HRP20220024T1 - Tekuća neurotoksinska formulacija stabilizirana triptofanom ili tirozinom - Google Patents
Tekuća neurotoksinska formulacija stabilizirana triptofanom ili tirozinom Download PDFInfo
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- HRP20220024T1 HRP20220024T1 HRP20220024TT HRP20220024T HRP20220024T1 HR P20220024 T1 HRP20220024 T1 HR P20220024T1 HR P20220024T T HRP20220024T T HR P20220024TT HR P20220024 T HRP20220024 T HR P20220024T HR P20220024 T1 HRP20220024 T1 HR P20220024T1
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- Prior art keywords
- liquid preparation
- botulinum neurotoxin
- disorders
- tryptophan
- preparation according
- Prior art date
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- 239000007788 liquid Substances 0.000 title claims 19
- QIVBCDIJIAJPQS-VIFPVBQESA-N L-tryptophane Chemical compound C1=CC=C2C(C[C@H](N)C(O)=O)=CNC2=C1 QIVBCDIJIAJPQS-VIFPVBQESA-N 0.000 title claims 9
- QIVBCDIJIAJPQS-UHFFFAOYSA-N Tryptophan Natural products C1=CC=C2C(CC(N)C(O)=O)=CNC2=C1 QIVBCDIJIAJPQS-UHFFFAOYSA-N 0.000 title claims 7
- 101710138657 Neurotoxin Proteins 0.000 title claims 5
- OUYCCCASQSFEME-QMMMGPOBSA-N L-tyrosine Chemical compound OC(=O)[C@@H](N)CC1=CC=C(O)C=C1 OUYCCCASQSFEME-QMMMGPOBSA-N 0.000 title claims 3
- OUYCCCASQSFEME-UHFFFAOYSA-N tyrosine Natural products OC(=O)C(N)CC1=CC=C(O)C=C1 OUYCCCASQSFEME-UHFFFAOYSA-N 0.000 title claims 3
- 238000009472 formulation Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 239000002581 neurotoxin Substances 0.000 title 1
- 231100000618 neurotoxin Toxicity 0.000 title 1
- 108030001720 Bontoxilysin Proteins 0.000 claims 12
- 231100001103 botulinum neurotoxin Toxicity 0.000 claims 11
- 206010040954 Skin wrinkling Diseases 0.000 claims 8
- 229960004799 tryptophan Drugs 0.000 claims 7
- 230000037303 wrinkles Effects 0.000 claims 6
- 150000001413 amino acids Chemical class 0.000 claims 5
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 4
- 239000004094 surface-active agent Substances 0.000 claims 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 2
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 2
- 241001465754 Metazoa Species 0.000 claims 2
- 210000001061 forehead Anatomy 0.000 claims 2
- 239000002736 nonionic surfactant Substances 0.000 claims 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims 2
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 2
- 229920000136 polysorbate Polymers 0.000 claims 2
- 229950008882 polysorbate Drugs 0.000 claims 2
- 229920000053 polysorbate 80 Polymers 0.000 claims 2
- 229940068968 polysorbate 80 Drugs 0.000 claims 2
- 230000002265 prevention Effects 0.000 claims 2
- 108090000623 proteins and genes Proteins 0.000 claims 2
- 102000004169 proteins and genes Human genes 0.000 claims 2
- 229910052708 sodium Inorganic materials 0.000 claims 2
- 239000011734 sodium Substances 0.000 claims 2
- 239000011780 sodium chloride Substances 0.000 claims 2
- 239000001488 sodium phosphate Substances 0.000 claims 2
- 229910000162 sodium phosphate Inorganic materials 0.000 claims 2
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims 2
- 208000017701 Endocrine disease Diseases 0.000 claims 1
- 208000021642 Muscular disease Diseases 0.000 claims 1
- 208000012902 Nervous system disease Diseases 0.000 claims 1
- 208000025966 Neurological disease Diseases 0.000 claims 1
- 229920001213 Polysorbate 20 Polymers 0.000 claims 1
- 229920001214 Polysorbate 60 Polymers 0.000 claims 1
- 208000027520 Somatoform disease Diseases 0.000 claims 1
