WO2020023666A1 - Emballage prêt à l'emploi, stérile aux extrémités pour antiseptique chirurgical et procédé d'utilisation - Google Patents

Emballage prêt à l'emploi, stérile aux extrémités pour antiseptique chirurgical et procédé d'utilisation Download PDF

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Publication number
WO2020023666A1
WO2020023666A1 PCT/US2019/043288 US2019043288W WO2020023666A1 WO 2020023666 A1 WO2020023666 A1 WO 2020023666A1 US 2019043288 W US2019043288 W US 2019043288W WO 2020023666 A1 WO2020023666 A1 WO 2020023666A1
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WO
WIPO (PCT)
Prior art keywords
iodine
composition
povidone
package
bottle
Prior art date
Application number
PCT/US2019/043288
Other languages
English (en)
Inventor
Javad Parvizi
Peter F. Sharkey
Craig J. DELLA VALLE
David L. KIRSCHMAN
Harold G. Brittain
Mayank M. PARMAR
Alan B. Miller
Original Assignee
Orthophor, Llc
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 Orthophor, Llc filed Critical Orthophor, Llc
Priority to AU2019309381A priority Critical patent/AU2019309381A1/en
Priority to EP19840284.4A priority patent/EP3826688A4/fr
Priority to CA3107304A priority patent/CA3107304A1/fr
Priority to JP2021527011A priority patent/JP2021532182A/ja
Publication of WO2020023666A1 publication Critical patent/WO2020023666A1/fr
Priority to US17/152,565 priority patent/US20210137887A1/en

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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

