WO2007049626A1 - Preparation orale solide contenant de la cabergoline - Google Patents

Preparation orale solide contenant de la cabergoline Download PDF

Info

Publication number
WO2007049626A1
WO2007049626A1 PCT/JP2006/321202 JP2006321202W WO2007049626A1 WO 2007049626 A1 WO2007049626 A1 WO 2007049626A1 JP 2006321202 W JP2006321202 W JP 2006321202W WO 2007049626 A1 WO2007049626 A1 WO 2007049626A1
Authority
WO
WIPO (PCT)
Prior art keywords
sugar
preparation
preparation according
hydrophobic substance
oral solid
Prior art date
Application number
PCT/JP2006/321202
Other languages
English (en)
Japanese (ja)
Inventor
Ken Kanada
Yasuhiro Takeda
Kazuki Mimura
Original Assignee
Kissei Pharmaceutical Co., Ltd.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Kissei Pharmaceutical Co., Ltd. filed Critical Kissei Pharmaceutical Co., Ltd.
Priority to JP2007542607A priority Critical patent/JPWO2007049626A1/ja
Publication of WO2007049626A1 publication Critical patent/WO2007049626A1/fr

Links

Classifications

    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/48—Ergoline derivatives, e.g. lysergic acid, ergotamine
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/14—Drugs for genital or sexual disorders; Contraceptives for lactation disorders, e.g. galactorrhoea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs

Definitions

  • Strength bermolin is an ergolin derivative having an excellent dopamine D receptor stimulating action.
  • US6316027 consists of a mixture of dopamine agonist, gelatin, mannitol and water as active ingredients, and is prepared by freeze-drying water from the mixture.
  • An internally disintegrating tablet and a method for producing the same are disclosed, and it has been suggested that force belgorin is applicable as a dopamine agonist (see, for example, Patent Document 2).
  • this manufacturing method is not suitable for the formulation of drugs that are unstable in the presence of water, such as strong belgorin, because dopamine agonists and large amounts of water are in direct contact. .
  • the ratio of sugar and / or sugar alcohol contained in the granulated product composed of sugar and / or sugar alcohol and hydrophobic substance to the total weight of sugar and / or sugar alcohol is 5 to 100% by weight.
  • the strength berogolin contained as an active ingredient in the oral solid preparation of the present invention may contain a very low content of l.Omg or less in the unit dosage formulation. It is important to ensure sufficient content uniformity.
  • the dose of strength belgorin contained in the oral solid preparation of the present invention is about 0.
  • This granulated product (3.03 g), lactose (6.57 g) and partially alpha-monoized starch (PCS, manufactured by Asahi Kasei Co., Ltd.) (0.3 g) were mixed for 3 minutes, then 0.1 g of sodium stearyl fumarate was added, and 30 seconds Mixed.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Reproductive Health (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Endocrinology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Psychology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L’invention a trait à une préparation orale solide contenant de la cabergoline et faisant preuve d’une bonne stabilité au stockage. Ladite préparation est caractérisée en ce qu’elle contient a) de la cabergoline en tant qu’ingrédient actif, b) un sucre et/ou alcool de sucre et c) une substance hydrophobe, et en ce qu’elle est préparée sans utiliser de solvant ni mettre la cabergoline sensiblement en contact avec un solvant. La préparation de l’invention peut être produite par mélangeage à sec ou granulation à sec a) de cabergoline, b) d’un sucre et/ou alcool de sucre et c) d’une substance hydrophobe.
PCT/JP2006/321202 2005-10-27 2006-10-25 Preparation orale solide contenant de la cabergoline WO2007049626A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2007542607A JPWO2007049626A1 (ja) 2005-10-27 2006-10-25 カベルゴリン含有経口固形製剤

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2005312132 2005-10-27
JP2005-312132 2005-10-27

Publications (1)

Publication Number Publication Date
WO2007049626A1 true WO2007049626A1 (fr) 2007-05-03

Family

ID=37967736

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2006/321202 WO2007049626A1 (fr) 2005-10-27 2006-10-25 Preparation orale solide contenant de la cabergoline

Country Status (2)

Country Link
JP (1) JPWO2007049626A1 (fr)
WO (1) WO2007049626A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007131542A (ja) * 2005-11-08 2007-05-31 Towa Yakuhin Kk 安定化されたカベルゴリン固形製剤
WO2015156302A1 (fr) * 2014-04-09 2015-10-15 ゴールドクレスト医薬研究所株式会社 Agent permettant d'atténuer les symptômes cutanés, agent pour la croissance des cheveux ou agent amincissant
CN114732791A (zh) * 2022-03-17 2022-07-12 成都倍特药业股份有限公司 一种含有卡麦角林的组合物及其制备方法和用途

