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1. (WO2018122867) THIN FILM FORMULATIONS OF 4-DIPHENYLMETHYL-1-PIPERAZINE DERIVATIVES AND THEIR SALTS
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Pub. No.: WO/2018/122867 International Application No.: PCT/IN2017/050613
Publication Date: 05.07.2018 International Filing Date: 22.12.2017
IPC:
A61K 9/24 (2006.01) ,A61K 9/70 (2006.01) ,C07D 295/03 (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
20
Pills, lozenges or tablets
22
Sustained or differential release type
24
Layered or laminated unitary dosage forms
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
70
Web, sheet or filament bases
C CHEMISTRY; METALLURGY
07
ORGANIC CHEMISTRY
D
HETEROCYCLIC COMPOUNDS
295
Heterocyclic compounds containing polymethylene-imine rings with at least five ring members, 3-azabicyclo [3.2.2] nonane, piperazine, morpholine or thiomorpholine rings, having only hydrogen atoms directly attached to the ring carbon atoms
02
containing only hydrogen and carbon atoms in addition to the ring hetero elements
027
containing only one hetero ring
03
with the ring nitrogen atoms directly attached to acyclic carbon atoms
Applicants:
ZIM LABORATORIES LIMITED [IN/IN]; B-21/22, MIDC Area, Kalmeshwar – 441 501, Maharashtra, IN
Inventors:
DAUD, Anwar Siraj; IN
SAPKAL, Nidhi Prakash; IN
BONDE, Minal Nandkumar; IN
BARVE, Shikha; IN
Agent:
SAVANGIKAR, Vasant Anantrao; IN
Priority Data:
20162104448827.12.2016IN
Title (EN) THIN FILM FORMULATIONS OF 4-DIPHENYLMETHYL-1-PIPERAZINE DERIVATIVES AND THEIR SALTS
(FR) FORMULATIONS DE FILM MINCE DE DÉRIVÉS DE 4-DIPHÉNYLMÉTHYL-1-PIPÉRAZINE ET DE LEURS SELS
Abstract:
(EN) This invention comprises a stable oral dispersible thin film and a process of making the same, the film comprising a 4-Diphenylmethyl-1-piperazinyl derivative or its pharmaceutically acceptable salts; characterized by, during storage of the film, level of the individual impurities arising out of degradation of the 4-Diphenylmethyl-1-piperazinyl derivative or its pharmaceutically acceptable salts not exceeding 1% of the added drug, and total impurities not exceeding 2% and the taste is not less than "acceptable" when scored by a taste panel on a scale of Excellent (5), Pleasant (4), Acceptable (3), Bitter (2) and Extremely bitter (1). The film is also thin, translucent, non-curving, non-tacky and flexible with folding endurance of 25 or more, dissolution not less than 75% in 45 minute. The process comprises a step of adding sodium hydroxide before the film casting is done, selecting temperature range for drying step of the film appropriate for getting a stable film, and adding plasticizer/s.
(FR) La présente invention concerne un film mince dispersible oral stable et un procédé de fabrication de celui-ci, le film comprenant un dérivé de 4-diphénylméthyl-1-pipérazinyle ou ses sels pharmaceutiquement acceptables; caractérisé par, pendant le stockage du film, le niveau des impuretés individuelles résultant de la dégradation du dérivé de 4-diphénylméthyl-1-pipérazinyle ou de ses sels pharmaceutiquement acceptables ne dépassant pas 1 % du médicament ajouté, et les impuretés totales ne dépassant pas 2 % et le goût n'est pas moins que "acceptable" lorsqu'il est évalué par un jury de dégustation à une échelle comprenant : Excellent (5), Agréable (4), Acceptable (3), Amer (2) et Extrêmement amer (1). Le film est également mince, translucide, non incurvé, non collant et souple avec une endurance au pliage de 25 ou plus, une dissolution au moins égale à 75 % en 45 minutes. Le procédé comprend une étape consistant à ajouter de l'hydroxyde de sodium avant que la coulée de film soit effectuée, à sélectionner une plage de température pour sécher l'étape du film approprié pour obtenir un film stable, et à ajouter un ou plusieurs plastifiants.
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)