WO2019220189A1 - Système d'administration de médicament comprenant de l'acétate de médroxyprogestérone destiné à être utilisé dans la contraception féminine - Google Patents

Système d'administration de médicament comprenant de l'acétate de médroxyprogestérone destiné à être utilisé dans la contraception féminine Download PDF

Info

Publication number
WO2019220189A1
WO2019220189A1 PCT/IB2018/055004 IB2018055004W WO2019220189A1 WO 2019220189 A1 WO2019220189 A1 WO 2019220189A1 IB 2018055004 W IB2018055004 W IB 2018055004W WO 2019220189 A1 WO2019220189 A1 WO 2019220189A1
Authority
WO
WIPO (PCT)
Prior art keywords
cartridge
injection device
injectable solution
pen injection
medroxyprogesterone acetate
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.)
Ceased
Application number
PCT/IB2018/055004
Other languages
English (en)
Inventor
Kalak Abdul HAFEEZ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of WO2019220189A1 publication Critical patent/WO2019220189A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • 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
    • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules

Definitions

  • the present disclosure relates to technical field of drug delivery systems.
  • the present disclosure relates to a drug delivery system comprising medroxyprogesterone acetate for use in female contraception.
  • Medroxyprogesterone acetate also known as 6-alpha-Methyl-l7-alpha- hydroxyprogesterone acetate, is a steroidal progestin used therapeutically as a contraceptive, in hormone replacement therapy and for the treatment of endometriosis. Medroxyprogesterone acetate and its preparation method are described in US Patent No. 3377364.
  • United States Patent No. 4826831 discloses a method of hormonal treatment for menopausal disorders in a female subject, which comprises oral or intramuscular (IM) administration to the female subject of a combination of medroxyprogesterone acetate and an estrogen.
  • IM intramuscular
  • IM intramuscular
  • intramuscular injection product requires syringe with needle and a well-trained medical professional to accomplish administration of the drug product.
  • intramuscular injection is often quite painful, which leads to patient discomfort and poor regimen compliance.
  • Oral administration of medroxyprogesterone acetate is not satisfactory because the active ingredient is destroyed in the digestive tract with digestive juices and enzymes.
  • oral dosage forms, such as tablets and capsules require various pharmaceutical excipients to be admixed with the active ingredient. This unnecessarily increases the cost of final product.
  • medroxyprogesterone acetate injection products e.g., Cyclofem®
  • frequent intramuscular injection of medroxyprogesterone acetate causes considerable pain and discomfort to patient, thereby resulting in patient non-compliance with recommended usage instructions.
  • the commercially available injectable contraceptive preparations for example Cyclofem®, combine medroxyprogesterone acetate with an estrogen.
  • the estrogen contained in such combination is considered to cause certain metabolic disturbances and hepatic or thrombo-embolic accidents. Consequently, this type of contraception is not feasible in all situations due to the risks of estrogen therapy or its contra-indication in certain patients.
  • the present disclosure provides drug delivery device, formulation, and method for subcutaneous administration of medroxyprogesterone acetate, to provide progestin-only contraception in human female to prevent pregnancy.
  • the present disclosure is directed to a pen injection device for subcutaneously administering a predefined dose of an injectable solution of medroxyprogesterone acetate to produce a contraceptive effect in human female.
  • the pen injection device can include: a cartridge comprising an injectable solution of medroxyprogesterone acetate, wherein the cartridge is transparent so as to allow a visual inspection of quality and quantity of the injectable solution in the cartridge; a cartridge housing configured to hold the cartridge, wherein the cartridge housing is transparent; and an injecting means to subcutaneously deliver a dose of the injectable solution to a human female.
  • the cartridge used in the pen injection device can have a capacity of about 3 ml.
  • the injecting means used in the pen injection device can be a hollow needle, an array of hollow micro-needles or a needle free injection system.
  • the injectable solution comprises medroxyprogesterone acetate at a concentration of 104 mg per 0.65 ml of the injectable solution, i.e. l60mg/ml solution.
  • the cartridge comprises 2.6 ml of the injectable solution.
  • the cartridge comprises four doses of the injectable solution, wherein each dose comprises 0.65 ml of the injectable solution.
  • each single dose of the injectable solution can be administered via subcutaneous route in a once- every-three month dosing regimen for the purpose of achieving a contraceptive effect in a female of reproductive age.
  • the present disclosure provides a method for providing progestin- only contraception in a human female, the method comprises subcutaneously administering an injectable solution of medroxyprogesterone acetate to the human female using the pen injection device of the present disclosure.
  • the injectable solution comprises medroxyprogesterone acetate at a concentration of 104 mg per 0.65 ml of the injectable solution, i.e. l60mg/ml solution.
