CN102573496B - 缓释镁组合物及其用途 - Google Patents
缓释镁组合物及其用途 Download PDFInfo
- Publication number
- CN102573496B CN102573496B CN201080038632.7A CN201080038632A CN102573496B CN 102573496 B CN102573496 B CN 102573496B CN 201080038632 A CN201080038632 A CN 201080038632A CN 102573496 B CN102573496 B CN 102573496B
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- CN
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- Prior art keywords
- magnesium
- dosage form
- peroral dosage
- threose
- acid
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- 239000011777 magnesium Substances 0.000 title claims abstract description 389
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 title claims abstract description 323
- 229910052749 magnesium Inorganic materials 0.000 title claims abstract description 323
- 239000000203 mixture Substances 0.000 title abstract description 151
- 239000002253 acid Substances 0.000 claims abstract description 160
- 150000003839 salts Chemical class 0.000 claims abstract description 150
- YTBSYETUWUMLBZ-QWWZWVQMSA-N D-threose Chemical compound OC[C@@H](O)[C@H](O)C=O YTBSYETUWUMLBZ-QWWZWVQMSA-N 0.000 claims abstract description 130
- 239000002243 precursor Substances 0.000 claims abstract description 24
- 239000002552 dosage form Substances 0.000 claims description 138
- -1 sulfate radical Chemical class 0.000 claims description 90
- 238000000034 method Methods 0.000 claims description 47
- 238000002360 preparation method Methods 0.000 claims description 43
- 238000013270 controlled release Methods 0.000 claims description 41
- 229920000642 polymer Polymers 0.000 claims description 38
- 238000000576 coating method Methods 0.000 claims description 35
- 239000011248 coating agent Substances 0.000 claims description 33
- 239000002245 particle Substances 0.000 claims description 28
- 238000004090 dissolution Methods 0.000 claims description 27
- 235000005911 diet Nutrition 0.000 claims description 26
- 230000037213 diet Effects 0.000 claims description 26
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims description 20
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 20
- 239000003814 drug Substances 0.000 claims description 19
- 239000000843 powder Substances 0.000 claims description 16
- 239000000853 adhesive Substances 0.000 claims description 15
- 230000001070 adhesive effect Effects 0.000 claims description 15
- 150000002148 esters Chemical class 0.000 claims description 15