- 108010057266 Type A Botulinum Toxins Proteins 0.000 claims 1
- 208000030137 articulation disease Diseases 0.000 claims 1
- 108010069022 botulinum toxin type D Proteins 0.000 claims 1
- 108010069023 botulinum toxin type E Proteins 0.000 claims 1
- 108010069038 botulinum toxin type F Proteins 0.000 claims 1
- 108010069071 botulinum toxin type G Proteins 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 208000035475 disorder Diseases 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 230000001815 facial effect Effects 0.000 claims 1
- 208000027866 inflammatory disease Diseases 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 208000018360 neuromuscular disease Diseases 0.000 claims 1
- 208000027753 pain disease Diseases 0.000 claims 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 1
- 239000001818 polyoxyethylene sorbitan monostearate Substances 0.000 claims 1
- 235000010989 polyoxyethylene sorbitan monostearate Nutrition 0.000 claims 1
- 229940068977 polysorbate 20 Drugs 0.000 claims 1
- 229940113124 polysorbate 60 Drugs 0.000 claims 1
- 229910001414 potassium ion Inorganic materials 0.000 claims 1
- 230000002797 proteolythic effect Effects 0.000 claims 1
- 208000020016 psychiatric disease Diseases 0.000 claims 1
- 108010074523 rimabotulinumtoxinB Proteins 0.000 claims 1
- 208000014001 urinary system disease Diseases 0.000 claims 1
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Claims (15)
1. Tekući pripravak, naznačen time, što sadrži proteinski neurotoksin, surfaktant, aminokiselinu odabranu od triptofana i tirozina, pufer koji sadrži natrijeve, kloridne i fosfatne ione,
pri čemu navedeni tekući pripravak ima pH vrijednost između 5,5 i 8,
te time, da navedeni pripravak ne sadrži proteine dobivene iz životinja, i
gdje je navedeni tekući pripravak stabilan u vremenskom periodu od dva mjeseca pri temperaturi od 2-8 °C.
2. Tekući pripravak prema patentnom zahtjevu 1, naznačen time, što je navedeni surfaktant neionski surfaktant.
3. Tekući pripravak prema patentnom zahtjevu 2, naznačen time, što navedeni neionski surfaktant jest polisorbat, poželjno polisorbat 20, polisorbat 60 ili polisorbat 80.
4. Tekući pripravak prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time, što navedena aminokiselina je triptofan, poželjno L-triptofan.
5. Tekući pripravak prema bilo kojem od patentnih zahtjeva 1 do 4, naznačen time, što navedeni pufer nadalje sadrži kalijeve ione;
i/ili
time, da navedeni pripravak ima pH vrijednost između 6,0 i 7,5; i/ili
time, da ne dolazi do više od 30% gubitaka izvanstanične proteolitske aktivnosti u dodatnom periodu od 2, 3, 6, 12, 18, 24 ili 36 mjeseci na 5 °C.
6. Tekući pripravak prema bilo kojem od patentnih zahtjeva 1 do 5, naznačen time, što proteinski neurotoksin je botulinski neurotoksin koji je odabran od prirodnog botulinskog neurotoksina u obliku kompleksa, prirodnog botulinskog neurotoksina velike čistoće i rekombinantnog botulinskog neurotoksina;
pri čemu poželjno, navedeni botulinski neurotoksin je rekombinantni botulinski neurotoksin koji se bira od botulinskog neurotoksina A, B, C, D, E, F ili G, modificiranog botulinskog neurotoksina i kimernog botulinskog neurotoksina.
7. Tekući pripravak prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time, što navedeni tekući pripravak sadrži:
• 4 do 10000 LD50 jedinica botulinskog neurotoksina po mL,
• 0,001 do 15% v/v polisorbata,
• 0,1 do 5 mg/mL triptofana,
• 10 do 500 mM NaCl,
• 1 do 50 mM KCl,
• 1 do 100 mM natrijevog fosfata,
ima pH vrijednost između 5,5 i 8, te je stabilan tijekom 12 mjeseci na 5 °C.
