JPWO2021185921A5 - - Google Patents
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- JPWO2021185921A5 JPWO2021185921A5 JP2022548034A JP2022548034A JPWO2021185921A5 JP WO2021185921 A5 JPWO2021185921 A5 JP WO2021185921A5 JP 2022548034 A JP2022548034 A JP 2022548034A JP 2022548034 A JP2022548034 A JP 2022548034A JP WO2021185921 A5 JPWO2021185921 A5 JP WO2021185921A5
- Authority
- JP
- Japan
- Prior art keywords
- liquid formulation
- concentration
- peg
- formulation according
- rhgm
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 239000012669 liquid formulation Substances 0.000 claims 24
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims 9
- 229920001030 Polyethylene Glycol 4000 Polymers 0.000 claims 8
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 7
- 229930195725 Mannitol Natural products 0.000 claims 7
- 239000000594 mannitol Substances 0.000 claims 7
- 235000010355 mannitol Nutrition 0.000 claims 7
- 102100039620 Granulocyte-macrophage colony-stimulating factor Human genes 0.000 claims 5
- 239000002202 Polyethylene glycol Substances 0.000 claims 5
- 229920001223 polyethylene glycol Polymers 0.000 claims 5
- YASYEJJMZJALEJ-UHFFFAOYSA-N Citric acid monohydrate Chemical compound O.OC(=O)CC(O)(C(O)=O)CC(O)=O YASYEJJMZJALEJ-UHFFFAOYSA-N 0.000 claims 4
- 102000008100 Human Serum Albumin Human genes 0.000 claims 4
- 108091006905 Human Serum Albumin Proteins 0.000 claims 4
- 229960002303 citric acid monohydrate Drugs 0.000 claims 4
- 108010032806 molgramostim Proteins 0.000 claims 4
- 229960003063 molgramostim Drugs 0.000 claims 4
- 102000009027 Albumins Human genes 0.000 claims 3
- 108010088751 Albumins Proteins 0.000 claims 3
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 3
- 229920000053 polysorbate 80 Polymers 0.000 claims 3
- 230000002685 pulmonary effect Effects 0.000 claims 3
- 150000005846 sugar alcohols Chemical class 0.000 claims 3
- 239000007853 buffer solution Substances 0.000 claims 2
- 239000012535 impurity Substances 0.000 claims 2
- 208000015181 infectious disease Diseases 0.000 claims 2
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims 1
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims 1
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 claims 1
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims 1
- 206010001881 Alveolar proteinosis Diseases 0.000 claims 1
- 208000035143 Bacterial infection Diseases 0.000 claims 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 1
- WQZGKKKJIJFFOK-QTVWNMPRSA-N D-mannopyranose Chemical compound OC[C@H]1OC(O)[C@@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-QTVWNMPRSA-N 0.000 claims 1
- 206010017533 Fungal infection Diseases 0.000 claims 1
- 101000746373 Homo sapiens Granulocyte-macrophage colony-stimulating factor Proteins 0.000 claims 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 claims 1
- 208000031888 Mycoses Diseases 0.000 claims 1
- 229920002560 Polyethylene Glycol 3000 Polymers 0.000 claims 1
