PE20241337A1 - Administracion facilitada de formulaciones concentradas de anticuerpos mediante el uso de hialuronidasa - Google Patents
Administracion facilitada de formulaciones concentradas de anticuerpos mediante el uso de hialuronidasaInfo
- Publication number
- PE20241337A1 PE20241337A1 PE2024000465A PE2024000465A PE20241337A1 PE 20241337 A1 PE20241337 A1 PE 20241337A1 PE 2024000465 A PE2024000465 A PE 2024000465A PE 2024000465 A PE2024000465 A PE 2024000465A PE 20241337 A1 PE20241337 A1 PE 20241337A1
- Authority
- PE
- Peru
- Prior art keywords
- pharmaceutical formulation
- hyaluronidase
- antibodies
- aliquot
- immunoglobulin
- Prior art date
Links
Classifications
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
- C12N9/14—Hydrolases (3)
- C12N9/24—Hydrolases (3) acting on glycosyl compounds (3.2)
- C12N9/2402—Hydrolases (3) acting on glycosyl compounds (3.2) hydrolysing O- and S- glycosyl compounds (3.2.1)
- C12N9/2474—Hyaluronoglucosaminidase (3.2.1.35), i.e. hyaluronidase
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
- C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
- C12Y302/01035—Hyaluronoglucosaminidase (3.2.1.35), i.e. hyaluronidase
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Genetics & Genomics (AREA)
- Epidemiology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Microbiology (AREA)
- Biophysics (AREA)
- General Engineering & Computer Science (AREA)
- Gastroenterology & Hepatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Mycology (AREA)
- Dermatology (AREA)
- Biomedical Technology (AREA)
- Biotechnology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Abstract
Se proporciona una formulacion farmaceutica concentrada de una inmunoglobulina (IG), combinaciones, composiciones y kits que contienen una composicion de inmunoglobulina (IG) y una composicion de hialuronidasa soluble formuladas para administracion subcutanea. Dichos productos se pueden utilizar en metodos para tratar enfermedades o afecciones tratables con IG. En particular, se refiere a un kit que comprende: (a) un primer recipiente que comprende una formulacion farmaceutica de hialuronidasa humana recombinante en un portador farmaceuticamente aceptable; (b) un segundo recipiente que comprende una formulacion farmaceutica de IgG al 20% (p/v) en un portador farmaceuticamente aceptable; y (c) instrucciones que proporcionan orientacion para la infusion subcutanea secuencial en un primer sitio de infusion, (i), una primera alicuota de una dosis predeterminada de la formulacion farmaceutica de hialuronidasa humana recombinante y, (ii), despues de (i), una primera alicuota de una dosis predeterminada de la formulacion farmaceutica de IgG al 20% (p/v).
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202163243832P | 2021-09-14 | 2021-09-14 | |
| PCT/IB2022/058670 WO2023042096A1 (en) | 2021-09-14 | 2022-09-14 | Facilitated delivery of concentrated antibody formulations using hyaluronidase |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PE20241337A1 true PE20241337A1 (es) | 2024-07-03 |
Family
ID=83508634
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2024000465A PE20241337A1 (es) | 2021-09-14 | 2022-09-14 | Administracion facilitada de formulaciones concentradas de anticuerpos mediante el uso de hialuronidasa |
