JPWO2017115745A1 - 圧縮成型製剤 - Google Patents
圧縮成型製剤 Download PDFInfo
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- JPWO2017115745A1 JPWO2017115745A1 JP2017559178A JP2017559178A JPWO2017115745A1 JP WO2017115745 A1 JPWO2017115745 A1 JP WO2017115745A1 JP 2017559178 A JP2017559178 A JP 2017559178A JP 2017559178 A JP2017559178 A JP 2017559178A JP WO2017115745 A1 JPWO2017115745 A1 JP WO2017115745A1
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- polymer
- compression
- water
- enteric
- insoluble
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- VJHCJDRQFCCTHL-UHFFFAOYSA-N acetic acid 2,3,4,5,6-pentahydroxyhexanal Chemical compound CC(O)=O.OCC(O)C(O)C(O)C(O)C=O VJHCJDRQFCCTHL-UHFFFAOYSA-N 0.000 description 1
- 229960001138 acetylsalicylic acid Drugs 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 239000001361 adipic acid Substances 0.000 description 1
- 235000011037 adipic acid Nutrition 0.000 description 1
- 238000013019 agitation Methods 0.000 description 1
- 229940072056 alginate Drugs 0.000 description 1
- 235000010443 alginic acid Nutrition 0.000 description 1
- 229920000615 alginic acid Polymers 0.000 description 1
- 229910052783 alkali metal Inorganic materials 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- WNROFYMDJYEPJX-UHFFFAOYSA-K aluminium hydroxide Chemical compound [OH-].[OH-].[OH-].[Al+3] WNROFYMDJYEPJX-UHFFFAOYSA-K 0.000 description 1
- 229950011249 ampiroxicam Drugs 0.000 description 1
- LSNWBKACGXCGAJ-UHFFFAOYSA-N ampiroxicam Chemical compound CN1S(=O)(=O)C2=CC=CC=C2C(OC(C)OC(=O)OCC)=C1C(=O)NC1=CC=CC=N1 LSNWBKACGXCGAJ-UHFFFAOYSA-N 0.000 description 1
- 150000008064 anhydrides Chemical class 0.000 description 1
- 229960004543 anhydrous citric acid Drugs 0.000 description 1
- 230000000181 anti-adherent effect Effects 0.000 description 1
- 230000003254 anti-foaming effect Effects 0.000 description 1
- QRZAKQDHEVVFRX-UHFFFAOYSA-N biphenyl-4-ylacetic acid Chemical compound C1=CC(CC(=O)O)=CC=C1C1=CC=CC=C1 QRZAKQDHEVVFRX-UHFFFAOYSA-N 0.000 description 1
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 description 1
- NEDGUIRITORSKL-UHFFFAOYSA-N butyl 2-methylprop-2-enoate;2-(dimethylamino)ethyl 2-methylprop-2-enoate;methyl 2-methylprop-2-enoate Chemical compound COC(=O)C(C)=C.CCCCOC(=O)C(C)=C.CN(C)CCOC(=O)C(C)=C NEDGUIRITORSKL-UHFFFAOYSA-N 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 239000000378 calcium silicate Substances 0.000 description 1
- 229910052918 calcium silicate Inorganic materials 0.000 description 1