8. Tekući pripravak prema patentnom zahtjevu 7, naznačen time, što navedeni tekući pripravak sadrži:
• 10 do 2000 LD50 jedinica botulinskog neurotoksina po mL,
• 0,05 do 0,2% v/v polisorbata 80,
• 0,1 do 5 mg/mL triptofana,
• 25 do 300 mM NaCl,
• 1 do 10 mM KCl,
• 2 do 50 mM natrijevog fosfata,
ima pH vrijednost između 6,0 i 7,5, te je stabilan tijekom 18 mjeseci na 5 °C.
9. Tekući pripravak prema bilo kojem od patentnih zahtjeva 1 do 8, naznačen time, što je za uporabu u liječenju.
10. Tekući pripravak prema patentnom zahtjevu 9, naznačen time, što je za uporabu u liječenju ili prevenciji muskularnih poremećaja, neuromuskularnih poremećaja, neuroloških poremećaja, oftalmoloških poremećaja, poremećaja boli, psiholoških poremećaja, artikulacijskih poremećaja, upalnih poremećaja, endokrinih poremećaja ili uroloških poremećaja.
11. Uporaba tekućeg pripravka prema bilo kojem od patentnih zahtjeva 1 do 8, naznačena time, što je za estetsku medicinu, primjerice za obradu ili prevenciju naborane kože, posebice nabora na licu kao što su linije mrštenja lica, konturne bore oko očiju, horizontalne linije mrštenja na čelu, linije spuštenih usana, bore na vratu (platizmalne vrpce), bore na bradi (musculus mentalis, narančina kora, namreškana brada), naborane linije čela, bore poput „izgrebane kože“, postupak podizanja nosa ili bore od spavanja.
12. Uporaba aminokiseline odabrane od triptofana i tirozina, naznačena time, što služi za zaštitu proteinskog neurotoksina od propadanja u tekućem pripravku u kojemu nema proteina dobivenih iz životinja, pri čemu tekući pripravak ostaje stabilan u vremenskom periodu od dva mjeseca na 2-8 °C.
13. Uporaba prema patentnom zahtjevu 12, naznačena time, što navedena aminokiselina jest triptofan.
14. Uporaba prema patentnom zahtjevu 12 ili 13, naznačena time, što navedeni proteinski neurotoksin jest botulinski neurotoksin.
15. Uporaba prema patentnom zahtjevu 12, naznačena time, što se navedena aminokiselina upotrebljava u kombinaciji sa surfaktantom i puferom koji sadrži natrijeve, kloridne i fosfatne ione, i navedeni tekući pripravak ima pH vrijednost između 5,5 i 8.
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| EP2016062085 | 2016-05-27 | ||
| EP20152386.7A EP3679946B1 (en) | 2016-05-27 | 2017-05-26 | Liquid neurotoxin formulation stabilized with tryptophan or tyrosine |
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| HRP20202070TT HRP20202070T1 (hr) | 2016-05-27 | 2020-12-28 | Tekuća neurotoksinska formulacija stabilizirana s triptofanom ili tirozinom |
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| EP (3) | EP4026532A1 (hr) |
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| US8168206B1 (en) | 2005-10-06 | 2012-05-01 | Allergan, Inc. | Animal protein-free pharmaceutical compositions |
| SG10202100698QA (en) | 2008-12-31 | 2021-02-25 | Revance Therapeutics Inc | Injectable Botulinum Toxin Formulations |
| IL268980B (en) | 2009-06-25 | 2022-09-01 | Revance Therapeutics Inc | Botulinum toxin formulations without albumin |
| US9480731B2 (en) | 2013-12-12 | 2016-11-01 | Medy-Tox, Inc. | Long lasting effect of new botulinum toxin formulations |