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 15
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 15
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 13
- 229940079593 drug Drugs 0.000 claims description 12
- 239000007788 liquid Substances 0.000 claims description 11
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims description 10
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 claims description 10
- 239000011575 calcium Substances 0.000 claims description 10
- 229910052791 calcium Inorganic materials 0.000 claims description 10
- 239000013589 supplement Substances 0.000 claims description 10
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 claims description 9
- REFJWTPEDVJJIY-UHFFFAOYSA-N Quercetin Chemical compound C=1C(O)=CC(O)=C(C(C=2O)=O)C=1OC=2C1=CC=C(O)C(O)=C1 REFJWTPEDVJJIY-UHFFFAOYSA-N 0.000 claims description 9
- 239000000314 lubricant Substances 0.000 claims description 9
- 239000011591 potassium Substances 0.000 claims description 9
- 229910052700 potassium Inorganic materials 0.000 claims description 9
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims description 8
- 230000000536 complexating effect Effects 0.000 claims description 8
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 8
- 239000011734 sodium Substances 0.000 claims description 8
- 229910052708 sodium Inorganic materials 0.000 claims description 8
- XOAAWQZATWQOTB-UHFFFAOYSA-N taurine Chemical compound NCCS(O)(=O)=O XOAAWQZATWQOTB-UHFFFAOYSA-N 0.000 claims description 8
- ZZZCUOFIHGPKAK-UHFFFAOYSA-N D-erythro-ascorbic acid Natural products OCC1OC(=O)C(O)=C1O ZZZCUOFIHGPKAK-UHFFFAOYSA-N 0.000 claims description 7
- JPIJQSOTBSSVTP-GBXIJSLDSA-N D-threonic acid Chemical compound OC[C@@H](O)[C@H](O)C(O)=O JPIJQSOTBSSVTP-GBXIJSLDSA-N 0.000 claims description 7
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 7
- 208000012902 Nervous system disease Diseases 0.000 claims description 7
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- 230000001965 increasing effect Effects 0.000 claims description 7
- 235000019154 vitamin C Nutrition 0.000 claims description 7
- 239000011718 vitamin C Substances 0.000 claims description 7
- FERIUCNNQQJTOY-UHFFFAOYSA-N Butyric acid Chemical compound CCCC(O)=O FERIUCNNQQJTOY-UHFFFAOYSA-N 0.000 claims description 6
- PVNIIMVLHYAWGP-UHFFFAOYSA-N Niacin Chemical compound OC(=O)C1=CC=CN=C1 PVNIIMVLHYAWGP-UHFFFAOYSA-N 0.000 claims description 6