- OYACROKNLOSFPA-UHFFFAOYSA-N calcium;dioxido(oxo)silane Chemical compound [Ca+2].[O-][Si]([O-])=O OYACROKNLOSFPA-UHFFFAOYSA-N 0.000 description 1
- 229920003123 carboxymethyl cellulose sodium Polymers 0.000 description 1
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 description 1
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- 239000007910 chewable tablet Substances 0.000 description 1
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- 239000003086 colorant Substances 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 239000011246 composite particle Substances 0.000 description 1
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- 238000001816 cooling Methods 0.000 description 1
- 239000011162 core material Substances 0.000 description 1
- 229960001681 croscarmellose sodium Drugs 0.000 description 1
- 229960000913 crospovidone Drugs 0.000 description 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
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- 238000009826 distribution Methods 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 238000010828 elution Methods 0.000 description 1
- UNXHWFMMPAWVPI-ZXZARUISSA-N erythritol Chemical compound OC[C@H](O)[C@H](O)CO UNXHWFMMPAWVPI-ZXZARUISSA-N 0.000 description 1
- 235000019414 erythritol Nutrition 0.000 description 1
- 229940009714 erythritol Drugs 0.000 description 1
- SBNKFTQSBPKMBZ-UHFFFAOYSA-N ethenzamide Chemical compound CCOC1=CC=CC=C1C(N)=O SBNKFTQSBPKMBZ-UHFFFAOYSA-N 0.000 description 1
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 description 1
- 229960005293 etodolac Drugs 0.000 description 1
- XFBVBWWRPKNWHW-UHFFFAOYSA-N etodolac Chemical compound C1COC(CC)(CC(O)=O)C2=N[C]3C(CC)=CC=CC3=C21 XFBVBWWRPKNWHW-UHFFFAOYSA-N 0.000 description 1
- 239000000194 fatty acid Substances 0.000 description 1
- 229930195729 fatty acid Natural products 0.000 description 1
- 229960000192 felbinac Drugs 0.000 description 1
- ZWJINEZUASEZBH-UHFFFAOYSA-N fenamic acid Chemical compound OC(=O)C1=CC=CC=C1NC1=CC=CC=C1 ZWJINEZUASEZBH-UHFFFAOYSA-N 0.000 description 1
- 229960001395 fenbufen Drugs 0.000 description 1
- ZPAKPRAICRBAOD-UHFFFAOYSA-N fenbufen Chemical compound C1=CC(C(=O)CCC(=O)O)=CC=C1C1=CC=CC=C1 ZPAKPRAICRBAOD-UHFFFAOYSA-N 0.000 description 1
- 229960001419 fenoprofen Drugs 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 229960004369 flufenamic acid Drugs 0.000 description 1
- LPEPZBJOKDYZAD-UHFFFAOYSA-N flufenamic acid Chemical compound OC(=O)C1=CC=CC=C1NC1=CC=CC(C(F)(F)F)=C1 LPEPZBJOKDYZAD-UHFFFAOYSA-N 0.000 description 1
- 229960002449 glycine Drugs 0.000 description 1
