CN1233952A - 由鼻给药的去氨加压素 - Google Patents
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Abstract
本发明揭示了单剂有效和恒定血药浓度的经鼻给药的药物组合物,它包括体积为约5—75微升和约0.2—2.0mg/ml醋酸去氨加压素、摩尔相应量的去氨加压素或去氨加压素的药学上可接受的盐的水性溶液。该组合物能用来治疗诸如选自尿崩症、尿失禁、一般性遗尿和夜遗尿的泌尿疾病。
Description
发明领域
本发明涉及经鼻给药的去氨加压素、醋酸去氨加压素和其它药学上可接受的去氨加压素盐，本发明也涉及供这类给药的最佳组合物。
发明背景
由鼻给药是一条释放治疗用肽的优秀途径。但是，该技术在使肽类药物在鼻内沉积的最佳条件上是有缺陷的，在最佳条件下，所述的肽类药物通过鼻粘膜屏障，进入全身循环，并以有效的形式释放到外周的靶器官。另外，适合经鼻给药的大多数已知肽很昂贵，现在的趋向是过度释放这类昂贵的鼻用肽类而造成浪费。因此，本技术领域需要对经鼻给药的肽类进行改进。
报道中用鼻用泵使分配体积低于50微升的情况是不可接受的，因为这不能确保有效地释放到靶器官的剂量准确性和可能性；另一方面，高于150微升的较高体积也被本技术领域认为是不合适的，因为，这会导致溢出：F.Moren，医用气雾剂(Aerosols in Medicine)，Moren等，Elsevier Scientific,Amsterdam(1993)。
人们需要准确释放和经济的系统供有效地经鼻给予肽类。特别是需要准确和最佳的释放系统供有效地经鼻给予去氨加压素(下面也称为“DDAVP”)。
发明目的
本发明的一个目的是提供经鼻给药的去氨加压素、醋酸去氨加压素或其它药学上可接受的去氨加压素盐的单剂药物组合物，该组合物的改进处在于提供了对外周靶最佳、有效地给药。
本发明的另一个目的是提供去氨加压素、醋酸去氨加压素或去氨加压素盐的水性贮备溶液。
本发明的再一个目的是提供经鼻给予去氨加压素、醋酸去氨加压素或其它药学上可接受的去氨加压素盐的水性贮备溶液的手段，它能重复和恒定地分配5-75微升，更好地是10-50微升，特别是约20-45微升的容量。
本发明的另一个目的是提供经鼻给予去氨加压素、醋酸去氨加压素或其它药学上可接受的去氨加压素盐合适的方法，结果能将恒定、有效的浓度释放到病人的血浆里。
本发明的另外目的是提供制备治疗选自尿崩症、尿失禁、一般性遗尿和夜遗尿的尿疾病的药物的制备方法。
在了解了本发明的益处后本发明的这些目的和其它目的对本技术领域的人员来说是很显然的。
发明综述
在本文中，去氨加压素(DDAVP)是1-(3-巯基丙酸)-8-D-精氨酸加压素。术语“鼻”包括术语“鼻内”，在本文中表示经鼻粘膜释放给药。
本发明包括经鼻给予的单剂量药物组合物，它包括容积为约5-75微升的水溶液，该溶液含约0.1-2.0mg/ml选自去氨加压素、醋酸去氨加压素或去氨加压素的药学上可接受的盐的化合物。溶液的容积为约10-50微升；20-45微升；或约35微升。溶液中化合物约占0.1-0.5mg/ml或约0.5-2.0mg/ml。
本发明也包括一种配合鼻喷雾泵给药的手段或对鼻滴加给药的设备，供重复分配容积为约5-75微升含约0.1-2.0mg/ml去氨加压素、醋酸去氨加压素或药学上可接受的去氨加压素盐的水性溶液。该释放设备里的溶液的容积为约10-50微升；较好的是约20-45微升，最好是约35微升。
本发明的再一个方面是释放血药浓度恒定的经鼻给予的去氨加压素、醋酸去氨加压素或药学上可接受的去氨加压素盐，它为约10-50微升水性溶液，溶液中含约0.1-2.0mg/ml范围的去氨加压素、醋酸去氨加压素或药学上可接受的去氨加压素盐的方法。该方法可用来治疗诸如尿崩症、尿失禁、一般性遗尿和夜遗尿的尿疾病。
附图简述
图1是与本发明有关的研究结果曲线图。
发明详述
本发明提供了水性溶液形式、体积为5-75微升、含有0.1-2.0mg/ml去氨加压素、醋酸去氨加压素或其尔相应量的药学上可接受的盐的单剂药物组合物。
本发明组合物可用来治疗诸如尿崩症、尿失禁、一般性遗尿和夜遗尿的尿疾病。
水性溶液优选的体积为10-75微升，更好的是15-50微升，最好的体积为20-45微升。不受溶液的优选体积的束，去氨加压素的浓度范围为0.1-0.5mg/ml，或0.5-2.0mg/ml。
本发明提供了专用于鼻喷雾泵或对鼻滴加给药设备的密封容器，供重复分配体积5-75微升，更优选的是10-50微升，最好是20-45微升体积的去氨加压素、醋酸去氨加压素或其它药学上可接受的去氨加压素盐的水性贮备溶液。
密封容器分配单剂、恒定剂量的贮备溶液，所述的贮备溶液含0.1-0.5mg/ml，或0.5-2.0mg/ml醋酸去氨加压素或摩尔相应量的去氨加压素或其它合适的去氨加压素的药学上可接受的盐。喷雾泵或供滴加给药的设备可与容器成整体，并可弃置。喷雾泵优选的是预压缩类型的，并设计成给药体积在5-75微升范围里。
本发明的单剂组合物和贮备溶液可含诸如氯化钠的渗透压控制剂；诸如氯丁醇或氯化苄烷铵的防腐剂；将pH维持在约4-6，优选地维持在5的诸如磷酸钠或柠檬酸钠的缓冲剂；和诸如胆汁盐、大环醇的单月桂酸醚和梭链孢酸酯的吸收增强剂。
在密封容器中用于喷雾泵或对鼻滴加给予单剂量去氨加压素、醋酸去氨加压素或与本文揭示的摩尔当量的其它药学上可接受的去氨加压素盐的其它药学上可接受的溶液和组合物都在本发明的范围里。
本文也揭示了治疗选自尿崩症、尿失禁、一般性遗尿和夜遗尿的尿疾病的药物的制备方法，该药物包括选自去氨加压素、醋酸去氨加压素和药学上可接受的去氨加压素盐，该药物包括约10-75微升含约0.1-2.0mg/ml所述化合物的水性溶液。
本发明基于这样的发现：鼻内给予约1.5微克/微升浓度的醋酸去氨加压素，其去氨加压素血药浓度曲线与不依赖给药剂量的25-100微升范围里的成人的血药浓度曲线基本相似，它的效果与这类给药范围的相等。甚至可采用更少的体积，对于成人如10-15微升，对于孩子，低于10微升，如约5-7微升。
