IL307930A - Method for syringe sterilization - Google Patents

Method for syringe sterilization

Info

Publication number
IL307930A
IL307930A IL307930A IL30793023A IL307930A IL 307930 A IL307930 A IL 307930A IL 307930 A IL307930 A IL 307930A IL 30793023 A IL30793023 A IL 30793023A IL 307930 A IL307930 A IL 307930A
Authority
IL
Israel
Prior art keywords
oxybutynin
syringe
hydrochloride
piston
sterile
Prior art date
Application number
IL307930A
Other languages
Hebrew (he)
Original Assignee
Farco Gmbh
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
Priority claimed from DE102021112033.0A external-priority patent/DE102021112033B4/en
Application filed by Farco Gmbh filed Critical Farco Gmbh
Publication of IL307930A publication Critical patent/IL307930A/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • 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—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/04—Heat
    • A61L2/06—Hot gas
    • A61L2/07—Steam
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/001—Apparatus specially adapted for cleaning or sterilising syringes or needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A61M5/3134—Syringe barrels characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31513—Piston constructions to improve sealing or sliding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/10—Drugs for disorders of the urinary system of the bladder
    • 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
    • A61L2103/00—Materials or objects being the target of disinfection or sterilisation
    • A61L2103/23—Containers other than laboratory or medical, e.g. bottles or mail
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3104—Caps for syringes without needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3118—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
    • A61M2005/312—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula comprising sealing means, e.g. severable caps, to be removed prior to injection by, e.g. tearing or twisting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/27—General characteristics of the apparatus preventing use
    • A61M2205/273—General characteristics of the apparatus preventing use preventing reuse, e.g. of disposables
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production
    • A61M2207/10—Device therefor

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Vascular Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Epidemiology (AREA)
  • Urology & Nephrology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Emergency Medicine (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Claims (15)

