JP2018528242A5 - - Google Patents

Download PDF

Info

Publication number
JP2018528242A5
JP2018528242A5 JP2018515619A JP2018515619A JP2018528242A5 JP 2018528242 A5 JP2018528242 A5 JP 2018528242A5 JP 2018515619 A JP2018515619 A JP 2018515619A JP 2018515619 A JP2018515619 A JP 2018515619A JP 2018528242 A5 JP2018528242 A5 JP 2018528242A5
Authority
JP
Japan
Prior art keywords
formulation
aprotic solvent
ionization
glucagon peptide
salt
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.)
Granted
Application number
JP2018515619A
Other languages
English (en)
Japanese (ja)
Other versions
JP6835831B2 (ja
JP2018528242A (ja
Filing date
Publication date
Priority claimed from US15/136,650 external-priority patent/US9649364B2/en
Application filed filed Critical
Publication of JP2018528242A publication Critical patent/JP2018528242A/ja
Publication of JP2018528242A5 publication Critical patent/JP2018528242A5/ja
Application granted granted Critical
Publication of JP6835831B2 publication Critical patent/JP6835831B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

JP2018515619A 2015-09-25 2016-09-25 非プロトン性極性溶媒中の安定な治療用グルカゴン製剤を製造するための方法 Active JP6835831B2 (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201562233032P 2015-09-25 2015-09-25
US62/233,032 2015-09-25
US15/136,650 US9649364B2 (en) 2015-09-25 2016-04-22 Methods for producing stable therapeutic formulations in aprotic polar solvents
US15/136,650 2016-04-22
PCT/US2016/053628 WO2017053922A1 (en) 2015-09-25 2016-09-25 Methods for producing stable therapeutic glucagon formulations in aprotic polar solvents

Publications (3)

Publication Number Publication Date
JP2018528242A JP2018528242A (ja) 2018-09-27
JP2018528242A5 true JP2018528242A5 (enExample) 2019-09-12
JP6835831B2 JP6835831B2 (ja) 2021-02-24

Family

ID=57113760

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2018515619A Active JP6835831B2 (ja) 2015-09-25 2016-09-25 非プロトン性極性溶媒中の安定な治療用グルカゴン製剤を製造するための方法

Country Status (17)

Country Link
US (6) US9649364B2 (enExample)
EP (2) EP3352780B1 (enExample)
JP (1) JP6835831B2 (enExample)
KR (2) KR102662530B1 (enExample)
CN (2) CN108135980B (enExample)
AU (1) AU2016326749B2 (enExample)
CA (2) CA2999404C (enExample)
DK (2) DK3352780T3 (enExample)
EA (1) EA201890704A1 (enExample)
ES (2) ES2970863T3 (enExample)
IL (1) IL258298B (enExample)
MX (1) MX2018003705A (enExample)
PL (1) PL4327804T3 (enExample)
PT (1) PT4327804T (enExample)
SA (1) SA518391187B1 (enExample)
WO (1) WO2017053922A1 (enExample)
ZA (2) ZA201801912B (enExample)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11357857B2 (en) 2014-06-20 2022-06-14 Comera Life Sciences, Inc. Excipient compounds for protein processing
WO2015196091A1 (en) 2014-06-20 2015-12-23 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
US10478498B2 (en) 2014-06-20 2019-11-19 Reform Biologics, Llc Excipient compounds for biopolymer formulations
BR112020000447A2 (pt) * 2017-07-14 2020-07-21 Xeris Pharmaceuticals, Inc. métodos de tratamento de hiperinsulinismo congênito
WO2019126753A1 (en) * 2017-12-22 2019-06-27 Xeris Pharmaceuticals, Inc. Treatment of exercise-induced hypoglycemia in type 1 and insulin using type 2 diabetes
CN111936159A (zh) * 2018-01-23 2020-11-13 Xeris药物公司 使用微剂量的稳定胰高血糖素治疗减肥术后低血糖症
JP7256816B2 (ja) * 2018-03-07 2023-04-12 コメラ ライフ サイエンシズ，インコーポレイテッド タンパク質製剤用の賦形剤化合物
US11576951B2 (en) * 2019-05-31 2023-02-14 Xeris Pharmaceuticals, Inc. Stable therapeutic compositions in aprotic polar solvents and methods of manufacturing the same
CN112807281A (zh) * 2019-10-31 2021-05-18 南京海维医药科技有限公司 包含血管紧张素ii的稳定组合物及其制备方法、使用方法
EP4171509A1 (en) 2020-06-26 2023-05-03 Xeris Pharmaceuticals, Inc. Stable sustained release therapeutic compositions in aprotic polar solvents and methods of manufacturing the same
US12128089B2 (en) 2022-05-26 2024-10-29 Slayback Pharma Llc Stable liquid compositions of glucagon
US20240148678A1 (en) 2022-10-19 2024-05-09 Xeris Pharmaceuticals, Inc. Sustained release injectable therapeutic formulations using aprotic polar solvents
US20240148680A1 (en) 2022-10-19 2024-05-09 Xeris Pharmaceuticals, Inc. Stable levothyroxine compositions in aprotic polar solvents
WO2025184608A1 (en) * 2024-02-28 2025-09-04 I2O Therapeutics, Inc. Compositions comprising pharmaceutically acceptable salts and other derivatives of an amylin analog and uses thereof
WO2025184589A1 (en) * 2024-02-28 2025-09-04 I2O Therapeutics, Inc. Compositions comprising pharmaceutically acceptable salts and other derivatives of glucagon-like peptide-1 receptor agonists and uses thereof