Country Status (15)
| Country | Link |
|---|---|
| US (1) | US20240392273A1 (es) |
| EP (1) | EP4401758A1 (es) |
| JP (1) | JP2024535021A (es) |
| KR (1) | KR20240055077A (es) |
| CN (1) | CN118139636A (es) |
| AU (1) | AU2022347379A1 (es) |
| CA (1) | CA3232451A1 (es) |
| CL (1) | CL2024000725A1 (es) |
| CR (1) | CR20240161A (es) |
| EC (1) | ECSP24028472A (es) |
| IL (1) | IL311429A (es) |
| MX (1) | MX2024003093A (es) |
| PE (1) | PE20241337A1 (es) |
| TW (1) | TW202327644A (es) |
| WO (1) | WO2023042096A1 (es) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TW202440064A (zh) | 2022-12-22 | 2024-10-16 | 美商哈洛賽恩公司 | 用於高容量施予之玻尿酸酶調製劑 |
Family Cites Families (34)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3710795A (en) | 1970-09-29 | 1973-01-16 | Alza Corp | Drug-delivery device with stretched, rate-controlling membrane |
| US4532414A (en) | 1980-05-12 | 1985-07-30 | Data Chem., Inc. | Controlled temperature blood warming apparatus |
| EP0175528B1 (en) | 1984-09-06 | 1991-05-08 | Genshiro Ogawa | Electronically-controlled heating device for infusion liquids |
| US5052558A (en) | 1987-12-23 | 1991-10-01 | Entravision, Inc. | Packaged pharmaceutical product |
| US5033352A (en) | 1989-01-19 | 1991-07-23 | Yamaha Corporation | Electronic musical instrument with frequency modulation |
| US5250032A (en) | 1991-12-13 | 1993-10-05 | Spectralogic, Inc. | Heater for in vivo blood infusion |
| US5323907A (en) | 1992-06-23 | 1994-06-28 | Multi-Comp, Inc. | Child resistant package assembly for dispensing pharmaceutical medications |
| US5782805A (en) | 1996-04-10 | 1998-07-21 | Meinzer; Randolph | Medical infusion pump |
| US6554791B1 (en) | 1999-09-29 | 2003-04-29 | Smisson-Cartledge Biomedical, Llc | Rapid infusion system |
| ES2342456T3 (es) | 2001-02-22 | 2010-07-07 | Terumo Kabushiki Kaisha | Bomba de jeringuilla. |
| US7871607B2 (en) | 2003-03-05 | 2011-01-18 | Halozyme, Inc. | Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminoglycanases |
| US20060104968A1 (en) | 2003-03-05 | 2006-05-18 | Halozyme, Inc. | Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminogly ycanases |
| ES2564103T3 (es) | 2003-03-05 | 2016-03-17 | Halozyme, Inc. | Glicoproteína hialuronidasa soluble (sHASEGP), proceso para prepararla, usos y composiciones farmacéuticas que la comprenden |
| CA2531921C (en) | 2003-07-09 | 2011-03-15 | Enginivity Llc | Medical fluid warming system |
| US7316666B1 (en) | 2004-04-12 | 2008-01-08 | Arizant Healthcare Inc. | Fluid warming cassette with rails and a stiffening member |
| US7891974B2 (en) | 2004-07-07 | 2011-02-22 | The Board Of Regents Of The University Of Texas System | Portable fluid warming system |
| US7164852B2 (en) | 2005-01-11 | 2007-01-16 | Gaymar Industries, Inc. | Fluid reservoir with integrated heater |
| US20080119782A1 (en) | 2006-10-25 | 2008-05-22 | Steinman Christopher P | Method for delivering solutions to a patient |
| US20080262409A1 (en) | 2007-04-23 | 2008-10-23 | Joel Brian Derrico | High flow rate disposable cassette heat exchanger |
| US7803217B2 (en) | 2007-04-24 | 2010-09-28 | Arizant Healthcare, Inc. | Bubble trap for high flow rate infusion |
