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WO2018025248A1 - Injection d'edta et son procédé de fabrication. - Google Patents

Injection d'edta et son procédé de fabrication. Download PDF

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Publication number
WO2018025248A1
WO2018025248A1 PCT/IB2017/054809 IB2017054809W WO2018025248A1 WO 2018025248 A1 WO2018025248 A1 WO 2018025248A1 IB 2017054809 W IB2017054809 W IB 2017054809W WO 2018025248 A1 WO2018025248 A1 WO 2018025248A1
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WIPO (PCT)
Prior art keywords
edta
injection
sodium
water
dextrose
Prior art date
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Ceased
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PCT/IB2017/054809
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English (en)
Inventor
Shashi Shanker Parsad SINGH
Venkataramana Rao PATHIPATI
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Jodas Expoim Private Ltd
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Jodas Expoim Private Ltd
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Publication of WO2018025248A1 publication Critical patent/WO2018025248A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/429—Thiazoles condensed with heterocyclic ring systems
    • A61K31/43—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/429—Thiazoles condensed with heterocyclic ring systems
    • A61K31/43—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
    • A61K31/431—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems containing further heterocyclic rings, e.g. ticarcillin, azlocillin, oxacillin
    • 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
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/542—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/545—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine
    • A61K31/546—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine containing further heterocyclic rings, e.g. cephalothin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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

