WO2023042107A1 - Formulation pharmaceutique injectable, stable et prête à diluer de mitomycine - Google Patents

Formulation pharmaceutique injectable, stable et prête à diluer de mitomycine Download PDF

Info

Publication number
WO2023042107A1
WO2023042107A1 PCT/IB2022/058697 IB2022058697W WO2023042107A1 WO 2023042107 A1 WO2023042107 A1 WO 2023042107A1 IB 2022058697 W IB2022058697 W IB 2022058697W WO 2023042107 A1 WO2023042107 A1 WO 2023042107A1
Authority
WO
WIPO (PCT)
Prior art keywords
mitomycin
pharmaceutical formulation
injectable pharmaceutical
pharmaceutically acceptable
dimethylacetamide
Prior art date
Application number
PCT/IB2022/058697
Other languages
English (en)
Inventor
Nisarg Pravinkumar SHAH
Maheshkumar Parasmalji SONI
Dhavalkumar Vallabhadas DADHANIYA
Ajeet Kumar Singh
Ashish Sehgal
Original Assignee
Intas Pharmaceuticals Ltd.
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 Intas Pharmaceuticals Ltd. filed Critical Intas Pharmaceuticals Ltd.
Priority to CA3229273A priority Critical patent/CA3229273A1/fr
Priority to AU2022347385A priority patent/AU2022347385A1/en
Publication of WO2023042107A1 publication Critical patent/WO2023042107A1/fr

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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/407—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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

