CN1575795A - 盐酸纳洛酮鼻腔喷雾剂 - Google Patents
盐酸纳洛酮鼻腔喷雾剂 Download PDFInfo
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- CN1575795A CN1575795A CN 200410049659 CN200410049659A CN1575795A CN 1575795 A CN1575795 A CN 1575795A CN 200410049659 CN200410049659 CN 200410049659 CN 200410049659 A CN200410049659 A CN 200410049659A CN 1575795 A CN1575795 A CN 1575795A
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- nasal mist
- naloxone hydrochloride
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- 239000007922 nasal spray Substances 0.000 title claims description 30
- RGPDIGOSVORSAK-STHHAXOLSA-N naloxone hydrochloride Chemical compound Cl.O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(O)C2=C5[C@@]13CCN4CC=C RGPDIGOSVORSAK-STHHAXOLSA-N 0.000 title claims description 23
- 229960005250 naloxone hydrochloride Drugs 0.000 title claims description 21
- 229940097496 nasal spray Drugs 0.000 title description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 16
- 230000003204 osmotic effect Effects 0.000 claims abstract description 8
- 239000007921 spray Substances 0.000 claims abstract description 8
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical group [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 10
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical group CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 9
- 230000002421 anti-septic effect Effects 0.000 claims description 9
- 239000003961 penetration enhancing agent Substances 0.000 claims description 8
- 239000011780 sodium chloride Substances 0.000 claims description 5
- WPYMKLBDIGXBTP-UHFFFAOYSA-N benzoic acid Chemical compound OC(=O)C1=CC=CC=C1 WPYMKLBDIGXBTP-UHFFFAOYSA-N 0.000 claims description 4
- OSASVXMJTNOKOY-UHFFFAOYSA-N chlorobutanol Chemical compound CC(C)(O)C(Cl)(Cl)Cl OSASVXMJTNOKOY-UHFFFAOYSA-N 0.000 claims description 4
- FGIUAXJPYTZDNR-UHFFFAOYSA-N potassium nitrate Chemical compound [K+].[O-][N+]([O-])=O FGIUAXJPYTZDNR-UHFFFAOYSA-N 0.000 claims description 4
- GHMLBKRAJCXXBS-UHFFFAOYSA-N resorcinol Chemical compound OC1=CC=CC(O)=C1 GHMLBKRAJCXXBS-UHFFFAOYSA-N 0.000 claims description 4
- 150000001298 alcohols Chemical class 0.000 claims description 3
- -1 dimethyl sulfoxine Chemical compound 0.000 claims description 3
- 150000002148 esters Chemical class 0.000 claims description 3
- 229960001617 ethyl hydroxybenzoate Drugs 0.000 claims description 3
- 239000004403 ethyl p-hydroxybenzoate Substances 0.000 claims description 3
- 235000010228 ethyl p-hydroxybenzoate Nutrition 0.000 claims description 3
- NUVBSKCKDOMJSU-UHFFFAOYSA-N ethylparaben Chemical compound CCOC(=O)C1=CC=C(O)C=C1 NUVBSKCKDOMJSU-UHFFFAOYSA-N 0.000 claims description 3