Family Cites Families (109)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3016895A (en) 1958-08-01 1962-01-16 Pan American Lab Inc Injector for subcutaneous implantation of solids
US5260306A (en) 1981-07-24 1993-11-09 Fisons Plc Inhalation pharmaceuticals
GB2119248A (en) 1982-04-28 1983-11-16 John Kenneth Mcmullen Insulin formulations and method of producing them
CH664005A5 (de) 1984-05-19 1988-01-29 Glatt Maschinen & Apparatebau Verfahren zum trocknen eines teilchenfoermigen gutes und einrichtung zur durchfuehrung des verfahrens.
US5124317A (en) 1985-08-02 1992-06-23 Farmitalia Carlo Erba S.P.A. Injectable ready-to-use solutions containing an antitumor anthracycline glycoside
US5977082A (en) 1985-08-02 1999-11-02 Pharmacia & Upjohn Company Injectable ready-to-use solutions containing an antitumor anthracycline glycoside
US4927571A (en) 1987-05-18 1990-05-22 Liposome Technology, Inc. Preparation of injectable doxorubicin/liposome suspension
US4848094A (en) 1988-04-29 1989-07-18 Union Carbide Corporation Droplet freezing method and apparatus
US5031336A (en) 1989-08-31 1991-07-16 Abbott Laboratories Lyophilization of bulk pharmaceuticals
US5092843A (en) 1990-04-12 1992-03-03 Survival Technology, Inc. Dispersion multichamber auto-injector
EP0527940A1 (en) 1990-05-08 1993-02-24 Liposome Technology, Inc. Direct spray-dried drug/lipid powder composition
DK0532546T3 (da) 1990-05-10 1998-12-28 Nycomed Pharma As Farmaceutisk præparat indeholdende N-glycofuroler og N-ethylenglycoler
US5208998A (en) 1991-02-25 1993-05-11 Oyler Jr James R Liquid substances freeze-drying systems and methods
JP3277342B2 (ja) 1992-09-02 2002-04-22 武田薬品工業株式会社 徐放性マイクロカプセルの製造法
DK0625917T3 (da) 1992-12-15 1998-09-28 Sanofi Sa Indretning til præparation af en opløsning, en suspension eller en emulsion af en medicinsk substans
US6051256A (en) 1994-03-07 2000-04-18 Inhale Therapeutic Systems Dispersible macromolecule compositions and methods for their preparation and use
US5652216A (en) 1994-05-26 1997-07-29 Novo Nordisk A/S Pharmaceutical preparation
US6290991B1 (en) 1994-12-02 2001-09-18 Quandrant Holdings Cambridge Limited Solid dose delivery vehicle and methods of making same
RU2147226C1 (ru) 1994-09-29 2000-04-10 Квадрант Хэлткэа (Ю Кей) Лимитед Высушенные распылением микрочастицы как терапевтические носители
US5932547A (en) 1996-07-03 1999-08-03 Alza Corporation Non-aqueous polar aprotic peptide formulations
US5945128A (en) 1996-09-04 1999-08-31 Romano Deghenghi Process to manufacture implants containing bioactive peptides
IN184589B (enExample) 1996-10-16 2000-09-09 Alza Corp
ATE318580T1 (de) 1996-12-20 2006-03-15 Alza Corp Gelzusammensetzungen und verfahren
US6001336A (en) 1996-12-31 1999-12-14 Inhale Therapeutic Systems Processes for spray drying aqueous suspensions of hydrophobic drugs and compositions thereof
DE69736140T2 (de) 1997-11-18 2007-04-19 Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. Pharmazeutische injizierbare Lösungen, die Paracetamol und Kombinationen aus Paracetamol mit anderen Aktivsubstanzen enthalten
FR2783433B1 (fr) 1998-09-18 2001-02-16 Delab Seringues pour l'administration de formulations pateuses ou semi-solides
SE9803662D0 (sv) 1998-10-26 1998-10-26 Pharmacia & Upjohn Ab Autoinjector
