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1. (WO2018197395) VAGINAL RING FOR THE SIMULTANEOUS RELEASE OF TWO ACTIVE INGREDIENTS
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Pub. No.: WO/2018/197395 International Application No.: PCT/EP2018/060302
Publication Date: 01.11.2018 International Filing Date: 23.04.2018
IPC:
A61K 9/70 (2006.01) ,A61K 31/565 (2006.01)
[IPC code unknown for A61K 9/70][IPC code unknown for A61K 31/565]
Applicants:
KERN PHARMA, S.L. [ES/ES]; Pol. Ind. Colon II Venus, 72 08228 TERRASSA, ES
Inventors:
SOLER RANZANI, Luis; ES
SALLÁN LEYES, Marta; ES
MILLÁN MARTÍNEZ, David; ES
Agent:
ZBM PATENTS - ZEA, BARLOCCI & MARKVARDSEN; Pl. Catalunya, 1 2nd floor 08002 BARCELONA, ES
Priority Data:
17382218.024.04.2017EP
Title (EN) VAGINAL RING FOR THE SIMULTANEOUS RELEASE OF TWO ACTIVE INGREDIENTS
(FR) ANNEAU VAGINAL POUR LA LIBÉRATION SIMULTANÉE DE DEUX PRINCIPES ACTIFS
Abstract:
(EN) It is provided a vaginal ring comprising a drug-loaded core comprising a progestogenic steroid compound, a estrogenic steroid compound, and an EVA copolymer having a vinyl acetate content from 25 to 35 wt.%, wherein the progestogenic steroid is dissolved in the core material in a relatively low degree of supersaturation; and a non-medicated outer layer of EVA copolymer having a vinyl acetate content from 5 to 15 wt.%; which is stable under storage at room temperature for at least12 months. It is also provided a process for the preparation of the vaginal ring disclosed above.
(FR) L'invention concerne un anneau vaginal comprenant un noyau chargé de médicament comprenant un composé stéroïde progestogénique, un composé stéroïde oestrogénique, et un copolymère d'éthylène et d'acétate de vinyle (EVA) ayant une teneur en acétate de vinyle de 25 à 35 % en poids,, le stéroïde progestogénique étant dissous dans le matériau de noyau dans un degré relativement faible de sursaturation; et une couche externe non médicamenteuse de copolymère d'EVA ayant une teneur en acétate de vinyle de 5 à 15 % en poids; ce qui est stable pendant le stockage à température ambiante pendant au moins 12 mois. L'invention concerne également un procédé de préparation de l'anneau vaginal décrit ci-dessus.
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)