- DNIAPMSPPWPWGF-GSVOUGTGSA-N (R)-(-)-Propylene glycol Chemical compound C[C@@H](O)CO DNIAPMSPPWPWGF-GSVOUGTGSA-N 0.000 claims description 2
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 claims description 2
- 239000005711 Benzoic acid Substances 0.000 claims description 2
- 229920000832 Cutin Polymers 0.000 claims description 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 2
- QOSMNYMQXIVWKY-UHFFFAOYSA-N Propyl levulinate Chemical compound CCCOC(=O)CCC(C)=O QOSMNYMQXIVWKY-UHFFFAOYSA-N 0.000 claims description 2
- 239000004902 Softening Agent Substances 0.000 claims description 2
- UMVBXBACMIOFDO-UHFFFAOYSA-N [N].[Si] Chemical compound [N].[Si] UMVBXBACMIOFDO-UHFFFAOYSA-N 0.000 claims description 2
- 125000000129 anionic group Chemical group 0.000 claims description 2
- 229960002233 benzalkonium bromide Drugs 0.000 claims description 2
- KHSLHYAUZSPBIU-UHFFFAOYSA-M benzododecinium bromide Chemical compound [Br-].CCCCCCCCCCCC[N+](C)(C)CC1=CC=CC=C1 KHSLHYAUZSPBIU-UHFFFAOYSA-M 0.000 claims description 2
- 235000010233 benzoic acid Nutrition 0.000 claims description 2
- XIWFQDBQMCDYJT-UHFFFAOYSA-M benzyl-dimethyl-tridecylazanium;chloride Chemical compound [Cl-].CCCCCCCCCCCCC[N+](C)(C)CC1=CC=CC=C1 XIWFQDBQMCDYJT-UHFFFAOYSA-M 0.000 claims description 2
- 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 2
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 claims description 2
- 239000004327 boric acid Substances 0.000 claims description 2
- 125000002091 cationic group Chemical group 0.000 claims description 2
- 229960004926 chlorobutanol Drugs 0.000 claims description 2
- BHQCQFFYRZLCQQ-OELDTZBJSA-N cholic acid Chemical class C([C@H]1C[C@H]2O)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H]([C@@H](CCC(O)=O)C)[C@@]2(C)[C@@H](O)C1 BHQCQFFYRZLCQQ-OELDTZBJSA-N 0.000 claims description 2
- 235000014113 dietary fatty acids Nutrition 0.000 claims description 2
- BEGBSFPALGFMJI-UHFFFAOYSA-N ethene;sodium Chemical group [Na].C=C BEGBSFPALGFMJI-UHFFFAOYSA-N 0.000 claims description 2
- 125000004494 ethyl ester group Chemical group 0.000 claims description 2
- 229930195729 fatty acid Natural products 0.000 claims description 2
- 239000000194 fatty acid Substances 0.000 claims description 2
- 150000004665 fatty acids Chemical class 0.000 claims description 2
- 239000008103 glucose Substances 0.000 claims description 2
- 150000002576 ketones Chemical class 0.000 claims description 2
- 239000000787 lecithin Substances 0.000 claims description 2
- 229940067606 lecithin Drugs 0.000 claims description 2
- 235000010445 lecithin Nutrition 0.000 claims description 2
- 239000004292 methyl p-hydroxybenzoate Substances 0.000 claims description 2
- 235000010270 methyl p-hydroxybenzoate Nutrition 0.000 claims description 2