| EP4269578B8 (en) | 2008-03-06 | 2024-07-17 | Halozyme, Inc. | Soluble hyaluronidase composition |
| CN102307993B (zh) | 2008-12-09 | 2014-06-25 | 哈洛齐梅公司 | 延长的可溶性ph20多肽及其用途 |
| CA2774053C (en) * | 2009-09-17 | 2015-04-28 | Baxter Healthcare, S.A. | Stable co-formulation of hyaluronidase and immunoglobulin, and methods of use thereof |
| EP2538973A2 (en) | 2010-02-26 | 2013-01-02 | Novo Nordisk A/S | Stable antibody containing compositions |
| US9931279B2 (en) | 2011-04-22 | 2018-04-03 | Medela Holding Ag | Neonatal fluid tubing heater |
| GB201109909D0 (en) | 2011-06-14 | 2011-07-27 | Mcgarvey Connie | Induction heating device for heating a liquid |
| CN104244968B (zh) | 2011-12-30 | 2017-07-25 | 哈洛齐梅公司 | Ph20多肽变体、配制物及其应用 |
| US11219578B2 (en) | 2015-06-19 | 2022-01-11 | Takeda Pharmaceutical Company Limited | Pooling device for single or multiple medical containers |
| AU2016383497B2 (en) | 2015-12-30 | 2021-02-25 | Bracco Injeneering Sa | Thermal conditioning device for an injection system |
| AU2019311658B2 (en) | 2018-07-25 | 2022-10-20 | Alteogen, Inc | Novel hyaluronidase variants and pharmaceutical composition comprising the same |
| BR112021006411A2 (pt) | 2018-10-03 | 2021-07-06 | Takeda Pharmaceuticals Co | dispositivo de agrupamento para um único ou múltiplos recipientes médicos |
| US20200268987A1 (en) | 2019-02-26 | 2020-08-27 | Minhong Yu | Cannula Assembly for Higher Viscosity Injectable Drugs |
| CN121015892A (zh) | 2019-03-25 | 2025-11-28 | 阿特根公司 | 用于皮下注射的包含人透明质酸酶ph20变体和药物的药物组合物 |
| CN120699939A (zh) | 2020-01-23 | 2025-09-26 | 阿特根公司 | 具有改善的稳定性的新玻尿酸酶变体及含有其的药物组合物 |
-
2022
- 2022-09-14 US US18/691,573 patent/US20240392273A1/en active Pending
- 2022-09-14 PE PE2024000465A patent/PE20241337A1/es unknown
- 2022-09-14 JP JP2024516432A patent/JP2024535021A/ja active Pending
- 2022-09-14 TW TW111134768A patent/TW202327644A/zh unknown
- 2022-09-14 IL IL311429A patent/IL311429A/en unknown
- 2022-09-14 CA CA3232451A patent/CA3232451A1/en active Pending
- 2022-09-14 MX MX2024003093A patent/MX2024003093A/es unknown
- 2022-09-14 AU AU2022347379A patent/AU2022347379A1/en active Pending
- 2022-09-14 WO PCT/IB2022/058670 patent/WO2023042096A1/en not_active Ceased
- 2022-09-14 EP EP22783017.1A patent/EP4401758A1/en active Pending
- 2022-09-14 CN CN202280071327.0A patent/CN118139636A/zh active Pending
- 2022-09-14 KR KR1020247011440A patent/KR20240055077A/ko active Pending
-
2023
- 2023-03-23 CR CR20240161A patent/CR20240161A/es unknown
-
2024
- 2024-03-12 CL CL2024000725A patent/CL2024000725A1/es unknown
- 2024-04-11 EC ECSENADI202428472A patent/ECSP24028472A/es unknown
Also Published As
| Publication number | Publication date |
|---|---|
| MX2024003093A (es) | 2024-04-08 |
| AU2022347379A1 (en) | 2024-03-21 |
| CA3232451A1 (en) | 2023-03-23 |
| ECSP24028472A (es) | 2024-05-31 |
| JP2024535021A (ja) | 2024-09-26 |
| CN118139636A (zh) | 2024-06-04 |
| KR20240055077A (ko) | 2024-04-26 |
| EP4401758A1 (en) | 2024-07-24 |
| IL311429A (en) | 2024-05-01 |
| WO2023042096A1 (en) | 2023-03-23 |
| CR20240161A (es) | 2024-08-23 |
| US20240392273A1 (en) | 2024-11-28 |
| CL2024000725A1 (es) | 2024-09-27 |
| TW202327644A (zh) | 2023-07-16 |
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