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1. (WO2018142313) AQUEOUS INJECTABLE PREPARATIONS OF DICLOFENAC AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS
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Pub. No.: WO/2018/142313 International Application No.: PCT/IB2018/050620
Publication Date: 09.08.2018 International Filing Date: 01.02.2018
IPC:
A61K 31/196 (2006.01) ,A61K 9/08 (2006.01)
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31
Medicinal preparations containing organic active ingredients
185
Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
19
Carboxylic acids, e.g. valproic acid
195
having an amino group
196
the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9
Medicinal preparations characterised by special physical form
08
Solutions
Applicants:
MALE, Srinivas Reddy [IN/IN]; IN (US)
PANJALA, Laxman [IN/IN]; IN (US)
KOLTE, Atul [IN/IN]; IN (US)
PAWAR, Shantaram Laxman [IN/IN]; IN (US)
HETERO HEALTHCARE LIMITED [IN/IN]; Sy. No. 80-84, Melange Towers, 4th Floor, C-wing, Patrikanagar, Madhapur, Telangana State Hyderabad 500081, IN
Inventors:
MALE, Srinivas Reddy; IN
PANJALA, Laxman; IN
KOLTE, Atul; IN
PAWAR, Shantaram Laxman; IN
Agent:
SURAPUREDDY, Padmaja; IN
Priority Data:
20174100393002.02.2017IN
Title (EN) AQUEOUS INJECTABLE PREPARATIONS OF DICLOFENAC AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS
(FR) PRÉPARATIONS AQUEUSES POUR INJECTION DE DICLOFÉNAC ET DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
Abstract:
(EN) The present invention relates to the stable aqueous injectable formulation comprising of Diclofenac or a pharmaceutically acceptable diclofenac salts suitable for intramuscular, intravenous, subcutaneous, nasal, ocular drops, intra-articular, and otic delivery, which causes significantly less pain at site of injection. The formulations medium comprising of water, along with one or more co-solvent(s)/solubilizer(s), antioxidants, chelating agents, buffers, alkali and stabilizers, which cause significantly less pain at the site of injection. The invention further provides a method for preparing said composition, wherein the dose of the diclofenac or a pharmaceutically acceptable diclofenac salts thereof is less than 75 mg, i.e. from about 18.75 mg to 37.5 mg. The present invention is also directed to methods of treatment or prevention of Prophylaxis of postoperative pain, Sprains, Bursitis and Strains, Tendinitis, Acute gout, Pain and inflammation associated with musculoskeletal and joint disorders, Rheumatoid arthritis and for treatment of inflammation after surgery or during surgical procedures, Dysmenorrhoea, Renal colic, pain control of total hip replacement arthroplasty.
(FR) La présente invention concerne la formule aqueuse stable pour injection comprenant du Diclofénac ou des sels de diclofénac pharmaceutiquement acceptables adaptés à une administration intramusculaire, intraveineuse, sous-cutanée, nasale, en collyre, intra-articulaire et otique, ce qui entraîne une douleur significativement diminuée au niveau du site d'injection. Le milieu de formulation comprend de l'eau, conjointement avec un ou plusieurs co-solvants/agents de solubilisation, des antioxydants, des agents de chélation, des tampons, des bases alcalines et des stabilisants, qui entraînent une douleur significativement diminuée au niveau du site d'injection. La présente invention concerne en outre un procédé de préparation de ladite composition, la dose du diclofénac ou de sels pharmaceutiquement acceptable de diclofénac étant inférieure à 75 mg, c'est-à-dire d'environ 18,75 mg à 37,5 mg. La présente invention concerne également des procédés de traitement prophylactique ou thérapeutique de la douleur postopératoire, des entorses, de la bursite et des entorses, de la tendinite, de la goutte aiguë, de la douleur et de l'inflammation associées aux troubles musculosquelettiques et articulaires, de la polyarthrite rhumatoïde, et de traitement de l'inflammation après chirurgie ou pendant des interventions chirurgicales, de la dysménorrhée, de la colique néphrétique, ainsi que de maîtrise de la douleur en arthroplastie totale de la hanche.
Designated States: 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
African Regional Intellectual Property Organization (ARIPO) (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Office (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (EPO) (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)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG)
Publication Language: English (EN)
Filing Language: English (EN)