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 claims description 2
- 229960002216 methylparaben Drugs 0.000 claims description 2
- 239000003960 organic solvent Substances 0.000 claims description 2
- WVDDGKGOMKODPV-ZQBYOMGUSA-N phenyl(114C)methanol Chemical compound O[14CH2]C1=CC=CC=C1 WVDDGKGOMKODPV-ZQBYOMGUSA-N 0.000 claims description 2
- 239000004323 potassium nitrate Substances 0.000 claims description 2
- 235000010333 potassium nitrate Nutrition 0.000 claims description 2
- 229960001755 resorcinol Drugs 0.000 claims description 2
- DCKVNWZUADLDEH-UHFFFAOYSA-N sec-butyl acetate Chemical compound CCC(C)OC(C)=O DCKVNWZUADLDEH-UHFFFAOYSA-N 0.000 claims description 2
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 claims description 2
- 239000004299 sodium benzoate Substances 0.000 claims description 2
- 235000010234 sodium benzoate Nutrition 0.000 claims description 2
- 239000004094 surface-active agent Substances 0.000 claims description 2
- 150000003505 terpenes Chemical class 0.000 claims description 2
- 235000007586 terpenes Nutrition 0.000 claims description 2
- 239000008215 water for injection Substances 0.000 claims description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 3
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 3
- 239000004283 Sodium sorbate Substances 0.000 claims 1
- BEFDCLMNVWHSGT-UHFFFAOYSA-N ethenylcyclopentane Chemical compound C=CC1CCCC1 BEFDCLMNVWHSGT-UHFFFAOYSA-N 0.000 claims 1
- LROWVYNUWKVTCU-STWYSWDKSA-M sodium sorbate Chemical compound [Na+].C\C=C\C=C\C([O-])=O LROWVYNUWKVTCU-STWYSWDKSA-M 0.000 claims 1
- 235000019250 sodium sorbate Nutrition 0.000 claims 1
- 239000004334 sorbic acid Substances 0.000 claims 1
- 235000010199 sorbic acid Nutrition 0.000 claims 1
- 229940075582 sorbic acid Drugs 0.000 claims 1
- 238000002360 preparation method Methods 0.000 abstract description 9
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 abstract description 8
- 239000002552 dosage form Substances 0.000 abstract 2
- 210000003928 nasal cavity Anatomy 0.000 abstract 1
- 239000003755 preservative agent Substances 0.000 abstract 1
- 230000002335 preservative effect Effects 0.000 abstract 1
- 238000002347 injection Methods 0.000 description 9
- 239000007924 injection Substances 0.000 description 9
- 239000007788 liquid Substances 0.000 description 5
- BQJCRHHNABKAKU-KBQPJGBKSA-N morphine Chemical compound O([C@H]1[C@H](C=C[C@H]23)O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O BQJCRHHNABKAKU-KBQPJGBKSA-N 0.000 description 4
- 229960004127 naloxone Drugs 0.000 description 3
- 230000000065 osmolyte Effects 0.000 description 3
- 208000007848 Alcoholism Diseases 0.000 description 2
- 231100000643 Substance intoxication Toxicity 0.000 description 2