Definitions

  • the present invention relates, generally, to a ready-to-use, sterilized surgical antiseptic and packaging therefor, and, more specifically, to a sterilized, povidone-iodine solution having a non-toxic concentration of iodine in a terminally sterile or sterilizable package to facilitate its use in surgical procedures without further dilution in the operating room, and within the sterile field without the need for initial preparations.
  • Povidone-iodine is a chemical complex of povidone, hydrogen iodide, and elemental iodine. It is antiseptic that works by releasing iodine which results in the death of a range of microorganisms. Povidone-iodine is available over-the-counter in concentrations from 9% to 12% available iodine.
  • Povidone-iodine has traditionally been used for skin disinfection before and after surgery. It may be used both to disinfect the skin of the patient and the hands of the healthcare providers. Although it may be used topically or on minor wounds“as is” over-the- counter, for larger wounds, surgical applications and application to mammalian tissue in general, the over-the-counter concentration is too high. Indeed, povidone-iodine can be toxic in concentrations greater than 3% if applied directly to the mammalian tissue. Accordingly, surgeons typically reduce the concentration of povidone-iodine to below 3% in the operating room.
  • This dilution requires opening the povidone-iodine packaging in the operating room, and mixing it with a saline solution at the time of use. This is typically performed outside the sterile field, as conventional packaging is not terminally sterile or sterilizable while maintaining the integrity of the povidone-iodine solution. Accordingly, the povidone-iodine solution is typically prepared by opening non-sterile packaging immediately outside the sterile field, and then passing the sterile solution into the sterile field. [0005] Although this technique is effective in disinfecting the incision and reducing the likelihood of infection, the task of having to mix the povidone-iodine in the operating room to reduce its concentration tends to be a distraction during the operation and a waste of valuable time.
  • What is needed is a ready-to-use solution of povidone-iodine having a non toxic concentration of povidone-iodine. Further, what is needed is a ready-to-use packaging that is terminally sterile (or sterilizable) while maintaining the integrity of the povidone iodine solution, such that the packaging may be opened and used within the sterile field, without the need to open the package and/or mix the solution outside the sterile field.
  • the povidone-iodine complex When in the solid state, the povidone-iodine complex is very stable. However, when the povidone-iodine complex is dissolved in water, an equilibrium reaction ensues where some dissociation of the complex takes place, producing iodide ion (G) as an effective degradation product. In simplified terms, one can describe the equilibrium between the povidone-iodine complex and iodide ion as follows: povidone-iodine 3 ⁇ 4 povidone + iodide (2)
  • Ke q [povidone] [iodide] / [povidone/iodine] (3) where the quantities in brackets reflect the concentrations of the species under the
  • the invention relates to a ready-to-use, gamma-ray sterilized, surgical antiseptic composition
  • a ready-to-use, gamma-ray sterilized, surgical antiseptic composition comprising: (a) an initial non-toxic concentration of povidone-iodine above a minimum effective concentration of available iodine; (b) iodide in sufficient quantity to provide donor iodine upon gamma irradiation to stabilize the povidone-iodine and maintain the minimum effective concentration of available iodine; and (c) a buffered saline solution.
  • the invention relates to a method of using the composition described above comprising: applying the composition non-topically to mammalian tissue without diluting the composition.
  • the invention relates to a method of preparing the composition of claim 1, comprising: (a) disposing the composition in a package; (b) exposing the package containing the composition to gamma radiation to sterilize the package and the composition; and (c) wherein, while being irradiated, the iodide donates iodine to stabilize the povidone-iodine to maintain the minimum concentration of available iodine.
  • the invention relates to a package containing the composition described above.
  • the package is a polypropylene squirt bottle.
  • the invention relates to a package containing a surgical antiseptic composition.
  • the package comprises: (a) an initial non-toxic concentration of povidone iodine above a minimum effective concentration of available iodine; (b) iodide in sufficient quantity to provide donor iodine upon gamma irradiation to stabilize the povidone iodine and maintain the minimum effective concentration of available iodine; and (c) a buffered saline solution.
  • the invention relates to a ready-to-use terminally sterile antiseptic delivery system comprising: (a) a sterile package constructed of a radiation safe material; (b) a sterile surgical antiseptic composition contained with the package, the surgical antiseptic composition comprising: (i) an initial non-toxic concentration of povidone iodine above a minimum effective concentration of available iodine; (ii) iodide in sufficient quantity to provide donor iodine upon gamma irradiation to stabilize the povidone iodine and maintain the minimum effective concentration of available iodine; and (iii) a buffered saline solution.
  • the invention relates to a package configured for compact storage, the package comprising: (a) a bottle comprising a closed body defining an internal cavity for receiving contents therein, the bottle extending along a longitudinal axis and, the bottle having a maximum width as measured transversely to the longitudinal axis, the bottle being asymmetrical about its longitudinal axis to form a longitudinally-extending depression in an outer surface of the first bottle adjacent a complementary longitudinally- extending protuberance in the outer surface of the bottle; (b) whereby a pair of the bottles has a combined width less than twice the maximum width of one bottle when the pair of bottles are positioned in a nested juxtaposed relationship in which the respective protuberance of each bottle is positioned within the respective depression of the other bottle.
  • Fig. l is a rear perspective view of an exemplary package in the nature of a bottle in accordance with an exemplary embodiment of the present invention
  • FIG. 2 is a front perspective view of the bottle of Fig. 1;
  • Fig. 3 is a right side view of the bottle of Fig.1;
  • Fig. 4 is a front side view of the bottle of Fig.1;
  • Fig. 5 is a left side view of the bottle of Fig.1;
  • Fig. 6 is a rear side view of the bottle of Fig.1;
  • Fig. 7 is a top end view of the bottle of Fig.1;
  • Fig. 8 is a bottom end view of the bottle of Fig.1;
  • Fig. 9 is a top view of a pair of bottles of Fig. 1, shown in a nested juxtaposed relationship;