- 210000001175 cerebrospinal fluid Anatomy 0.000 claims description 6
- 239000012738 dissolution medium Substances 0.000 claims description 6
- 239000002609 medium Substances 0.000 claims description 6
- 229960003512 nicotinic acid Drugs 0.000 claims description 6
- 229920002689 polyvinyl acetate Polymers 0.000 claims description 6
- 239000011118 polyvinyl acetate Substances 0.000 claims description 6
- 235000005875 quercetin Nutrition 0.000 claims description 6
- 230000001502 supplementing effect Effects 0.000 claims description 6
- GHOKWGTUZJEAQD-ZETCQYMHSA-N (D)-(+)-Pantothenic acid Chemical compound OCC(C)(C)[C@@H](O)C(=O)NCCC(O)=O GHOKWGTUZJEAQD-ZETCQYMHSA-N 0.000 claims description 5
- 208000024172 Cardiovascular disease Diseases 0.000 claims description 5
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims description 5
- 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 5
- QNVSXXGDAPORNA-UHFFFAOYSA-N Resveratrol Natural products OC1=CC=CC(C=CC=2C=C(O)C(O)=CC=2)=C1 QNVSXXGDAPORNA-UHFFFAOYSA-N 0.000 claims description 5
- LUKBXSAWLPMMSZ-OWOJBTEDSA-N Trans-resveratrol Chemical compound C1=CC(O)=CC=C1\C=C\C1=CC(O)=CC(O)=C1 LUKBXSAWLPMMSZ-OWOJBTEDSA-N 0.000 claims description 5
- 239000008103 glucose Substances 0.000 claims description 5
- 238000000338 in vitro Methods 0.000 claims description 5
- 229910052742 iron Inorganic materials 0.000 claims description 5
- 235000019136 lipoic acid Nutrition 0.000 claims description 5
- 208000030159 metabolic disease Diseases 0.000 claims description 5
- 239000011664 nicotinic acid Substances 0.000 claims description 5
- 235000001968 nicotinic acid Nutrition 0.000 claims description 5
- 235000021283 resveratrol Nutrition 0.000 claims description 5
- 229940016667 resveratrol Drugs 0.000 claims description 5
- 229960002663 thioctic acid Drugs 0.000 claims description 5
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 claims description 4
- AFSDNFLWKVMVRB-UHFFFAOYSA-N Ellagic acid Chemical compound OC1=C(O)C(OC2=O)=C3C4=C2C=C(O)C(O)=C4OC(=O)C3=C1 AFSDNFLWKVMVRB-UHFFFAOYSA-N 0.000 claims description 4
- ATJXMQHAMYVHRX-CPCISQLKSA-N Ellagic acid Natural products OC1=C(O)[C@H]2OC(=O)c3cc(O)c(O)c4OC(=O)C(=C1)[C@H]2c34 ATJXMQHAMYVHRX-CPCISQLKSA-N 0.000 claims description 4
- 229920002079 Ellagic acid Polymers 0.000 claims description 4
