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129. (WO2019020820) COMPOSITIONS IN THE FORM OF AN INJECTABLE AQUEOUS SOLUTION COMPRISING AT LEAST HUMAN INSULIN A21G AND A PRANDIAL ACTION GLUCAGON SUPPRESSOR
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Pub. No.: WO/2019/020820 International Application No.: PCT/EP2018/070510
Publication Date: 31.01.2019 International Filing Date: 27.07.2018
IPC:
A61K 9/00 (2006.01) ,A61K 38/26 (2006.01) ,A61K 38/28 (2006.01) ,A61K 45/06 (2006.01) ,A61K 47/02 (2006.01) ,A61K 9/08 (2006.01) ,A61K 31/198 (2006.01) ,C07K 14/62 (2006.01) ,A61P 3/10 (2006.01) ,A61P 5/48 (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
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38
Medicinal preparations containing peptides
16
Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17
from animals; from humans
22
Hormones
26
Glucagons
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38
Medicinal preparations containing peptides
16
Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17
from animals; from humans
22
Hormones
28
Insulins
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
45
Medicinal preparations containing active ingredients not provided for in groups A61K31/-A61K41/132
06
Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
02
Inorganic compounds
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
08
Solutions
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31
Medicinal preparations containing organic active ingredients
185
Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
19
Carboxylic acids, e.g. valproic acid
195
having an amino group
197
the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid (GABA), beta-alanine, epsilon-aminocaproic acid, pantothenic acid
198
Alpha-amino acids, e.g. alanine, edetic acid (EDTA)
C CHEMISTRY; METALLURGY
07
ORGANIC CHEMISTRY
K
PEPTIDES
14
Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
435
from animals; from humans
575
Hormones
62
Insulins
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
3
Drugs for disorders of the metabolism
08
for glucose homeostasis
10
for hyperglycaemia, e.g. antidiabetics
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
5
Drugs for disorders of the endocrine system
48
of the pancreatic hormones
Applicants:
ADOCIA [FR/FR]; 115 avenue Lacassagne 69003 LYON, FR
Inventors:
CHAN, You-Ping; FR
Agent:
TRIPOZ, Inès; FR
Priority Data:
175717227.07.2017FR
175718428.07.2017FR
185525014.06.2018FR
Title (EN) COMPOSITIONS IN THE FORM OF AN INJECTABLE AQUEOUS SOLUTION COMPRISING AT LEAST HUMAN INSULIN A21G AND A PRANDIAL ACTION GLUCAGON SUPPRESSOR
(FR) COMPOSITIONS SOUS FORME D'UNE SOLUTION AQUEUSE INJECTABLE COMPRENANT AU MOINS L'INSULINE HUMAINE A21G ET UN SUPPRESSEUR DE GLUCAGON A ACTION PRANDIALE
Abstract:
(EN) The invention relates to a composition in the form of an injectable aqueous solution having a pH of 3.5 to 4.4 and comprising at least human insulin A21G and at least one prandial action glucagon suppressor. In one embodiment, the prandial action glucagon suppressor is selected from the group consisting of an amylin analogue, or an amylin receptor agonist, or a GLP-1 analogue, or a GLP-1 receptor agonist (GLP-1 RA). In one embodiment, the prandial action glucagon suppressor is an amylin analogue or an amylin receptor agonist. In one embodiment, the prandial action glucagon suppressor peptide is pramlintide. The invention also relates to a method for obtaining human insulin A21G comprising at least a step of reacting human insulin A21G, B31R, B32R (glargine insulin) with rat carboxypeptidase B, with an insulin/carboxypeptidase ratio of between 500 and 2000, at a pH of 7.5 to 8.5 and a temperature of 20 to 30°C for 10 to 20 hours.
(FR) L'invention concerne une composition sous forme d'une solution aqueuse injectable, dont le pH est compris de 3,5 à 4,4 comprenant au moins l'insuline humaine A21G et au moins un suppresseur de glucagon à action prandiale. Dans un mode de réalisation, le suppresseur de glucagon à action prandiale est choisi dans le groupe constitué d'un analogue de l'amyline ou un agoniste du récepteur de l'amyline ou un analogue du GLP-1 ou un agoniste du récepteur au GLP-1 (GLP-1 RA). Dans un mode de réalisation, le suppresseur de glucagon à action prandiale est analogue de l 'amyline ou un agoniste du récepteur de l'amyline. Dans un mode de réalisation, le peptide suppresseur de glucagon à action prandiale est le pramlintide. Elle concerne également un procédé d'obtention de l'insuline humaine A21G comprenant au moins une étape consistant à faire réagir l'insuline humaine A21G, B31R, B32R (insuline glargine) avec la carboxypeptidase B de rat à un ratio insuline/carboxypeptidase compris entre 500 et 2000, à un pH compris de 7,5 à 8,5 et à une température comprise de 20 à 30°C pendant 10 à 20 heures.
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: French (FR)
Filing Language: French (FR)