目前市售的剂量喷雾泵不能用于再现地分配低于50微升下的体积。这是由于缺乏开发和出售这类泵的动机，因为本发明揭示的体积/浓度/去氨加压素血药浓度的关系是首次独特地在本文中揭示。
下列实施例显示去氨加压素血药效果对给定醋酸去氨加压素浓度的去氨加压素溶液的给药容量的不依赖性。
实施例
制备在蒸馏水中含0.3mg/ml醋酸去氨加压素的贮备溶液。对六个健康男性志愿者给予该贮备溶液的不同剂量。通过用装有喷雾头的剂量喷雾泵来给予鼻喷雾剂。
对每个志愿者的每个鼻孔给予下列剂量：25微升中75微克，50微升中150微克，70微升里210微克，及100微升中300微克。图1综述了组合的结果。虽然去氨加压素血药浓度分布图里会存在个体差异，但是剂量体积/血药浓度分布关系基本与所有试验个体相同。
图1显示在研究的剂量范围里，血药浓度效果不依赖于给定醋酸去氨加压素浓度(1.5微克/微升)的去氨加压素溶液的给药体积。在更宽的浓度范围里，如0.1-2微克/微升，和对去氨加压素和去氨加压素的非乙酸盐的其它药学上可接受的盐来说，该关系也得以保持。
基于本文可对本发明作出各种修饰和改变。这些改变和附加都在下列权利要求书限定的本发明的范围和精神里。
Claims (15)
1．一种经鼻给药的单剂药物组合物，包括：
体积为5-75微升的水性溶液；
所述的溶液含约0.1-2.0mg/ml选自去氨加压素、醋酸去氨加压素和去氨甲酸药学上可接受的盐的化合物。
2．根据权利要求1所述的组合物，其中所述的溶液体积为约10-50微升。
3．根据权利要求1所述的组合物，其中所述的溶液体积为约20-45微升。
4．根据权利要求1所述的组合物，其中所述的体积为约35微升。
5．根据权利要求1所述的组合物，其中所述的化合物在所述溶液中浓度为约0.1-0.5mg/ml。
6．根据权利要求1所述的组合物，其中所述的化合物在所述溶液中的浓度为约0.5-2.0mg/ml。
7．一种配合鼻喷雾泵或经鼻滴加给药装置的给药装置，它可供重复地分配体积为5-75微升水性溶液，所述的水性溶液含0.1-2.0mg/ml去氨加压素、去氨加压素乙酸酯或去氨加压素的药学上可接受的盐。
8．根据权利要求7所述的装置，其中所述的溶液体积为约10-50微升。
9．根据权利要求7所述的装置，其中所述的溶液体积为约20-45微升。
10．根据权利要求7所述的装置，其中所述的体积为约35微升。
11．一种释放肽类化合物恒定血药浓度的方法，包括经鼻给予约10-75微升含0.1-2.0mg/ml所述溶液的所述化合物的水溶液，所述化合物选自去氨加压素、醋酸去氨加压素和药学上可接受的去氨加压素盐的所述化合物。
12．根据权利要求11所述的方法，其中所述的体积是约10-50微升。
13．根据权利要求11所述的方法，其中所述的溶液体积为约20-45微升。
14．根据权利要求11所述的治疗选自尿崩症、尿失禁、一般性遗尿和夜遗尿的泌尿疾病的方法。
15．一种制备用来治疗选自尿崩症、尿失禁、一般性遗尿和夜遗尿的泌尿疾病的药物的方法，所述的药物包括选自去氨加压素、醋酸去氨加压素和药学上可接受的去氨加压素盐的化合物，该药物包括约10-75微升含约0.1-2.0mg/ml所述溶液的所述化合物的水性溶液。
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/667,047 | 1996-06-20 | ||
| US08/667,047 US5763398A (en) | 1996-06-20 | 1996-06-20 | Nasal administration of desmopressin |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1233952A true CN1233952A (zh) | 1999-11-03 |
Family
ID=24676595
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN97195712A Pending CN1233952A (zh) | 1996-06-20 | 1997-06-10 | 由鼻给药的去氨加压素 |
Country Status (24)
| Country | Link |
|---|---|
| US (1) | US5763398A (zh) |
| EP (1) | EP0921786A1 (zh) |
| JP (1) | JP2000502358A (zh) |
| KR (1) | KR20000016781A (zh) |
| CN (1) | CN1233952A (zh) |
| AU (1) | AU707527B2 (zh) |
| BR (1) | BR9700797A (zh) |
| CA (1) | CA2258552A1 (zh) |
| CZ (1) | CZ420198A3 (zh) |
| EE (1) | EE9800453A (zh) |
| HU (1) | HUP9903541A3 (zh) |
| IL (1) | IL127572A (zh) |
| LT (1) | LT4621B (zh) |
| LV (1) | LV12230B (zh) |
| NO (1) | NO985936L (zh) |
| NZ (1) | NZ333124A (zh) |
| PL (1) | PL330902A1 (zh) |
| RO (1) | RO120170B1 (zh) |
| RU (1) | RU2173559C2 (zh) |
| SI (1) | SI9720040A (zh) |
| SK (1) | SK176998A3 (zh) |
| TR (1) | TR199802596T2 (zh) |
| UA (1) | UA49888C2 (zh) |
| WO (1) | WO1997048379A1 (zh) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102355888A (zh) * | 2008-12-22 | 2012-02-15 | 阿勒根公司 | 鼻内去氨加压素给药 |