- IMQLKJBTEOYOSI-GPIVLXJGSA-N Inositol-hexakisphosphate Chemical compound OP(O)(=O)O[C@H]1[C@H](OP(O)(O)=O)[C@@H](OP(O)(O)=O)[C@H](OP(O)(O)=O)[C@H](OP(O)(O)=O)[C@@H]1OP(O)(O)=O IMQLKJBTEOYOSI-GPIVLXJGSA-N 0.000 claims description 4
- DCXYFEDJOCDNAF-REOHCLBHSA-N L-asparagine Chemical group OC(=O)[C@@H](N)CC(N)=O DCXYFEDJOCDNAF-REOHCLBHSA-N 0.000 claims description 4
- ZOKXTWBITQBERF-UHFFFAOYSA-N Molybdenum Chemical compound [Mo] ZOKXTWBITQBERF-UHFFFAOYSA-N 0.000 claims description 4
- 229910019142 PO4 Inorganic materials 0.000 claims description 4
- XBDQKXXYIPTUBI-UHFFFAOYSA-M Propionate Chemical compound CCC([O-])=O XBDQKXXYIPTUBI-UHFFFAOYSA-M 0.000 claims description 4
- BUGBHKTXTAQXES-UHFFFAOYSA-N Selenium Chemical compound [Se] BUGBHKTXTAQXES-UHFFFAOYSA-N 0.000 claims description 4
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 claims description 4
- 229940024606 amino acid Drugs 0.000 claims description 4
- 235000001014 amino acid Nutrition 0.000 claims description 4
- 150000001413 amino acids Chemical class 0.000 claims description 4
- 150000001450 anions Chemical class 0.000 claims description 4
- 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 4
- 229960002852 ellagic acid Drugs 0.000 claims description 4
- 235000004132 ellagic acid Nutrition 0.000 claims description 4
- 150000002596 lactones Chemical class 0.000 claims description 4
- 235000019359 magnesium stearate Nutrition 0.000 claims description 4
- BJEPYKJPYRNKOW-UHFFFAOYSA-N malic acid Chemical compound OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 claims description 4
- WPBNNNQJVZRUHP-UHFFFAOYSA-L manganese(2+);methyl n-[[2-(methoxycarbonylcarbamothioylamino)phenyl]carbamothioyl]carbamate;n-[2-(sulfidocarbothioylamino)ethyl]carbamodithioate Chemical compound [Mn+2].[S-]C(=S)NCCNC([S-])=S.COC(=O)NC(=S)NC1=CC=CC=C1NC(=S)NC(=O)OC WPBNNNQJVZRUHP-UHFFFAOYSA-L 0.000 claims description 4
- FAARLWTXUUQFSN-UHFFFAOYSA-N methylellagic acid Natural products O1C(=O)C2=CC(O)=C(O)C3=C2C2=C1C(OC)=C(O)C=C2C(=O)O3 FAARLWTXUUQFSN-UHFFFAOYSA-N 0.000 claims description 4
- 229910052750 molybdenum Inorganic materials 0.000 claims description 4
- 239000011733 molybdenum Substances 0.000 claims description 4
- 235000019161 pantothenic acid Nutrition 0.000 claims description 4
- 239000011713 pantothenic acid Substances 0.000 claims description 4
- 235000021317 phosphate Nutrition 0.000 claims description 4
- 239000010452 phosphate Substances 0.000 claims description 4
