JP2010535745A - 経口用デスモプレシン医薬組成物 - Google Patents
経口用デスモプレシン医薬組成物 Download PDFInfo
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- JP2010535745A JP2010535745A JP2010519481A JP2010519481A JP2010535745A JP 2010535745 A JP2010535745 A JP 2010535745A JP 2010519481 A JP2010519481 A JP 2010519481A JP 2010519481 A JP2010519481 A JP 2010519481A JP 2010535745 A JP2010535745 A JP 2010535745A
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- pharmaceutical composition
- desmopressin
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- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/08—Peptides having 5 to 11 amino acids
- A61K38/095—Oxytocins; Vasopressins; Related peptides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
-
- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
-
- 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
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/12—Antidiuretics, e.g. drugs for diabetes insipidus
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Diabetes (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Immunology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Organic Chemistry (AREA)
- Gastroenterology & Hepatology (AREA)
- Hematology (AREA)
- Zoology (AREA)
- Emergency Medicine (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Obesity (AREA)
- Endocrinology (AREA)
- Urology & Nephrology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Abstract
【選択図】なし
Description
本発明は、全般的には生物医学の分野に含まれ、特に、新規で用量可変な経口用液体デスモプレシン医薬組成物、並びに中枢性尿崩症、一次性夜尿症、血友病A患者及びフォンウィルブランド−ユルゲンス病患者における出血、並びに術後出血を治療するためのその使用に関する。
一般にデスモプレシンとして知られている、1−デアミノ−8−D−アルギニン−バソプレシンは、尿崩症の治療において有用な生物学的効果があり、抗利尿作用を示し、又長い出血時間を減少及び正常化させることがしばらく前から知られている。
本発明は、中枢性尿崩症、一次性夜尿症、血友病A患者及びフォンウィルブランド−ユルゲンス病患者における出血、並びに術後出血の治療に有用な、デスモプレシンを含む経口投与用液体医薬組成物を提供する。
本発明者らは、驚くべきことに、治療上有効な量のデスモプレシンを含み、浸透圧性薬剤も吸収促進剤もいずれも含まない、安定で用量可変な経口投与用液体医薬組成物を見出した。
本実施例は、本発明を例示するためのものであって、制限することを意図するものではない。
デスモプレシンの医薬組成物(表1)。
デスモプレシンの医薬組成物(表2)。
デスモプレシンの医薬組成物(表3)。
25℃における上記実施例の医薬組成物の安定性
Claims (15)
- 治療上有効な量のデスモプレシンを含み、浸透圧性薬剤も吸収促進剤もいずれも含まない、安定で用量可変な経口投与用液体医薬組成物。
- 治療上有効な量のデスモプレシンが、医薬として許容できるその塩の1つ又はいくつかの形態で投与される、請求項1に記載の医薬組成物。
- 治療上有効な量のデスモプレシンが、酢酸デスモプレシンの形態で投与される、請求項1又は2に記載の医薬組成物。
- デスモプレシンの治療上有効な量が、0.001mg/ml〜5mg/mlの間に含まれる、請求項1〜3のいずれか一項に記載の医薬組成物。
- デスモプレシンの治療上有効な量が、0.01mg/ml〜2mg/mlの間に含まれる、請求項4に記載の医薬組成物。
- デスモプレシンの治療上有効な量が、0.1mg〜1mg/mlの間に含まれる、請求項5に記載の医薬組成物。
- 保存剤、抗菌剤及び抗真菌剤、並びに組成物のpHを調整するための酸から形成される群から選ばれる、1つ又はいくつかの医薬として許容できる補助剤を含む、請求項1〜6のいずれか一項に記載の医薬組成物。
- 保存剤、抗菌剤及び抗真菌剤が、パラベン、その塩又はその混合物から選ばれる、請求項7に記載の医薬組成物。
- 保存剤、抗菌剤及び抗真菌剤が、メチルパラベン、エチルパラベン、プロピルパラベン、ブチルパラベン、イソブチルパラベン、イソプロピルパラベン、ベンジルパラベン、これらの塩又はこれらの混合物から選ばれる、請求項8に記載の医薬組成物。