- 229920000578 graft copolymer Polymers 0.000 description 1
- 239000011361 granulated particle Substances 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 238000009775 high-speed stirring Methods 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
- 229940071676 hydroxypropylcellulose Drugs 0.000 description 1
- DKYWVDODHFEZIM-UHFFFAOYSA-N ketoprofen Chemical compound OC(=O)C(C)C1=CC=CC(C(=O)C=2C=CC=CC=2)=C1 DKYWVDODHFEZIM-UHFFFAOYSA-N 0.000 description 1
- 229960000991 ketoprofen Drugs 0.000 description 1
- 238000004898 kneading Methods 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 239000010410 layer Substances 0.000 description 1
- FEWJPZIEWOKRBE-LWMBPPNESA-N levotartaric acid Chemical compound OC(=O)[C@@H](O)[C@H](O)C(O)=O FEWJPZIEWOKRBE-LWMBPPNESA-N 0.000 description 1
- 229940010454 licorice Drugs 0.000 description 1
- 229960002373 loxoprofen Drugs 0.000 description 1
- BAZQYVYVKYOAGO-UHFFFAOYSA-M loxoprofen sodium hydrate Chemical compound O.O.[Na+].C1=CC(C(C([O-])=O)C)=CC=C1CC1C(=O)CCC1 BAZQYVYVKYOAGO-UHFFFAOYSA-M 0.000 description 1
- VZCYOOQTPOCHFL-UPHRSURJSA-N maleic acid Chemical compound OC(=O)\C=C/C(O)=O VZCYOOQTPOCHFL-UPHRSURJSA-N 0.000 description 1
- 239000011976 maleic acid Substances 0.000 description 1
- 229940098895 maleic acid Drugs 0.000 description 1
- 239000000845 maltitol Substances 0.000 description 1
- 235000010449 maltitol Nutrition 0.000 description 1
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 description 1
- 229940035436 maltitol Drugs 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 229960003464 mefenamic acid Drugs 0.000 description 1
- 229960001929 meloxicam Drugs 0.000 description 1
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 1
- 229940117841 methacrylic acid copolymer Drugs 0.000 description 1
- 229920003145 methacrylic acid copolymer Polymers 0.000 description 1
- 125000005395 methacrylic acid group Chemical group 0.000 description 1
- 239000003094 microcapsule Substances 0.000 description 1
- 229960000429 mofezolac Drugs 0.000 description 1
- HWPKGOGLCKPRLZ-UHFFFAOYSA-M monosodium citrate Chemical compound [Na+].OC(=O)CC(O)(C([O-])=O)CC(O)=O HWPKGOGLCKPRLZ-UHFFFAOYSA-M 0.000 description 1
- 239000002524 monosodium citrate Substances 0.000 description 1
- 235000018342 monosodium citrate Nutrition 0.000 description 1
- DNKKLDKIFMDAPT-UHFFFAOYSA-N n,n-dimethylmethanamine;2-methylprop-2-enoic acid Chemical compound CN(C)C.CC(=C)C(O)=O.CC(=C)C(O)=O DNKKLDKIFMDAPT-UHFFFAOYSA-N 0.000 description 1
- 229960004270 nabumetone Drugs 0.000 description 1