US6199297B1 (en) 1999-02-01 2001-03-13 Integrated Biosystems, Inc. Lyophilization apparatus and methods
US7919109B2 (en) 1999-02-08 2011-04-05 Intarcia Therapeutics, Inc. Stable non-aqueous single phase viscous vehicles and formulations utilizing such vehicles
US6253463B1 (en) 1999-04-26 2001-07-03 Niro A/S Method of spray drying
US6309663B1 (en) 1999-08-17 2001-10-30 Lipocine Inc. Triglyceride-free compositions and methods for enhanced absorption of hydrophilic therapeutic agents
US7582311B1 (en) 1999-10-15 2009-09-01 Genentech, Inc. Injection vehicle for polymer-based formulations
US7651703B2 (en) 1999-10-15 2010-01-26 Genentech, Inc. Injection vehicle for polymer-based formulations
US20030180352A1 (en) * 1999-11-23 2003-09-25 Patel Mahesh V. Solid carriers for improved delivery of active ingredients in pharmaceutical compositions
US6478776B1 (en) 2000-04-05 2002-11-12 Biocardia, Inc. Implant delivery catheter system and methods for its use
AU4477001A (en) 2000-04-18 2001-10-30 Peptron Inc. Injectable sustained release pharmaceutical composition and processes for preparing the same
US6495164B1 (en) 2000-05-25 2002-12-17 Alkermes Controlled Therapeutics, Inc. I Preparation of injectable suspensions having improved injectability
JP2004511431A (ja) 2000-06-28 2004-04-15 アトゥル・ジェイ・シュクラ 生物活性物質を含む生分解性ビヒクルおよび送達システム
WO2002015908A1 (en) 2000-08-18 2002-02-28 Takeda Chemical Industries, Ltd. Injections
RO120121B1 (ro) 2000-12-18 2005-09-30 Elena Ionaşcu Soluţie injectabilă, cu efect antiinflamator, procedeu de obţinere şi metodă de tratament a bolilor autoimune
US8166969B2 (en) 2001-03-06 2012-05-01 Texas Research International, Inc. Chemically and biologically resistant hydration system
US6676958B2 (en) 2001-06-19 2004-01-13 Advanced Bioadjuvants, Llc Adjuvant composition for mucosal and injection delivered vaccines
ES2385030T3 (es) 2001-06-29 2012-07-17 Medgraft Microtech, Inc. Implantes inyectables biodegradables y procedimientos relacionados con su fabricación y uso
CN1310671C (zh) 2001-07-09 2007-04-18 安斯泰来制药有限公司 缓释注射剂用组合物的制造方法
US6733813B2 (en) 2001-08-02 2004-05-11 Ocean Spray Cranberries, Inc. Process for producing acids-enriched juice and acids-reduced juice
ATE507816T1 (de) 2001-11-14 2011-05-15 Durect Corp Injizierbare depotzusammensetzungen und deren verwendung
DE10161077A1 (de) 2001-12-12 2003-06-18 Boehringer Ingelheim Vetmed Hochkonzentrierte stabile Meloxicamlösungen zur nadellosen Injektion
US20050203175A1 (en) 2001-12-18 2005-09-15 Ioulia Tseti Parenteral composition of paracetamol
CN1171610C (zh) 2002-04-23 2004-10-20 张瑞香 一种治疗心脑血管和眼底病的中药针剂及其制备方法
US8871241B2 (en) 2002-05-07 2014-10-28 Psivida Us, Inc. Injectable sustained release delivery devices
JP4753581B2 (ja) 2002-10-17 2011-08-24 ザ・ユニバーシティ・オブ・ブリティッシュ・コロンビア Ｓｈｉｐ１モデュレーター
EP1558234B1 (en) 2002-10-25 2007-05-23 Dompé S.P.A. Painless injectable compositions containing salt of 2-arylpropionic acids
NZ540769A (en) 2002-12-18 2009-03-31 Algorx Pharmaceuticals Inc Administration of capsaicinoids for the treatment of pain
CN1507858A (zh) 2002-12-19 2004-06-30 王玉万 含氟化氯霉素的兽用液体制剂
EP1589901A4 (en) 2002-12-20 2006-08-09 Generipharm Inc INTRAKUTANE INJECTION
PL1468697T3 (pl) 2003-04-14 2008-05-30 Wyeth Corp Kompozycje zawierające piperacyklinę i tazobaktam przydatne do wstrzykiwań
