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1. WO2020004541 - PHARMACEUTICAL COMPOSITION COMPRISING OIL COMPONENT DISPERSION THAT CONTAINS ED-71 AND EPOXY FORM THEREOF IN FAT/OIL

Publication Number WO/2020/004541
Publication Date 02.01.2020
International Application No. PCT/JP2019/025572
International Filing Date 27.06.2019
IPC
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31
Medicinal preparations containing organic active ingredients
59
Compounds containing 9,10-seco-cyclopenta[a]hydro- phenanthrene ring systems
593
9,10-Secocholestane derivatives, e.g. cholecalciferol, vitamin D3
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9
Medicinal preparations characterised by special physical form
10
Dispersions; Emulsions
107
Emulsions
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9
Medicinal preparations characterised by special physical form
14
Particulate form, e.g. powders
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9
Medicinal preparations characterised by special physical form
20
Pills, lozenges or tablets
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
06
Organic compounds
26
Carbohydrates
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
30
Macromolecular compounds
36
Polysaccharides; Derivatives thereof
38
Cellulose; Derivatives thereof
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
19
Drugs for skeletal disorders
08
for bone diseases, e.g. rachitism, Paget's disease
10
for osteoporosis
A61K 31/593 (2006.01)
A61K 9/107 (2006.01)
A61K 9/14 (2006.01)
A61K 9/20 (2006.01)
A61K 47/26 (2006.01)
A61K 47/38 (2006.01)
CPC
A61K 31/593
A61K 47/26
A61K 47/38
A61K 9/107
A61K 9/14
A61K 9/20
Applicants
  • 中外製薬株式会社 CHUGAI SEIYAKU KABUSHIKI KAISHA [JP/JP]; 東京都北区浮間5丁目5番1号 5-1, Ukima 5-chome, Kita-ku, Tokyo 1158543, JP
Inventors
  • 杉本 健二 SUGIMOTO, Kenji; JP
  • 新居 啓司 NII, Keiji; JP
  • 篠倉 潔 SASAKURA, Kiyoshi; JP
Agents
  • 小野 新次郎 ONO, Shinjiro; JP
  • 山本 修 YAMAMOTO, Osamu; JP
  • 宮前 徹 MIYAMAE, Toru; JP
  • 中西 基晴 NAKANISHI, Motoharu; JP
  • 寺地 拓己 TERACHI, Takumi; JP
  • 一宮 維幸 ICHINOMIYA, Masayuki; JP
Priority Data
2018-12176127.06.2018JP
Publication Language Japanese (JA)
Filing Language Japanese (JA)
Designated States
Title
(EN) PHARMACEUTICAL COMPOSITION COMPRISING OIL COMPONENT DISPERSION THAT CONTAINS ED-71 AND EPOXY FORM THEREOF IN FAT/OIL
(FR) COMPOSITION PHARMACEUTIQUE COMPRENANT UNE DISPERSION À CONSTITUANTE LIPIDIQUE CONTENANT ED -71 ET SA FORME ÉPOXY DANS LE CORPS GRAS
(JA) 油脂中にED-71およびそのエポキシ体を含む油分分散体を含む医薬組成物
Abstract
(EN)
The present invention provides a method for producing a pharmaceutical composition comprising ED-71 and an epoxy form thereof, said method comprising a step for preparing an oil-in-water type of emulsion comprising a fat/oil solution of (5Z,7E)-(1R,2R,3R)-2-(3-hydroxypropoxy)-9,10-secocholesta-5,7,10(19)-triene-1,3,25-triol (ED-71) and an aqueous solution of a water-soluble polymer. The water-soluble polymer is selected from hydroxypropyl methylcellulose and hydroxypropyl cellulose.
(FR)
L'invention concerne un procédé de production d'une composition pharmaceutique comprenant ED-71 et sa forme époxy, ledit procédé comprenant une étape de préparation d'un type d'émulsion huile-dans-eau comprenant une solution de corps gras de (5Z,7E)-(1R,2R,3R)-2-(3-hydroxypropoxy)-9,10-sécocholesta-5,7,10(19)-triène-1,3,25-triol (ED -71) et une solution aqueuse d'un polymère hydrosoluble. Le polymère soluble dans l'eau est choisi parmi l'hydroxypropylméthylcellulose et l'hydroxypropylcellulose.
(JA)
本発明により、(5Z,7E)-(1R,2R,3R)-2-(3-ヒドロキシプロポキシ)-9,10-セココレスタ-5,7,10(19)-トリエン-1,3,25-トリオール(ED-71)の油脂溶液と水溶性高分子の水溶液とからなる水中油型乳化液を調製する工程を含み、ここで前記水溶性高分子は、ヒドロキシプロピルメチルセルロースおよびヒドロキシプロピルセルロースから選択される、ED-71およびそのエポキシ体を含む医薬組成物の製造方法が提供される。
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