Definitions

  • the present invention relates to a stable ready to dilute (RTD) injectable pharmaceutical formulation of Mitomycin or a pharmaceutically acceptable salt thereof.
  • the said formulation further comprises N, N - Dimethylacetamide (DMAC), Polyethylene glycol (PEG) and optionally other pharmaceutically acceptable excipients. Further, the present invention discloses process for the preparation of the said formulation.
  • Mitomycin is blue-violet crystalline powder. Mitomycin has an empirical formula of C 15 H 18 N 4 O 5 , a molecular weight of 334.33, and the following structural formula:
  • Mitomycin Mitomycin is marketed as topical and injectable dosage forms.
  • the injectable dosage forms are available as lyophilized powder for injection.
  • the marketed injectable dosage form is available in the form of lyophilized powder under the brand name MUTAMYCIN by Bristol Myers Squibb, MITOZYTREX by Supergen and MITOMYCIN by Medac.
  • the marketed formulation of MUTAMYCIN contains Mitomycin as active pharmaceutical ingredient and mannitol as pharmaceutically acceptable excipients.
  • MUTAMYCIN are available as three dosage strengths i.e., 5 mg per vial, 20 mg per vial, and 40 mg per vial.
  • marketed formulation of MITOZYTREX contains mitomycin as active pharmaceutical ingredient and hydroxypropyl ⁇ cyclodextrin (HP ⁇ CD) as pharmaceutically acceptable excipients.
  • MITOZYTREX is available as one dosage strengths i.e., 5 mg per vial. Furthermore, marketed formulation of MITOMYCIN by Medac contains mitomycin as active pharmaceutical ingredient and urea as pharmaceutically acceptable excipients. MITOMYCIN by Medac are available as four dosage strengths i.e., 2 mg per vial, 10 mg per vial, 20 mg per vial, and 40 mg per vial. All lyophilized products require reconstitution of the powder prior to administration to the patient in need thereof.
  • US10688049 discloses a lyophilized powder composition for parenteral administration comprising Mitomycin, which are characterized by high stability and can be rapidly reconstituted to form solutions. Further, it discloses a solution comprising a mixture of tert-butanol and water, and urea as additives.
  • US6048845 discloses a composition comprising an anti -ulceration effective amount of a substituted cyclodextrin compound, a cytotoxic drug i.e. Mitomycin, and mannitol as bulking agent.
  • Mitomycin has issues related to stability, solubility, reconstitution and their final concentration prior to administration when manufactured in the form of lyophilized powder formulation.
  • the previously available lyophilized product was facing the problems associated with longer reconstitution time and difficulty in making final concentration within the limit prior to administration.
  • the object of present invention is to provide a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof.
  • Another object of present invention is to provide a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof, N, N-Dimethylacetamide and Polyethylene glycol.
  • Another object of present invention is to provide a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof, N, N-Dimethylacetamide, Polyethylene glycol and optionally other pharmaceutically acceptable excipients.
  • Another object of present invention is to provide a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof, N, N-Dimethylacetamide, Polyethylene glycol and optionally other pharmaceutically acceptable excipients, which is diluted with either 0.45 % Sodium chloride injection, 0.9 % Sodium chloride Injection or Sodium lactate Injection to make desired final solution before administration.
  • Another object of present invention is to provide a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof, N, N-Dimethylacetamide, Polyethylene glycol and optionally other pharmaceutically acceptable excipients, which is diluted with either 0.45 % Sodium chloride injection, 0.9 % Sodium chloride Injection or Sodium lactate Injection to make desired final solution before administration, and further administered by intravenous and/or intravesical route of administration.
  • Another object of present invention is to provide a process for the preparation of a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof, N, N- Dimethylacetamide, Polyethylene glycol and optionally other pharmaceutically acceptable excipients.
  • the present invention provides a stable ready to dilute injectable pharmaceutical formulation of Mitomycin or a pharmaceutically acceptable salt thereof.
  • the said formulation further comprises N, N-Dimethylacetamide, Polyethylene glycol and optionally other pharmaceutically acceptable excipients. Further, the present invention discloses process for the preparation of the said formulation.
  • RTD ready to dilute
  • a formulation which is a sterile and stable injectable formulation that is not reconstituted from a solid by a healthcare provider prior to use, and it is further diluted with either 0.45 % Sodium chloride injection, 0.9 % Sodium chloride Injection or Sodium lactate Injection to make desired final solution before administration.