  • Fig. 10 is a perspective view of the pair of nested juxtaposed bottles of Fig. 9.
  • non-toxic concentration of povidone-iodine pertains to surgical applications in which the antiseptic solution is applied to human and other mammalian tissue, and does not pertain to safe levels of povidone-iodine for topical application on the skin, which is much higher. Therefore, the non-toxic concentration of povidone-iodine will be lower than topical applications.
  • one of skill in the art can determine non-toxic concentrations of povidone-iodine based on, for example, the tissue to be disinfected, the volume of disinfectant to be used, pre-existing conditions of the patient, the ability to remove excess disinfectant, temperature, pH of the solution, as well as other considerations.
  • the non-toxic concentration of povidone-iodine is no greater than 3%
  • the non-toxic concentration of povidone-iodine is no greater than 2%
  • concentration of povidone-iodine is no greater than 1%, and in yet another embodiment, the non-toxic concentration of povidone-iodine is no greater than .5%
  • the minimum effective concentration of iodine means the concentration of iodine below which its efficacy is impaired.
  • the minimum effective concentration of iodine based on, for example, the tissue to be disinfected, the volume of disinfectant to be used, pre-existing conditions of the patient, the ability to remove excess disinfectant, temperature, pH of the solution, as well as other considerations.
  • the minimum effective concentration of iodine is no less than 0.2%, in one embodiment, the minimum effective concentration of iodine is no less than 0.3%, and, in a more particular embodiment, is no less than 0.4%.
  • the relative concentration of iodide decreases.
  • x is the concentration of povidone-iodine
  • y is the concentration of iodide
  • the relative concentrations are as follows O. lx ⁇ y ⁇ 2x, in a more particular embodiment, 0.2x ⁇ y ⁇ lx, and, in a more particular embodiment, 0.3x ⁇ y ⁇ 0.6x.
  • Measurement of the amount of iodine in the composition is especially important for evaluation of the stability of the formulation, and a spectrophotometric method of analysis has been developed for this purpose.
  • the method is based on the observation that when dissolved in methanol, the povidone-iodine complex exhibits a peak maximum in its absorption spectrum at 360 nm.
  • three milliliters (Vinitiai) of methanol are first pipetted into a spectrophotometer cuvette, whereupon known microliter (Vadded) amounts of the povidone-iodine composition are pipetted into the cuvette. After mixing, the absorbance of the resulting solution at 360 nm is determined.
  • the relationship between absorbance at 360 nm (ABS) and the concentration of povidone-iodine in the analyzed solution has been determined, and over a measured absorbance range of 0.05 ABS units to 0.75 ABS units the following relationship exists:
  • the composition may also comprise surfactants, salts, and other additives to adjust the fluid’s surface tension, buffering/pH, viscosity, or other property.
  • surfactants such as sodium sulfate, sodium sulfate, sodium sulfate, sodium sulfate, sodium sulfate, sodium sulfate, sodium sulfate, sodium sulfate, sodium sulfate, sodium sulfate, sodium bicarbonate, sodium bicarbonate, sodium bicarbonate, sodium bicarbonate, sodium bicarbonate, sodium bicarbonate, sodium bicarbonate, sodium bicarbonate, sodium bicarbonate, sodium bicarbonate, sodium bicarbonate, sodium bicarbonate, sodium bicarbonate, sodium sulfate, sodium bicarbonate, sodium sulfate, sodium bicarbonate, sodium sulfate, sodium bicarbonate, sodium sulfate, sodium bicarbonate, sodium sulfate, sodium bicarbonate, sodium sulfate, sodium bicarbonate
  • the solution it is generally preferred for the solution to be slightly acidic. Accordingly, it should be understood that the
  • the povidone-iodine component of the composition is sourced as a powdered product that consists of a complex of polyvinyl pyrrolidone (povidone, or PVP) and iodine.
  • a powdered product that consists of a complex of polyvinyl pyrrolidone (povidone, or PVP) and iodine.
  • PVP polyvinyl pyrrolidone
  • iodine product identified by BASF Corporation as containing povidone K 30/06 in the composition.
  • the source of water-soluble iodide ion is also well known to those of skill in the art and is commercially available.
  • the iodide ion may any sodium iodide, potassium iodide, or ammonium iodide, just to name a few.
  • optional additives and, in particular, surfactants, although generally any surfactant may be used, nonionic surfactants tend to be preferred.
  • the pharmaceutically stable composition of povidone- iodine comprises 0.3% to 1.0% w/v of povidone/iodine, 0.05% to 0.5% w/v of a source of water-soluble iodide ion, 0.01 % to 0.02% w/v of a surfactant, 0.9% w/v sodium chloride, and 0.1 M sodium phosphate.
  • the pH of the composition is initially adjusted between pH 5.1 and 5.7 prior to gamma radiation sterilization.
  • the pharmaceutically stable composition of povidone-iodine comprises 0.3% to 1.0% w/v of povidone/iodine, 0.05% to 0.5% w/v of potassium iodide, 0.01 % to 0.02% w/v of vitamin E TPGS, 0.9% w/v sodium chloride, and 0.1 M sodium phosphate.
  • the pH of the composition is initially adjusted between pH 5.1 and 5.7 prior to sterilization by means of gamma radiation.
  • the pharmaceutically stable composition of povidone-iodine comprises 0.3% to 0.5% w/v of povidone/iodine, 0.1% to 0.3% w/v of potassium iodide, 0.01 % to 0.015% w/v of vitamin E TPGS, 0.9% w/v sodium chloride, and 0.1 M sodium phosphate.
  • the pH of the composition is initially adjusted between pH 5.2 and 5.7 prior to sterilization by means of gamma radiation.
  • the composition consists of an aqueous solution containing 0.4% w/v of povidone/iodine, 0.3% w/v potassium iodide, 0.015% w/v vitamin E TPGS, 0.9% w/v sodium chloride, and 0.1 M sodium phosphate.
  • the pH of the composition is initially adjusted to 5.5 prior to gamma radiation sterilization.
  • Figs. 1-10 are views of an exemplary package 10 in accordance with the present invention.
  • the exemplary package 10 is formed of a radiation-safe material, and in particularly a gamma radiation safe material.
  • a radiation-safe material is a material that can be irradiated for sterilization purposes without structural damage to the package such that the package may continue to contain its contents, and while permitting the contents of the package to be sterilized by the radiation without resulting in an unacceptable loss of integrity of the antiseptic solution contained therein.
  • An unacceptable loss of integrity of the antiseptic solution is a change in characteristics of the antiseptic solution that would render it unsafe or unsuitable for use for its intended purpose as an antiseptic solution.