1. Claims: 1. A method for producing a sterile oxybutynin-containing composition in a sterile ready-to-use piston syringe which sterile piston syringe is u001dilled with a sterile oxybutynin-containing composition, wherein the piston syringe comprises, on the one hand, a syringe body and, on the other hand, a syringe piston with a piston stopper, wherein the syringe body is formed from a polypropylene, and wherein the oxybutynin-containing u001dinal composition obtained after completion of the method is formed as a sterile aqueous composition and fulu001dills the following speciu001dication requirements (i), (ii) and (iii): (i) a predetermined speciu001dication concentration of oxybutynin or its hydrochloride with a predetermined deviation of at most ± 5 %, based on the concentration of oxybutynin or its hydrochloride, (ii) a predetermined speciu001dication pH value with a predetermined deviation of at most ± 0.5 pH value units, (iii) a predetermined speciu001dication maximum amount of oxybutynin degradation product(s); wherein the method comprises the following steps: (a) u001dilling the piston syringe with an oxybutynin-containing starting composition and subsequently (b) heat sterilization of the oxybutynin-containing starting composition in the piston syringe and the piston syringe u001dilled with the oxybutynin-containing starting composition to obtain a sterile ready-to-use piston syringe u001dilled with a sterile oxybutynin-containing u001dinal composition, wherein the migration and incorporation of oxybutynin or its hydrochloride into the syringe body and into the piston stopper, occurring in method step (b), and the degradation of oxybutynin or its hydrochloride, occurring in method step (b), are controlled and compensated in such a way and with the proviso, that the sterile oxybutynin-containing u001dinal composition obtained after performing method step (b) fulu001dills at least two of the speciu001dication requirements (i), (ii) and (iii); wherein the migration and incorporation of oxybutynin or its hydrochloride into the syringe body, occurring in method step (b), and the degradation of oxybutynin or its hydrochloride, occurring in method step (b), are controlled and compensated by at least one of the following measures (1), (2), (3) and (4): (1) use of an increased concentration of oxybutynin or its hydrochloride in the starting composition in comparison to the speciu001dication concentration of oxybutynin or its hydrochloride, (2) use of an increased pH value in the starting composition in comparison to the speciu001dication pH value, (3) adjustment of sterilization conditions selected from the group consisting of sterilization type, sterilization duration, sterilization temperature, sterilization pressure, sterilization atmosphere and combinations thereof, (4) treatment of the syringe body with at least one agent reducing at least one of migration and degradation of oxybutynin or its hydrochloride.
2. The method according to claim 1, wherein at least measure (1) in optional combination with at least one of measures (2), (3) and (4) is performed.
3. The method according to claim 1 or claim 2, wherein in measure (1), in the starting composition the concentration of oxybutynin or its hydrochloride is selected such to be by 1 % to 20 % above the speciu001dication concentration of oxybutynin or its hydrochloride in the u001dinal composition.
4. The method according to any of the preceding claims, wherein in measure (2), the pH value of the starting composition is selected such to be by 0.02 pH value units to 2.4 pH value units above the speciu001dication pH value of the u001dinal composition.
5. The method according to any of the preceding claims, wherein in measure (3), heat sterilization is performed as a water-vapor sterilization an F0 value in the range of from 6 minutes to 45 minutes.
6. The method according to any of the preceding claims, wherein the migration and incorporation of oxybutynin or its hydrochloride into the syringe body, occurring in method step b), and the degradation of oxybutynin or its hydrochloride, occurring in in method step b), is controlled and compensated by adjusting the ratio of (i) oxybutynin in the form of the free base, on the one hand, and (ii) oxybutynin in the form of its hydrochloride, on the other hand, wherein the ratio is shifted in the direction of (ii) oxybutynin in the form of its hydrochloride by adjusting the pH value in the starting composition by adding an acid to the starting composition.
7. The method according to any of the preceding claims, wherein the piston syringe u001dilled with the oxybutynin-containing composition, prior to performing the heat sterilization, has been transferred and inserted into a closed or sealed pack which pack is at least one of water-tight and germ-tight, wherein at least a part of the pack is at least permeable to water-vapor , wherein the pack is also sterilized when the heat sterilization is performed.
8. The method according to any of the preceding claims, wherein the oxybutynin-containing u001dinal composition obtained after completion of the method is formed as a sterile aqueous composition and fulu001dills the following speciu001dication requirements (i), (ii) and (iii): (i) a predetermined speciu001dication concentration of oxybutynin or its hydrochloride: 0.5 mg/ml to 2 mg/ml with a maximum deviation of ± 5 % based on the concentration of oxybutynin or its hydrochloride, (ii) a predetermined speciu001dication pH value: 2.8 to 5.2, (iii) a predetermined speciu001dication amount of oxybutynin degradation product(s): at most 0.5 wt.% based on the total amount of oxybutynin or its hydrochloride. 1
9. A sterile ready-to-use piston syringe, wherein the piston syringe comprises, on the one hand, a syringe body and, on the other hand, a syringe piston with a piston stopper, wherein the syringe body is formed from a polypropylene, wherein the sterile piston syringe is u001dilled with a sterile oxybutynin-containing composition comprising oxybutynin or its hydrochloride, wherein the oxybutynin-containing composition contained in the piston syringe, including the piston syringe, has been heat sterilized according to a method as deu001dined in any one of claims 1 to 8.
10. A sterile ready-to-use piston syringe, wherein the piston syringe comprises, on the one hand, a syringe body and, on the other hand, a syringe piston with a piston stopper, wherein the syringe body is formed from a polypropylene, wherein the sterile piston syringe is u001dilled with a sterile oxybutynin-containing composition comprising oxybutynin or its hydrochloride, wherein the oxybutynin-containing composition is formed as a sterile aqueous composition and fulu001dills the following speciu001dication requirements (i), (ii) and (iii): (i) a predetermined speciu001dication concentration of oxybutynin or its hydrochloride: 0.5 mg/ml to 2 mg/ml with a maximum deviation of ± 5 % based on the concentration of oxybutynin or its hydrochloride, (ii) a predetermined speciu001dication pH value: 2.8 to 5.2, (iii) a predetermined speciu001dication amount of oxybutynin degradation product(s): at most 0.5 wt.% based on the total amount of oxybutynin or its hydrochloride; wherein the oxybutynin-containing composition contained in the piston syringe, including the piston syringe, has been heat sterilized. 1
11. The sterile ready-to-use piston syringe according to claim 9 or claim 10, wherein the piston syringe u001dilled with the oxybutynin-containing composition, prior to performing the heat sterilization, has been transferred and inserted into a closed or sealed pack which pack is at least one of water-tight and germ-tight, wherein at least a part of the pack is at least permeable to water-vapor , wherein the pack is also sterilized when the heat sterilization is performed.
12. A packaging unit comprising at least one pack and at least one sterile ready-to-use piston syringe comprising a sterile oxybutynin-containing composition as deu001dined in any one of claims 9 to 11, wherein the sterile ready-to-use piston syringe is inserted into and present in the pack which pack is at least one of water-tight and germ-tight, wherein at least a part of the pack is at least permeable to water-vapor , wherein the pack is also sterilized via heat sterilization.
13. A kit-of-parts in the form of an application and instillation system, comprising: (i) at least one sterile ready-to-use piston syringe comprising a sterile oxybutynin-containing composition as deu001dined in any one of claims 9 to 11; (ii) at least one application and instillation device connectable to the piston syringe.
14. The kit-of-parts according to claim 13, wherein the application and instillation device comprises at least one of an instillation tube, a urinary bladder catheter and a connection device connectable to the piston syringe.
15. The kit-of-parts according to claim 13 or claim 14, further comprising (iii) at least one application and instillation instruction.
IL307930A 2021-04-24 2022-02-21 Method for syringe sterilization IL307930A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE102021002145 2021-04-24
DE102021112033.0A DE102021112033B4 (en) 2021-04-24 2021-05-07 Procedures for syringe sterilization
PCT/EP2022/054205 WO2022223174A1 (en) 2021-04-24 2022-02-21 Syringe sterilization method