| US11419914B2 (en) | 2009-06-18 | 2022-08-23 | Serenity Pharmaceuticals Llc | Safe desmopressin administration |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8765177B2 (en) * | 1997-09-12 | 2014-07-01 | Columbia Laboratories, Inc. | Bioadhesive progressive hydration tablets |
| US7153845B2 (en) * | 1998-08-25 | 2006-12-26 | Columbia Laboratories, Inc. | Bioadhesive progressive hydration tablets |
| JP2001233787A (ja) * | 2000-02-04 | 2001-08-28 | Patents Exploitation Co Bv | 小・中サイズのペプチド含有薬学的組成物 |
| EP1121935B1 (en) * | 2000-02-04 | 2008-08-13 | Patents Exploitation Company B.V. | Pharmaceutical composition containing a small or medium size peptide |
| KR20040088519A (ko) | 2002-02-22 | 2004-10-16 | 뉴 리버 파마슈티칼스, 인크. | 활성 제제 전달 시스템 및 활성 제제의 보호 및 투여 방법 |
| GB0210397D0 (en) * | 2002-05-07 | 2002-06-12 | Ferring Bv | Pharmaceutical formulations |
| US7094545B2 (en) | 2003-04-30 | 2006-08-22 | Ferring Bv | Pharmaceutical composition as solid dosage form and method for manufacturing thereof |
| ES2260563T3 (es) * | 2003-11-13 | 2006-11-01 | Ferring B.V. | Paquete de blister y forma farmaceutica solida para ello. |
| SE528446C2 (sv) * | 2006-03-02 | 2006-11-14 | Ferring Int Ct Sa | Farmaceutisk sammansättning innefattande desmopressin, kiseldioxid och stärkelse |
| ES2319054B1 (es) | 2007-08-06 | 2010-02-12 | Gp Pharm S.A. | Composicion farmaceutica oral de desmopresina. |
| CA2988753A1 (en) | 2007-08-06 | 2009-02-12 | Serenity Pharmaceuticals, Llc | Methods and devices for desmopressin drug delivery |
| US8986253B2 (en) | 2008-01-25 | 2015-03-24 | Tandem Diabetes Care, Inc. | Two chamber pumps and related methods |
| US20100286045A1 (en) | 2008-05-21 | 2010-11-11 | Bjarke Mirner Klein | Methods comprising desmopressin |
| US11963995B2 (en) | 2008-05-21 | 2024-04-23 | Ferring B.V. | Methods comprising desmopressin |
| EP2296686B2 (en) * | 2008-05-21 | 2017-11-01 | Ferring B.V. | Orodispersible desmopressin for increasing initial period of sleep undisturbed by nocturia |
| US8408421B2 (en) | 2008-09-16 | 2013-04-02 | Tandem Diabetes Care, Inc. | Flow regulating stopcocks and related methods |
| US8650937B2 (en) | 2008-09-19 | 2014-02-18 | Tandem Diabetes Care, Inc. | Solute concentration measurement device and related methods |
| CA2769030C (en) | 2009-07-30 | 2016-05-10 | Tandem Diabetes Care, Inc. | Infusion pump system with disposable cartridge having pressure venting and pressure feedback |
| FR2954774B1 (fr) * | 2009-10-30 | 2012-01-06 | Michelin Soc Tech | Methode de preparation d'un melange maitre de caoutchouc naturel et de silice |