  • a RTD formulation is supplied by a pharmaceutical manufacturer in a suitable container (e.g., vial, syringe, bag, and container) in liquid form.
  • stable ready to dilute injectable pharmaceutical formulation refers to a stable ready to dilute injectable pharmaceutical formulation, which comprises Mitomycin, N, N-Dimethylacetamide, Polyethylene glycol and optionally other pharmaceutically acceptable excipients, wherein impurity D and total impurity in the formulation individually are not more than (NMT) 1.0 % w/w when stored at 2-8 °C temperature for at least 3 months and 25 °C temperature / 60 % RH for at least 1 month; wherein the pH of the formulation is about 5 to 7.
  • total impurity refers to all the defined (i.e., Albomitomycin C (Impurity D), 1,2 cis 1 -hydroxy 2, 7-diaminomitosene, and 1,2 trans 1- hydroxy 2, 7-diaminomitosene) and other uncharacterized impurities.
  • the present invention provides a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof and process for the preparation of said formulation.
  • the present invention provides a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof, N, N-Dimethylacetamide and Polyethylene glycol.
  • the present invention provides a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof, N, N-Dimethylacetamide, Polyethylene glycol and optionally other pharmaceutically acceptable excipients.
  • a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof, N, N-Dimethylacetamide, Polyethylene glycol and optionally other pharmaceutically acceptable excipients; wherein N, N-Dimethylacetamide is present in an amount of about 0.1 ml to 0.5 ml.
  • a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof, N, N-Dimethylacetamide, Polyethylene glycol and optionally other pharmaceutically acceptable excipients; wherein Polyethylene glycol is present in an amount to make the volume up to 1 ml.
  • a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof, N, N-Dimethylacetamide, Polyethylene glycol and optionally other pharmaceutically acceptable excipients; wherein Mitomycin or a pharmaceutically acceptable salt thereof is present in a concentration of about 1 mg/ml to 50 mg/ml.
  • a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof, N, N-Dimethylacetamide, Polyethylene glycol and optionally other pharmaceutically acceptable excipients; wherein Mitomycin or a pharmaceutically acceptable salt thereof is present in a concentration of about 1 mg/ml to 50 mg/ml, N, N-Dimethylacetamide is present in an amount of about 0.1 ml to 0.5 ml and Polyethylene glycol is present in an amount to make the volume up to 1 ml; and the said formulation has pH of about 5.0 to 7.0.
  • a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof, N, N-Dimethylacetamide, Polyethylene glycol and optionally other pharmaceutically acceptable excipients; wherein Mitomycin or a pharmaceutically acceptable salt thereof is present in a concentration of about 1 mg/ml to 50 mg/ml, N, N-Dimethylacetamide is present in an amount of about 0.1 ml to 0.5 ml and Polyethylene glycol is present in an amount to make the volume up to 1 ml; and the said formulation has pH of about 5.0 to 7.0; which is diluted with either 0.45 % Sodium chloride injection, 0.9 % Sodium chloride Injection or Sodium lactate Injection to make desired final solution before administration.
  • a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof, N, N-Dimethylacetamide, Polyethylene glycol and optionally other pharmaceutically acceptable excipients; wherein Mitomycin or a pharmaceutically acceptable salt thereof is present in a concentration of about 1 mg/ml to 50 mg/ml, N, N-Dimethylacetamide is present in an amount of about 0.1 ml to 0.5 ml and Polyethylene glycol is present in an amount to make the volume up to 1 ml; and the said formulation has pH of about 5.0 to 7.0; which is diluted with either 0.45 % Sodium chloride injection, 0.9 % Sodium chloride Injection or Sodium lactate Injection to make desired final solution before administration, and further administered by intravenous and/or intravesical route of administration.
  • a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof, N, N-Dimethylacetamide, Polyethylene glycol and optionally other pharmaceutically acceptable excipients; wherein Mitomycin or a pharmaceutically acceptable salt thereof is present in a concentration of about 1 mg/ml to 50 mg/ml, more specifically Mitomycin or a pharmaceutically acceptable salt thereof is present in a concentration of about 2 mg/ml, 5 mg/ml, 10 mg/ ml, 20 mg/ml, or 40 mg/ml.
  • a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof, N, N-Dimethylacetamide, Polyethylene glycol and optionally other pharmaceutically acceptable excipients; wherein N, N-Dimethylacetamide is present in an amount of about 0.1 ml to 0.5 ml, more specifically N, N- Dimethylacetamide is present in an amount of about 0.1 ml, 0.15 ml, 0.2 ml, 0.25 ml, 0.3 ml, 0.35 ml, 0.4 ml, 0.45 ml, or 0.5 ml.
  • a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof
