TWIN-CHAMBER LYOPHILIZATION RECEPTACLE, METHOD FOR FILLING THE SAME, AND USE THEREOF

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TWIN-CHAMBER LYOPHILIZATION RECEPTACLE, METHOD FOR FILLING THE SAME, AND USE THEREOF
Publication Number: WO/2007/020240 International Application No.: PCT/EP2006/065241
Publication Date: 22.02.2007 International Filing Date: 11.08.2006

Int. Class.: A61M 5/28 (2006.01), B65D 51/24 (2006.01)
Applicants: BOEHRINGER INGELHEIM INTERNATIONAL GMBH [DE/DE]; Binger Str. 173, 55216 Ingelheim Am Rhein (DE) (AE, AG, AL, AM, AT, AU, AZ, BA, BB, BE, BF, BG, BJ, BR, BW, BY, BZ, CA, CF, CG, CH, CI, CM, CN, CO, CR, CU, CY, CZ, DK, DM, DZ, EC, EE, EG, ES, FI, FR, GA, GB, GD, GE, GH, GM, GN, GQ, GR, GW, HN, HR, HU, ID, IE, IL, IN, IS, IT, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LV, LY, MA, MC, MD, MG, MK, ML, MN, MR, MW, MX, MZ, NA, NE, NG, NI, NL, NO, NZ, OM, PG, PH, PL, PT, RO, RS, RU, SC, SD, SE, SG, SI, SK, SL, SM, SN, SY, SZ, TD, TG, TJ, TM, TN, TR, TT, TZ, UA, UG, UZ, VC, VN, ZA, ZM, ZW only).
BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG [DE/DE]; Binger Str. 173, 55216 Ingelheim Am Rhein (DE) (DE only).
BASSARAB, Stefan [DE/DE]; Fuenf-linden 59, 88400 Biberach (DE) (US Only).
BAUER, Alexander [DE/DE]; Kànigsbergallee 9/1, 88400 Biberach (DE) (US Only).
DENKINGER, Nicole [DE/DE]; Birkendorfer Str. 45/4, 88400 Biberach (DE) (US Only).
GARIDEL, Patrick [LU/DE]; Ulzburgerstr. 365, 22846 Norderstedt (DE) (US Only).
HEMMINGER, Markus [DE/DE]; Uferstrasse 12, 88400 Biberach (DE) (US Only).
KERN, Hans-Joachim [DE/DE]; Ayestrasse 41, 88441 Mittelbiberach (DE) (US Only).
LANGER, Andreas [DE/DE]; Schubertweg 35, 88437 Maselheim (DE) (US Only).
PRESSER, Ingo [DE/DE]; Widdersteinstr. 162, 88400 Biberach (DE) (US Only).
Inventors: BASSARAB, Stefan [DE/DE]; Fuenf-linden 59, 88400 Biberach (DE).
BAUER, Alexander [DE/DE]; Kànigsbergallee 9/1, 88400 Biberach (DE).
DENKINGER, Nicole [DE/DE]; Birkendorfer Str. 45/4, 88400 Biberach (DE).
GARIDEL, Patrick [LU/DE]; Ulzburgerstr. 365, 22846 Norderstedt (DE).
HEMMINGER, Markus [DE/DE]; Uferstrasse 12, 88400 Biberach (DE).
KERN, Hans-Joachim [DE/DE]; Ayestrasse 41, 88441 Mittelbiberach (DE).
LANGER, Andreas [DE/DE]; Schubertweg 35, 88437 Maselheim (DE).
PRESSER, Ingo [DE/DE]; Widdersteinstr. 162, 88400 Biberach (DE).
Agent: HAMMANN, Heinz; Binger Str. 173, 55216 Ingelheim Am Rhein (DE).
Priority Data: 10 2005 038 368.8 13.08.2005 DE

Abstract:
(EN) The invention relates to a twin-chamber receptacle for separately accommodating and combining a solid material, particularly lyophilisate, and a liquid reconstitution medium therefor. Said twin-chamber receptacle comprises a monolithic cylindrical member (15) with one respective closure (20, 60) at each of the two ends (5, 70) of the member (15), a movable top closure, especially a plug (60), towards the reconstitution medium and a bottom closure (20) towards the lyophilisate, which is embodied as a plug with a top face, a bottom, and a lateral surface, a separating plug (40) that is disposed in the cylindrical member (15), can be displaced by applying pressure, and is used as a seal between the top chamber (50) and the bottom chamber (30), as well as a bypass (35) located below the separating plug (40), having a length L that is greater than the height H of the separating plug (40). Means (21, 25, 28) for partially connecting the interior of the cylindrical member (15) to the environment during the lyophilization process are provided at the bottom end (5) in the wall of the cylindrical member (15) or in the bottom plug (20).