JP2016510064A - 硬カプセル製剤 - Google Patents
硬カプセル製剤 Download PDFInfo
- Publication number
- JP2016510064A JP2016510064A JP2015560825A JP2015560825A JP2016510064A JP 2016510064 A JP2016510064 A JP 2016510064A JP 2015560825 A JP2015560825 A JP 2015560825A JP 2015560825 A JP2015560825 A JP 2015560825A JP 2016510064 A JP2016510064 A JP 2016510064A
- Authority
- JP
- Japan
- Prior art keywords
- hard capsule
- gum
- agent
- hard
- acid
- Prior art date
- Legal status (The legal status 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 status listed.)
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4875—Compounds of unknown constitution, e.g. material from plants or 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P10/00—Shaping or working of foodstuffs characterised by the products
- A23P10/30—Encapsulation of particles, e.g. foodstuff additives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/48—Reproductive organs
- A61K35/50—Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/164—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
- A61K38/482—Serine endopeptidases (3.4.21)
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
- C12Y304/21—Serine endopeptidases (3.4.21)
- C12Y304/21062—Subtilisin (3.4.21.62)
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Gastroenterology & Hepatology (AREA)
- Food Science & Technology (AREA)
- Cell Biology (AREA)
- Developmental Biology & Embryology (AREA)
- Polymers & Plastics (AREA)
- Zoology (AREA)
- Biotechnology (AREA)
- Nutrition Science (AREA)
- Mycology (AREA)
- Virology (AREA)
- Biomedical Technology (AREA)
- Reproductive Health (AREA)
- Pregnancy & Childbirth (AREA)
- Botany (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
Description
優:10%以下
良:11%以上から20%以下
可:21%以上から50%以下
不適:51%以上
ランクAA:10%混合物に対して、浸透率10%以下
ランクA:25%混合物に対して、浸透率10%以下
ランクB:25%混合物に対して、浸透率15%以下
ランクC:25%混合物に対して、浸透率50%以下
ランク不適:上記以外のもの
Claims (9)
- 耐酸性を有し、腸溶コーティングで処理されていない硬カプセル;ならびに
前記硬カプセル中に、胃液の侵入を阻止する作用物質および医薬品
を含む硬カプセル製剤であって、
胃液の侵入を阻止する前記作用物質が、ステアリン酸カルシウム、ステアリン酸マグネシウム、およびカルナウバロウからなる群から選択される撥水剤を含む前記硬カプセル製剤。 - 撥水剤を含む、胃液の侵入を阻止する前記作用物質が、さらにゲル化剤を含む、請求項に1記載の硬カプセル製剤。
- 前記ゲル化剤は、グアーガム、ペクチン、ι(イオタ)型カラギーナン、λ(ラムダ)型カラギーナン、キサンタンガム、ローカストビーンガム、アルギナート、アルギン酸、タマリンドガム、グルコマンナン、寒天、カードラン、ジェランガム、およびコラーゲンからなる群から選択される、請求項2に記載の硬カプセル製剤。
- 前記ゲル化剤は、グアーガム、λ(ラムダ)型カラギーナン、キサンタンガム、およびローカストビーンガムからなる群から選択される、請求項2に記載の硬カプセル製剤。
- 前記医薬品は、タンパク質、酵素、または生菌である、請求項1に記載の硬カプセル製剤。
- 硬カプセル、ならびに
前記硬カプセル中に、胃液の侵入を阻止する作用物質および医薬品
を含む硬カプセル製剤であって、
胃液の侵入を阻止する前記作用物質が、グアーガム、λ(ラムダ)型カラギーナン、キサンタンガム、ローカストビーンガム、ステアリン酸カルシウム、ステアリン酸マグネシウム、およびカルナウバロウからなる群から選択される前記硬カプセル製剤。 - ステアリン酸カルシウム、ステアリン酸マグネシウム、およびカルナウバロウからなる群から選択される撥水剤を添加する工程を含む、硬カプセル中で酸分解を阻止する方法。
- グアーガム、ペクチン、ι(イオタ)型カラギーナン、λ(ラムダ)型カラギーナン、キサンタンガム、ローカストビーンガム、アルギナート、アルギン酸、タマリンドガム、グルコマンナン、寒天、カードラン、ジェランガム、およびコラーゲンからなる群から選択されるゲル化剤を添加する工程をさらに含む、請求項7に記載の方法。
- 前記医薬品は、タンパク質、酵素、または生菌である、請求項7または8に記載の方法。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2015560825A JP6420261B2 (ja) | 2013-03-07 | 2014-03-03 | 硬カプセル製剤 |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2013045989 | 2013-03-07 | ||
JP2013045989A JP2014172850A (ja) | 2013-03-07 | 2013-03-07 | ハードカプセル製剤 |