  • Polyethylene glycol is present in an amount to make the volume up to 1 ml; more specifically Polyethylene glycol is present in an amount of about 0.05 ml, 0.1 ml, 0.15 ml, 0.2 ml, 0.25 ml, 0.3 ml,
  • Polyethylene glycol is Polyethylene glycol 300.
  • a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof in a concentration of about 2 mg/ml, N, N-Dimethylacetamide is present in an amount of about 0.4 ml, Polyethylene glycol, and optionally other pharmaceutically acceptable excipients, wherein Polyethylene glycol is present in an amount to make the volume up to 1 ml; and the said formulation has pH of about 5.0 to 7.0; which is diluted with either 0.45 % Sodium chloride injection, 0.9 % Sodium chloride Injection or Sodium lactate Injection to make desired final solution before administration, and further administered by intravenous and/or intravesical route of administration.
  • a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof in a concentration of about 5 mg/ml, N, N-Dimethylacetamide in an amount of about 0.4 ml, Polyethylene glycol, and optionally other pharmaceutically acceptable excipients, wherein Polyethylene glycol is present in an amount to make the volume up to 1 ml; and the said formulation has pH of about 5.0 to 7.0; which is diluted with either 0.45 % Sodium chloride injection, 0.9 % Sodium chloride Injection or Sodium lactate Injection to make desired final solution before administration, and further administered by intravenous and/or intravesical route of administration.
  • a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof at a concentration of about 10 mg/ml, N, N-Dimethylacetamide in an amount of about 0.4 ml, Polyethylene glycol, and optionally other pharmaceutically acceptable excipients, wherein Polyethylene glycol is present in an amount to make the volume up to 1 ml; and the said formulation has pH of about 5.0 to 7.0; which is diluted with either 0.45 % Sodium chloride injection, 0.9 % Sodium chloride Injection or Sodium lactate Injection to make desired final solution before administration, and further administered by intravenous and/or intravesical route of administration.
  • a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof at a concentration of about 20 mg/ml, N, N-Dimethylacetamide in an amount of about 0.4 ml, Polyethylene glycol, and optionally other pharmaceutically acceptable excipients, wherein Polyethylene glycol is present in an amount to make the volume up to 1 ml; and the said formulation has pH of about 5.0 to 7.0; which is diluted with either 0.45 % Sodium chloride injection, 0.9 % Sodium chloride Injection or Sodium lactate Injection to make desired final solution before administration, and further administered by intravenous and/or intravesical route of administration.
  • a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof at a concentration of about 20 mg/ml, N, N-Dimethylacetamide at an amount of about 0.2 ml, Polyethylene glycol, and optionally other pharmaceutically acceptable excipients, wherein Polyethylene glycol is present in an amount to make the volume up to 1 ml; and the said formulation has pH of about 5.0 to 7.0; which is diluted with either 0.45 % Sodium chloride injection, 0.9 % Sodium chloride Injection or Sodium lactate Injection to make desired final solution before administration, and further administered by intravenous and/or intravesical route of administration.
  • a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin or a pharmaceutically acceptable salt thereof at a concentration of about 40 mg/ml, N, N-Dimethylacetamide in an amount of about 0.4 ml, Polyethylene glycol, and optionally other pharmaceutically acceptable excipients, wherein Polyethylene glycol is present in an amount to make the volume up to 1 ml; and the said formulation has pH of about 5.0 to 7.0; which is diluted with either 0.45 % Sodium chloride injection, 0.9 % Sodium chloride Injection or Sodium lactate Injection to make desired final solution before administration, and further administered by intravenous and/or intravesical route of administration.
  • a stable ready to dilute injectable pharmaceutical formulation can comprise N, N-Dimethylacetamide and Polyethylene glycol are in a weight ratio ranging from about 1 :9 to about 9: 1.
  • the weight ratio of the N, N-Dimethylacetamide and Polyethylene glycol can range from about 1 :9 to about 9: 1.
  • the other pharmaceutically acceptable excipients may comprise of antioxidants.
  • the antioxidants can be selected from but not limited to methionine, monothioglycerol, L-cysteine, Thioglycolic acid, Butylated Hydroxy Anisole (BHA), Butylated Hydroxy Toluene (BHT) and mixtures thereof.
  • the present invention provides a process for the preparation of a stable ready to dilute injectable pharmaceutical formulation comprising, Mitomycin, N, N-Dimethylacetamide, Polyethylene glycol and optionally other pharmaceutically acceptable excipients, wherein the formulation is prepared by process comprising the following steps: a. Take required quantity of N, N-Dimethylacetamide in a manufacturing vessel and sparge inert gas (e.g., nitrogen) with stirring, b. Optionally add other pharmaceutically acceptable excipients into step a, c. Add required quantity of Mitomycin into step b with stirring, d. Add Polyethylene glycol to solution of step c to make up the volume up to batch size with stirring for proper mixing; e. Filter the bulk solution obtained in step d; and f. Fill the filtered bulk solution into glass vials. Stopper the vials with rubber stopper and seal the vials.
