JP2626247C

JP2626247C -

Info

Publication number: JP2626247C
Authority: JP; Japan
Prior art keywords: freeze; emulsion; particle size; maltose; dried preparation
Prior art date: 1999-01-20
Legal status : Expired - Lifetime

Application number

Other languages

English (en)

Japanese (ja)

Publication date

1999-01-20

Links

239000002245 particle Substances 0.000 claims description 88
239000000839 emulsion Substances 0.000 claims description 63
GUBGYTABKSRVRQ-YOLKTULGSA-N Maltose Natural products O([C@@H]1[C@H](O)[C@@H](O)[C@H](O)O[C@H]1CO)[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 GUBGYTABKSRVRQ-YOLKTULGSA-N 0.000 claims description 44
238000004519 manufacturing process Methods 0.000 claims description 35
239000003814 drug Substances 0.000 claims description 28
229940079593 drugs Drugs 0.000 claims description 27
239000002960 lipid emulsion Substances 0.000 claims description 26
238000002360 preparation method Methods 0.000 claims description 26
238000004108 freeze drying Methods 0.000 claims description 18
150000002632 lipids Chemical class 0.000 claims description 9
235000013343 vitamin Nutrition 0.000 claims description 6
239000011782 vitamin Substances 0.000 claims description 6
229930003231 vitamins Natural products 0.000 claims description 6
APKFDSVGJQXUKY-INPOYWNPSA-N BRL-49594 Chemical compound O[C@H]1[C@@H](N)[C@H](O)[C@@H](C)O[C@H]1O[C@H]1/C=C/C=C/C=C/C=C/C=C/C=C/C=C/[C@H](C)[C@@H](O)[C@@H](C)[C@H](C)OC(=O)C[C@H](O)C[C@H](O)CC[C@@H](O)[C@H](O)C[C@H](O)C[C@](O)(C[C@H](O)[C@H]2C(O)=O)O[C@H]2C1 APKFDSVGJQXUKY-INPOYWNPSA-N 0.000 claims description 4
229940088594 Vitamin Drugs 0.000 claims description 3
150000001413 amino acids Chemical class 0.000 claims description 3
229960003942 amphotericin B Drugs 0.000 claims description 3
230000003115 biocidal Effects 0.000 claims description 3
230000003182 bronchodilatating Effects 0.000 claims description 3
239000000032 diagnostic agent Substances 0.000 claims description 3
239000003589 local anesthetic agent Substances 0.000 claims description 3
150000003722 vitamin derivatives Chemical class 0.000 claims description 3
229940006211 Anticholinergic mydriatics and cycloplegics Drugs 0.000 claims description 2
229940065524 Anticholinergics inhalants for obstructive airway diseases Drugs 0.000 claims description 2
208000010412 Glaucoma Diseases 0.000 claims description 2
229960005015 Local anesthetics Drugs 0.000 claims description 2
229940083877 Local anesthetics for treatment of hemorrhoids and anal fissures for topical use Drugs 0.000 claims description 2
210000002464 Muscle, Smooth, Vascular Anatomy 0.000 claims description 2
210000002307 Prostate Anatomy 0.000 claims description 2
239000002671 adjuvant Substances 0.000 claims description 2
230000000240 adjuvant Effects 0.000 claims description 2
239000000556 agonist Substances 0.000 claims description 2
239000002160 alpha blocker Substances 0.000 claims description 2
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230000003266 anti-allergic Effects 0.000 claims description 2
230000000879 anti-atherosclerotic Effects 0.000 claims description 2
230000001093 anti-cancer Effects 0.000 claims description 2
230000001078 anti-cholinergic Effects 0.000 claims description 2
230000001387 anti-histamine Effects 0.000 claims description 2
230000003110 anti-inflammatory Effects 0.000 claims description 2
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239000003434 antitussive agent Substances 0.000 claims description 2
OYPRJOBELJOOCE-UHFFFAOYSA-N calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims description 2
239000011575 calcium Substances 0.000 claims description 2
229910052791 calcium Inorganic materials 0.000 claims description 2
239000003576 central nervous system agent Substances 0.000 claims description 2
230000000973 chemotherapeutic Effects 0.000 claims description 2
239000000812 cholinergic antagonist Substances 0.000 claims description 2
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201000009673 liver disease Diseases 0.000 claims description 2
229940064003 local anesthetic throat preparations Drugs 0.000 claims description 2
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239000002516 radical scavenger Substances 0.000 claims description 2
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229940077717 Prostaglandin drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD) Drugs 0.000 claims 1
