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1. (WO2018039318) BIODEGRADABLE POLYMER FORMULATIONS FOR EXTENDED EFFICACY OF BOTULINUM TOXIN
Latest bibliographic data on file with the International BureauSubmit observation

Pub. No.: WO/2018/039318 International Application No.: PCT/US2017/048174
Publication Date: 01.03.2018 International Filing Date: 23.08.2017
Chapter 2 Demand Filed: 26.06.2018
IPC:
A61K 9/14 (2006.01) ,A61K 38/48 (2006.01) ,A61K 9/16 (2006.01) ,A61K 9/00 (2006.01) ,A61K 47/34 (2017.01) ,A61K 47/36 (2006.01) ,A61K 9/113 (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
14
Particulate form, e.g. powders
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
43
Enzymes; Proenzymes; Derivatives thereof
46
Hydrolases (3)
48
acting on peptide bonds (3.4)
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
14
Particulate form, e.g. powders
16
Agglomerates; Granulates; Microbeadlets
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
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
30
Macromolecular compounds
34
Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
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
30
Macromolecular compounds
36
Polysaccharides; Derivatives thereof
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
10
Dispersions; Emulsions
107
Emulsions
113
Multiple emulsions, e.g. oil-in-water-in-oil
Applicants:
AKINA, INC. [US/US]; 3495 Kent Avenue, Suite O 100 West Lafayette, IN 47906-1385, US
Inventors:
PARK, Kinam; US
YUN, Yeonhee; US
SKIDMORE, Sarah Michelle; US
LEE, Byung Kook; US
GARNER, John Solomon; US
Agent:
PABST, Patrea L.; US
MONHEIT, Rivka, D.; US
RAYMOND, Adam, S.; US
SHYNTUM, Yvone, Y.; US
HODGES, Robert, A.; US
Priority Data:
62/380,22926.08.2016US
Title (EN) BIODEGRADABLE POLYMER FORMULATIONS FOR EXTENDED EFFICACY OF BOTULINUM TOXIN
(FR) FORMULATIONS DE POLYMÈRE BIODÉGRADABLE POUR PROLONGER L'EFFICACITÉ DE LA TOXINE BOTULIQUE.
Abstract:
(EN) Methods for the formulation of biodegradable microparticles for delivery of protein drugs, such as botulinum toxin, have been developed. The methods include the steps of precipitating and washing proteins with organic solvent to remove water prior to dispersing in polymer-dissolved organic solvent to prevent exposure to water/solvent interfaces and maintain bioactivity of the protein drugs and fabrication of microparticles by either template or emulsion method. Biodegradable microparticles, formed of one or more biodegradable polymers having entrapped in the polymer one or more protein agents, such as botulinum toxin, are also provided. Precipitated botulinum toxin and botulinum toxin-loaded microparticles can also be formulated into thermogels or crosslinked hydrogels. The stability of the protein within these microparticles, as well as the controlled release of the entrapped agents, provides for sustained efficacy of the agents.
(FR) Des procédés ont été développés pour la formulation de microparticules biodégradables pour l'administration de médicaments protéiques, tels que la toxine botulique. Les procédés comprennent les étapes consistant à précipiter et à laver des protéines avec un solvant organique, pour éliminer l'eau, avant la dispersion dans un solvant organique, dissous dans un polymère, pour empêcher l'exposition aux interfaces eau/solvant et maintenir la bioactivité des médicaments protéiques et la fabrication de microparticules par un procédé de matrice ou d'émulsion. L'invention concerne également des microparticules biodégradables, formées d'un ou de plusieurs polymères biodégradables ayant piégé dans le polymère un ou plusieurs agents protéiques, tels que la toxine botulique. La toxine botulique précipitée, et les microparticules chargées en toxine botulique, peuvent également être formulées en thermogels ou en hydrogels réticulés. La stabilité de la protéine dans ces microparticules, ainsi que la libération contrôlée des agents piégés, permet une efficacité prolongée des agents.
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 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, KM, ML, MR, NE, SN, TD, TG)
Publication Language: English (EN)
Filing Language: English (EN)