- 206010070863 Toxicity to various agents Diseases 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 230000001154 acute effect Effects 0.000 description 2
- 201000007930 alcohol dependence Diseases 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 238000010438 heat treatment Methods 0.000 description 2
- 239000007937 lozenge Substances 0.000 description 2
- 239000012982 microporous membrane Substances 0.000 description 2
- 238000005303 weighing Methods 0.000 description 2
- 241000220324 Pyrus Species 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000005557 antagonist Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
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- 238000011835 investigation Methods 0.000 description 1
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- 235000021017 pears Nutrition 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
本发明涉及盐酸纳洛酮的鼻腔喷雾剂及制备方法，本发明制剂可以单剂量及多剂量形式使用。本发明喷雾剂包括盐酸纳洛酮、渗透压调节剂、防腐剂、渗透促进剂及水。
Description
发明领域
本发明涉及盐酸纳洛酮鼻腔喷雾剂及其制备方法。本发明还涉及盐酸纳洛酮单剂量及多剂量的鼻腔喷雾剂。本发明的鼻腔喷雾剂包括盐酸纳洛酮、渗透压调节剂、防腐剂、渗透促进剂及水。
背景技术
盐酸纳洛酮(Naloxone Hydrochloride)为吗啡拮抗剂，可用于吗啡类药物中毒急救及急性酒精中毒的救治等。该药临床应用有注射剂及舌下含片，但注射剂通常要到医院或诊所使用，两者均存在使用不便且顺从性差的问题；从而降低药效且吸收和生物利用度会受到影响。
发明内容
本发明的目的是克服目前盐酸纳洛酮注射液及舌下含片两种制剂存在的不足，开发吸收快，生物利用度高，使用方便，不需特定条件，可自用、互用的一种新的盐酸纳洛酮单剂量及多剂量鼻腔喷雾剂。
本发明人通过深入研究，现已发现将盐酸纳洛酮，与选用的防腐剂，渗透调节剂、渗透促进剂及水混合形成了一种新的鼻腔喷雾给药剂型。该制剂具有吸收迅速，生物利用度高及刺激性小的单剂量及多剂量鼻腔喷雾剂。该制剂适合规模生产及储存。
因此，本发明第一方面涉及含有纳洛酮的经鼻腔给药的喷雾制剂，其包括盐酸纳洛酮，渗透调节剂，防腐剂、渗透促进剂及水。
本发明再一方面涉及含有盐酸钠洛酮的鼻腔喷雾剂在缓解或治疗吗啡类药物中毒急救及急性酒精中毒等的用途。
根据本发明，本发明鼻喷雾剂中使用的防腐剂选自对羟基苯甲酸甲酯、乙酯、丙酯、丁酯，三梨酸，苯甲酸，苯甲酸钠，苯甲醇，苯扎氯胺，苯扎溴胺，三氯叔丁醇，间苯二酚及乙二胺四乙酸钠等，渗透压调节剂选自氯化钠，硝酸钾，硼酸及葡萄糖。渗透促进剂选自①有机溶剂中醇类、酯类、二甲亚砜及同系物；②脂肪酸、脂肪醇及胆酸盐类；③月硅氮酮及同系物；④表面活性剂如阳离子型、阴离子型、非离子型及卵磷脂；⑤萜烯类；⑥角质保湿与软化剂。
本发明还提供二种含盐酸纳洛酮的鼻腔喷雾剂的制备方法，其包括将盐酸纳洛酮、防腐剂、渗透压调节剂、渗透促进剂与注射用水混合使溶解，调节pH值至3.0～4.5，过滤，然后，分别灌装于单剂量及多剂量鼻喷雾装置中。
本发明以喷雾剂药液重量计，盐酸纳洛酮的含量为0.1～10.0重量％，渗透调节剂、防腐剂及水含量为94.0～99.9重量％，喷雾粒度为5～200μm。
本发明的鼻腔喷雾剂以单剂量或多剂量使用形式，每次鼻腔喷雾给药量为20～200μl。
下列实施例用于进一步说明本发明，但不意味着对本发明有任何限制作用。
实施例1 盐酸纳洛酮的鼻腔喷雾剂的制备。
称取对羟基苯甲酸乙酯0.03g，置100ml量瓶中，加注射用水适量，温水浴加热使溶解，冷却至室温，再加入盐酸纳洛酮干燥品1.0g，氯化钠0.9g，振摇使溶解，加注射用水近刻度，摇匀，用0.1mol/L盐酸调节至pH值3.8±0.8，再加注射用水至刻度，摇匀，用0.25μm微孔滤膜过滤至药液澄明，即得盐酸纳洛酮鼻腔喷雾剂药液。随后分别灌装于单剂量及多剂量鼻喷雾装置中，包装备用。
实施例2 盐酸纳洛酮的鼻腔喷雾剂的制备。
称取对羟基苯甲酸乙酯0.03g，置100ml量瓶中，加丙二醇20g，再加注射用水适量，温水浴加热使溶解，冷却至室温，再加入盐酸纳洛酮干燥品1.0g，氯化钠0.9g，振摇使溶解，加注射用水近刻度，摇匀，用0.1mol/L盐酸调节至pH值3.8±0.8，再加注射用水至刻度，摇匀，用0.25μm微孔滤膜过滤至药液澄明，即得盐酸纳洛酮鼻腔喷雾剂药液。随后分别灌装于单剂量及多剂量鼻喷雾装置中，包装备用。
Claims (12)
1.盐酸纳洛酮的鼻腔喷雾剂，包括盐酸纳洛酮、渗透压调节剂、渗透促进剂、防腐剂及水。
2.权利要求1的鼻腔喷雾剂，其中渗透压调节剂选自氯化钠，硝酸钾，硼酸及葡萄糖。
3.权利要求1或2的鼻腔喷雾剂，其中防腐剂选自对羟基苯甲酸甲酯、乙酯、丙酯、丁酯，山梨酸，山梨酸钠，苯甲酸，苯甲酸钠，苯甲醇，苯扎氯胺，苯扎溴胺，三氯叔丁醇，间苯二酚及乙二胺四乙酸钠。
4.权利要求1～3要求的鼻腔喷雾剂，其渗透促进剂包括①有机溶剂中醇类、酯类、二甲亚砜及同系物；②脂肪酸、脂肪醇及胆酸盐类；③月硅氮酮及同系物；④表面活性剂如阳离子型、阴离子型、非离子型及卵磷脂；⑤萜烯类；⑥角质保湿与软化剂。