- 組成物のpHが3.5〜5.0の間の値に調整される、請求項7に記載の医薬組成物。
- 組成物のpHを調整するための酸が、無機酸、有機酸及び/又はアミノ酸から選ばれる、請求項7に記載の医薬組成物。
- 組成物のpHを調整するための酸が、塩酸、硝酸、リン酸、硫酸、酢酸、安息香酸、クエン酸、アスコルビン酸、アスパラギン酸、ジアトリゾ酸、酒石酸、乳酸、ヒドロアクリル酸、グルタミン酸、マレイン酸、コハク酸、シュウ酸、リンゴ酸、マロン酸、マンデル酸、ピルビン酸又はこれらの混合物によって形成される群から選ばれる、請求項11に記載の医薬組成物。
- 提示形態が、口腔粘膜及び/又は舌下粘膜を通じて吸収される、経口投与用の滴剤である、請求項1〜12のいずれか一項に記載の医薬組成物。
- 提示形態が、経口消化管投与用のシロップ、又は口腔粘膜及び/又は舌下粘膜を通じて吸収される経口投与用のシロップである、請求項1〜12のいずれか一項に記載の医薬組成物。
- 中枢性尿崩症、一次性夜尿症、血友病A患者及びフォンウィルブランド−ユルゲンス病患者における出血、並びに術後出血を治療するための医薬の調製における、請求項1〜14のいずれか一項に記載の医薬組成物の使用。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
ESP200702215 | 2007-08-06 | ||
ES200702215A ES2319054B1 (es) | 2007-08-06 | 2007-08-06 | Composicion farmaceutica oral de desmopresina. |
PCT/ES2008/000539 WO2009027561A2 (es) | 2007-08-06 | 2008-08-01 | Composición farmacéutica oral de desmopresina |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2010535745A true JP2010535745A (ja) | 2010-11-25 |
JP5626682B2 JP5626682B2 (ja) | 2014-11-19 |
Family
ID=40032884
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2010519481A Active JP5626682B2 (ja) | 2007-08-06 | 2008-08-01 | 経口用デスモプレシン医薬組成物 |
Country Status (18)
Country | Link |
---|---|
US (1) | US8993521B2 (ja) |
EP (1) | EP2174652B1 (ja) |
JP (1) | JP5626682B2 (ja) |
CN (2) | CN106265494A (ja) |
AR (1) | AR068337A1 (ja) |
BR (1) | BRPI0814835B8 (ja) |
CY (1) | CY1118459T1 (ja) |
DK (1) | DK2174652T3 (ja) |
ES (2) | ES2319054B1 (ja) |
HR (1) | HRP20161676T1 (ja) |
HU (1) | HUE032667T2 (ja) |
LT (1) | LT2174652T (ja) |
MX (1) | MX2010001456A (ja) |
PL (1) | PL2174652T3 (ja) |
PT (1) | PT2174652T (ja) |
RU (1) | RU2474414C2 (ja) |
SI (1) | SI2174652T1 (ja) |
WO (1) | WO2009027561A2 (ja) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JO3400B1 (ar) * | 2010-09-30 | 2019-10-20 | Ferring Bv | مركب صيدلاني من كاربيتوسين |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH09502424A (ja) * | 1993-06-29 | 1997-03-11 | フエリング ビー ヴイ | 安定化製薬性ペプチド組成 |
JP2003529562A (ja) * | 2000-02-16 | 2003-10-07 | ゲブロ ファルマ ゲーエムベーハー | 経鼻、経口又は経舌下投与のための安定な医薬製剤 |
JP2006516567A (ja) * | 2003-01-24 | 2006-07-06 | マグル ホールディング エービー | 経粘膜伝達用組成物材料 |
Family Cites Families (21)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
SE8306367L (sv) | 1983-11-18 | 1985-05-19 | Ferring Ab | Antidiuretiskt verkande farmaceutiskt preparat |
EP0381345B1 (en) * | 1989-01-30 | 1994-07-13 | Corint, Ltd. | Aqueous liquid desmopressin-CMC pharmaceutical composition |
JP2653255B2 (ja) * | 1990-02-13 | 1997-09-17 | 武田薬品工業株式会社 | 長期徐放型マイクロカプセル |
CA2070061C (en) | 1991-06-07 | 2004-02-10 | Shigeyuki Takama | Physiologically active polypeptide-containing pharmaceutical composition |