  • the injectable solution can be administered to the human female subcutaneously at a dose of l04mg/0.65 ml once every 3 months for the purpose of providing contraception in the human female.
  • FIG. 1 illustrates an exemplary system diagram of a pen injection device, in accordance with an embodiment of the present disclosure.
  • FIG. 2 illustrates exemplary configuration of one embodiment of a pen injection device of the present disclosure.
  • the present disclosure provides drug delivery device, formulation, and method for subcutaneous administration of medroxyprogesterone acetate, to provide progestin-only contraception in human female to prevent pregnancy.
  • the present disclosure is directed to a pen injection device for subcutaneously administering a predefined dose of an injectable solution of medroxyprogesterone acetate to produce a contraceptive effect in human female.
  • the pen injection device can include: a cartridge comprising an injectable solution of medroxyprogesterone acetate, wherein the cartridge is transparent so as to allow a visual inspection of quality and quantity of the injectable solution in the cartridge; a cartridge housing configured to hold the cartridge, wherein the cartridge housing is transparent; and an injecting means to subcutaneously deliver a dose of the injectable solution to a human female.
  • the cartridge used in the pen injection device has a capacity of 3 ml.
  • the transparent cartridge can have graduation marks that indicate quantity of the injectable contraceptive solution.
  • the injectable solution comprises medroxyprogesterone acetate at a concentration of 104 mg per 0.65 ml of the injectable solution, i.e. l60mg/ml solution.
  • the transparent cartridge comprises four doses of the injectable solution, wherein each dose comprises 0.65 ml of the injectable solution.
  • Each single dose of the injectable solution can be administered subcutaneously in a once-every- three month dosing regimen for the purpose of achieving a contraceptive effect in a female of reproductive age, without loss of contraceptive effect during the intervening period.
  • the pen injection device can include one or more labels containing information about the medication, such as dose, dosage regimen, therapeutic indication, medical warnings and patient information.
  • the cartridge is prefilled with a predefined volume of the injectable contraceptive solution.
  • the cartridge is disposable.
  • the cartridge comprises 2.6 ml of the injectable solution.
  • the injecting means used in the pen injection device can be a hollow needle, an array of hollow micro-needles or a needle free injection system.
  • the injectable solution of medroxyprogesterone acetate can further include one or more pharmaceutically acceptable excipients.
  • pharmaceutically acceptable excipients that can be used in the injectable solution of medroxyprogesterone acetate can include, but not limited to, aqueous solvent, non-aqueous vehicles, lubricants, preservatives, chelating agents, surfactants, antioxidants, buffers, pH adjusting agents, tonicity adjusting agents, antimicrobial agents, and any other parenterally acceptable excipients known to the art, including any mixtures thereof.
  • each 0.65 ml of the injectable solution of medroxyprogesterone acetate comprises:
  • FIG. 1 illustrates an exemplary system diagram of pen injection device 100 (hereinafter referred to as “device”), in accordance with an embodiment of the present disclosure.
  • the device 100 can include a cartridge housing 102, a cartridge 104 and an injecting means 106.
  • the pen injection device 100 can be made from materials that are non-corrosive, shatterproof and safe to be used for medical purposes. The materials can include, but not be limited to, plastics, glass, polymers etc.
  • the pen injection device 100 can dispense the injectable contraceptive solution through one or more needles using a mechanism that can be any or a combination of mechanical, vacuum, pneumatic etc.
  • the cartridge housing 102 is transparent.
  • the cartridge housing 102 can removably receive and hold the cartridge 104 containing an injectable solution of medroxyprogesterone acetate in its loaded position.
  • the cartridge 104 is transparent so as to allow a visual inspection of quality and quantity of the injectable contraceptive solution in the cartridge.
  • the quantity of the injectable solution can be dosage administered at each use, or the amount of the medicine remaining in the cartridge for future use.
  • the parameters for quality assessment can be any or a combination of the medicine being stale, presence of air bubbles in the cartridge, absence of required amount of dosage present in the cartridge.
  • the transparent cartridge 104 can include graduated marks on an external surface thereof so as to indicate number of doses of the contraceptive solution injected out or remaining within said cartridge.
  • the injecting means 106 used in the pen injection device 100 can be a hollow hypodermic needle suitable for subcutaneous injection.
  • the injecting means 106 comprises an array of micro-needles through which a dose of the injectable contraceptive solution can be subcutaneously injected.
  • the pen injection device 100 can utilize needle-free injection technology for subcutaneously delivering a dose of the injectable contraceptive solution to a human female.