- 229960001860 salicylate Drugs 0.000 claims description 4
- YGSDEFSMJLZEOE-UHFFFAOYSA-M salicylate Chemical compound OC1=CC=CC=C1C([O-])=O YGSDEFSMJLZEOE-UHFFFAOYSA-M 0.000 claims description 4
- 229910052711 selenium Inorganic materials 0.000 claims description 4
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- 230000004083 survival effect Effects 0.000 claims description 4
- 229960003080 taurine Drugs 0.000 claims description 4
- 229910052725 zinc Inorganic materials 0.000 claims description 4
- 239000011701 zinc Substances 0.000 claims description 4
- BTBUEUYNUDRHOZ-UHFFFAOYSA-N Borate Chemical compound [O-]B([O-])[O-] BTBUEUYNUDRHOZ-UHFFFAOYSA-N 0.000 claims description 3
- CPELXLSAUQHCOX-UHFFFAOYSA-M Bromide Chemical compound [Br-] CPELXLSAUQHCOX-UHFFFAOYSA-M 0.000 claims description 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims description 3
- VYZAMTAEIAYCRO-UHFFFAOYSA-N Chromium Chemical compound [Cr] VYZAMTAEIAYCRO-UHFFFAOYSA-N 0.000 claims description 3
- JVTAAEKCZFNVCJ-UHFFFAOYSA-M Lactate Chemical compound CC(O)C([O-])=O JVTAAEKCZFNVCJ-UHFFFAOYSA-M 0.000 claims description 3
- WHXSMMKQMYFTQS-UHFFFAOYSA-N Lithium Chemical compound [Li] WHXSMMKQMYFTQS-UHFFFAOYSA-N 0.000 claims description 3
- ZVOLCUVKHLEPEV-UHFFFAOYSA-N Quercetagetin Natural products C1=C(O)C(O)=CC=C1C1=C(O)C(=O)C2=C(O)C(O)=C(O)C=C2O1 ZVOLCUVKHLEPEV-UHFFFAOYSA-N 0.000 claims description 3
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- BECPQYXYKAMYBN-UHFFFAOYSA-N casein, tech. Chemical compound NCCCCC(C(O)=O)N=C(O)C(CC(O)=O)N=C(O)C(CCC(O)=N)N=C(O)C(CC(C)C)N=C(O)C(CCC(O)=O)N=C(O)C(CC(O)=O)N=C(O)C(CCC(O)=O)N=C(O)C(C(C)O)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=O)N=C(O)C(CCC(O)=O)N=C(O)C(COP(O)(O)=O)N=C(O)C(CCC(O)=N)N=C(O)C(N)CC1=CC=CC=C1 BECPQYXYKAMYBN-UHFFFAOYSA-N 0.000 claims description 3
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- MWDZOUNAPSSOEL-UHFFFAOYSA-N kaempferol Natural products OC1=C(C(=O)c2cc(O)cc(O)c2O1)c3ccc(O)cc3 MWDZOUNAPSSOEL-UHFFFAOYSA-N 0.000 claims description 3
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- 235000002949 phytic acid Nutrition 0.000 claims description 3
- SIOXPEMLGUPBBT-UHFFFAOYSA-N picolinic acid Chemical compound OC(=O)C1=CC=CC=N1 SIOXPEMLGUPBBT-UHFFFAOYSA-N 0.000 claims description 3
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- 125000002887 hydroxy group Chemical group [H]O* 0.000 claims description 2