- 229960002009 naproxen Drugs 0.000 description 1
- CMWTZPSULFXXJA-VIFPVBQESA-N naproxen Chemical compound C1=C([C@H](C)C(O)=O)C=CC2=CC(OC)=CC=C21 CMWTZPSULFXXJA-VIFPVBQESA-N 0.000 description 1
- 229960002739 oxaprozin Drugs 0.000 description 1
- OFPXSFXSNFPTHF-UHFFFAOYSA-N oxaprozin Chemical compound O1C(CCC(=O)O)=NC(C=2C=CC=CC=2)=C1C1=CC=CC=C1 OFPXSFXSNFPTHF-UHFFFAOYSA-N 0.000 description 1
- FJKROLUGYXJWQN-UHFFFAOYSA-N papa-hydroxy-benzoic acid Natural products OC(=O)C1=CC=C(O)C=C1 FJKROLUGYXJWQN-UHFFFAOYSA-N 0.000 description 1
- XNGIFLGASWRNHJ-UHFFFAOYSA-L phthalate(2-) Chemical compound [O-]C(=O)C1=CC=CC=C1C([O-])=O XNGIFLGASWRNHJ-UHFFFAOYSA-L 0.000 description 1
- 229960002702 piroxicam Drugs 0.000 description 1
- QYSPLQLAKJAUJT-UHFFFAOYSA-N piroxicam Chemical compound OC=1C2=CC=CC=C2S(=O)(=O)N(C)C=1C(=O)NC1=CC=CC=N1 QYSPLQLAKJAUJT-UHFFFAOYSA-N 0.000 description 1
- 229940100467 polyvinyl acetate phthalate Drugs 0.000 description 1
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 description 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 229920001592 potato starch Polymers 0.000 description 1
- 229960003101 pranoprofen Drugs 0.000 description 1
- 229940088417 precipitated calcium carbonate Drugs 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 150000003138 primary alcohols Chemical class 0.000 description 1
- 235000019423 pullulan Nutrition 0.000 description 1
- 238000010298 pulverizing process Methods 0.000 description 1
- 238000012552 review Methods 0.000 description 1
- 235000019204 saccharin Nutrition 0.000 description 1
- CVHZOJJKTDOEJC-UHFFFAOYSA-N saccharin Chemical compound C1=CC=C2C(=O)NS(=O)(=O)C2=C1 CVHZOJJKTDOEJC-UHFFFAOYSA-N 0.000 description 1
- 229940081974 saccharin Drugs 0.000 description 1
- 239000000901 saccharin and its Na,K and Ca salt Substances 0.000 description 1
- 229960004889 salicylic acid Drugs 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- ZLGIYFNHBLSMPS-ATJNOEHPSA-N shellac Chemical compound OCCCCCC(O)C(O)CCCCCCCC(O)=O.C1C23[C@H](C(O)=O)CCC2[C@](C)(CO)[C@@H]1C(C(O)=O)=C[C@@H]3O ZLGIYFNHBLSMPS-ATJNOEHPSA-N 0.000 description 1
- 239000004208 shellac Substances 0.000 description 1
- 229940113147 shellac Drugs 0.000 description 1
- 235000013874 shellac Nutrition 0.000 description 1
- 238000007873 sieving Methods 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 239000001509 sodium citrate Substances 0.000 description 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 1
- 235000011083 sodium citrates Nutrition 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 235000019408 sucralose Nutrition 0.000 description 1