- 229920002562 Polyethylene Glycol 3350 Polymers 0.000 claims 1
- 229920002594 Polyethylene Glycol 8000 Polymers 0.000 claims 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 1
- 229930006000 Sucrose Natural products 0.000 claims 1
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 1
- 208000036142 Viral infection Diseases 0.000 claims 1
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims 1
- WQZGKKKJIJFFOK-PHYPRBDBSA-N alpha-D-galactose Chemical compound OC[C@H]1O[C@H](O)[C@H](O)[C@@H](O)[C@H]1O WQZGKKKJIJFFOK-PHYPRBDBSA-N 0.000 claims 1
- 230000001363 autoimmune Effects 0.000 claims 1
- 208000029618 autoimmune pulmonary alveolar proteinosis Diseases 0.000 claims 1
- 230000001580 bacterial effect Effects 0.000 claims 1
- 208000022362 bacterial infectious disease Diseases 0.000 claims 1
- 229930182830 galactose Natural products 0.000 claims 1
- 238000004128 high performance liquid chromatography Methods 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- 210000004072 lung Anatomy 0.000 claims 1
- 125000003071 maltose group Chemical group 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 229920002523 polyethylene Glycol 1000 Polymers 0.000 claims 1
- -1 rHA Chemical compound 0.000 claims 1
- 108010056532 regramostim Proteins 0.000 claims 1
- 229950006324 regramostim Drugs 0.000 claims 1
- 108010038379 sargramostim Proteins 0.000 claims 1
- 229960002530 sargramostim Drugs 0.000 claims 1
- 239000000600 sorbitol Substances 0.000 claims 1
- 239000005720 sucrose Substances 0.000 claims 1
- 230000003612 virological effect Effects 0.000 claims 1
Claims (20)
ｂ．アルブミンと、 b. albumin and
ｃ．ポリエチレングリコール（ＰＥＧ）と c. polyethylene glycol (PEG) and
を含む、組換えヒト顆粒球マクロファージコロニー刺激因子（ｒｈＧＭ－ＣＳＦ）の安定した液体製剤。A stable liquid formulation of recombinant human granulocyte macrophage colony stimulating factor (rhGM-CSF) comprising:
ｂ．少なくとも２５ｍｇ／ｍＬの濃度のマンニトールと、 b. mannitol at a concentration of at least 25 mg/mL;
ｃ．少なくとも０．２ｍｇ／ｍＬの濃度のｒＨＡと、 c. rHA at a concentration of at least 0.2 mg/mL;
ｄ．最大１ｍｇ／ｍＬの濃度のＰＥＧ－４０００と d. PEG-4000 at a concentration of up to 1 mg/mL
を含む、請求項８に記載の液体製剤。9. The liquid formulation according to claim 8, comprising:
ｂ．前記組換えヒトアルブミンの濃度は、０．５ｍｇ／ｍＬ～１．５０ｍｇ／ｍＬであり、 b. The concentration of the recombinant human albumin is 0.5 mg/mL to 1.50 mg/mL,
ｃ．前記ＰＥＧ－４０００の濃度は、０．０５ｍｇ／ｍＬ～０．１５ｍｇ／ｍＬであり、 c. The concentration of the PEG-4000 is 0.05 mg/mL to 0.15 mg/mL,
ｄ．前記マンニトールの濃度は、４５ｍｇ／ｍＬ～１００ｍｇ／ｍＬである、d. the concentration of the mannitol is 45 mg/mL to 100 mg/mL;
請求項９に記載の液体製剤。Liquid formulation according to claim 9.
ｂ．前記組換えヒトアルブミンの濃度は、０．５ｍｇ／ｍＬ～１．５０ｍｇ／ｍＬであり、 b. The concentration of the recombinant human albumin is 0.5 mg/mL to 1.50 mg/mL,
ｃ．前記ＰＥＧ－４０００の濃度は、０．０５ｍｇ／ｍＬ～０．１５ｍｇ／ｍＬであり、 c. The concentration of the PEG-4000 is 0.05 mg/mL to 0.15 mg/mL,
ｄ．前記マンニトールの濃度は、４５ｍｇ／ｍＬ～１００ｍｇ／ｍＬである、 d. The concentration of mannitol is 45 mg/mL to 100 mg/mL,
請求項１０に記載の液体製剤。Liquid formulation according to claim 10.