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- AGBQKNBQESQNJD-UHFFFAOYSA-M lipoate Chemical compound [O-]C(=O)CCCCC1CCSS1 AGBQKNBQESQNJD-UHFFFAOYSA-M 0.000 claims 1
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- YVJOHOWNFPQSPP-PZXRSRGQSA-L magnesium;(2s,3r)-2,3,4-trihydroxybutanoate Chemical compound [Mg+2].OC[C@@H](O)[C@H](O)C([O-])=O.OC[C@@H](O)[C@H](O)C([O-])=O YVJOHOWNFPQSPP-PZXRSRGQSA-L 0.000 description 53
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Abstract
本发明提供了含有镁和苏糖酸盐或苏糖酸盐前体分子的组合物,所述组合物被配制用于延缓或改进释放以提供希望时间内的生理浓度。所述缓释或改进释放形式特别适用于向受试者提供Mg,同时避免了例如腹泻的不良副作用。
Description
相关申请
本申请要求2009年7月1日提交的美国临时申请61/222,420的优先权,其全部在此通过参考而引入。
发明背景
镁是人体内第四丰富的矿物质,在保持身体健康中起着多种作用。在分子水平上,镁是负责包括人类在内的哺乳动物中的一些最重要的生物活性的三百多种酶的辅助因子。在活细胞中,镁还参与其它矿物质(例如钠、钾和钙)的体内平衡,以及三磷酸腺苷(ATP)的形成、转运、贮存和利用,所述三磷酸腺苷是活细胞的主要能量来源。在人体中,镁参与维持正常的肌肉和神经功能、心节律、骨强度和免疫系统健康。镁还参与血糖水平的调节和促进正常血压。
镁缺乏与几种疾病有关,包括高血压、动脉粥样硬化、心律失常、糖尿病和代谢综合征。此外,镁缺乏加速了细胞老化过程(Killilea DW,Ames BN.Magnesium deficiency accelerates cellular senescence in culturedhuman fibroblasts.Proc Natl Acad Sci U S A.2008 Apr 15;105:5768-73)。镁对脑功能也很重要。例如,镁缺乏参与导致注意缺陷障碍(Kozielec T,Starobrat-Hermelin B.Magnes Res.1997 Jun;10:143-8;Mousain-Bosc M,Roche M,Polge A,Pradal-Prat D,Rapin J,Bali JP.Magnes Res.2006Mar;19:46-52)、情感障碍(Murck H.Nutritional neuroscience.2002Dec;5:375-89)、阿尔茨海默氏症(Andrasi E,Pali N,Molnar Z,Kosel S.JAlzheimers Dis.2005 Aug;7:273-84;Cilliler AE,Ozturk S,Ozbakir S.Gerontology.2007 Nov 8;53:419-22;Lemke MR.Biol Psychiatry.1995 Mar1;37:341-3)、偏头痛(Ramadan NM,Halvorson H,Vande-Linde A,LevineSR,Helpern JA,Welch KM.Headache.1989 Oct;29:590-3;Facchinetti F,Sances G,Borella P,Genazzani AR,Nappi G.Magnesium prophylaxis ofmenstrual migraine:effects on intracellular magnesium.Headache.1991May;31:298-301)和自闭症(Martineau J,Barthelemy C,Garreau B,LelordG.Biol Psychiatry.1985 May;20:467-78;Pfeiffer SI,Norton J,Nelson L,Shott S.J Autism Dev Disord.1995 Oct;25:481-93;Strambi M,Longini M,Hayek J,Berni S,Macucci F,Scalacci E,Vezzosi P.,Biol Trace Elem Res.2006 Feb;109:97-104)。
最近发现,细胞外镁的升高导致所培养海马神经元的突触可塑性和突触密度显著增加(Slutsky I,Sadeghpour S,Li B,Liu G.Neuron.2004Dec 2;44:835-49)。突触网络被认为参与了早期发育以及学习和记忆过程中神经环路的组织。事实上,在患有阿尔茨海默氏症的病人中,突触数量和认知功能障碍程度之间存在很大的逆相关(Terry RD,Masliah E,Salmon DP,Butters N,DeTeresa R,Hill R,Hansen LA,Katzman R.AnnNeurol.1991 Oct;30:572-80;Selkoe DJ.Science.2002 Oct25;298:789-91)。在正常的老化过程中,记忆力下降还与突触损失相关(Terry RD,Masliah E,Salmon DP,Butters N,DeTeresa R,Hill R,HansenLA,Katzman R.Ann Neurol.1991 Oct;30:572-80)。有趣的是,AD患者脑内的镁含量比正常受试者要低(Andrasi E,Pali N,Molnar Z,Kosel S.JAlzheimers Dis.2005 Aug;7:273-84;Cilliler AE,Ozturk S,Ozbakir S.Gerontology.2007 Nov 8;53:419-22)。增加脑内的镁可能有利于防止老化和AD病理过程中的突触损失和改善记忆力衰退。
