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1. (WO2019026085) SUBLINGUAL FILM COMPOSITION
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Pub. No.: WO/2019/026085 International Application No.: PCT/IN2018/050473
Publication Date: 07.02.2019 International Filing Date: 20.07.2018
IPC:
A61K 9/00 (2006.01) ,A61K 47/10 (2017.01) ,A61K 31/485 (2006.01)
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
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
06
Organic compounds
08
containing oxygen
10
Alcohols; Phenols; Salts thereof
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31
Medicinal preparations containing organic active ingredients
33
Heterocyclic compounds
395
having nitrogen as a ring hetero atom, e.g. guanethidine, rifamycins
435
having six-membered rings with one nitrogen as the only ring hetero atom
47
Quinolines; Isoquinolines
485
Morphinan derivatives, e.g. morphine, codeine
Applicants:
ALKEM LABORATORIES LTD. [IN/IN]; Alkem House Devashish, S B Marg Lower Parel Mumbai 400013, IN
Inventors:
JAIN, Girish Kumar; IN
DEWANGAN, Ashok; IN
GAJULA, Koteswararao; IN
Agent:
KHER, Sanjay; IN
Priority Data:
20172102773904.08.2017IN
Title (EN) SUBLINGUAL FILM COMPOSITION
(FR) COMPOSITION DE FILM SUBLINGUALE
Abstract:
(EN) The present invention relates to a stable sublingual film comprising a therapeutically effective amount of buprenorphine or a pharmaceutically acceptable salt thereof, a therapeutically effective amount of naloxone or a pharmaceutically acceptable salt thereof; and a non-aqueous solvent, wherein the formulation does not use water and buffer, wherein the said buprenorphine and naloxone are solubilized during formation of the film, and wherein the film is stable for at least 6 months at 40ºC/75% RH condition.
(FR) La présente invention concerne un film sublinguale stable comprenant une quantité thérapeutiquement efficace de buprénorphine ou un sel pharmaceutiquement acceptable de celle-ci, une quantité thérapeutiquement efficace de naloxone ou un sel pharmaceutiquement acceptable de celle-ci; et un solvant non aqueux, la formulation n'utilisant pas d'eau et de tampon, lesdites buprénorphine et naloxone étant solubilisées pendant la formation du film, et le film étant stable pendant au moins 6 mois à une température de 40 °C et une humidité relative de 75 %.
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)