| EP3436054B2 (en) | 2016-09-13 | 2022-07-27 | Allergan, Inc. | Stabilized non-protein clostridial toxin compositions |
| JP2021508453A (ja) * | 2017-12-20 | 2021-03-11 | アラーガン、インコーポレイテッドＡｌｌｅｒｇａｎ，Ｉｎｃｏｒｐｏｒａｔｅｄ | ボツリヌス毒素細胞結合ドメインポリペプチドおよび皮膚の若返りのための使用方法 |
| TW202112348A (zh) * | 2019-06-07 | 2021-04-01 | 英商益普生生物製藥有限公司 | 中度至極重度眉間紋及眼角外紋之治療 |
| AU2023207838A1 (en) | 2022-01-14 | 2024-07-04 | Galderma Holding SA | Treatment of moderate to very severe glabellar lines and lateral canthal lines |
| WO2023156389A1 (en) * | 2022-02-15 | 2023-08-24 | Merz Pharma Gmbh & Co. Kgaa | Liquid botulinum toxin formulation and use thereof |
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| TWI240627B (en) * | 1996-04-26 | 2005-10-01 | Chugai Pharmaceutical Co Ltd | Erythropoietin solution preparation |
| TW574036B (en) * | 1998-09-11 | 2004-02-01 | Elan Pharm Inc | Stable liquid compositions of botulinum toxin |
| DE60125986T3 (de) * | 2000-02-08 | 2011-07-28 | Allergan, Inc., 92612, Calif. | Pharmazeutische Zusammensetzungen mit Botulinum Toxin |
| US20030118598A1 (en) * | 2000-02-08 | 2003-06-26 | Allergan, Inc. | Clostridial toxin pharmaceutical compositions |
| US20060269575A1 (en) * | 2000-02-08 | 2006-11-30 | Allergan, Inc. | Botulinum toxin pharmaceutical compositions formulated with recombinant albumin |
| US7163671B2 (en) * | 2000-02-29 | 2007-01-16 | Chugai Seiyaku Kabushiki Kaisha | Long-term stabilized formulations |
| US6627602B2 (en) * | 2001-11-13 | 2003-09-30 | Duke University | Preventing desensitization of receptors |
| DE10333317A1 (de) | 2003-07-22 | 2005-02-17 | Biotecon Therapeutics Gmbh | Formulierung für Proteinarzneimittel ohne Zusatz von humanem Serumalbumin (HSA) |
| GB2416122A (en) * | 2004-07-12 | 2006-01-18 | Ipsen Ltd | Botulinum neurotoxin composition |
| EP2266600B1 (en) * | 2004-07-26 | 2014-09-10 | Merz Pharma GmbH & Co. KGaA | Therapeutic composition with a botulinum neurotoxin |
| EP1778279B1 (en) * | 2004-08-04 | 2014-12-03 | Ipsen Biopharm Limited | Pharmaceutical composition containing botulinum neurotoxin a2 |
| US20080220021A1 (en) | 2005-02-14 | 2008-09-11 | Pankaj Modi | Topical Botulinum Toxin Compositions for the Treatment of Hyperhidrosis |
| FR2902341B1 (fr) | 2006-06-16 | 2011-02-25 | Scras | Utilisation therapeutique simultanee, separee ou etalee dans le temps d'au moins une neurotoxine botulique, et d'au moins un derive opiace |
| CN101687046B (zh) * | 2007-07-10 | 2012-12-26 | 株式会社美地拓斯 | 稳定性改善的肉毒毒素药物液体组合物 |
| US9107815B2 (en) * | 2008-02-22 | 2015-08-18 | Allergan, Inc. | Sustained release poloxamer containing pharmaceutical compositions |
| KR101910490B1 (ko) | 2011-06-01 | 2018-10-22 | 바이오메디슨, 인코퍼레이티드 | 비-ｆｒｅｔ 보툴리눔 검정법 |
| KR101640694B1 (ko) | 2011-09-29 | 2016-07-18 | 셀스냅, 엘엘씨 | 독소생산능 시험용 조성물 및 방법 |
| KR101357999B1 (ko) * | 2012-03-20 | 2014-02-03 | 함종욱 | 보툴리눔 에이형 독소의 액상제품 |
| EP3052120A1 (en) | 2013-09-30 | 2016-08-10 | Galderma S.A. | Prostate cancer treatment |
| GB201407525D0 (en) * | 2014-04-29 | 2014-06-11 | Syntaxin Ltd | Manufacture of recombinant clostridium botulinum neurotoxins |
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