尽管镁具有重要的生理作用,但是在人们的饮食中可能没有消费足够的镁。在美国的全国抽样中,年龄在20-30岁之间的每日镁的平均值为白种人~300mg,而黑人男性~250mg。在大于70岁的老年人中,由于食物消费量的减少,日摄取量也降低至~200mg。另一方面,建议男性的每日供给量(RDA)为420mg/天。所以,大多数的美国男性人群可能镁缺乏,特别是在衰老过程中。相似程度的缺失也存在于美国女性人群中(Ford ES,Mokdad AH.J Nutr.2003 Sep;133:2879-82)。基于该研究,大多数美国人需要在他们的饮食中补充额外~200mg/天的镁。有趣的是,食物中所含的镁提供相对高的镁吸收率(~50%),这可能意味着仍然需要~100mg/天的镁吸收到人体。一般情况下,大多数市售的镁制剂具有≤~40%的镁吸收率。例如,氧化镁可能是最广泛使用的镁补剂,它的镁吸收率仅约4%(Firoz M,Graber M.Bioavailability of UScommercial magnesium preparations.Magnes Res.2001 Dec;14:257-62))。本发明提供了用作镁饮食补剂的控释镁组合物。
发明概述
为给人们供应足够的镁,需要非常高剂量的镁补剂才能达到建议的每日供给量(RDA)。例如,需要4克氧化镁作为口服补剂。缓释镁组合物提供了几个优点。缓释避免了在胃肠道(GI)内镁的浓度过高。胃肠道中未吸收的镁通常会导致腹泻。缓释能避免未吸收镁的蓄积,并减少了这类副作用。本发明公开了这类剂型及其应用。
一方面,本发明提供了一种包含镁(Mg)和苏糖酸盐(T)的口服剂型,其中所述苏糖酸盐包含一种或多种苏糖酸盐或苏糖酸盐前体,其中所述口服剂型在溶出介质中具有体外溶出曲线(dissolution profile),并且其中所述溶出曲线在使用美国药典II型(桨式)溶出系统于75rpm和37℃的温度下测定时,其范围为在约2小时内小于或等于5%,在约4小时内小于10%,在约6小时内小于40%,在约10小时内大于或等于60%,和在约12小时内大于或等于80%。
在一些实施方式中,所述口服剂型中的镁和苏糖酸盐被包封到片剂中。在一些实施方式中,至少部分所述镁(Mg)和苏糖酸盐(T)以MgT2的盐形式络合。在一些实施方式中,至少部分所述镁(Mg)和苏糖酸盐(T)以MgT2的盐形式络合,并且按重量以等于至少约20mg Mg的量存在。在其它的实施方式中,所述苏糖酸盐(T)和所述镁(T)的摩尔比大于或等于约0.1至2。在再其它的实施方式中,苏糖酸盐前体包含苏糖酸、苏糖酸酯或苏糖酸内酯。在更其它的实施方式中,所述镁(Mg)以大于约1重量%的量存在。在进一步的实施方式中,所述镁(Mg)以大于约5重量%的量存在,或以大于约7重量%的量存在。
在一些实施例中,所述镁(Mg)与选自氯化物、牛磺酸根、乳酸根、葡萄糖酸根、柠檬酸根、苹果酸根、琥珀酸根、硫酸根、丙酸根、氢氧化物、氧化物、乳清酸根、磷酸根、硼酸根、水杨酸根、碳酸根、溴化物、硬脂酸根、氨基酸、丁酸根、天门冬氨酸根、抗坏血酸根、吡啶甲酸根、泛酸根、烟酸根、苯甲酸根、肌醇六磷酸根、酪蛋白酸根、棕榈酸根、丙酮酸根和苏糖酸根的阴离子络合。在其它的实施方式中,口服剂型进一步包含选自钙、钾、钠、铬、铁、硒、锌、锰、钼、钒和锂的金属离子。在其它的一些实施方式中,口服剂型进一步包含一种或多种选自白藜芦醇、鞣花酸、槲皮素(quecertin)、硫辛酸和维生素C的抗氧化剂。
在一些实施方式中,所述溶出曲线在使用美国药典II型(桨式)溶出系统于75rpm和37℃的温度下测定时,其范围为在约2小时内小于5%,在约4小时内小于10%,在约6小时内小于40%,在约10小时内大于或等于60%,和在约12小时内大于或等于80%。在一些实施方式中,该溶出曲线是零级。
在一些实施方式中,在所述口服剂型中有至少75%的所述镁(Mg)和苏糖酸盐(T)以控释剂型提供。在一些实施方式中,在所述口服剂型中有至少95%的所述镁(Mg)和苏糖酸盐(T)以控释剂型提供。在一些实施方式中,在所述口服剂型中有100%的所述镁(Mg)和苏糖酸盐(T)以控释剂型提供。
在一些实施方式中,溶出介质是盐溶液。在一些实施方式中,口服剂型进一步包含与镁(Mg)和苏糖酸盐(T)混合的聚合物粘合剂。在一些实施方式中,聚合物包含聚乙烯吡咯烷酮。在一些实施方式中,口服剂型进一步包含药学上可接受量的硬脂酸镁。在一些实施方式中,口服剂型进一步包含聚乙烯吡咯烷酮、聚乙酸乙烯酯或丙二醇中的一种或多种。
在另一方面,本发明提供了一种包含约10mg至500mg元素镁(Mg)的口服剂型,其中所述口服剂型是控释制剂,并且一经向Sprague-Dawley大鼠施用等于或小于约75mg/kg/天的所述口服剂型,腹泻的发病率小于20%。在一些实施方式中,当以等于或小于约75mg/kg/天的剂量施用至少约3天时,腹泻的发病率小于20%。在一些实施方式中,剂型中镁的溶出速率为在约6至10小时内溶出约40-80%。在一些实施方式中,当以等于或小于约130mg/kg/天的剂量施用所述口服剂型时,腹泻的发病率小于50%。
