JP2019023216A - 硬カプセル製剤 - Google Patents
硬カプセル製剤 Download PDFInfo
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- JP2019023216A JP2019023216A JP2018191350A JP2018191350A JP2019023216A JP 2019023216 A JP2019023216 A JP 2019023216A JP 2018191350 A JP2018191350 A JP 2018191350A JP 2018191350 A JP2018191350 A JP 2018191350A JP 2019023216 A JP2019023216 A JP 2019023216A
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- Prior art keywords
- hard capsule
- gum
- agent
- hard
- acid
- Prior art date
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- 239000007902 hard capsule Substances 0.000 title claims abstract description 108
- 239000000203 mixture Substances 0.000 title claims abstract description 27
- 238000009472 formulation Methods 0.000 title claims abstract description 22
- 239000002253 acid Substances 0.000 claims abstract description 29
- 239000001814 pectin Substances 0.000 claims abstract description 21
- 235000010987 pectin Nutrition 0.000 claims abstract description 21
- 229920001277 pectin Polymers 0.000 claims abstract description 21
- 239000003349 gelling agent Substances 0.000 claims abstract description 20
- 230000002940 repellent Effects 0.000 claims abstract description 19
- 239000005871 repellent Substances 0.000 claims abstract description 19
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 19
- 229920002907 Guar gum Polymers 0.000 claims abstract description 18
- 235000010417 guar gum Nutrition 0.000 claims abstract description 18
- 239000000665 guar gum Substances 0.000 claims abstract description 18
- 229960002154 guar gum Drugs 0.000 claims abstract description 18
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 16
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 14
- 108090000790 Enzymes Proteins 0.000 claims abstract description 13
- 102000004190 Enzymes Human genes 0.000 claims abstract description 13
- 229920001285 xanthan gum Polymers 0.000 claims abstract description 9
- 235000010493 xanthan gum Nutrition 0.000 claims abstract description 9
- 239000000230 xanthan gum Substances 0.000 claims abstract description 9
- 229940082509 xanthan gum Drugs 0.000 claims abstract description 9
- 239000002702 enteric coating Substances 0.000 claims abstract description 8
- 238000009505 enteric coating Methods 0.000 claims abstract description 8
- 241000894006 Bacteria Species 0.000 claims abstract description 7
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 7
- 239000008177 pharmaceutical agent Substances 0.000 claims abstract description 7
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims abstract description 6
- 235000013539 calcium stearate Nutrition 0.000 claims abstract description 6
- 239000008116 calcium stearate Substances 0.000 claims abstract description 6
- 239000004203 carnauba wax Substances 0.000 claims abstract description 6
- 235000013869 carnauba wax Nutrition 0.000 claims abstract description 6
- 230000009545 invasion Effects 0.000 claims abstract description 6
- 102000004169 proteins and genes Human genes 0.000 claims abstract description 5
- 108090000623 proteins and genes Proteins 0.000 claims abstract description 5
- 235000010418 carrageenan Nutrition 0.000 claims description 21
- 239000000679 carrageenan Substances 0.000 claims description 21
- 229920001525 carrageenan Polymers 0.000 claims description 21
- 229940113118 carrageenan Drugs 0.000 claims description 21
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 claims description 21
- 235000010443 alginic acid Nutrition 0.000 claims description 13
- 229920000615 alginic acid Polymers 0.000 claims description 13
- 239000000783 alginic acid Substances 0.000 claims description 10
- 229960001126 alginic acid Drugs 0.000 claims description 10
- 150000004781 alginic acids Chemical class 0.000 claims description 10
- 210000004051 gastric juice Anatomy 0.000 claims description 10
- 229920002148 Gellan gum Polymers 0.000 claims description 9
- 235000010492 gellan gum Nutrition 0.000 claims description 9
- 239000000216 gellan gum Substances 0.000 claims description 9
- 229920000161 Locust bean gum Polymers 0.000 claims description 8
- 235000010420 locust bean gum Nutrition 0.000 claims description 8
- 239000000711 locust bean gum Substances 0.000 claims description 8