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001354566A (ja) * 2000-06-16 2001-12-25 Ohara Yakuhin Kogyo Kk ニセルゴリンの錠剤
WO2002049608A1 (fr) * 2000-12-21 2002-06-27 Par Pharmaceutical Inc. Compositions pharmaceutiques de cabergoline et leurs procedes d'utilisation
JP2005525994A (ja) * 2001-08-10 2005-09-02 ベーリンガー インゲルハイム ファルマ ゲゼルシャフト ミット ベシュレンクテル ハフツング ウント コンパニー コマンディトゲゼルシャフト 快感消失症治療用化合物

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001354566A (ja) * 2000-06-16 2001-12-25 Ohara Yakuhin Kogyo Kk ニセルゴリンの錠剤
WO2002049608A1 (fr) * 2000-12-21 2002-06-27 Par Pharmaceutical Inc. Compositions pharmaceutiques de cabergoline et leurs procedes d'utilisation
JP2005525994A (ja) * 2001-08-10 2005-09-02 ベーリンガー インゲルハイム ファルマ ゲゼルシャフト ミット ベシュレンクテル ハフツング ウント コンパニー コマンディトゲゼルシャフト 快感消失症治療用化合物

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
MATSUDA Y. ET AL: "Iyakuhin Tenkazai Yoran", KABUSHIKI KAISHA YAKUGYO JIHOSHA, 25 November 1992 (1992-11-25), pages 42 - 45, XP003011921 *
MATSUMOTO M.: "Yakuzai Manual", NANZANDO, 20 March 1989 (1989-03-20), pages 113, XP003011922 *

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007131542A (ja) * 2005-11-08 2007-05-31 Towa Yakuhin Kk 安定化されたカベルゴリン固形製剤
WO2015156302A1 (fr) * 2014-04-09 2015-10-15 ゴールドクレスト医薬研究所株式会社 Agent permettant d'atténuer les symptômes cutanés, agent pour la croissance des cheveux ou agent amincissant
JP6026706B2 (ja) * 2014-04-09 2016-11-16 ゴールドクレスト医薬研究所株式会社 皮膚症状の改善剤、育毛剤又はスリミング剤
CN114732791A (zh) * 2022-03-17 2022-07-12 成都倍特药业股份有限公司 一种含有卡麦角林的组合物及其制备方法和用途
CN114732791B (zh) * 2022-03-17 2023-09-29 成都倍特药业股份有限公司 一种含有卡麦角林的组合物及其制备方法和用途

Also Published As

Publication number Publication date
JPWO2007049626A1 (ja) 2009-04-30

Similar Documents

Publication Publication Date Title
JP5752227B2 (ja) 口腔内崩壊錠
KR101801424B1 (ko) 날부핀-기재 제제 및 그것의 용도
EP2939662B1 (fr) Composition pharmaceutique ayant une stabilité améliorée, contenant du témozolomide et son procédé de préparation
KR102241643B1 (ko) 비정질 톨밥탄을 함유하는 경구 투여 현탁제
KR20130030306A (ko) 약학 조성물
WO2008072534A1 (fr) Préparation médicale sous forme solide contenant un mannitol ou un lactose
TW201408299A (zh) 不含鹼化劑之拉喹莫德（ｌａｑｕｉｎｉｍｏｄ）調配物
WO2019151405A1 (fr) Comprimés et leur procédé de production
WO2007049626A1 (fr) Preparation orale solide contenant de la cabergoline
TW201713343A (zh) 經口投與用醫藥組成物
JP3037393B2 (ja) 経口投与用固形薬剤の製造方法
JP2023036924A (ja) レナリドミドを含む医薬組成物
JP2019019125A (ja) 口腔内崩壊錠及びその製造方法
KR100267525B1 (ko) 시타라빈 옥포스페이트 경질 캡슐제
JP2020518611A (ja) 水溶解度及びバイオアベイラビリティが改善された組成物
JP7322474B2 (ja) アジルサルタンを含有する錠剤
EP2903593B1 (fr) Comprimé contenant un composite renfermant de la cyclodextrine
JP2020196713A (ja) エドキサバンを含有する口腔内崩壊錠
CA3108993A1 (fr) Composition pharmaceutique pour administration par voie orale
JPWO2003075919A1 (ja) 塩酸ピルジカイニド含有錠剤（乾式）
TW201431553A (zh) Ｎ－［５－［２－（３，５－二甲氧基苯基）乙基］－２ｈ－吡唑－３－基］－４－［（３ｒ，５ｓ）－３，５－二甲基哌□－１－基］苯甲醯胺之醫藥調配物
JP5900702B2 (ja) 経口投与用医薬組成物
JP2864737B2 (ja) 徐放性製剤用基剤並びに徐放性製剤及び該製剤の製造方法
EP3162368A1 (fr) Composition pharmaceutique à administration orale
JP2022072050A (ja) エドキサバンを含有する口腔内崩壊錠

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application
ENP Entry into the national phase

Ref document number: 2007542607

Country of ref document: JP

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 06822179

Country of ref document: EP

Kind code of ref document: A1