Title:
ENTERIC HARD CAPSULE
Document Type and Number:
WIPO Patent Application WO/2019/245031
Kind Code:
A1
Abstract:
The present invention provides a hard capsule that can be formed by means of a cold gelation process and comprises a hard capsule coating that is enterosoluble. Provided is an enteric hard capsule comprising a coating which contains (a) a first component and a second component or (b) contains a first component and a second component and further contains at least one component from among a third component and a fourth component, wherein: the first component is methylcellulose and/or hydroxypropyl methylcellulose having a viscosity value of 6 mPa·s or higher, the second component is an enterosoluble methacrylic acid copolymer, the third component is a water-insoluble alkyl (meth)acrylate copolymer and/or ethylcellulose, and the fourth component is at least one compound selected from the group consisting of plasticizers that are acceptable pharmaceutically and as food additives and surfactants; and when 100 mass% is the total mass of the first component, the second component, the third component, and the fourth component included in the coating, the ratio of the first component is 30–70 mass%, the ratio of the second component is 30–60 mass%, and the total of the ratios of the first component and the second component is 70 mass% or higher.
Inventors:
OSAKI YOSHIRO (JP)
ASO MAKOTO (JP)
UENO KOKI (JP)
ASO MAKOTO (JP)
UENO KOKI (JP)
Application Number:
PCT/JP2019/024713
Publication Date:
December 26, 2019
Filing Date:
June 21, 2019
Export Citation:
Assignee:
QUALICAPS CO LTD (JP)
International Classes:
A61K47/38; A61K9/48; A61K31/381; A61K31/4439; A61K31/616; A61K47/32; A61P1/00; A61P25/24; A61P29/00
Domestic Patent References:
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MOGHIMIPOUR ESKANDAR, DORKOOSH FARID ABEDIN, REZAEI MOHSEN, KOUCHAK MARYAM, FATAHIASL JAFAR, ANGALI KAMBIZ AHMADI, RAMEZANI ZAHRA,: "In vivo evaluation of pH and time-dependent polymers as coating agent for colonic delivery using central composite design", JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY, vol. 43, 14 September 2017 (2017-09-14), pages 50 - 56, XP009525443, DOI: 10.1016/j.jddst.2017.09.010
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RANI, SOBHITA, P. ET AL.: "Development and in- vitro drug release studies of satranidazole capsules for colon specific drug delivery", ASIAN JOURNAL OF PHARMACEUTICAL AND CLINICAL RESEARCH, vol. 7, no. 3, 2014, pages 203 - 211, XP055772265
JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 106, 2017, pages 1042 - 1050
INTERNATIONAL JOURNAL OF PHARMACEUTICS, vol. 231, 2002, pages 83 - 95
DRUG DEV. IND. PHARM., vol. 27, 2011, pages 1131 - 1140
INTERNATIONAL JOURNAL OF PHARMACEUTICS, vol. 440, 2013, pages 264 - 272
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JOURNAL OF APPLIED PHARMACEUTICAL SCIENCE, vol. 3, 2013, pages 139 - 144
AAPS PHARAMSCIETECH, vol. 16, 2015, pages 934 - 943
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EUR. J. PHARM. BIOPHARM., vol. 42, 1996, pages 12 - 15
JAPANESE JOURNAL OF POLYMER SCIENCE AND TECHNOLOGY, vol. 38, 1981, pages 133 - 137
J. POLYM. SCI. C, vol. 36, 1971, pages 491 - 508
"Japanese Pharmaceutical Excipients", 2018
"Pharmaceutical Excipients Directory", 2016, PHARMACEUTICAL EXCIPIENTS ASSOCIATION, YAKUJI NIPPO, LTD
"Pharmacopoeia", article "Paddle Method", pages: 6.10 - 1.2
See also references of EP 3811976A4
ZHANG, JING ET AL.: "Formulation and preparation of rabeprazole sodium enteric-coated capsules", CENTRAL SOUTH PHARMACY, vol. 14, no. 7, July 2016 (2016-07-01), pages 712 - 716, XP055772263
RANI, SOBHITA, P. ET AL.: "Development and in- vitro drug release studies of satranidazole capsules for colon specific drug delivery", ASIAN JOURNAL OF PHARMACEUTICAL AND CLINICAL RESEARCH, vol. 7, no. 3, 2014, pages 203 - 211, XP055772265
JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 106, 2017, pages 1042 - 1050
INTERNATIONAL JOURNAL OF PHARMACEUTICS, vol. 231, 2002, pages 83 - 95
DRUG DEV. IND. PHARM., vol. 27, 2011, pages 1131 - 1140
INTERNATIONAL JOURNAL OF PHARMACEUTICS, vol. 440, 2013, pages 264 - 272
REPORTS OF THE MIE PREFECTURE INDUSTRIAL RESEARCH INSTITUTE, vol. 33, 2009, pages 59 - 64
"Drug Targeting Technology", 2001, CRC PRESS, pages: 1 - 29
JOURNAL OF APPLIED PHARMACEUTICAL SCIENCE, vol. 3, 2013, pages 139 - 144
AAPS PHARAMSCIETECH, vol. 16, 2015, pages 934 - 943
J. SOC. POWDER TECHNOL., JAPAN, vol. 42, 2005, pages 811
JAPANESE JOURNAL OF POLYMER SCIENCE AND TECHNOLOGY, vol. 40, 1983, pages 273 - 278
EUR. J. PHARM. BIOPHARM., vol. 42, 1996, pages 12 - 15
JAPANESE JOURNAL OF POLYMER SCIENCE AND TECHNOLOGY, vol. 38, 1981, pages 133 - 137
J. POLYM. SCI. C, vol. 36, 1971, pages 491 - 508
"Japanese Pharmaceutical Excipients", 2018
"Pharmaceutical Excipients Directory", 2016, PHARMACEUTICAL EXCIPIENTS ASSOCIATION, YAKUJI NIPPO, LTD
"Pharmacopoeia", article "Paddle Method", pages: 6.10 - 1.2
See also references of EP 3811976A4
Attorney, Agent or Firm:
SAEGUSA & PARTNERS (JP)
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