | 大塚美國製藥股份有限公司 | 施加流體的裝置和方法 |
| JP5543737B2 (ja) * | 2009-07-27 | 2014-07-09 | リバテープ製薬株式会社 | ポビドンヨード製剤及びその製造方法 |
-
2019
- 2019-07-24 AU AU2019309381A patent/AU2019309381A1/en active Pending
- 2019-07-24 WO PCT/US2019/043288 patent/WO2020023666A1/fr unknown
- 2019-07-24 EP EP19840284.4A patent/EP3826688A4/fr active Pending
- 2019-07-24 JP JP2021527011A patent/JP2021532182A/ja active Pending
- 2019-07-24 CA CA3107304A patent/CA3107304A1/fr active Pending
-
2024
- 2024-05-08 JP JP2024075978A patent/JP2024096382A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| CA3107304A1 (fr) | 2020-01-30 |
| EP3826688A4 (fr) | 2022-04-13 |
| WO2020023666A1 (fr) | 2020-01-30 |
| EP3826688A1 (fr) | 2021-06-02 |
| JP2024096382A (ja) | 2024-07-12 |
| JP2021532182A (ja) | 2021-11-25 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PC1 | Assignment before grant (sect. 113) |
Owner name: CAREFUSION 213, LLC Free format text: FORMER APPLICANT(S): ORTHOPHOR, LLC |
|
| DA3 | Amendments made section 104 |
Free format text: THE NATURE OF THE AMENDMENT IS: AMEND THE NAME OF THE INVENTOR TO READ PARVIZI, JAVAD; SHARKEY, PETER F.; DELLA VALLE, CRAIG J.; KIRSCHMAN, DAVID L.; BRITTAIN, HARRY G.; PARMAR, MAYANK M. AND MILLER, ALAN B. |