US5298256A (en) | 1992-04-28 | 1994-03-29 | Corint, Ltd. | Desmopressin buccal patch composition |
IT1255460B (it) | 1992-07-28 | 1995-11-02 | Poli Ind Chimica Spa | Composizioni farmaceutiche in forma di microemulsioni o di dispersioni liposomiali bioadesive per la somministrazione transmucosale di sostanze peptidiche e di proteine farmacologicamente attive |
SE9300937L (sv) | 1993-03-19 | 1994-09-20 | Anne Fjellestad Paulsen | Komposition för oral administrering av peptider |
SE9400918L (sv) | 1994-03-18 | 1995-09-19 | Anne Fjellstad Paulsen | Stabiliserad komposition för oral administrering av peptider |
US5763398A (en) * | 1996-06-20 | 1998-06-09 | Ferring B.V. | Nasal administration of desmopressin |
US20030095926A1 (en) * | 1997-10-01 | 2003-05-22 | Dugger Harry A. | Buccal, polar and non-polar spray or capsule containing drugs for treating disorders of the gastrointestinal tract or urinary tract |
RU2232608C2 (ru) * | 1998-11-02 | 2004-07-20 | Элзэ Копэрейшн | Устройство для чрескожной доставки лекарственного средства электропереносом и способ его изготовления, способ чрескожной доставки лекарственного средства пациенту электропереносом |
US6894026B1 (en) | 2000-01-11 | 2005-05-17 | Atossa Healthcare, Inc. | Long-acting oxytocin analogues for the treatment and prevention of breast cancer and psychiatric disorders |
EP1121935B1 (en) * | 2000-02-04 | 2008-08-13 | Patents Exploitation Company B.V. | Pharmaceutical composition containing a small or medium size peptide |
GB0210397D0 (en) | 2002-05-07 | 2002-06-12 | Ferring Bv | Pharmaceutical formulations |
AU2003269747A1 (en) * | 2002-05-15 | 2003-12-02 | Sun Pharmaceutical Industries Limited | A stable aqueous composition of a peptide |
ITMI20021684A1 (it) | 2002-07-29 | 2004-01-29 | Therapicon Srl | Composizione farmaceutica di peptide nasale |
EP1473029B1 (en) | 2003-04-30 | 2005-03-23 | Ferring B.V. | Solid dosage form comprising desmopressin |
ES2243840T3 (es) | 2003-07-25 | 2005-12-01 | Ferring B.V. | Composicion farmaceutica de desmopresina como forma farmaceutica solida de dosificacion y metodo para la fabricacion de la misma. |
CN1878563A (zh) | 2003-11-10 | 2006-12-13 | 西摩·H·费恩 | 包含低剂量去氨加压素的药物组合物 |
GB0406048D0 (en) | 2004-03-18 | 2004-04-21 | Ardana Bioscience Ltd | Drug formulations |
US20050244502A1 (en) | 2004-04-28 | 2005-11-03 | Mathias Neil R | Composition for enhancing absorption of a drug and method |
-
2007
- 2007-08-06 ES ES200702215A patent/ES2319054B1/es active Active
-
2008
- 2008-08-01 DK DK08805367.3T patent/DK2174652T3/en active
