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WO 2018/025248 Al 08 February 2018 (08.02.2018) W !P O PCT

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WO 2018/025248 Al 08 February 2018 (08.02.2018) W !P O PCT (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2018/025248 Al 08 February 2018 (08.02.2018) W !P O PCT (51) International Patent Classification: Declarations under Rule 4.17: A61K 47/18 (2017.01) A61K 47/12 (2006.01) — of inventorship (Rule 4.1 7(iv)) (21) International Application Number: Published: PCT/IB20 17/054809 — with international search report (Art. 21(3)) (22) International Filing Date: — before the expiration of the time limit for amending the 05 August 2017 (05.08.2017) claims and to be republished in the event of receipt of amendments (Rule 48.2(h)) (25) Filing Language: English (26) Publication Langi English (30) Priority Data: 201641026854 05 August 2016 (05.08.2016) IN (71) Applicant: JODAS EXPOIM PRIVATE LIMITED [IN/IN]; H.No: 8-2-293/82/A/1359, 1st Floor, Road No. 45, Jubilee Hills, Telangana, Hyderabad 500 033 (IN). (72) Inventors; and (71) Applicants (for US only): SINGH, Shashi Shanker Parsad [IN/IN]; H.No: 8-2-293/82/A/1359, 1st Floor, Road No. 45, Jubilee Hills, Telangana., Hyderabad 500 033 (IN). PATHIPATI, Venkataramana Rao [IN/IN]; H.No: 8-2-293/82/ A/1 359, 1st Floor, Road No. 45, Jubilee Hills, Telangana., Hyderabad 500 033 (IN). (74) Agent: SURAPUREDDY, Padmaja ; iProPAT Intellectual Property Solutions, 2nd Floor, Above Apollo Clinic, Suresh Square, Plot No 1-58/91/SS, Survey No 228 & 229/1, Mad- inaguda, Miyapur, Hyderabad 500 049 (IN). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, 00 KM, ML, MR, NE, SN, TD, TG). © (54) Title: EDTA INJECTION AND PROCESS FOR MAKING THE SAME 00 (57) Abstract: The present invention relates to the field of parenteral preparations. The invention specifically relates to parenteral o preparations comprising Ethylenediammetetraacetic acid (EDTA) and water for injection. The present invention also relates to proce dure for manufacturing parenteral preparations comprising Ethylenediammetetraacetic acid (EDTA) and water for injection which can be used as diluent. EDTA INJECTION AND PROCESS FOR MAKING THE SAME FIELD OF INVENTION 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. BACKGROUND OF INVENTION Ethylenediaminetetraacetic acid (EDTA) 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. 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. Other names for this ingredient include Edetic Acid (EDTA); Ethylene Diamine Tetra Acetic Acid; N,N'-l,2-Ethanediylbis[N-(Carboxymethyl)Glycine]; Glycine, N,N'-1,2- Ethanediylbis[N-(Carboxymethyl)- (Wenninger and McEwen, 1997); Versenic Acid (Grant, 1972); Edetate (Taylor, 1988); Edathamil (Budavari, 1989; Gennaro, 1990; U.S. Pharmacopeial Convention, Inc.,1995); Ethylenedinitrilotetraacetic Acid; Ethylenebisiminodiacetic Acid (Lewis, 1993); and 3,6-Diazooctanedioic Acid, 3,6- bis(Carboxymethyl)- [Registry of Toxic Effects of Chemical Substances (RTECS), 1997]. 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) and its 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). Grey et al. have disclosed in their article titled 'The Effect of Ethylenediaminetetra- acetic Acid on the Cell Walls of Some Gram-Negative Bacteria' published in J .gen. Microbiol, February 1965, 39: 385-399, it was stated that the cell walls of P. aeruginosa and A. faecalis, against which ethylenediaminetetra- acetic acid (EDTA) has a potent bactericidal action, differed from those of the other organisms principally in their sugar components and in their high content of phosphorus. EDTA at alkaline pH selectively solubilized a high proportion of the carbohydrate and phosphorus present, apparently as lipopolysaccharides, in the walls of sensitive organisms. 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. This invention also discloses 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. All the prior art
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