  • the package 10 is terminally sterilizable in that the package can be gamma-ray sterilized, while containing a povidone iodine solution with a concentration of available iodine above the minimum effective concentration, to provide a ready-to-use terminally sterilized package containing a gamma ray sterilized povidone iodine solution with a concentration of available iodine above the minimum effective concentration.
  • the terminally sterilized package can be introduced into the sterile field, be handled and opened within the sterile field, and can be used to dispense its sterile contents, without compromising the integrity of the sterile field.
  • the radiation-safe material is a polypropylene material, and particularly, a gamma radiation safe polypropylene material.
  • the package 10 may have any suitable form, in this exemplary embodiment, the package has the form of a bottle. Referring now to Fig. 1, the
  • package/bottle 10 has a closed body 12 defining an internal cavity 14 for receiving contents therein.
  • the closed body is continuous to fully enclose the internal cavity.
  • the closed body may be punctured to provide an opening for dispensing the contents of the bottle.
  • the exemplary bottle 10 shown is configured as a squirt bottle in that it is tapered to include a nozzle 14 and is constructed of pliable material that can be readily squeezed by hand, such that the contents of the bottle can be dispensed via an opening by manual squeezing of the body 12.
  • the opening may be provided by puncturing the nozzle at its tip 16, and the tip 16 may be provided with a depression 18 or other surface feature to guide or facilitate puncturing of the bottle in a preferred location, as shown in Fig. 1.
  • the closed body is manufactured to be substantially closed except for an opening forming a mouth of the bottle, and the package 10 includes a cap 60 matable with the closed body to fully enclose the internal cavity, as best shown in Fig. 2.
  • a mounting structure may be provided adjacent the tip 16 to facilitate mounting of the cap 20 to the bottle, e.g., after the tip has been punctured.
  • the mounting structure includes external screw threads 20, and the cap 60 includes complementary internal threads (not shown).
  • the package may contain a sterile surgical antiseptic composition within its cavity.
  • the surgical antiseptic composition may comprise: an initial non-toxic concentration of povidone iodine above a minimum effective concentration of available iodine; iodide in sufficient quantity to provide donor iodine upon gamma irradiation to stabilize the povidone iodine and maintain the minimum effective concentration of available iodine; and a buffered saline solution.
  • the pliable material may be a radiation safe polypropylene material for the reasons discussed herein.
  • the bottle may include a substantially closed body terminating in a nozzle defining an opening, such that manually squeezing the relatively soft material of the bottle’s body results in ejection of solution from within the bottle.
  • the squirt bottle may be used as an applicator apparatus for delivery of the surgical antiseptic solution.
  • a ready-to-use terminally sterile antiseptic delivery system includes a sterile package constructed of a radiation safe material, and a sterile surgical antiseptic composition contained with the package. Accordingly, the antiseptic delivery system may be sterilized, e.g., by exposure to gamma rays or other radiation, to sterilize both the package and the antiseptic solution, in particularly, in a single irradiation process while the antiseptic solution is contained within the package.
  • the closed body 12 is elongated to extend along a longitudinal axis, shown as AA’.
  • the package is specially-configured for compact storage, e.g., when two packages are co- packaged in a box for shipping or storage purposes.
  • the exemplary package 10 is so configured, as shown in Figs. 1-10. More particularly, the exemplary closed body/bottle 12 is asymmetrical about its longitudinal axis AA (e.g., in cross-section transverse to AA’) as will be appreciated from Figs. 1, 7, 8 and 9.
  • the bottle is asymmetrical to form a longitudinally- extending depression 24 in an outer surface 26 of the bottle 10 adjacent a complementary longitudinally-extending protuberance 28 in the outer surface 26 of the bottle, as best shown in Figs. 1, 7 and 8.
  • the depression and the bottle are hermaphroditic, in that a single bottle forms complementary male and female portions arranged such that the bottle is
  • Figs. 9 and 10 are top and perspective views of a pair of bottles of Fig. 1. As will be appreciated from Figs. 9 and 10, each bottle is asymmetrical about its longitudinal axis to form a longitudinally-extending depression. The depression causes the bottle to have a cross-sectional area than is smaller than a corresponding cross-sectional area if the cross- section were to be symmetrical, without the depression.
  • the depression is hermaphroditic in shape, such that two bottles having identical (or nearly identical, but complementary structure, at least with respect to the depression) may be placed in a nested juxtaposed relationship, such that distance between their respective longitudinal axes is less than a corresponding distance would be if the bottles were symmetrical about their axes (with a corresponding diameter or other dimension), as will be appreciated from Fig. 9.
  • bottle/body 12 has a maximum width MW measured transversely to the longitudinal axis, as best shown in Figs. 1, 7 and 9.
  • a pair of bottles would thus have a combined maximum width (MCW) equal to 2MW.
  • the bottles herein described have a minimum combined width less than twice the maximum width of one bottle when the pair of bottles are positioned in a nested juxtaposed relationship in which the respective protuberance 28 of each bottle is positioned within the respective depression 24 of the other bottle, as will be appreciated from Fig. 9.
  • two of the bottles 10 can be arranged (e.g., co-packaged) in a nested relationship, in a relatively more compact arrangement that if the bottles lacked such depressions.
  • a ready-to-use terminally sterile antiseptic delivery system may include two sterile packages constructed of a radiation safe material.
  • the first sterile package may contain a sterile surgical antiseptic composition
  • second sterile package may contain a sterile irrigation solution, such as sterile saline.
  • the two sterile packages may be co-packed while they are in nested juxtaposed relationship, to provide for a compact packaged arrangement of the sterile packages.
  • Another aspect of the invention relates to a method of using the composition described above.
  • the method comprises opening a package containing the composition, and, without diluting the composition, applying the composition non- topically to mammalian tissue.
  • the package is opened within the sterile field of an operating room.
  • the invention relates to a package containing the composition described above.
  • the package is a polypropylene squirt bottle.
  • a radiation safe e.g., polypropylene