  • a stable ready to dilute injectable pharmaceutical formulation comprises, Mitomycin, N, N-Dimethylacetamide, Polyethylene glycol, and optionally other pharmaceutically acceptable excipients, wherein impurity D and total impurity in the formulation individually are not more than (NMT) 1.0 % w/w when stored at 2-8 °C temperature for at least 3 months and 25 °C temperature / 60 % RH for at least 1 month; wherein the pH of the formulation is about 5 to 7.
  • Example 1 a-d Ready to dilute injectable pharmaceutical formulation
  • Example 2 a-d Ready to dilute injectable pharmaceutical formulation (2 mg/ml)
  • Example 3 a-d Ready to dilute injectable pharmaceutical formulation (5 mg/ml)
  • Example 4 a-d Ready to dilute injectable pharmaceutical formulation (10 mg/ml)
  • Example 5 a-d Ready to dilute injectable pharmaceutical formulation (20 mg/ml)
  • Example 6 a-d Ready to dilute injectable pharmaceutical formulation (40 mg/ml)
  • Example 7 a-d Ready to dilute injectable pharmaceutical formulation (20 mg/ml)
  • Process for preparation of formulation of example la and 2-7 a a. Take required quantity of N, N-Dimethylacetamide in a manufacturing vessel and sparge nitrogen gas with stirring; b. Add required quantity of Mitomycin into step a; and stir with nitrogen sparging to dissolve it; c. Add Polyethylene glycol to solution of step b to make up the volume up to batch size and stir with nitrogen sparging for proper mixing; d. Filter the above bulk solution; and e. Fill the filtered solution into amber glass vial. Stopper the vials with rubber stopper and seal the vials.
  • Process for preparation of formulation of example lb and 2-7b a. Take required quantity of N, N-Dimethylacetamide in a manufacturing vessel and sparge nitrogen gas with stirring; b. Add required quantity of Butylated Hydroxy Anisole into step a and stir with nitrogen sparging to dissolve it; c. Add required quantity of Butylated Hydroxy Toluene into step b and stir with nitrogen sparging to dissolve it; d. Add required quantity of Mitomycin into step c and stir with nitrogen sparging to dissolve it; e. Add Polyethylene glycol to solution obtained in step d to make up the volume up to batch size and stir with nitrogen sparging for proper mixing; f. Filter the above bulk solution; g. Fill the filtered solution into amber glass vial. Stopper the vials with rubber stopper and seal the vials.
  • Process for preparation of formulation of example 1 c and 2-7 c a. Take required quantity of N, N-Dimethylacetamide in a manufacturing vessel and sparge nitrogen gas with stirring; b. Add required quantity of Butylated Hydroxy Anisole into step a and stir with nitrogen sparging to dissolve it; c. Add required quantity of Mitomycin into step b and stir with nitrogen sparging to dissolve it;
  • step d Add Polyethylene glycol to solution obtained in step c to make up the volume up to batch size and stir with nitrogen sparging for proper mixing; e. Filter the above bulk solution; f. Fill the filtered solution into amber glass vial. Stopper the vials with rubber stopper and seal the vials.
  • Process for preparation of formulation of example Id and 2-7 d a. Take required quantity of N, N-Dimethylacetamide in a manufacturing vessel and sparge nitrogen gas with stirring;
  • step b Add required quantity of Butylated Hydroxy Toluene into step a and stir with nitrogen sparging to dissolve it; c. Add required quantity of Mitomycin into step b and stir with nitrogen sparging to dissolve it; d. Add Polyethylene glycol to solution obtained in step c to make up the volume
  • N, N- Dimethylacetamide and Polyethylene glycol can be used in preparation of a stable ready to dilute injectable pharmaceutical formulation comprising Mitomycin.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La présente invention concerne une formulation pharmaceutique injectable, stable et prête à diluer (RTD) de mitomycine ou d'un sel pharmaceutiquement acceptable de celle-ci. Ladite formulation comprend en outre du N, N-diméthylacétamide (DMAC), du polyéthylène glycol (PEG) et éventuellement d'autres excipients pharmaceutiquement acceptables. En outre, la présente invention concerne un procédé de préparation de ladite formulation.
PCT/IB2022/058697 2021-09-17 2022-09-15 Formulation pharmaceutique injectable, stable et prête à diluer de mitomycine WO2023042107A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CA3229273A CA3229273A1 (fr) 2021-09-17 2022-09-15 Formulation pharmaceutique injectable, stable et prete a diluer de mitomycine
AU2022347385A AU2022347385A1 (en) 2021-09-17 2022-09-15 A stable ready to dilute injectable pharmaceutical formulation of mitomycin