- 2008-08-01 BR BRPI0814835A patent/BRPI0814835B8/pt not_active IP Right Cessation
- 2008-08-01 RU RU2010105031/15A patent/RU2474414C2/ru active
- 2008-08-01 HU HUE08805367A patent/HUE032667T2/en unknown
- 2008-08-01 JP JP2010519481A patent/JP5626682B2/ja active Active
- 2008-08-01 CN CN201610700664.8A patent/CN106265494A/zh active Pending
- 2008-08-01 LT LTEP08805367.3T patent/LT2174652T/lt unknown
- 2008-08-01 EP EP08805367.3A patent/EP2174652B1/en active Active
- 2008-08-01 US US12/672,255 patent/US8993521B2/en active Active
- 2008-08-01 ES ES08805367.3T patent/ES2608816T3/es active Active
- 2008-08-01 WO PCT/ES2008/000539 patent/WO2009027561A2/es active Application Filing
- 2008-08-01 SI SI200831737A patent/SI2174652T1/sl unknown
- 2008-08-01 PL PL08805367T patent/PL2174652T3/pl unknown
- 2008-08-01 MX MX2010001456A patent/MX2010001456A/es active IP Right Grant
- 2008-08-01 PT PT88053673T patent/PT2174652T/pt unknown
- 2008-08-01 CN CN200880105631A patent/CN101808621A/zh active Pending
- 2008-08-06 AR ARP080103430A patent/AR068337A1/es not_active Application Discontinuation
-
2016
- 2016-12-08 HR HRP20161676TT patent/HRP20161676T1/hr unknown
-
2017
- 2017-01-03 CY CY20171100005T patent/CY1118459T1/el unknown
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH09502424A (ja) * | 1993-06-29 | 1997-03-11 | フエリング ビー ヴイ | 安定化製薬性ペプチド組成 |
JP2003529562A (ja) * | 2000-02-16 | 2003-10-07 | ゲブロ ファルマ ゲーエムベーハー | 経鼻、経口又は経舌下投与のための安定な医薬製剤 |
JP2006516567A (ja) * | 2003-01-24 | 2006-07-06 | マグル ホールディング エービー | 経粘膜伝達用組成物材料 |
Non-Patent Citations (1)
Title |
---|
JPN6013003522; VILHARDT,H.: Drug Investigation Vol.2, 1990, p.2-8 * |
Also Published As
Publication number | Publication date |
---|---|
BRPI0814835B8 (pt) | 2021-05-25 |
HUE032667T2 (en) | 2017-10-30 |
BRPI0814835A2 (pt) | 2015-03-31 |
PT2174652T (pt) | 2016-12-23 |
ES2319054B1 (es) | 2010-02-12 |
CY1118459T1 (el) | 2017-07-12 |
WO2009027561A3 (es) | 2009-07-16 |
EP2174652A2 (en) | 2010-04-14 |
WO2009027561A2 (es) | 2009-03-05 |
DK2174652T3 (en) | 2017-01-23 |
RU2474414C2 (ru) | 2013-02-10 |
CN106265494A (zh) | 2017-01-04 |
EP2174652B1 (en) | 2016-10-05 |
JP5626682B2 (ja) | 2014-11-19 |
AR068337A1 (es) | 2009-11-11 |
RU2010105031A (ru) | 2011-09-20 |
US8993521B2 (en) | 2015-03-31 |
CN101808621A (zh) | 2010-08-18 |
ES2319054A1 (es) | 2009-05-01 |
PL2174652T3 (pl) | 2017-06-30 |
HRP20161676T1 (hr) | 2017-02-24 |
ES2608816T3 (es) | 2017-04-17 |
SI2174652T1 (sl) | 2017-04-26 |
BRPI0814835B1 (pt) | 2020-10-27 |
US20110251123A1 (en) | 2011-10-13 |
MX2010001456A (es) | 2010-06-02 |
LT2174652T (lt) | 2017-02-27 |
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