JP2015560825A JP6420261B2 (ja) | 2013-03-07 | 2014-03-03 | 硬カプセル製剤 |
PCT/IB2014/059408 WO2014136038A1 (en) | 2013-03-07 | 2014-03-03 | Hard capsule formulation |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2018191350A Division JP6856601B2 (ja) | 2013-03-07 | 2018-10-10 | 硬カプセル製剤 |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2016510064A true JP2016510064A (ja) | 2016-04-04 |
JP6420261B2 JP6420261B2 (ja) | 2018-11-07 |
Family
ID=50280447
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2013045989A Pending JP2014172850A (ja) | 2013-03-07 | 2013-03-07 | ハードカプセル製剤 |
JP2015560825A Active JP6420261B2 (ja) | 2013-03-07 | 2014-03-03 | 硬カプセル製剤 |
JP2018191350A Active JP6856601B2 (ja) | 2013-03-07 | 2018-10-10 | 硬カプセル製剤 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2013045989A Pending JP2014172850A (ja) | 2013-03-07 | 2013-03-07 | ハードカプセル製剤 |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2018191350A Active JP6856601B2 (ja) | 2013-03-07 | 2018-10-10 | 硬カプセル製剤 |
Country Status (5)
Country | Link |
---|---|
US (1) | US10172803B2 (ja) |
EP (1) | EP2988734A1 (ja) |
JP (3) | JP2014172850A (ja) |
BR (1) | BR112015020307B1 (ja) |
WO (1) | WO2014136038A1 (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10172803B2 (en) | 2013-03-07 | 2019-01-08 | Capsugel Belgium Nv | Hard capsule formulation |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU2010299527A1 (en) | 2009-09-24 | 2012-04-19 | Capsugel Belgium Nv | Acid resistant capsules |
WO2021245458A1 (en) * | 2020-05-31 | 2021-12-09 | Eirgen Pharma Ltd. | Hard capsule dosage form and uses thereof |
CN112472715B (zh) * | 2020-12-18 | 2023-06-23 | 华熙生物科技股份有限公司 | 一种碳酸氢钠肠溶胶囊及其制备方法 |
Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS57149219A (en) * | 1981-03-12 | 1982-09-14 | Eisai Co Ltd | Hard capsule preparation containing tocopherol nicotinate in high concentration |
JPH05194246A (ja) * | 1991-09-05 | 1993-08-03 | Tsumura & Co | 漢方薬硬カプセル剤の製造方法 |
JPH0710746A (ja) * | 1993-04-26 | 1995-01-13 | Takeda Chem Ind Ltd | 服用時の付着性を改良した硬カプセル剤 |
WO2005025609A1 (ja) * | 2003-09-10 | 2005-03-24 | Nrl Pharma, Inc. | ラクトフェリン素材組成物 |
WO2006082824A1 (ja) * | 2005-02-03 | 2006-08-10 | Nrl Pharma, Inc. | マトリックス型腸溶性・徐放性組成物 |
WO2007098612A1 (en) * | 2006-03-02 | 2007-09-07 | Laboratoires Mauves Inc. | Gastric acid resistant gelatin capsule composition and method for producing same |
JP2007302570A (ja) * | 2006-05-08 | 2007-11-22 | Fancl Corp | チオクト酸を含有する徐放性製剤 |
JP2013505928A (ja) * | 2009-09-24 | 2013-02-21 | キャプシュゲル・ベルジウム・エヌ・ヴィ | 耐酸性カプセル |
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US3374146A (en) * | 1966-04-18 | 1968-03-19 | American Cyanamid Co | Sustained release encapsulation |
DE3022137A1 (de) * | 1980-06-13 | 1982-01-07 | A. Nattermann & Cie GmbH, 5000 Köln | Verfahren zum abfuellen von bei raumtemperatur hochviskosen pharmazeutischen massen in hartkapseln |
US4601896A (en) * | 1984-03-21 | 1986-07-22 | Mark Nugent | Pharmaceutical capsule compositions and structures for gastric sensitive materials |
US5849327A (en) | 1994-07-29 | 1998-12-15 | Advanced Polymer Systems, Inc. | Delivery of drugs to the lower gastrointestinal tract |