- BAQAVOSOZGMPRM-QBMZZYIRSA-N sucralose Chemical compound O[C@@H]1[C@@H](O)[C@@H](Cl)[C@@H](CO)O[C@@H]1O[C@@]1(CCl)[C@@H](O)[C@H](O)[C@@H](CCl)O1 BAQAVOSOZGMPRM-QBMZZYIRSA-N 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 229960000894 sulindac Drugs 0.000 description 1
- MLKXDPUZXIRXEP-MFOYZWKCSA-N sulindac Chemical compound CC1=C(CC(O)=O)C2=CC(F)=CC=C2\C1=C/C1=CC=C(S(C)=O)C=C1 MLKXDPUZXIRXEP-MFOYZWKCSA-N 0.000 description 1
- 229960002871 tenoxicam Drugs 0.000 description 1
- WZWYJBNHTWCXIM-UHFFFAOYSA-N tenoxicam Chemical compound O=C1C=2SC=CC=2S(=O)(=O)N(C)C1=C(O)NC1=CC=CC=N1 WZWYJBNHTWCXIM-UHFFFAOYSA-N 0.000 description 1
- 229960002905 tolfenamic acid Drugs 0.000 description 1
- YEZNLOUZAIOMLT-UHFFFAOYSA-N tolfenamic acid Chemical compound CC1=C(Cl)C=CC=C1NC1=CC=CC=C1C(O)=O YEZNLOUZAIOMLT-UHFFFAOYSA-N 0.000 description 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
- 229950004227 zaltoprofen Drugs 0.000 description 1
Classifications
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- 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
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
-
- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
- A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
-
- 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
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Inorganic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
イブプロフェン600g、結晶セルロース330g、ポリビニルアセタールジエチルアミノアセテート24g、アクリル酸エチル・メタクリル酸メチルコポリマー分散液(固形分30%)40g、DL−リンゴ酸12g、ポリビニルアルコール(部分けん化物)12g、精製水100gを高速攪拌式混合造粒機に投入して造粒した。続いて、得られた造粒物を流動層乾燥機を用いて乾燥し、整粒機を用いて整粒し、平均粒子径235μmの核粒子を得た。この核粒子950gを取り、流動層中でメタアクリレートコポリマーLD分散液(固形分30%)450g、クエン酸トリエチル13.5g、軽質無水ケイ酸13.5g、精製水333gを均一に混合したコーティング液を核粒子の質量増が10.9%になるまで噴霧して被覆粒子を得た。この被覆粒子450g、結晶セルロース139.4g、トウモロコシデンプン110.7g、アセスルファムカリウム7.4g、アスパルテーム7.4g、DL−リンゴ酸11.1g、香料0.7g、軽質無水ケイ酸3.7g、タルク3.7g、ステアリン酸マグネシウム3.7gを均一に混合して打錠用粉末とした。この打錠用粉末を、直径12mmφの臼杵を用い、ロータリー式打錠機により圧縮成型し、厚さ約4.6mm、1錠あたり質量600mg、イブプロフェン200mgを含有する錠剤を得た。
この錠剤中の各成分の含有量(質量%)を下記表2に示す。
製造後の実施例1の錠剤について、被験者20名により、不快な味の官能試験を行った。各被験者が錠剤を舌の上でかまずに服用し、崩壊するまでそのまま静置し、服用した際の苦味・ピリピリ感及びザラツキ・粉っぽさについて、それぞれ下記基準に従って評価した。また、各被験者が、服用後口の中で錠剤が崩壊するまでの時間も測定した。各被験者の評価結果と平均を併せて表3に示す。
(評点) (内容)
4点 : マスキング効果が非常にある
3点 : マスキング効果がある
2点 : マスキング効果が少しある
1点 : マスキング効果が僅かにある
0点 : マスキング効果が全く無い
(評点) (内容)
4点 : ザラツキ・粉っぽさが全く無い
3点 : ザラツキ・粉っぽさが僅かにある
2点 : ザラツキ・粉っぽさが少しある
1点 : ザラツキ・粉っぽさがある
0点 : ザラツキ・粉っぽさ効果が非常にある
実施例1と同様に打錠用粉末を製し、直径9mmφの臼杵を用い、ロータリー式打錠機により圧縮成型し、厚さ約4mm、1錠あたりの質量300mg、イブプロフェン100mgを含有する錠剤を得た。