Definitions

  • the present invention relates to the field of parenteral preparations.
  • the invention specifically relates to parenteral preparations comprising Ethylenediaminetetraacetic acid (EDTA) and water for injection.
  • the present invention also relates to procedure for manufacturing parenteral preparations comprising Ethylenediaminetetraacetic acid (EDTA) and water for injection.
  • Ethylenediaminetetraacetic acid was developed by Franz Munz in Germany during the 1930s as an alternative to citric acid. EDTA was approved by the US Food and Drug Administration (FDA) as a food additive in 1947. Since the early 1950s, EDTA has been used in chelation treatment for lead poisoning.
  • FDA US Food and Drug Administration
  • EDTA (CAS No. 60-00-4) is a substituted diamine.
  • the food- and pharmaceutical- grade compound contains not less than 98.0% and not more than 100.5% of C10H16N2O8 (U.S. Pharmacopeial Convention, Inc., 1995).
  • EDTA chemically known as "2-( ⁇ 2- [Bis(carboxymethyl)amino]ethyl ⁇ (carboxymethyl)amino) acetic acid” has the structural formula as follows:
  • EDTA is a colorless crystalline substance widely used to chelate metal ions.
  • EDTA is a common polydentate ligand. In EDTA, the hydrogen atoms are easily removed in solution to produce anionic EDTA. In its anionic form EDTA has six binding atoms, two nitrogen and four oxygen atoms. EDTA binds to a metal ion at the six binding sites, wrapping itself around the metal ion, forming a very stable complex.
  • EDTA Edetic Acid
  • Ethylene Diamine Tetra Acetic Acid N,N'-l,2-Ethanediylbis[N-(Carboxymethyl)Glycine]
  • Glycine N,N'-1,2- Ethanediylbis[N-(Carboxymethyl)-
  • Versenic Acid Grant, 1972
  • Edetate Tetralor, 1988
  • Edathamil Budavari, 1989; Gennaro, 1990; U.S. Pharmacopeial Convention, Inc.
  • EDTA is marketed in its salt forms such as sodium EDTA or calcium EDTA.
  • EDTA has industrial and medical uses as a chelating agent.
  • EDTA ethylenediamine tetraacetic acid
  • EDTA and their salts are substituted diamines.
  • EDTA and their salts include Calcium disodium EDTA, Diammonium EDTA, Dipotassium EDTA, Disodium EDTA, TEA-EDTA, Tetrasodium EDTA, Tripotassium EDTA and Trisodium EDTA.
  • EDTA injection was approved as Endrate which is a sterile, nonpyrogenic, concentrated solution of edetate disodium in water for injection which as a result of a pH adjustment with sodium hydroxide contains varying amounts of disodium and trisodium salts. After dilution, it is administered by intravenous infusion.
  • Water for injection which is defined as the water for the preparation of medicines for parenteral administration when water is used as vehicle (water for injections in bulk) and for dissolving or diluting substances or preparations for parenteral administration (sterilized water for injections).
  • US 2,130,505 disclose polyamino polycarboxylic acids.
  • the invention specifically relates to the Ethylenediaminetetraacetic acid product which is scarcely soluble in water and may be recrystallized from water.
  • IN 236996 discloses pharmaceutical composition for combating beta lactamase antibiotic resistance using beta-lactamase inhibitor as sterile dry powder for injection using EDTA as chelating agent.
  • This invention also discloses a process for preparing the composition for combating beta lactamase mediated antibiotic resistance using beta-lactmase inhibitors capable of pharmaceutical application.
  • RU 2 397 768 discloses pharmaceutical composition to overcome beta-lactamase mediated antibiotic resistance using beta-lactamase inhibitor, intended for parenteral injection for use as antimicrobial combination with fixed doses using EDTA as an inhibitor of solid particles formation after reconstitution for creating pharmaceutically effective and therapeutically safe composition.
  • composition is a single dose in a sealed container for parenteral administration after reconstitution volume of aqueous solvent selected from the group consisting of water for injection.
  • US 6,585,890 discloses a system for producing sterile, pyrogen-free water for injection. This invention relates to process and apparatus for producing sterile water for injection from potable water.
  • CN 101401786 discloses nelarabine injection containing EDTA or edetate, water for injection along with sodium chloride. This invention also discloses the usage of hydrochloric acid or sodium hydroxide for adjusting the pH to 5.0-7.5.
  • CN 102462659 discloses a method for preparing sodium phosphate choline injection cell containing citicoline sodium, disodium edetate, sodium hydrogen sulfite for adjusting pH and water for injection.
  • CN 102973524 discloses a process for preparing esomeprazole sodium freeze-dried powder containing esomeprazole sodium, disodium edetate and / or EDTA, sodium hydroxide for adjusting pH and water for injection.
  • CN 103263415 discloses Levo pantoprazole sodium composition containing pantoprazole sodium, mannitol, EDTA and water for injection.