AU2003230899A1 (en) 2003-04-14 2004-11-26 Wyeth Holdings Corporation Compositions containing piperacillin and tazobactam useful for injection
KR100517643B1 (ko) 2003-07-25 2005-09-28 한국과학기술연구원 온도 감응성 폴리포스파젠계 고분자, 이의 제조방법 및이를 이용한 주입형 온도 감응성 폴리포스파젠 하이드로젤
US20050100538A1 (en) 2003-07-31 2005-05-12 Attawia Mohamed Intradiscal injection of anti-oxidants
DE60305687T2 (de) 2003-07-31 2007-02-22 Emdoka Bvba, Drug Registration And Marketing Wässrige injizierbare Suspensionen für Tiere enthaltend Florfenicol
JP4777067B2 (ja) 2003-08-22 2011-09-21 ジングルス・テヒノロギース・アクチェンゲゼルシャフト ディスク状基板の結合のための方法およびこの方法を実行するための装置
WO2005032523A1 (en) 2003-09-30 2005-04-14 Acusphere, Inc. Injectable, oral, or topical sustained release pharmaceutical formulations
EP1722819B1 (en) 2004-03-12 2007-12-26 Intercell AG Method for solubilising peptide mixtures
US20080248999A1 (en) 2007-04-04 2008-10-09 Biodel Inc. Amylin formulations
US20050240166A1 (en) 2004-04-26 2005-10-27 Microsolutions, Inc. Implantable device, formulation and method for anti-psychotic therapy using risperidone
CN103393601A (zh) 2004-05-12 2013-11-20 巴克斯特国际公司 含有蛋白并在高浓度蛋白下显示可注射性的微球体
US20060160823A1 (en) 2004-05-28 2006-07-20 Leonore Witchey-Lakshmanan Particulate-stabilized injectable pharmaceutical compositions of Posaconazole
CN101056643A (zh) 2004-09-13 2007-10-17 Pr药品有限公司 雌二醇代谢物的长效可注射晶体制剂及其应用方法
EP1845787B1 (en) 2005-01-27 2015-04-15 Erimos Pharmaceuticals LLC Formulations for injection of catecholic butanes, including ndga compounds, into animals
EP1909824B1 (en) 2005-04-08 2011-05-18 Amylin Pharmaceuticals, Inc. Pharmaceutical formulations comprising incretin peptide and aprotic polar solvent
US20080305161A1 (en) 2005-04-13 2008-12-11 Pfizer Inc Injectable depot formulations and methods for providing sustained release of nanoparticle compositions
NZ560354A (en) 2005-06-17 2010-10-29 Ligand Pharm Inc Androgen receptor modulator compounds and methods
WO2007033180A1 (en) 2005-09-12 2007-03-22 Abela Pharmaceuticals, Inc. Materials for facilitating administration of dimethyl sulfoxide (dmso) and related compounds
CA2637569C (en) 2006-01-18 2013-01-08 Yuhua Li Pharmaceutical compositions with enhanced stability
AR054215A1 (es) 2006-01-20 2007-06-13 Eriochem Sa Una formulacion farmaceutica de un taxano, una composicion solida de un taxano liofilizado a partir de una solucion de acido acetico, un procedimiento para la preparacion de dicha composicion solida de un taxano, una composicion solubilizante de un taxano liofilizado, y un conjunto de elementos (kit
US20090143737A1 (en) 2006-05-17 2009-06-04 Terumo Kabushiki Kaisha, Indwelling needle assembly
CA2653200A1 (en) 2006-05-25 2007-12-06 The General Hospital Corporation Anti-cross-linking agents and methods for inhibiting cross-linking of injectable hydrogel formulations
MX2009002552A (es) 2006-09-07 2009-03-30 Merial Ltd Formulaciones de antibiotico veterinarias masticables blandas, de tableta e inyectables de larga accion, novedosas.
US20100098735A1 (en) 2006-10-05 2010-04-22 Rajesh Jain Injectable depot compositions and its process of preparation
WO2008098212A2 (en) 2007-02-08 2008-08-14 Diobex, Inc. Extended release formulations of glucagon and other peptides and proteins