| US9180242B2 (en) | 2012-05-17 | 2015-11-10 | Tandem Diabetes Care, Inc. | Methods and devices for multiple fluid transfer |
| US9173998B2 (en) | 2013-03-14 | 2015-11-03 | Tandem Diabetes Care, Inc. | System and method for detecting occlusions in an infusion pump |
| RU2605311C1 (ru) * | 2015-07-14 | 2016-12-20 | Федеральное государственное бюджетное научное учреждение "Институт экспериментальной медицины" (ФГБНУ "ИЭМ") | Способ лечения болевого синдрома у больных с дегенеративно-дистрофическими заболеваниями позвоночника |
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| CH495957A (de) * | 1966-09-15 | 1970-09-15 | Ceskoslovenska Akademie Ved | Verfahren zur Herstellung eines antidiuretisch wirksamen Polypeptids |
| US4271068A (en) * | 1968-05-10 | 1981-06-02 | Ciba-Geigy Corporation | Process for the manufacture of cystine-containing peptides |
| CH517705A (de) * | 1969-12-16 | 1972-01-15 | Ciba Geigy Ag | Verfahren zur Herstellung von Cystin-haltigen Peptiden |
| US3929758A (en) * | 1974-09-12 | 1975-12-30 | Armour Pharma | Cyclization of cysteine-containing peptides |
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| US4216141A (en) * | 1978-07-19 | 1980-08-05 | The Salk Institute For Biological Studies | Method for cyclization of peptides |
| DE2923787A1 (de) * | 1979-06-12 | 1980-12-18 | Max Planck Gesellschaft | Verfahren zur selektiven bildung von disulfidbruecken in polypeptiden und die dabei erhaltenen produkte als wirkstoffe enthaltende arzneimittel |
| IE56021B1 (en) * | 1982-10-13 | 1991-03-27 | Akzo Nv | Peptides |
| US5066716A (en) * | 1988-12-13 | 1991-11-19 | The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services | Synthesis of chloroacetyl and bromoacetyl modified peptides for the preparation of synthetic peptide polymers, conjugated peptides, and cyclic peptides |
| US5500413A (en) * | 1993-06-29 | 1996-03-19 | Ferring Ab | Process for manufacture of 1-deamino-8-D-arginine vasopressin |
| US5482931A (en) * | 1993-06-29 | 1996-01-09 | Ferring Ab | Stabilized pharmaceutical peptide compositions |
| WO1995001183A1 (en) * | 1993-06-29 | 1995-01-12 | Ferring B.V. | Compositions for nasal administration of desmopressin |
-
1996
- 1996-06-20 US US08/667,047 patent/US5763398A/en not_active Expired - Fee Related
-
1997
- 1997-01-28 BR BR9700797A patent/BR9700797A/pt not_active Application Discontinuation
- 1997-06-10 CN CN97195712A patent/CN1233952A/zh active Pending
- 1997-06-10 TR TR1998/02596T patent/TR199802596T2/xx unknown
- 1997-06-10 AU AU32802/97A patent/AU707527B2/en not_active Ceased
- 1997-06-10 SK SK1769-98A patent/SK176998A3/sk unknown