  • CN 103301077 discloses an injectable preparation of esomeprazole sodium composition by lyophilization technique containing esomeprazole sodium, disodium edetate, sodium hydroxide solution and water for injection.
  • CN 102525893 discloses a preparation process phenylephrine hydrochloride injection containing phenylephrine hydrochloride, sodium chloride, disodium edetate and water for injection.
  • CN 104146953 discloses a fertile for paroxetine hydrobromide injection containing paroxetine hydrobromide, EDTA or edetate, sodium chloride and water for injection.
  • the objective of the present invention is to provide a parenteral composition comprising EDTA.
  • Another objective of the present invention is to provide the specific procedure for formulating EDTA composition containing EDTA and water for injection, optionally with other excipients.
  • Another objective of use of present composition to improve the efficacy of antibiotic formulations.
  • the present invention provides an EDTA injection composition suitable for parenteral administration.
  • Another embodiment of the present invention provides a parenteral composition comprising EDTA and Water for injection for use in parenteral preparations.
  • Yet another embodiment of the present invention provides a parenteral composition which further contains citric acid.
  • Yet another embodiment of the present invention provides a parenteral composition which can be used a diluent for injection.
  • Yet another embodiment of the present invention provides an Injection composition for use in preparing antibiotics intended for parenteral administration, which is prepared by dissolving required quantity of Disodium Edetate (EDTA) in sufficient volume of Water for injection. Then injection solution containing EDTA and water for injection is filtered through 0.22 micron membrane filters. Filtered solution is filled into the type-I glass vials and sealed with aluminum flip-off seals.
  • the vials can be a PP or glass or LDPE, preferably it will be either glass or PP and sizes are in range of 2 mL to 100 mL, preferably 2 mL to 20 mL in capacity. Seals can be aluminium with PP disc, aluminium with plastic cap or plastic twist-off caps or ports etc.
  • Yet another embodiment of the present invention provides an EDTA injection composition for use along with lyophilized products as a diluent intended for parenteral administration for improving the potency of the drugs.
  • Still yet another embodiment of the present invention provides a parenteral composition for antibiotics intended for parenteral administration containing EDTA, Water for injection and Citric acid.
  • Still yet another embodiment of the present invention provides an EDTA injection composition for antibiotics intended for parenteral administration which are used in the treatment of bacterial infections.
  • Still yet another embodiment of the present invention provides antibiotic composition supplied with Disodium Edetate (EDTA) and water for injection composition kit comprising: a) Sterile APIs or Combination of two or more sterile API's filled in a cleaned and depyrogenated type-I glass vials, purge the filled vials with pre filtered nitrogen gas in head space at very low pressure to avoid flashing of powder, and b) Disodium Edetate (EDTA) and water for injection diluent which is supplied in a type-I glass vials and seal with aluminum flip-off seals.
  • EDTA Disodium Edetate
  • Still yet another embodiment of the present invention provides a composition of Ceftriaxone sodium and Sulbactam Sodium supplied with Disodium Edetate (EDTA) and water for injection composition kit comprising:
  • EDTA Disodium Edetate
  • Still yet another embodiment of the present invention provides a composition of Cefoperazone sodium and Sulbactam Sodium supplied with Disodium Edetate (EDTA) and water for injection composition kit comprising:
  • EDTA Disodium Edetate
  • Still yet another embodiment of the present invention provides a composition of Cefepime Hydrochloride monohydrate and Sulbactam Sodium supplied with Disodium Edetate (EDTA) and water for injection composition kit comprising:
  • EDTA Disodium Edetate
  • Still yet another embodiment of the present invention provides a composition of Cefpirome Sulfate and Sulbactam Sodium supplied with Disodium Edetate (EDTA) and water for injection composition kit comprising:
  • EDTA Disodium Edetate
  • composition of Ceftazidime Sodium and Sulbactam Sodium supplied with Disodium Edetate (EDTA) and water for injection composition kit comprising:
  • composition of Ceftalozone Sulfate and Sulbactam Sodium supplied with Disodium Edetate (EDTA) and water for injection composition kit comprising:
  • EDTA Disodium Edetate
  • composition of Cefotaxime Sodium and Sulbactam Sodium supplied with Disodium Edetate (EDTA) and water for injection composition, kit comprising:
  • EDTA Disodium Edetate
  • composition of Cefoperazone Sodium and Tazobactam Sodium supplied with Disodium Edetate (EDTA) and water for injection composition kit comprising:
  • EDTA Disodium Edetate