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN202121042020 2021-09-17
IN202121042020A IN202121042020A (fr) 2021-09-17 2021-09-17

Publications (1)

Publication Number Publication Date
WO2023042107A1 true WO2023042107A1 (fr) 2023-03-23

Family

ID=85602499

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2022/058697 WO2023042107A1 (fr) 2021-09-17 2022-09-15 Formulation pharmaceutique injectable, stable et prête à diluer de mitomycine

Country Status (4)

Country Link
AU (1) AU2022347385A1 (fr)
CA (1) CA3229273A1 (fr)
IN (1) IN202121042020A (fr)
WO (1) WO2023042107A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024079565A1 (fr) * 2022-10-12 2024-04-18 Harshal Prabhakar Bhagwatwar Concentrés stables de mitomycine

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998036776A2 (fr) * 1997-02-20 1998-08-27 Matrix Pharmaceutical, Inc. Vehicules d'administration en gel pour agents s'opposant a la proliferation cellulaire
WO2001039741A2 (fr) * 1999-11-29 2001-06-07 Medac Gesellschaft für klinische Spezialpräparate mbH Solution de mitomycine c
US20160256391A1 (en) * 2013-10-22 2016-09-08 Medac Gesellschaft für klinische Spezialpräparate mbH Process for the preparation of a freeze-dried pharmaceutical composition containing mitomycin c

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998036776A2 (fr) * 1997-02-20 1998-08-27 Matrix Pharmaceutical, Inc. Vehicules d'administration en gel pour agents s'opposant a la proliferation cellulaire
WO2001039741A2 (fr) * 1999-11-29 2001-06-07 Medac Gesellschaft für klinische Spezialpräparate mbH Solution de mitomycine c
US20160256391A1 (en) * 2013-10-22 2016-09-08 Medac Gesellschaft für klinische Spezialpräparate mbH Process for the preparation of a freeze-dried pharmaceutical composition containing mitomycin c

Also Published As

Publication number Publication date
AU2022347385A1 (en) 2024-02-22
IN202121042020A (fr) 2023-03-24
CA3229273A1 (fr) 2023-03-23

Similar Documents

Publication Publication Date Title
KR101053780B1 (ko) 도세탁셀을 함유하는 단일액상의 안정한 약제학적 조성물
JP6008849B2 (ja) 置換β−シクロデキストリンにより安定化されたポサコナゾール静脈注射用溶液製剤
US20150073000A1 (en) Stable ready-to-use pharmaceutical composition of pemetrexed
US11642355B2 (en) Pharmaceutical compositions of testosterone
EP1574221A1 (fr) Préparations stables et injectables comprenant de la diclofénac
WO2023042107A1 (fr) Formulation pharmaceutique injectable, stable et prête à diluer de mitomycine
JP6949849B2 (ja) バンコマイシンの製剤
US20210106591A1 (en) Meloxicam composition, preparation and preparation method and use thereof
CN113559277B (zh) 一种注射用卡巴他赛组合物及其制备方法
US20220265674A1 (en) Parenteral compositions comprising methylene blue
US20030165568A1 (en) Stabilized steroidal suspension
WO2021033145A1 (fr) Nouvelles formulations injectables d'artésunate
JP4475405B2 (ja) 医薬組成物
US20180280295A1 (en) Single vial ready to use cabazitaxel formulations with increased stability and methods of preparations
US11826466B2 (en) Bendamustine solution formulations
TW201106961A (en) Ipamorelin diacetate injection and infusion solutions
CN112891307A (zh) 拉米夫定的液体药物制剂
WO2024009319A1 (fr) Compositions injectables liquides de trilaciclib
KR101770605B1 (ko) 페메트렉시드 또는 그것의 약제학적으로 허용가능 한 염을 함유하는 안정한 약제학적 조성물
RU2575768C2 (ru) Составы внутривенных растворов позаконазола, стабилизированные посредством замещенного бета-циклодекстрина

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: 22869512

Country of ref document: EP

Kind code of ref document: A1

WWE Wipo information: entry into national phase

Ref document number: AU2022347385

Country of ref document: AU

WWE Wipo information: entry into national phase

Ref document number: 808053

Country of ref document: NZ

WWE Wipo information: entry into national phase

Ref document number: 3229273

Country of ref document: CA

ENP Entry into the national phase

Ref document number: 2022347385

Country of ref document: AU

Date of ref document: 20220915

Kind code of ref document: A

WWE Wipo information: entry into national phase

Ref document number: 2022869512

Country of ref document: EP

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2022869512

Country of ref document: EP

Effective date: 20240417