前記液体製剤は、 The liquid formulation includes:
０．４ｍｇ／ｍＬまでの濃度のモルグラモスチム（配列番号１）と、 molgramostim (SEQ ID NO: 1) at a concentration of up to 0.4 mg/mL;
５０ｍｇ／ｍＬまでの濃度のマンニトールと、 mannitol at a concentration up to 50 mg/mL;
１ｍｇ／ｍＬまでの濃度のｒＨＡと、 rHA at a concentration of up to 1 mg/mL;
１ｍｇ／ｍＬまでの濃度のＰＥＧ－４０００と、を含み、 PEG-4000 at a concentration of up to 1 mg/mL;
前記Ｔｗｅｅｎ ８０、Ｎａ Said Tween 80, Na ２2 ＨＰＯHPO ４4 、およびクエン酸一水和物の１つ以上は、, and one or more of citric acid monohydrate,
０ｍｇ／ｍＬ～０．１ｍｇ／ｍＬのＴｗｅｅｎ ８０の濃度、 a concentration of Tween 80 from 0 mg/mL to 0.1 mg/mL;
２．６ｍｇ／ｍＬ～１５．５ｍｇ／ｍＬのＮａ 2.6mg/mL to 15.5mg/mL Na ２2 ＨＰＯHPO ４4 の濃度、および／またはconcentration, and/or
０．２８ｍｇ／ｍＬ～１．７ｍｇ／ｍＬのクエン酸一水和物の濃度を含む、 containing a concentration of citric acid monohydrate from 0.28 mg/mL to 1.7 mg/mL;
請求項１２に記載の液体製剤。Liquid formulation according to claim 12.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202062990810P | 2020-03-17 | 2020-03-17 | |
| US62/990,810 | 2020-03-17 | ||
| EP20164648 | 2020-03-20 | ||
| EP20164648.6 | 2020-03-20 | ||
| PCT/EP2021/056851 WO2021185921A1 (en) | 2020-03-17 | 2021-03-17 | Liquid formulation of gm-csf for inhalation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2023517480A JP2023517480A (en) | 2023-04-26 |
| JPWO2021185921A5 true JPWO2021185921A5 (en) | 2024-03-21 |
Family
ID=74871418
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022548034A Pending JP2023517480A (en) | 2020-03-17 | 2021-03-17 | Liquid formulation of GM-CSF for inhalation |
Country Status (11)
| Country | Link |
|---|---|
| US (1) | US20230201307A1 (en) |
| EP (1) | EP4121000A1 (en) |
| JP (1) | JP2023517480A (en) |
| KR (1) | KR20220154214A (en) |
| CN (1) | CN115297844A (en) |
| AU (1) | AU2021237761A1 (en) |
| BR (1) | BR112022018501A2 (en) |
| CA (1) | CA3168421A1 (en) |
| IL (1) | IL295406A (en) |
| MX (1) | MX2022011498A (en) |
| WO (1) | WO2021185921A1 (en) |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20020141970A1 (en) | 2001-03-05 | 2002-10-03 | Pettit Dean K. | Stable aqueous solutions of granulocyte macrophage colony-stimulating factor |
| WO2007009208A1 (en) * | 2005-06-02 | 2007-01-25 | Cangene Corporation | Poly(ethylene glocol) modified human gm-csf with increased biological activity |
| CN100394981C (en) * | 2005-09-16 | 2008-06-18 | 深圳市孚沃德生物技术有限公司 | Human granulocyte-macrophage colony stimulating factor spray and its prepn process |
| CN1939534B (en) * | 2005-09-27 | 2010-12-01 | 长春金赛药业股份有限公司 | Externally-applied preparation containing human growth incretion or human granular leukocyte macrophage stimulus factor for treating injury ulceration |
| RU2446173C1 (en) * | 2010-08-13 | 2012-03-27 | Зао "Биокад" | New functional, high-purity stable conjugate of granulocyte colony-stimulating factor (g-csf) and polyethylene glycol with prolonged biological action, applicable for medical purposes, and based immunobiological agent |
| WO2020002650A1 (en) * | 2018-06-29 | 2020-01-02 | Targovax Asa | A formulation |
-
2021
- 2021-03-17 CN CN202180022141.1A patent/CN115297844A/en active Pending
- 2021-03-17 MX MX2022011498A patent/MX2022011498A/en unknown
- 2021-03-17 CA CA3168421A patent/CA3168421A1/en active Pending
- 2021-03-17 BR BR112022018501A patent/BR112022018501A2/en unknown
- 2021-03-17 US US17/906,599 patent/US20230201307A1/en active Pending
- 2021-03-17 EP EP21711594.8A patent/EP4121000A1/en active Pending
- 2021-03-17 IL IL295406A patent/IL295406A/en unknown
- 2021-03-17 KR KR1020227035847A patent/KR20220154214A/en unknown
- 2021-03-17 WO PCT/EP2021/056851 patent/WO2021185921A1/en active Application Filing
- 2021-03-17 JP JP2022548034A patent/JP2023517480A/en active Pending
- 2021-03-17 AU AU2021237761A patent/AU2021237761A1/en active Pending
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