  • composition of Cefepime Hydrochloride monohydrate and Tazobactam Sodium supplied with Disodium Edetate (EDTA) and water for injection composition kit comprising:
  • EDTA Disodium Edetate
  • composition of Cefpirome Sulfate and Tazobactam Sodium supplied with Disodium Edetate (EDTA) and water for injection composition kit comprising:
  • EDTA Disodium Edetate
  • composition of Ceftazidime Sodium and Tazobactam Sodium supplied with Disodium Edetate (EDTA) and water for injection composition kit comprising:
  • EDTA Disodium Edetate
  • composition of Ceftalozone Sulfate and Tazobactam Sodium supplied with Disodium Edetate (EDTA) and water for injection composition kit comprising:
  • composition of Piperacillin Sodium and Tazobactam Sodium supplied with Disodium Edetate (EDTA) and water for injection composition kit comprising:
  • EDTA Disodium Edetate
  • Ceftazidime Sodium and Avibactam Sodium supplied with Disodium Edetate (EDTA) and water for injection composition kit comprising:
  • EDTA Disodium Edetate
  • composition of Piperacillin and Tazobactam supplied with Disodium Edetate (EDTA) and water for injection composition kit comprising:
  • a) Mixture of sterile Piperacillin and Tazobactam is filled in a cleaned and depyrogenated type-I glass vials, purge the filled vials with pre filtered nitrogen gas in head space at very low pressure to avoid flashing of powder, and b) Disodium Edetate (EDTA), citric acid and water for injection as diluent which is supplied in a type-I glass vials and seal with aluminum flip-off seals.
  • EDTA Disodium Edetate
  • Another embodiment of the present invention provides an EDTA injection composition containing EDTA and Water for injection for parenteral preparations.
  • Another embodiment of the present invention provides an EDTA injection composition for antibiotics intended for parenteral administration, which is prepared by dissolving required quantity of Disodium Edetate (EDTA) in quantity sufficient volume of Water for injection. Then diluent solution containing EDTA and water for injection is filtered through 0.22 micron PVDF membrane filters. Filtered solution is filled into the type-I glass vials and seal with aluminum flip-off seals.
  • the vials can be a PP or glass or LDPE, preferably it will be either glass or PP and sizes are in range of 2mL to 100 mL, preferably 2 mL to 20 mL in capacity. Seals can be aluminium with PP disc, aluminium with plastic cap or plastic twist-off caps or ports etc.
  • EDTA ethylenediamine tetraacetic acid
  • EDTA and their salts are substituted diamines.
  • EDTA and their salts include Calcium disodium EDTA, Diammonium EDTA, Dipotassium EDTA, Disodium EDTA, TEA-EDTA, Tetrasodium EDTA, Tripotassium EDTA and Trisodium EDTA.
  • Water for Injections is a clear, colourless, particle-free, odourless and tasteless liquid. It is sterile, with a pH of 5.0-7.0 and contains no anti-microbial agents .Water for injection is indicated to serve as a vehicle for dilution and reconstitution of suitable medicinal products for parenteral administration.
  • the diluent of the present invention wherein the aqueous vehicle includes Water for
  • WFI Water Injection
  • BWFI Bacteriostatic Water for Injection
  • SWFI Sterile Water for Injection
  • the diluent of the present invention can be used alone or in mixture with any other diluents such as Normal saline (0.9% Sodium Chloride), Dextran 6% in saline, 0.167M Sodium lactate, Lactated Ringer's solution, 5% Dextrose, 5% Dextrose in 0.45% saline, all combinations of dextrose injection and sodium chloride injection ( USP), containing up to 2.5% dextrose (USP), and 0.45% sodium chloride (USP), 5% Dextrose in 0.9% saline, sterile water for injection, M/6 Sodium Lactate Injection, 10% invert sugar and all combinations of dextrose injection and sodium chloride injection (USP), containing up to 2.5% dextrose (USP), and 0.45% sodium chloride ( USP), 10% Dextrose Injection (USP), Bacteriostatic Water for Injection [Benzyl Alcohol or Parabens], Bacteriostatic saline [Benzyl Alcohol or Parabens], Normo
  • the EDTA injection of the present invention is used for reconstitution of any parenteral product before administration. Reconstitution before administration offers a good stability compared to a ready for injection product.
  • Parenteral product as used herein refers to any pharmaceutical product used for the treatment of a disease.
  • the product can be selected from antibiotics, antiseptics, anti-infective agents, antimicrobial agents, antibacterial agents, antifungal agents, antiviral agents, antiprotozoal agents, sporicidal agents, antiparasitic agents, peripheral neuropathy agents, neuropathic agents, analgesic agents, anti-inflammatory agents, anti-allergic agents, anti- hypertension agents, mitomycin-type antibiotics, polyene antifungal agents, antiperspirant agents, decongestants, anti-kinetosis agents, central nervous system agents, wound healing agents, anti-VEGF agents, anti-tumor agents, escharotic agents, anti-psoriasis agents, antidiabetic agents, anti-arthritis agents, anti-itching agents, antipruritic agents, anesthetic agents, anti-malarial agents, dermatological agents, anti-arrhythmic agents, anticonvulsants, antie