実施例1と同様に打錠用粉末を製し、直径11mmφの臼杵を用い、ロータリー式打錠機により圧縮成型し、厚さ約4.1mm、1錠あたり質量450mg、イブプロフェン150mgを含有する錠剤を得た。
実施例1と同様に打錠用粉末を製し、直径15mmφの臼杵を用い、ロータリー式打錠機により圧縮成型し、厚さ約5.8mm、1錠あたり質量1200mg、イブプロフェン400mgを含有する錠剤を得た。
実施例1で得られた錠剤をPTP包装し、アルミ中袋に乾燥剤と共に入れ密封した。室温(25℃40%RHの恒温室)にて24か月保管後、被験者12名により、試験例1と同じ評価基準で官能試験を行った。各被験者の評価結果及び平均を併せて表4に示す。
Claims (25)
- 酸性薬物、胃溶性高分子、水不溶性高分子及び水溶性高分子を含有する核粒子に腸溶性高分子の皮膜を施した被覆粒子を含有する圧縮成型製剤。
- 酸性薬物が、プロピオン酸系非ステロイド抗炎症薬である請求項1記載の圧縮成型製剤。
- 胃溶性高分子が、胃溶性メタクリル酸系高分子化合物及びポリビニルアセタール系高分子よりなる群から選ばれる1種または2種以上である請求項1または2に記載の圧縮成型製剤。
- 水不溶性高分子が、水不溶性メタクリル酸系高分子化合物及び水不溶性セルロース系高分子化合物よりなる群から選ばれる1種または2種以上である請求項1〜3のいずれかの項記載の圧縮成型製剤。
- 水不溶性高分子が、アクリル酸エチル−メタクリル酸メチル共重合体及び結晶セルロースを含有するものである請求項4記載の圧縮成型製剤。
- 核粒子中のアクリル酸エチル−メタクリル酸メチル共重合体と結晶セルロースとの含有質量比が、1:5〜200である請求項5記載の圧縮成型製剤。
- 水溶性高分子が、メチルセルロース、ヒプロメロース、ヒドロキシプロピルセルロース、ポリエチレングリコール、ポリビニルアルコール(部分けん化物)及びポリビニルピロリドンよりなる群から選ばれる1種または2種以上である請求項1〜6のいずれかの項記載の圧縮成型製剤。
- 核粒子中に、さらにpH調節剤を含有するものである請求項1〜7のいずれかの項記載の圧縮成型製剤。
- 核粒子中の胃溶性高分子の含有量が0.1〜50質量%、水不溶性高分子の含有量が1〜70質量%、水溶性高分子の含有量が0.1〜12質量%である請求項1〜8のいずれかの項記載の圧縮成型製剤。
- 腸溶性高分子が、腸溶性メタクリル酸系高分子化合物及び腸溶性セルロース系高分子化合物よりなる群から選ばれる1種または2種以上である請求項1〜9のいずれかの項記載の圧縮成型製剤。
- 被覆粒子中の腸溶性高分子の含有量が1〜30質量%である請求項1〜10のいずれかの項記載の圧縮成型製剤。
- 酸性薬物、胃溶性高分子、水不溶性高分子及び水溶性高分子を造粒して核粒子を得て、次いで当該核粒子に腸溶性高分子の皮膜を施して被覆粒子を得た後、当該被覆粒子を圧縮成型することを特徴とする圧縮成型製剤の製造方法。
- 酸性薬物が、プロピオン酸系非ステロイド抗炎症薬である請求項12記載の圧縮成型製剤の製造方法。
- 胃溶性高分子が、胃溶性メタクリル酸系高分子化合物及びポリビニルアセタール系高分子よりなる群から選ばれる1種または2種以上である請求項12または13に記載の圧縮成型製剤の製造方法。
- 水不溶性高分子が、水不溶性メタクリル酸系高分子化合物及び水不溶性セルロース系高分子化合物よりなる群から選ばれる1種または2種以上である請求項12〜14のいずれかの項記載の圧縮成型製剤の製造方法。
- 水溶性高分子が、メチルセルロース、ヒプロメロース、ヒドロキシプロピルセルロース、ポリエチレングリコール、ポリビニルアルコール(部分けん化物)及びポリビニルピロリドンよりなる群から選ばれる1種または2種以上である請求項12〜15のいずれかの項記載の圧縮成型製剤の製造方法。
- 腸溶性高分子が、腸溶性メタクリル酸系高分子化合物及び腸溶性セルロース系高分子化合物よりなる群から選ばれる1種または2種以上である請求項12〜16のいずれかの項記載の圧縮成型製剤の製造方法。
- 被覆粒子中の腸溶性高分子の含有量が1〜30質量%となるように腸溶性高分子の皮膜を施すものである請求項12〜17のいずれかの項記載の圧縮成型製剤の製造方法。
- 酸性薬物、胃溶性高分子、水不溶性高分子及び水溶性高分子を造粒して核粒子を得て、次いで当該核粒子に腸溶性高分子の皮膜を施して被覆粒子を得た後、当該被覆粒子を圧縮成型することを特徴とする圧縮成型製剤の不快な味のマスキング方法。
- 酸性薬物が、プロピオン酸系非ステロイド抗炎症薬である請求項19記載の圧縮成型製剤の不快な味のマスキング方法。
- 胃溶性高分子が、胃溶性メタクリル酸系高分子化合物及びポリビニルアセタール系高分子よりなる群から選ばれる1種または2種以上である請求項19または20に記載の圧縮成型製剤の不快な味のマスキング方法。
- 水不溶性高分子が、水不溶性メタクリル酸系高分子化合物及び水不溶性セルロース系高分子化合物よりなる群から選ばれる1種または2種以上である請求項19〜21のいずれかの項記載の圧縮成型製剤の不快な味のマスキング方法。
- 水溶性高分子が、メチルセルロース、ヒプロメロース、ヒドロキシプロピルセルロース、ポリエチレングリコール、ポリビニルアルコール(部分けん化物)及びポリビニルピロリドンよりなる群から選ばれる1種または2種以上である請求項19〜22のいずれかの項記載の圧縮成型製剤の不快な味のマスキング方法。
- 腸溶性高分子が、腸溶性メタクリル酸系高分子化合物及び腸溶性セルロース系高分子化合物よりなる群から選ばれる1種または2種以上である請求項19〜23のいずれかの項記載の圧縮成型製剤の不快な味のマスキング方法。
- 被覆粒子中の腸溶性高分子の含有量が1〜30質量%となるように腸溶性高分子の皮膜を施すものである請求項19〜24のいずれかの項記載の圧縮成型製剤の不快な味のマスキング方法。
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