CA2206691A1 (en) * | 1994-12-05 | 1996-06-13 | Shintaro Tashiro | Method of drug delivery and coatings for use in the method |
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CA2520813C (en) * | 2003-04-25 | 2009-10-27 | Mitsubishi Pharma Corporation | Sustained release formulations of alkylene dioxybenzene derivatives useful as 5-ht1a agonists |
JP3688279B2 (ja) * | 2003-08-01 | 2005-08-24 | 森下仁丹株式会社 | 耐熱性カプセルおよびその製造方法 |
US20070148248A1 (en) * | 2005-12-22 | 2007-06-28 | Banner Pharmacaps, Inc. | Gastric reflux resistant dosage forms |
JP2007211006A (ja) * | 2006-01-16 | 2007-08-23 | Ono Pharmaceut Co Ltd | 溶出安定性を有するコーティング固形製剤 |
US9011843B2 (en) * | 2006-12-14 | 2015-04-21 | Master Supplements, Inc. | Formulations including monovalent alginate to enhance effectiveness of administered digestive enzymes |
JP2010168309A (ja) * | 2009-01-22 | 2010-08-05 | Kaneka Corp | 粒子状組成物およびその製造方法 |
US9056050B2 (en) * | 2009-04-13 | 2015-06-16 | Curemark Llc | Enzyme delivery systems and methods of preparation and use |
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JP2014172850A (ja) | 2013-03-07 | 2014-09-22 | Capsugel Belgium Nv | ハードカプセル製剤 |
-
2013
- 2013-03-07 JP JP2013045989A patent/JP2014172850A/ja active Pending
-
2014
- 2014-03-03 BR BR112015020307-8A patent/BR112015020307B1/pt active IP Right Grant
- 2014-03-03 US US14/771,161 patent/US10172803B2/en active Active
- 2014-03-03 JP JP2015560825A patent/JP6420261B2/ja active Active
- 2014-03-03 EP EP14710394.9A patent/EP2988734A1/en active Pending
- 2014-03-03 WO PCT/IB2014/059408 patent/WO2014136038A1/en active Application Filing
-
2018
- 2018-10-10 JP JP2018191350A patent/JP6856601B2/ja active Active
Patent Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS57149219A (en) * | 1981-03-12 | 1982-09-14 | Eisai Co Ltd | Hard capsule preparation containing tocopherol nicotinate in high concentration |
JPH05194246A (ja) * | 1991-09-05 | 1993-08-03 | Tsumura & Co | 漢方薬硬カプセル剤の製造方法 |
JPH0710746A (ja) * | 1993-04-26 | 1995-01-13 | Takeda Chem Ind Ltd | 服用時の付着性を改良した硬カプセル剤 |
WO2005025609A1 (ja) * | 2003-09-10 | 2005-03-24 | Nrl Pharma, Inc. | ラクトフェリン素材組成物 |
WO2006082824A1 (ja) * | 2005-02-03 | 2006-08-10 | Nrl Pharma, Inc. | マトリックス型腸溶性・徐放性組成物 |
WO2007098612A1 (en) * | 2006-03-02 | 2007-09-07 | Laboratoires Mauves Inc. | Gastric acid resistant gelatin capsule composition and method for producing same |
JP2007302570A (ja) * | 2006-05-08 | 2007-11-22 | Fancl Corp | チオクト酸を含有する徐放性製剤 |
JP2013505928A (ja) * | 2009-09-24 | 2013-02-21 | キャプシュゲル・ベルジウム・エヌ・ヴィ | 耐酸性カプセル |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10172803B2 (en) | 2013-03-07 | 2019-01-08 | Capsugel Belgium Nv | Hard capsule formulation |
Also Published As
Publication number | Publication date |
---|---|
JP6420261B2 (ja) | 2018-11-07 |
JP2019023216A (ja) | 2019-02-14 |
US20160015651A1 (en) | 2016-01-21 |
JP2014172850A (ja) | 2014-09-22 |
US10172803B2 (en) | 2019-01-08 |
BR112015020307A2 (pt) | 2017-07-18 |
BR112015020307B1 (pt) | 2022-12-20 |
WO2014136038A1 (en) | 2014-09-12 |
EP2988734A1 (en) | 2016-03-02 |
JP6856601B2 (ja) | 2021-04-07 |
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