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  • 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)
  • Containers Having Bodies Formed In One Piece (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)

Abstract

Une composition antiseptique chirurgicale prête à l'emploi, stérilisée aux rayons gamma, comprend une concentration initiale non toxique de povidone-iode supérieure à une concentration minimale efficace d'iode disponible ,de l'iodure en quantité suffisante pour fournir de l'iode donneur lors d'une irradiation gamma pour stabiliser ladite povidone-iode et maintenir ladite concentration effective minimale d'iode disponible, et une solution saline tamponnée.
PCT/US2019/043288 2018-07-24 2019-07-24 Emballage prêt à l'emploi, stérile aux extrémités pour antiseptique chirurgical et procédé d'utilisation WO2020023666A1 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
AU2019309381A AU2019309381A1 (en) 2018-07-24 2019-07-24 Ready-to-use, terminally sterile packaging for surgical antiseptic and method of use
EP19840284.4A EP3826688A4 (fr) 2018-07-24 2019-07-24 Emballage prêt à l'emploi, stérile aux extrémités pour antiseptique chirurgical et procédé d'utilisation
CA3107304A CA3107304A1 (fr) 2018-07-24 2019-07-24 Emballage pret a l'emploi, sterile aux extremites pour antiseptique chirurgical et procede d'utilisation
JP2021527011A JP2021532182A (ja) 2018-07-24 2019-07-24 外科消毒剤用の直ぐに使用できる最終的に滅菌した包装及び使用方法
US17/152,565 US20210137887A1 (en) 2018-07-24 2021-01-19 Ready-to-use, terminally sterile packaging for surgical antiseptic and method of use

Applications Claiming Priority (4)

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

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US17/152,565 Continuation-In-Part US20210137887A1 (en) 2018-07-24 2021-01-19 Ready-to-use, terminally sterile packaging for surgical antiseptic and method of use

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EP (1) EP3826688A4 (fr)
JP (1) JP2021532182A (fr)
AU (1) AU2019309381A1 (fr)
CA (1) CA3107304A1 (fr)
WO (1) WO2020023666A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210401878A1 (en) * 2019-08-18 2021-12-30 Iview Therapeutics, Inc. Stable Pharmaceutical Articles Containing Dilute Povidone Iodine Formulations

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WO1997008238A1 (fr) * 1995-08-29 1997-03-06 Exxon Chemical Patents Inc. Polypropylene supportant les rayonnements et articles utiles realises a partir de cette matiere
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EP3826688A1 (fr) 2021-06-02
JP2021532182A (ja) 2021-11-25
CA3107304A1 (fr) 2020-01-30
AU2019309381A1 (en) 2021-02-18
EP3826688A4 (fr) 2022-04-13

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