EP2157967B1 (en) 2007-04-23 2013-01-16 Intarcia Therapeutics, Inc Suspension formulations of insulinotropic peptides and uses thereof
JP2010525033A (ja) 2007-04-30 2010-07-22 ノボ・ノルデイスク・エー／エス 高濃縮のインスリン溶液及び組成物
WO2008132224A2 (en) 2007-04-30 2008-11-06 Novo Nordisk A/S Method for drying a protein composition, a dried protein composition and a pharmaceutical composition comprising the dried protein
TW200922635A (en) 2007-08-31 2009-06-01 Archimedes Dev Ltd Non-aqueous pharmaceutical compositions
US20090088393A1 (en) 2007-09-28 2009-04-02 Zomanex, Llc Methods and formulations for converting intravenous and injectable drugs into oral dosage forms
WO2009060473A2 (en) 2007-11-06 2009-05-14 Panacea Biotec Limited Injectable compositions, processes and uses thereof
EP2060268A1 (en) 2007-11-15 2009-05-20 Novo Nordisk A/S Pharmaceutical compositions for pulmonary or nasal delivery of peptides
WO2009070298A1 (en) 2007-11-28 2009-06-04 Teva Pharmaceutical Industries, Ltd. Method of delaying the onset of clinically definite multiple sclerosis
CN101945853B (zh) 2007-12-21 2014-08-20 配体药物公司 选择性雄激素受体调节剂(sarm)及其应用
SG2013054218A (en) 2008-01-15 2014-10-30 Abbott Gmbh & Co Kg Powdered protein compositions and methods of making same
KR101517415B1 (ko) 2008-05-14 2015-05-07 에스케이바이오팜 주식회사 난용성 항경련제를 함유하는 경비 항경련성 약학 조성물
AU2009280803B2 (en) 2008-07-23 2013-10-31 Bharat Serums And Vaccines Ltd. Stable injectable oil-in-water Docetaxel nanoemulsion
GB0815435D0 (en) * 2008-08-22 2008-10-01 Camurus Ab Formulations
CA2735146A1 (en) 2008-08-25 2010-03-04 Denki Kagaku Kogyo Kabushiki Kaisha Syringe
CN104224703A (zh) 2008-09-25 2014-12-24 赛福伦公司 苯达莫司汀的液体配制品
US20110118578A1 (en) 2009-11-17 2011-05-19 Roche Diagnostics Operations, Inc. Hypoglycemic treatment methods and systems
US20110223208A1 (en) 2010-03-09 2011-09-15 Beth Hill Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations
GB2513060B (en) 2010-06-08 2015-01-07 Rb Pharmaceuticals Ltd Microparticle buprenorphine suspension
US20120046225A1 (en) 2010-07-19 2012-02-23 The Regents Of The University Of Colorado, A Body Corporate Stable glucagon formulations for the treatment of hypoglycemia
JP5632226B2 (ja) 2010-07-30 2014-11-26 株式会社細川洋行 医療用多層チューブ、および医療用輸液バッグ
WO2012122535A2 (en) 2011-03-10 2012-09-13 Xeris Pharmaceuticals, Inc. Stable formulations for parenteral injection of peptide drugs
JP6117811B2 (ja) 2011-10-31 2017-04-19 ゼリス ファーマシューティカルズ インコーポレイテッド 糖尿病を処置するための製剤
SI2849723T1 (sl) 2012-05-18 2018-09-28 Genentech, Inc. Formulacije z visoko koncentracijo monoklonskih protiteles
US9522235B2 (en) 2012-05-22 2016-12-20 Kaleo, Inc. Devices and methods for delivering medicaments from a multi-chamber container
US9125805B2 (en) 2012-06-27 2015-09-08 Xeris Pharmaceuticals, Inc. Stable formulations for parenteral injection of small molecule drugs
EP2890391A4 (en) 2012-08-29 2016-03-09 Mannkind Corp METHOD AND COMPOSITION FOR TREATING HYPERGLYCEMIA
US9018162B2 (en) * 2013-02-06 2015-04-28 Xeris Pharmaceuticals, Inc. Methods for rapidly treating severe hypoglycemia
WO2015120231A2 (en) 2014-02-06 2015-08-13 Xeris Phrmaceuticals, Inc. Stable peptide formulations and methods for preparation
WO2015153728A1 (en) 2014-04-02 2015-10-08 Xeris Pharmaceuticals, Inc. Polar aprotic solvent-compatible infusion sets, components, and methods