  • Any needle-free injection technology known in the art for parenteral administration of a liquid medicament to an animal or human can be readily deployed in the practice of the present invention.
  • the injecting means 106 can be a needle- free injection system which works by a mechanism in which injectable solution is forced at a high pressure through a small opening that is held against an injection site. Due to this an ultrafine stream of high pressure medicine is created, that penetrates skin without the use of a needle.
  • the pen injection device 100 can have at least one unique identifier such as, e.g., a barcode, an RFID tag, a 2D barcodes, and/or NFC technology.
  • the at least one used unique identifier can enable tracking and tracing of the device from the moment of release by a manufacturer of the device until the moment of quality control.
  • RFID tags or barcodes can be used on the injection device.
  • the RFID tags or the barcodes help prevent counterfeiting of the pen injection device.
  • FIG. 2 illustrates exemplary configuration of a pen injection device 200 in accordance with one embodiment of the present disclosure.
  • the device 200 includes a transparent cartridge housing 202, a transparent cartridge 204, a needle 210, an injectable contraceptive solution comprising medroxyprogesterone acetate 208, and graduated marks 206.
  • the cartridge housing 202 is transparent allowing visible inspection of the cartridge 204 held inside the housing 202.
  • the cartridge housing 202 houses the cartridge 204 containing the injectable solution, wherein the cartridge 204 is transparent.
  • the transparent cartridge 204 can have a capacity of about 3 ml.
  • the graduated marks can be used to determine dosage to be administered at each use 206, and the amount of injectable solution 208 left in the cartridge for future use.
  • the needle 210 can be a hypodermic needle suitable for subcutaneous administration of the injectable solution.
  • the needle 210 can have multiple configurations based on size, thickness and flexibility. In an embodiment the needle 210 is retractable.
  • the pen injection device 200 can have at least one unique identifier such as, e.g., a barcode, an RFID tag, a 2D barcodes, and/or NFC technology.
  • the at least one used unique identifier can enable tracking and tracing of the device from the moment of release by a manufacturer of the device until the moment of quality control.
  • Another aspect of the present disclosure is directed to a method for providing progestin-only contraception in a human female, the method comprises subcutaneously administering an injectable solution of medroxyprogesterone acetate to the human female using the pen injection device of the present disclosure.
  • the injectable solution comprises medroxyprogesterone acetate at a concentration of 104 mg per 0.65 ml of the injectable solution, i.e. l60mg/ml solution.
  • the injectable solution can be administered to the human female subcutaneously at a dose of l04mg/0.65 ml once every 3 months for the purpose of providing contraception in the human female.
  • the present disclosure provides a medroxyprogesterone acetate drug delivery system that provides higher compliance rates and more lifestyle convenience for females who require contraception.
  • the present disclosure provides a drug delivery system that facilitates needleless injection of medroxyprogesterone acetate contraceptive formulation into a patient.
  • the present disclosure provides a drug delivery system that delivers a predefined dose of medroxyprogesterone acetate to body painlessly.
  • the present disclosure provides a drug delivery system for subcutaneous administration of an injectable contraceptive formulation comprising medroxyprogesterone acetate, which is safe, reliable and easy to use for self-administration by a human female in need of contraception.
  • the present disclosure provides a medroxyprogesterone acetate drug delivery system which can be easily used by patients self-administering medication.
  • the present disclosure provides a drug delivery system which comprises an injectable medroxyprogesterone acetate contraceptive formulation which provides long term contraceptive effect in human female.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un dispositif d'administration de médicament, une formulation et un procédé d'administration sous-cutanée d'acétate de médroxyprogestérone, pour fournir une contraception à la progestine uniquement chez un humaine de sexe féminin pour empêcher la grossesse. Selon un aspect, la présente invention concerne un dispositif d'injection à stylo destiné à être utilisé dans une contraception féminine, le dispositif comprenant (a) une cartouche comprenant une solution injectable d'acétate de médroxyprogestérone, la cartouche étant transparente de façon à permettre une inspection visuelle de la qualité et de la quantité de la solution injectable dans la cartouche ; (b) un boîtier de cartouche conçu pour contenir la cartouche, le boîtier de cartouche étant transparent ; et (c) un moyen d'injection pour administrer par voie sous-cutanée une dose de la solution injectable à un humaine de sexe féminin.
PCT/IB2018/055004 2018-05-18 2018-07-06 Système d'administration de médicament comprenant de l'acétate de médroxyprogestérone destiné à être utilisé dans la contraception féminine Ceased WO2019220189A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201841018776 2018-05-18
IN201841018776 2018-05-18