5.权利要求1～4任一要求的鼻腔喷雾剂，其中所述的防腐剂为对羟基苯甲酸乙酯。
6.权利要求5要求的鼻腔喷雾剂，其渗透压调节剂为氯化钠。
7.权利要求6的鼻腔喷雾剂，其渗透促进剂为丙二醇。
8.权利要求7要求的鼻腔喷雾剂，其中所述的水为注射用水或能与水混合的醇类如丙二醇、丙三醇、乙醇及酯类。
9.权利要求1～4任一要求的鼻腔喷雾剂，其中盐酸纳洛酮单次给药剂量为0.1～10mg。
10.权利要求1～4任一要求的鼻腔喷雾剂，其中喷雾粒度为5～200μm。
11.权利要求1～4任一要求的鼻腔喷雾剂，其中所述喷雾剂为单剂量或多剂量形式的喷雾剂。
12.权利要求1～4任一要求的鼻腔喷雾剂，其中鼻腔喷雾剂的pH为3.0-4.5。
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410049659 CN1575795A (zh) | 2003-06-25 | 2004-06-23 | 盐酸纳洛酮鼻腔喷雾剂 |
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| Application Number | Priority Date | Filing Date | Title |
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| CN03147840.9 | 2003-06-25 | ||
| CN03147840 | 2003-06-25 | ||
| CN 200410049659 CN1575795A (zh) | 2003-06-25 | 2004-06-23 | 盐酸纳洛酮鼻腔喷雾剂 |
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| CN1575795A true CN1575795A (zh) | 2005-02-09 |
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Cited By (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2012156317A2 (en) | 2011-05-13 | 2012-11-22 | Euro-Celtique S.A. | Intranasal pharmaceutical dosage forms comprising naloxone |
| CN1726915B (zh) * | 2004-07-27 | 2013-04-24 | 中国人民解放军军事医学科学院毒物药物研究所 | 盐酸纳洛酮鼻腔给药系统或组合物及其制备方法 |
| CN104606136A (zh) * | 2015-01-06 | 2015-05-13 | 中国人民解放军军事医学科学院毒物药物研究所 | 甲氧氯普胺鼻腔喷雾剂、其制备方法及用途 |
| WO2015095644A1 (en) * | 2013-12-20 | 2015-06-25 | AntiOP, Inc. | Intranasal naloxone compositions and methods of making and using same |
| US9211253B2 (en) | 2014-03-14 | 2015-12-15 | Lightlake Therapeutics Inc. | Nasal drug products and methods of their use |
| US9468747B2 (en) | 2014-03-14 | 2016-10-18 | Opiant Pharmaceuticals, Inc. | Nasal drug products and methods of their use |
| US9561177B2 (en) | 2014-03-14 | 2017-02-07 | Adapt Pharma Limited | Nasal drug products and methods of their use |
| EP3177146A4 (en) * | 2014-07-08 | 2018-01-03 | Insys Pharma, Inc. | Sublingual naloxone spray |
| WO2018034920A1 (en) | 2016-08-17 | 2018-02-22 | Insys Development Company, Inc. | Liquid naloxone spray |
| US10085937B2 (en) | 2014-03-14 | 2018-10-02 | Adapt Pharma Limited | Nasal drug products and methods of their use |
| EP3349756A4 (en) * | 2015-09-17 | 2019-05-15 | Adapt Pharma Limited | NASAL MEDICAMENT PRODUCTS AND METHOD FOR USE THEREOF |
| WO2020033402A1 (en) * | 2018-08-06 | 2020-02-13 | Summit Biosciences Inc. | Drug products for nasal administration and uses thereof |
| US11975096B2 (en) | 2014-07-08 | 2024-05-07 | Hikma Pharmaceuticals Usa Inc. | Liquid naloxone spray |
| US12514854B2 (en) | 2020-02-05 | 2026-01-06 | Summit Biosciences Inc. | Drug products for intranasal administration and uses thereof |
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2004
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