- 1997-06-10 SI SI9720040A patent/SI9720040A/sl not_active IP Right Cessation
- 1997-06-10 JP JP10502778A patent/JP2000502358A/ja active Pending
- 1997-06-10 RU RU99100320/14A patent/RU2173559C2/ru not_active IP Right Cessation
- 1997-06-10 CA CA002258552A patent/CA2258552A1/en not_active Abandoned
- 1997-06-10 EE EE9800453A patent/EE9800453A/xx unknown
- 1997-06-10 EP EP97928577A patent/EP0921786A1/en not_active Withdrawn
- 1997-06-10 PL PL97330902A patent/PL330902A1/xx unknown
- 1997-06-10 RO RO98-01718A patent/RO120170B1/ro unknown
- 1997-06-10 KR KR1019980710391A patent/KR20000016781A/ko not_active Application Discontinuation
- 1997-06-10 NZ NZ333124A patent/NZ333124A/xx unknown
- 1997-06-10 WO PCT/SE1997/001010 patent/WO1997048379A1/en not_active Application Discontinuation
- 1997-06-10 CZ CZ984201A patent/CZ420198A3/cs unknown
- 1997-06-10 HU HU9903541A patent/HUP9903541A3/hu unknown
- 1997-06-10 IL IL12757297A patent/IL127572A/xx not_active IP Right Cessation
- 1997-10-06 UA UA98126542A patent/UA49888C2/uk unknown
-
1998
- 1998-12-08 LV LVP-98-275A patent/LV12230B/en unknown
- 1998-12-17 NO NO985936A patent/NO985936L/no not_active Application Discontinuation
- 1998-12-18 LT LT98-188A patent/LT4621B/lt not_active IP Right Cessation
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102355888A (zh) * | 2008-12-22 | 2012-02-15 | 阿勒根公司 | 鼻内去氨加压素给药 |
| CN105963834A (zh) * | 2008-12-22 | 2016-09-28 | 阿勒根公司 | 鼻内去氨加压素给药 |
| US11419914B2 (en) | 2009-06-18 | 2022-08-23 | Serenity Pharmaceuticals Llc | Safe desmopressin administration |
Also Published As
| Publication number | Publication date |
|---|---|
| KR20000016781A (ko) | 2000-03-25 |
| HUP9903541A2 (hu) | 2000-04-28 |
| JP2000502358A (ja) | 2000-02-29 |
| WO1997048379A1 (en) | 1997-12-24 |
| SK176998A3 (en) | 1999-05-07 |
| IL127572A0 (en) | 1999-10-28 |
| LV12230A (lv) | 1999-03-20 |
| EE9800453A (et) | 1999-08-16 |
| TR199802596T2 (xx) | 1999-03-22 |
| RU2173559C2 (ru) | 2001-09-20 |
| HUP9903541A3 (en) | 2000-10-30 |
| PL330902A1 (en) | 1999-06-07 |
| NO985936L (no) | 1999-02-16 |
| NZ333124A (en) | 1999-05-28 |
| LT4621B (lt) | 2000-02-25 |
| AU707527B2 (en) | 1999-07-15 |
| CZ420198A3 (cs) | 1999-04-14 |
| IL127572A (en) | 2003-04-10 |
| NO985936D0 (no) | 1998-12-17 |
| UA49888C2 (uk) | 2002-10-15 |
| BR9700797A (pt) | 1998-10-06 |
| RO120170B1 (ro) | 2005-10-28 |
| AU3280297A (en) | 1998-01-07 |
| LT98188A (en) | 1999-11-25 |
| EP0921786A1 (en) | 1999-06-16 |
| US5763398A (en) | 1998-06-09 |
| CA2258552A1 (en) | 1997-12-24 |
| LV12230B (en) | 1999-06-20 |
| SI9720040A (sl) | 1999-08-31 |
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