- 238000000034 method Methods 0.000 claims description 8
- 238000002360 preparation method Methods 0.000 claims description 7
- LUEWUZLMQUOBSB-FSKGGBMCSA-N (2s,3s,4s,5s,6r)-2-[(2r,3s,4r,5r,6s)-6-[(2r,3s,4r,5s,6s)-4,5-dihydroxy-2-(hydroxymethyl)-6-[(2r,4r,5s,6r)-4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-4,5-dihydroxy-2-(hydroxymethyl)oxan-3-yl]oxy-6-(hydroxymethyl)oxane-3,4,5-triol Chemical compound O[C@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@@H](O[C@@H]2[C@H](O[C@@H](OC3[C@H](O[C@@H](O)[C@@H](O)[C@H]3O)CO)[C@@H](O)[C@H]2O)CO)[C@H](O)[C@H]1O LUEWUZLMQUOBSB-FSKGGBMCSA-N 0.000 claims description 4
- 229920002581 Glucomannan Polymers 0.000 claims description 4
- 235000004298 Tamarindus indica Nutrition 0.000 claims description 4
- 240000004584 Tamarindus indica Species 0.000 claims description 4
- 229940046240 glucomannan Drugs 0.000 claims description 4
- 229920000591 gum Polymers 0.000 claims description 4
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 4
- 229940127557 pharmaceutical product Drugs 0.000 claims description 4
- FHVDTGUDJYJELY-UHFFFAOYSA-N 6-{[2-carboxy-4,5-dihydroxy-6-(phosphanyloxy)oxan-3-yl]oxy}-4,5-dihydroxy-3-phosphanyloxane-2-carboxylic acid Chemical compound O1C(C(O)=O)C(P)C(O)C(O)C1OC1C(C(O)=O)OC(OP)C(O)C1O FHVDTGUDJYJELY-UHFFFAOYSA-N 0.000 claims description 3
- 229920001817 Agar Polymers 0.000 claims description 3
- 102000008186 Collagen Human genes 0.000 claims description 3
- 108010035532 Collagen Proteins 0.000 claims description 3
- 229920002558 Curdlan Polymers 0.000 claims description 3
- 239000001879 Curdlan Substances 0.000 claims description 3
- 239000008272 agar Substances 0.000 claims description 3
- 229940023476 agar Drugs 0.000 claims description 3
- 235000010419 agar Nutrition 0.000 claims description 3
- 229940072056 alginate Drugs 0.000 claims description 3
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 3
- 229920001436 collagen Polymers 0.000 claims description 3
- 235000019316 curdlan Nutrition 0.000 claims description 3
- 229940078035 curdlan Drugs 0.000 claims description 3
- 230000015556 catabolic process Effects 0.000 claims description 2
- 238000006731 degradation reaction Methods 0.000 claims description 2
- 230000002401 inhibitory effect Effects 0.000 claims description 2
- 210000002784 stomach Anatomy 0.000 abstract description 8
- 239000012530 fluid Substances 0.000 abstract description 7
- 230000002496 gastric effect Effects 0.000 abstract description 7
- 210000000936 intestine Anatomy 0.000 abstract description 3
- 229960000292 pectin Drugs 0.000 abstract 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 34
- 239000008101 lactose Substances 0.000 description 34
- 239000000843 powder Substances 0.000 description 26
- 230000035515 penetration Effects 0.000 description 17
- 239000003929 acidic solution Substances 0.000 description 16
- 239000002775 capsule Substances 0.000 description 16
- 239000011812 mixed powder Substances 0.000 description 16
- 229940088598 enzyme Drugs 0.000 description 10
- 239000000243 solution Substances 0.000 description 9
- 230000000052 comparative effect Effects 0.000 description 7
- 239000000546 pharmaceutical excipient Substances 0.000 description 7
- 239000003814 drug Substances 0.000 description 6
- 239000000463 material Substances 0.000 description 6
- 238000002156 mixing Methods 0.000 description 6
- 210000002826 placenta Anatomy 0.000 description 6
- 239000000126 substance Substances 0.000 description 6
- 238000012360 testing method Methods 0.000 description 5
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 description 4
- 235000008636 Bacillus subtilis subsp natto Nutrition 0.000 description 3
- 244000075779 Bacillus subtilis subsp natto Species 0.000 description 3
- SGHZXLIDFTYFHQ-UHFFFAOYSA-L Brilliant Blue Chemical compound [Na+].[Na+].C=1C=C(C(=C2C=CC(C=C2)=[N+](CC)CC=2C=C(C=CC=2)S([O-])(=O)=O)C=2C(=CC=CC=2)S([O-])(=O)=O)C=CC=1N(CC)CC1=CC=CC(S([O-])(=O)=O)=C1 SGHZXLIDFTYFHQ-UHFFFAOYSA-L 0.000 description 3
- 108010010803 Gelatin Proteins 0.000 description 3
- 239000007864 aqueous solution Substances 0.000 description 3
- 230000008859 change Effects 0.000 description 3