  • Antibiotics of the present invention includePenicillins, Cephalosporins, Monobactams, Carbapenems, Macrolide Antibiotics, Lincosamides, Streptogramins, Aminoglycoside Antibiotics, Quinolone Antibiotics, Sulfonamides, Tetracycline Antibiotics and Other Antibiotics or combinations thereof.
  • Penicillins include Amoxicillin, Ampicillin, Bacampicillin, Carbenicillin, Cloxacillin, DicloxaciUin, FlucloxaciUin, Mezlocillin, Nafcillin, Oxacillin, Penicillin G, Penicillin V, Piperacillin, Pivampicillin, Pivmecillinam, Ticarcillin etc or combination thereof.
  • Cephalosporins include first generation, second generation, third generation, fourth generation, fifth generation, not classified and combinations.
  • First generation cephalosporins include Cefacetrile (cephacetrile), Cefadroxil (cefadroxyl), Cefalexin (cephalexin), Cefaloglycin (cephaloglycin), Cefalonium (cephalonium), Cefaloridine (cephaloradine), Cefalotin (cephalothin), Cefapirin (cephapirin), Cefatrizine, Cefazaflur, Cefazedone, Cefazolin (cephazolin), Cefradine (cephradine), Cefroxadine, Ceftezole etc.
  • cephalosporins include Cefaclor, Cefamandole, Cefmetazole, Cefonicid, Cefotetan, Cefoxitin, Cefprozil (cefproxil), Cefuroxime, Cefuzonam etc.
  • cephalosporins include Cefcapene, Cefdaloxime, Cefdinir, Cefditoren, Cefetamet, Cefixime, Cefmenoxime, Cefodizime, Cefotaxime, Cefpimizole, Cefpodoxime, Cefteram, Ceftibuten, Ceftiofur, Ceftiolene, Ceftizoxime, Ceftriaxone, Cefoperazone, Ceftazidime etc.
  • cephalosporins includeCefclidine, Cefepime, Cefluprenam, Cefoselis, Cefozopran, Cefpirome, Cefquinome etc.
  • cephalosporins include Ceftobiprole, Ceftaroline etc.
  • cephalosporins include Cefaclomezine, Cefaloram, Cefaparole, Cefcanel, Cefedrolor, Cefempidone, Cefetrizole, Cefivitril, Cefmatilen, Cefmepidium, Cefovecin, Cefoxazole, Cefrotil, Cefsumide, Cefuracetime, Ceftioxide etc.
  • Combinations include Ceftazidime/ Avibactam.
  • Monobactams include Aztreonam etc.
  • Carbapenems include Imipenem, Imipenem/cilastatin, Doripenem, Meropenem, Ertapenem, Faropenem etc.
  • Macrolide Antibiotics includes Azithromycin, Erythromycin, Clarithromycin, Dirithromycin, Roxithromycin, Ketolides (eg: Telithromycin) etc.
  • Lincosamides include Clindamycin, Lincomycin etc.
  • Streptogramins include Pristinamycin, Quinupristin/dalfopristin etc.
  • Aminoglycoside Antibiotics includes Amikacin, Gentamicin, Kanamycin, Neomycin, Netilmicin, Paromomycin, Streptomycin, Tobramycin etc.
  • Quinolone Antibiotics include first generation, second generation, third generation, fourth generation.
  • First generation quinolone antibiotics include Flumequine, Nalidixic acid, Oxolinic acid, Piromidic acid, Pipemidic acid, Rosoxacin etc.
  • Second generation quinolone antibiotics include Ciprofloxacin, Enoxacin, Lomefloxacin, Nadifloxacin, Norfloxacin, Ofloxacin, Pefloxacin, Rufloxacin etc.
  • Third generation quinolone antibiotics include Balofloxacin, Gatifloxacin, Grepafloxacin, Levofloxacin, Moxifloxacin, Pazufloxacin, Sparfloxacin, Temafloxacin, Tosufloxacin etc.
  • Fourth generation quinolone antibiotics include Besifloxacin, Clinafloxacin, Gemifloxacin, Sitafloxacin, Trovafloxacin, Prulifloxacin etc.
  • Sulfonamides include Sulfamethizole, Sulfamethoxazole, Sulfisoxazole, Trimethoprim-Sulfamethoxazole etc.
  • Tetracycline Antibiotics include Demeclocycline, Doxycycline, Minocycline,
  • Antibiotics include Chloramphenicol, Metronidazole, Tinidazole, Nitrofurantoin, Glycopeptides (eg: Vancomycin, Teicoplanin), Lipoglycopeptides (eg: Telavancin), Oxazolidinones (Linezolid, Cycloserine 2), Rifamycins (eg: Rifampin, Rifabutin, Rifapentine, Rifalazil), Polypeptides (eg: Bacitracin, Polymyxin B), Tuberactinomycins (eg: Viomycin, Capreomycin) etc.
  • Glycopeptides eg: Vancomycin, Teicoplanin
  • Lipoglycopeptides eg: Telavancin
  • Oxazolidinones Linezolid, Cycloserine 2
  • Rifamycins eg: Rifampin, Rifabutin, Rifapentine, Rifalazil
  • Polypeptides
  • Example 6 S.No. Ingredients %w/w
  • Citric acid q.s. to adjust osmolality
  • Citric acid q.s. to adjust Osmolarity
  • Example 13 S.No. Ingredients %w/w
  • Drug Product for some combinations sterile mixture is available and for others where it's not available in a mixture, below procedure to be followed.
  • Diluent Add and dissolve required qty of Disodium Edetate (EDTA) in q.s. volume of WFI. Filter the above solution through 0.22 micron membrane filters, fill the filtered solution into type-I glass vials and seal with aluminum flip-off seals.
  • EDTA Disodium Edetate
  • composition as described in the present invention can be used as diluent for reconstitution of the parenteral product before administration thereby offering stability to the product.
  • the EDTA is not mixed with the API's thereby avoiding the interaction of EDTA with the API and other excipients if any in the parenteral product.
  • the diluent is supplied separately thus the diluent can be used for reconstituting any parenteral product instead of adding EDTA to every drug product.