239000000168 bronchodilator agent Substances 0.000 claims 1
239000003326 hypnotic agent Substances 0.000 claims 1
229940094443 oxytocics Prostaglandins Drugs 0.000 claims 1
239000006166 lysate Substances 0.000 description 26
238000005429 turbidity Methods 0.000 description 26
-1 trehalose Chemical class 0.000 description 18
238000004090 dissolution Methods 0.000 description 15
238000005336 cracking Methods 0.000 description 13
239000008215 water for injection Substances 0.000 description 11
235000012970 cakes Nutrition 0.000 description 10
JLPULHDHAOZNQI-ZTIMHPMXSA-N 1-hexadecanoyl-2-(9Z,12Z-octadecadienoyl)-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCC\C=C/C\C=C/CCCCC JLPULHDHAOZNQI-ZTIMHPMXSA-N 0.000 description 8
210000002969 Egg Yolk Anatomy 0.000 description 8
229940067606 Lecithin Drugs 0.000 description 8
239000007864 aqueous solution Substances 0.000 description 8
HEDRZPFGACZZDS-UHFFFAOYSA-N chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 description 8
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235000013345 egg yolk Nutrition 0.000 description 8
239000000787 lecithin Substances 0.000 description 8
235000010445 lecithin Nutrition 0.000 description 8
OKKJLVBELUTLKV-UHFFFAOYSA-N methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 8
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 8
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239000011148 porous material Substances 0.000 description 7
239000003549 soybean oil Substances 0.000 description 7
235000012424 soybean oil Nutrition 0.000 description 7
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DHMQDGOQFOQNFH-UHFFFAOYSA-N glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 4
239000007788 liquid Substances 0.000 description 4
239000011259 mixed solution Substances 0.000 description 4
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FAPWRFPIFSIZLT-UHFFFAOYSA-M sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 4
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WQZGKKKJIJFFOK-GASJEMHNSA-N D-Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 3
229920002307 Dextran Polymers 0.000 description 3
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NWIBSHFKIJFRCO-WUDYKRTCSA-N Mytomycin Chemical compound C1N2C(C(C(C)=C(N)C3=O)=O)=C3[C@@H](COC(N)=O)[C@@]2(OC)[C@@H]2[C@H]1N2 NWIBSHFKIJFRCO-WUDYKRTCSA-N 0.000 description 3
HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 description 3
HDTRYLNUVZCQOY-LIZSDCNHSA-N Trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 description 3
229940029983 VITAMINS Drugs 0.000 description 3
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239000000654 additive Substances 0.000 description 3
LFQSCWFLJHTTHZ-UHFFFAOYSA-N ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 3
238000009472 formulation Methods 0.000 description 3
239000008103 glucose Substances 0.000 description 3
LYCAIKOWRPUZTN-UHFFFAOYSA-N glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 3
238000000034 method Methods 0.000 description 3
235000013336 milk Nutrition 0.000 description 3
239000008267 milk Substances 0.000 description 3
IPCSVZSSVZVIGE-UHFFFAOYSA-M palmitate Chemical compound CCCCCCCCCCCCCCCC([O-])=O IPCSVZSSVZVIGE-UHFFFAOYSA-M 0.000 description 3
OAICVXFJPJFONN-UHFFFAOYSA-N phosphorus Chemical compound [P] OAICVXFJPJFONN-UHFFFAOYSA-N 0.000 description 3
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PMATZTZNYRCHOR-CGLBZJNRSA-N (3S,6S,9S,12R,15S,18S,21S,24S,30S,33S)-30-ethyl-33-[(E,1R,2R)-1-hydroxy-2-methylhex-4-enyl]-1,4,7,10,12,15,19,25,28-nonamethyl-6,9,18,24-tetrakis(2-methylpropyl)-3,21-di(propan-2-yl)-1,4,7,10,13,16,19,22,25,28,31-undecazacyclotritriacontane-2,5,8,11,14,17 Chemical compound CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\C=C\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O PMATZTZNYRCHOR-CGLBZJNRSA-N 0.000 description 2
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FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 2
CZMRCDWAGMRECN-UGDNZRGBSA-N D-sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 2
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CGIGDMFJXJATDK-UHFFFAOYSA-N Indometacin Chemical compound CC1=C(CC(O)=O)C2=CC(OC)=CC=C2N1C(=O)C1=CC=C(Cl)C=C1 CGIGDMFJXJATDK-UHFFFAOYSA-N 0.000 description 2
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