Similar Documents

Publication Publication Date Title
JP6835831B2 (ja) 非プロトン性極性溶媒中の安定な治療用グルカゴン製剤を製造するための方法
JP2014507484A5 (enExample)
JP2017519018A5 (enExample)
JP6763777B2 (ja) 安定なペプチド製剤、および調製のための方法
BR112013023062B1 (pt) Solução estável para a injeção parenteral e método de fabricação da mesma
BRPI0616300A2 (pt) formulaÇço aquosa de hfsh
JP6882538B2 (ja) 注射用組成物
BR112016002939A2 (pt) composições farmacêuticas parenterais aquosas estáveis de peptídeos insulinotrópicos
ES3002132T3 (en) Lyophilized pharmaceutical composition of fc-peptide fusion protein
JP2017514868A5 (enExample)
JP2017516848A5 (enExample)
JP2021511386A5 (enExample)
JP2017514924A5 (enExample)
WO2015190378A1 (ja) 安定なアダリムマブ水性製剤
UY37550A (es) Nueva formulación que comprende un derivado de bencimidazol
JP2022533759A5 (enExample)
JP2021527084A5 (enExample)
JP2010105965A (ja) バンコマイシン製剤
US12115164B2 (en) Pemetrexed formulations
HRP20211558T1 (hr) Formulacija
JPWO2017179683A1 (ja) ミカファンギンの安定化された医薬組成物
AU2019228913C1 (en) Pharmaceutical composition with excellent storage stability
TW201831184A (zh) 含有普多沙星(pradofloxacin)之液態組成物
RU2829138C2 (ru) Новый состав для инъекций, включающий 1-(5-(2,4-дифторфенил)-1-((3-фторфенил)сульфонил)-4-метокси-1h-пиррол-3-ил)-n-метилметанамин
WO2015056613A1 (ja) 安定化されたポリペプチド水性製剤