Publications (1)

Publication Number Publication Date
WO2019220189A1 true WO2019220189A1 (fr) 2019-11-21

Family

ID=68539625

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2018/055004 Ceased WO2019220189A1 (fr) 2018-05-18 2018-07-06 Système d'administration de médicament comprenant de l'acétate de médroxyprogestérone destiné à être utilisé dans la contraception féminine

Country Status (1)

Country Link
WO (1) WO2019220189A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000021511A2 (fr) * 1998-10-09 2000-04-20 Pharmacia & Upjohn Company Acetate de medroxyprogesterone administre par voie sous-cutanee en vue du traitement de la menopause et de l'endometriose
WO2009014955A2 (fr) * 2007-07-20 2009-01-29 Amylin Pharmaceuticals, Inc. Dispositif d'injection pour stylo et son procédé d'utilisation

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000021511A2 (fr) * 1998-10-09 2000-04-20 Pharmacia & Upjohn Company Acetate de medroxyprogesterone administre par voie sous-cutanee en vue du traitement de la menopause et de l'endometriose
WO2009014955A2 (fr) * 2007-07-20 2009-01-29 Amylin Pharmaceuticals, Inc. Dispositif d'injection pour stylo et son procédé d'utilisation

Similar Documents

Publication Publication Date Title
AU2022203652B2 (en) Medical delivery system
CN107921219B (zh) 注射器装置
JP4871492B2 (ja) 流体移送用医療用コネクタアッセンブリ
AU2010294628B2 (en) Drug delivery system and device with cap function
BRPI0609008B1 (pt) sistema de transferência de fluido, método para transferir uma substância médica e dispositivo de distribuição
JP2002520098A (ja) 薬剤放出装置並びにこれに使用されるカートリッジ集合体
WO2017001923A1 (fr) Ensemble doseur pour dispositif de distribution
CN110678194B (zh) 奥曲肽注射液
US10272206B2 (en) Leuprolide injection
EP2662073B1 (fr) Injection d'octréotide
US9636462B2 (en) Drug delivery device with shield operated needle actuator
JP2019529031A (ja) 単回注射により少なくとも２つの製剤を制御された量で個別に投与するシリンジ−コネクタ装置
WO2019220189A1 (fr) Système d'administration de médicament comprenant de l'acétate de médroxyprogestérone destiné à être utilisé dans la contraception féminine
US20200375847A1 (en) Anesthetics needle device to facilitate the use of buffered anesthetics
ATE397954T1 (de) Arzneiverabreichungssystem mit halter und arzneimittelbehälter
WO2019220190A1 (fr) Dispositif d'injection de médicament de type stylo intelligent destiné à être utilisé en thérapie contraceptive
CA3021989C (fr) Systeme d'administration de medicament
Baxter et al. Medicines and their Management
WO2016081069A1 (fr) Système de seringue pédiatrique à base de poids
HK1254290B (zh) 注射器装置
ES284095U (es) Disposicion de canulas perfeccionada para la administracion terapeutica de medicamentos.

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 18918650

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 18918650

Country of ref document: EP

Kind code of ref document: A1