- 238000010586 diagram Methods 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 239000008273 gelatin Substances 0.000 description 3
- 229920000159 gelatin Polymers 0.000 description 3
- 235000019322 gelatine Nutrition 0.000 description 3
- 235000011852 gelatine desserts Nutrition 0.000 description 3
- 229940086319 nattokinase Drugs 0.000 description 3
- 108010073682 nattokinase Proteins 0.000 description 3
- 230000003472 neutralizing effect Effects 0.000 description 3
- 230000000149 penetrating effect Effects 0.000 description 3
- FQENQNTWSFEDLI-UHFFFAOYSA-J sodium diphosphate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]P([O-])(=O)OP([O-])([O-])=O FQENQNTWSFEDLI-UHFFFAOYSA-J 0.000 description 3
- 235000019818 tetrasodium diphosphate Nutrition 0.000 description 3
- 241000186000 Bifidobacterium Species 0.000 description 2
- 102000014171 Milk Proteins Human genes 0.000 description 2
- 108010011756 Milk Proteins Proteins 0.000 description 2
- UDSAIICHUKSCKT-UHFFFAOYSA-N bromophenol blue Chemical compound C1=C(Br)C(O)=C(Br)C=C1C1(C=2C=C(Br)C(O)=C(Br)C=2)C2=CC=CC=C2S(=O)(=O)O1 UDSAIICHUKSCKT-UHFFFAOYSA-N 0.000 description 2
- 239000005515 coenzyme Substances 0.000 description 2
- 238000007922 dissolution test Methods 0.000 description 2
- -1 etc.) Proteins 0.000 description 2
- 238000011049 filling Methods 0.000 description 2
- 210000004211 gastric acid Anatomy 0.000 description 2
- 235000014655 lactic acid Nutrition 0.000 description 2
- 239000004310 lactic acid Substances 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 235000021239 milk protein Nutrition 0.000 description 2
- 238000000465 moulding Methods 0.000 description 2
- 230000035699 permeability Effects 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 235000018102 proteins Nutrition 0.000 description 2
- 229940109850 royal jelly Drugs 0.000 description 2
- 240000002234 Allium sativum Species 0.000 description 1
- 239000004373 Pullulan Substances 0.000 description 1
- 229920001218 Pullulan Polymers 0.000 description 1
- 239000002696 acid base indicator Substances 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000003466 anti-cipated effect Effects 0.000 description 1
- 239000011324 bead Substances 0.000 description 1
- 238000012937 correction Methods 0.000 description 1
- 239000002270 dispersing agent Substances 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 230000003631 expected effect Effects 0.000 description 1
- 235000013373 food additive Nutrition 0.000 description 1
- 239000002778 food additive Substances 0.000 description 1
- 235000004611 garlic Nutrition 0.000 description 1
- 239000000499 gel Substances 0.000 description 1
- 235000013402 health food Nutrition 0.000 description 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 239000004482 other powder Substances 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 239000004014 plasticizer Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 229920001282 polysaccharide Polymers 0.000 description 1
- 239000005017 polysaccharide Substances 0.000 description 1
- 150000004804 polysaccharides Chemical class 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 235000019423 pullulan Nutrition 0.000 description 1
- 230000002441 reversible effect Effects 0.000 description 1
- 210000000998 shell membrane Anatomy 0.000 description 1
- 230000008961 swelling Effects 0.000 description 1
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)
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- 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 Containing Material From Animals Or Micro-Organisms (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
【解決手段】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に、タンパク質、酵素、または生菌等の医薬品とステアリン酸カルシウム、ステアリン酸マグネシウムやカルナウバロウ等の胃液の侵入を阻止する撥水剤およびグアーガム、ペクチン、キサンタンガム等のゲル化剤を含む製剤。
【選択図】なし
Description
劣化する医薬品等を含む硬カプセル製剤であって、医薬品等が、硬カプセルの外殻中に浸透する胃酸によって劣化しない前記硬カプセル製剤を作り出すことである。
ることができるが、特に医療または健康食品用途のカプセルとして使用することができる。
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
株式会社製GENU Pectin DD slow set−J)は、AAのランクを受けた。キサンタンガムおよびローカストビーンガムは、Aのランクを受けた。ステアリン酸マグネシウム、タマリンドガム、グルコマンナン、およびι(イオタ)型カラギーナンは、Bのランクを受けた。アルギン酸は、Cのランクを受けた。
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。
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