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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La présente invention concerne le domaine de la préparation parentérale. L'invention concerne spécifiquement les préparations parentérales contenant de l'acide éthylènediaminetétraacétique (EDTA) et de l'eau pour les injections. La présente invention concerne également un procédé de fabrication de préparations parentérales comprenant de l'acide éthylènediaminetétraacétique (EDTA), et de l'eau qui peut être utilisée comme diluant pour les injections.
PCT/IB2017/054809 2016-08-05 2017-08-05 Injection d'edta et son procédé de fabrication. Ceased WO2018025248A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201641026854 2016-08-05
IN201641026854 2016-08-05

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WO2018025248A1 true WO2018025248A1 (fr) 2018-02-08

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PCT/IB2017/054809 Ceased WO2018025248A1 (fr) 2016-08-05 2017-08-05 Injection d'edta et son procédé de fabrication.

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4129281A4 (fr) * 2020-04-30 2023-12-06 Denka Company Limited Formulation liquide et produit pharmaceutique contenant de la cilastatine

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040204372A1 (en) * 2003-04-14 2004-10-14 Wyeth Holdings Corporation Compositions containing pipercillin and tazobactam sodium useful for injection
WO2004091666A1 (fr) * 2003-04-14 2004-10-28 Wyeth Holdings Corporation Compositions contenant de la piperacilline et du tazobactam pour injection
WO2004098643A1 (fr) * 2003-04-14 2004-11-18 Wyeth Holdings Corporation Compositions d'injection contenant piperacilline et tazobactame
WO2006120705A2 (fr) * 2005-05-13 2006-11-16 Venus Remedies Limited Traitement et prevention d'infections graves telles que la fibrose cystique

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040204372A1 (en) * 2003-04-14 2004-10-14 Wyeth Holdings Corporation Compositions containing pipercillin and tazobactam sodium useful for injection
WO2004091666A1 (fr) * 2003-04-14 2004-10-28 Wyeth Holdings Corporation Compositions contenant de la piperacilline et du tazobactam pour injection
WO2004098643A1 (fr) * 2003-04-14 2004-11-18 Wyeth Holdings Corporation Compositions d'injection contenant piperacilline et tazobactame
WO2006120705A2 (fr) * 2005-05-13 2006-11-16 Venus Remedies Limited Traitement et prevention d'infections graves telles que la fibrose cystique

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4129281A4 (fr) * 2020-04-30 2023-12-06 Denka Company Limited Formulation liquide et produit pharmaceutique contenant de la cilastatine

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