Publications (1)

Publication Number Publication Date
IL307930A true IL307930A (en) 2023-12-01

Family

ID=80683831

Family Applications (1)

Application Number Title Priority Date Filing Date
IL307930A IL307930A (en) 2021-04-24 2022-02-21 Method for syringe sterilization

Country Status (5)

Country Link
EP (2) EP4297725B1 (en)
KR (1) KR20240005775A (en)
ES (1) ES3005682T3 (en)
IL (1) IL307930A (en)
WO (1) WO2022223174A1 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115970025B (en) * 2023-02-03 2024-07-23 太原市农业综合行政执法队 Medical vehicle for livestock and veterinary use

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE59900071D1 (en) * 1999-09-22 2001-05-17 Klaus Stegemann Sealed sterile packaging with a set for intravesical instillation
DE102011105840A1 (en) 2011-04-07 2012-10-11 Klosterfrau Berlin Gmbh Container filled with medical filling product, which is sterilized by thermal sterilization comprising a sterilization process step including thermal sterilization of container in the presence of steam-containing sterilization atmosphere
WO2012154779A1 (en) 2011-05-10 2012-11-15 Theravida. Inc. Combinations of oxybutynin and salivary stimulants for the treatment of overactive bladder
DE202017101330U1 (en) 2017-02-07 2018-02-09 Klosterfrau Berlin Gmbh Sterilization of medical items
JP2022530581A (en) * 2020-04-03 2022-06-30 ファルコ－ファルマ ゲーエムベーハー A syringe filled with an oxybutynin-containing composition, a method for producing the syringe, and a kit containing the syringe.

Also Published As

Publication number Publication date
EP4297725A1 (en) 2024-01-03
ES3005682T3 (en) 2025-03-17
EP4297725C0 (en) 2024-10-23
KR20240005775A (en) 2024-01-12
EP4360669A2 (en) 2024-05-01
WO2022223174A1 (en) 2022-10-27
EP4360669A3 (en) 2024-07-17
EP4297725B1 (en) 2024-10-23

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