STABILIZATION OF IMMUNOGLOBULINS THROUGH AQUEOUS FORMULATION WITH HISTIDINE AT WEAK ACIDIC TO NEUTAL PH

• Main Authors: TESCHNER, WOLFGANG, HOFBAUER, LUCIA, KOELBL, BERNHARD, BUTTERWECK, HARALD ARNO, SCHWARZ, HANS-PETER
• Format: Patent
• Language: English
• Published: 19.11.2015
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES

(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization IN International Bureau (43) International Publication Date H(10) International Publication Number 22 March 2012 (22.03.2012) PCT W O 2012/037534 A1 (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K38/00 (2006.01) A61K47/18 (2006.01) kind of national protection available): AE, AG, AL, AM, A61K38/48 (2006.01) A61K 9/00 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, A61K39/395 (2006.01) A61K47/12 (2006.01) CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, A61K47/02 (2006.01) DZ, EC, EE, EG, ES, Fl, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, (21) International Application Number: KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, PCT/US201 1/052053 ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, (22) International Filing Date: NO, NZ, OM, PE, PG, PH, PL, PT, QA, RO, RS, RU, 16 September 2011 (16.09.2011) 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, (25) Filing Language: English ZM, ZW. (26) Publication Language: English (84) Designated States (unless otherwise indicated, for every (30) Priority Data: kind of regional protection available): ARIPO (BW, GH, 61/384,209 17 September 2010 (17.09.2010) US GM, KE, LR, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, (71) Applicants (for all designated States except US): BAX- TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, TER INTERNATIONAL INC. [US/US]; One Baxter EE, ES, Fl, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, Parkway, Deefield, IL 60015 (US). BAXTER HEALTH- LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, CARE S.A. [CH/CH]; Thurgauerstrasse 130, 8152 SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, Glattpark (Opfikon) (CH). GW, ML, MR, NE, SN, TD, TG). (72) Inventors; and Declarations under Rule 4.17: (75) Inventors/Applicants (for US only): BUTTERWECK, _ as to applicant's entitlement to applyfor and be granted Harald, Arno [AT/AT]; Naufahrtweg 5, A-1220 Wien a t appl enii)) (AT). KOLBL, Bernhard [AT/AT]; Hintausstrasse 20/5, 2481 Achau (AT). HOFBAUER, Lucia [AT/AT]; - as to the applicant's entitlement to claim the priority of Grafenbert 9, A-3730 Eggenburg (AT). TESCHNER, the earlier application (Rule 4.17(iii)) Wolfgang [DE/AT]; Gestettengasse 19/14, A-1030 Wien Published: (AT). SCHWARZ, Hans-Peter [AT/AT]; Weimarer Strasse 76, A-1 180 Wien (AT). - with international search report (Art. 21(3)) (74) Agent: PARENT, Annette, S.; Morgan, Lewis & Bock- - before the expiration of the time limit for amending the ius LLP, One Market, Spear Street Tower, San Francisco, claims and to be republished in the event of receipt of CA 94105 (US). amendments (Rule 48.2(h)) (54) Title: STABILIZATION OF IMMUNOGLOBULINS THROUGH AQUEOUS FORMULATION WITH HISTIDINE AT WEAK ACIDIC TO NEUTRAL PH 6 Months Stability Data NaCl Concentration and pH range -2- 0 1mM NaCl _- X-150 rnM NaG! 5.5 6.0 6.5 7.0 7.5 pH O (57) Abstract: The present invention provides, among other aspects, storage stabile aqueous formulations of immunoglobulins with histidine at a mildly acidic to neutral pH. The present invention also provides methods for stabilizing immunoglobulin com positions by formulating with histidine at a mildly acidic to neutral pH. Advantageously, the methods and formulations provided herein allow stabile aqueous compositions of immunoglobulins at mildly acidic to neutral pH useful for parenteral administration.