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1. (WO2013045566) N-ACETYLCYSTEINE EFFERVESCENT TABLET AND ITS THERAPEUTICAL APPLICATIONS
Latest bibliographic data on file with the International Bureau   

Pub. No.:    WO/2013/045566    International Application No.:    PCT/EP2012/069111
Publication Date: 04.04.2013 International Filing Date: 27.09.2012
IPC:
A61K 9/00 (2006.01), A61K 31/198 (2006.01), A61P 11/00 (2006.01), A61P 1/16 (2006.01)
Applicants: FRIULCHEM SPA [IT/IT]; Zona Artigianale Via San Marco 23 I-33099 Vivaro (IT)
Inventors: PERRI, Lidia; (IT).
COPPI, Germano; (IT)
Agent: AHNER, Francis; Cabinet Regimbeau 20, rue de Chazelles F-75847 Paris Cedex 17 (FR)
Priority Data:
11182999.0 27.09.2011 EP
61/539,656 27.09.2011 US
Title (EN) N-ACETYLCYSTEINE EFFERVESCENT TABLET AND ITS THERAPEUTICAL APPLICATIONS
(FR) COMPRIMÉ EFFERVESCENT DE N-ACÉTYLCYSTÉINE ET SES APPLICATIONS THÉRAPEUTIQUES
Abstract: front page image
(EN)The present invention is directed to a pharmaceutical composition in the form of an effervescent tablet comprising: (a) 1200 mg of N-acetylcysteine; and (b) at least 1200 mg of sodium hydrogen carbonate; and (c) less than 1200 mg of anhydrous citric acid; and (d) at least one lubricant and/or glidant agent; and (e) at least one sweetener and/or flavouring agent; and said pharmaceutical composition having a pH in the range of 4.1 and 4.4 after tablet dissolution. Preferably, the composition of the invention has no sulphur smell and taste. A manufacturing process is also disclosed. The claimed pharmaceutical composition is used in the treatment of abnormal, viscid, or inspissated mucous secretions.
(FR)La présente invention porte sur une composition pharmaceutique sous la forme d'un comprimé effervescent, comprenant : (a) 1200 mg de N-acétylcystéine ; (b) au moins 1200 mg d'hydrogénocarbonate de sodium ; (c) moins de 1200 mg d'acide citrique anhydre ; (d) au moins un lubrifiant et/ou agent de glissement ; et (e) au moins un édulcorant et/ou agent aromatisant ; ladite composition pharmaceutique ayant un pH dans la plage de 4,1 à 4,4 après dissolution du comprimé. De préférence, la composition de l'invention n'a pas d'odeur ni de goût de soufre. L'invention porte également sur un procédé de fabrication. La composition pharmaceutique de l'invention est utilisée dans le traitement de sécrétions muqueuses anormales, visqueuses ou épaissies.
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, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, 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, 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 (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Organization (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (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, ML, MR, NE, SN, TD, TG).
Publication Language: English (EN)
Filing Language: English (EN)