在另一方面,本发明提供了一种包含镁(Mg)和苏糖酸盐(T)的口服剂型,其中所述苏糖酸盐包含一种或多种苏糖酸盐或苏糖酸盐前体,其中所述口服剂型有效增加高热量饮食受试者的寿命。在一些实施方式中,对高热量饮食受试者施用所述口服剂型产生保护作用,使得所述受试者的寿命与中等体重受试者的平均寿命相当。在一些实施方式中,所述口服剂型以约1mg元素镁/kg/天至约16mg元素镁/kg/天的剂量施用于人类受试者。在一些实施方式中,对于具有高热量饮食至少约60周的受试者,该口服剂型增加至少约40%的生存率。
在另一方面,本发明提供了一种包含镁(Mg)和苏糖酸盐(T)的口服剂型,其中所述苏糖酸盐包含一种或多种苏糖酸盐或苏糖酸盐前体,其中将所述口服剂型施用于受试者后能提供保护以对抗所述受试者高热量饮食所产生的不良作用。该不良作用可包括但不限于动脉粥样硬化、心肌梗死、中风、血栓栓塞、代谢综合征和糖尿病。在一些实施方式中,所述口服剂型以约1mg元素镁/kg/天至约16mg元素镁/kg/天的剂量施用于人类受试者。在一些实施方式中,对于具有高热量饮食至少约60周的受试者,该口服剂型增加至少约40%的生存率。
在另一方面,本发明提供了包含镁(Mg)和苏糖酸盐(T)的口服剂型,其中所述苏糖酸盐包含一种或多种苏糖酸盐或苏糖酸盐前体,其中在对受试者施用所述口服剂型后,所述口服剂型易于吸收或保留,当将所述口服剂型以约20mg/kg/天或更高的剂量施用时,至少约50%所述施用的镁被所述受试者吸收,或者至少约30%施用于受试者的镁保留至少2天的时间。
在一些实施方式中,所述受试者是Sprague-Dawley大鼠。在一些实施方式中,大于约60%所述施用的镁在所述受试者被吸收。在一些实施方式中,当将所述口服剂型以约20mg/kg/天或更高的剂量施用时,大于约40%所述施用的镁保留至少2天的时间。在一些实施方式中,当以约20mg/kg/天至约80mg/kg/天的量施用于受试者时,该口服剂型中被吸收的镁呈现出与剂量成比例的增加。
在一些实施方式中,本发明的口服剂型包含镁(Mg)和苏糖酸盐(T),其中所述苏糖酸盐包含一种或多种苏糖酸盐或苏糖酸盐前体,并且其中所述口服剂型当施用于受试者时,在受试者的脑脊液中提供浓度增加的镁,其中与没有施用镁的基线镁浓度相比,在对所述受试者施用所述口服剂型约10天后,在所述受试者脑脊液中增加的镁浓度范围为增加约5%至增加约10%。
在另一方面,本发明提供了一种治疗与镁缺乏相关的病症的方法,包括对有需要的受试者施用本文公开的口服剂型。在一些实施方式中,该病症选自神经疾病、心血管疾病和代谢紊乱。
在再另一方面,本发明提供了一种提高有需要的受试者中枢神经系统内镁的方法,包括对所述受试者施用本发明提供的口服剂型。
在再另一方面,本发明提供了一种保持高热量饮食但没有高热量相关不良作用的重大危险的方法,包括对有需要的受试者施用本发明提供的口服剂型。
在更另一方面,本发明提供了一种对有需要的受试者补充镁的方法,包括对所述受试者施用本发明提供的口服剂型至少每天一次。
在更另一方面,本发明提供了一种对有需要的受试者补充镁的方法,包括对所述受试者施用本发明提供的口服剂型至少每天两次,时间为1个月或更长。
本发明还提供了一种制备上述口服剂型的方法,包括将含有镁(Mg)和苏糖酸盐(T)的粉末与聚合物混合,其中镁(Mg)和苏糖酸盐(T)均以盐形式存在,所述聚合物的量足以产生含有镁(Mg)、苏糖酸盐(T)和聚合物的颗粒,其中所述颗粒具有足以保留在12目筛上的尺寸。在一些实施方式中,该方法进一步包括使用12目筛过滤所述颗粒以除去未结合的苏糖酸盐;干燥颗粒;向所述颗粒中加入药学上可接受量的润滑剂;将颗粒压制成大小在约100mg至2000mg之间的一种或多种小丸;以及用包含聚乙烯吡咯烷酮、聚乙酸乙烯酯或丙二醇中一种或多种的聚合物包衣膜对所述一种或多种小丸包衣。
通过参考引入
在本说明书中提及的所有出版物、专利和专利申请在本文中以相同程度通过参考被引入,如同指明每个单独的出版物、专利或专利申请通过参考被具体且单独地引入。
附图简述
本发明的新特征在所附的权利要求书中具体陈述。参照下列阐述说明性实施例的具体描述,将更好地理解本发明的特点和优点,其中使用本发明的方法,其相应的附图为:
图1描绘了对大鼠提供不同镁制剂后的腹泻发病率图。y-轴是腹泻发病率,x-轴是每kg每天的元素镁剂量。镁化合物是柠檬酸镁(MgCitrate)、氯化镁(MgCl2)、葡萄糖酸镁(MgG)、于牛奶中的葡萄糖酸镁(MgG+牛奶)和苏糖酸镁(MgT)。
图2描绘了显示不同镁制剂的吸收、重吸收和保留率的系列图。所述制剂包括氯化镁(MgCl2)、柠檬酸镁(MgCitrate)、葡萄糖酸镁(MgG)、甘氨酸镁(MgGly)和苏糖酸镁(MgT)。图2A描绘了对于苏糖酸镁(MgT)和MgCl2,镁(Mg)摄取和镁吸收量之间的关系。吸收率通过线性回归评估。图2B描绘了表示为百分比的不同镁制剂的吸收率。图2C描绘了被吸收镁和尿液中排泄的镁之间的关系。排泄率通过线性回归评估。图2D描绘了表示为百分比的不同镁制剂的排泄率。图2E描绘了镁摄取和其在体内保留之间的关系。保留率通过线性回归评估。图2F描绘了表示为百分比的不同镁制剂的保留率。
图3描绘了用不同制剂治疗后脑脊液中镁浓度([Mg2+]CSF)的增加图。y-轴显示了[Mg2+]CSF的变化,而x-轴表示时间为天。镁化合物是氯化镁(MgCl2)、于牛奶中的葡萄糖酸镁(MgG+牛奶)和苏糖酸镁(MgT)。
图4A描绘了补充和未补充苏糖酸镁(MgT)的雄性小鼠的生存曲
线。图4B描绘了补充和未补充苏糖酸镁(MgT)的雌性小鼠的生存曲线。
图5A描绘了小鼠喂食标准或高热量(HC)饮食后随时间的体重。
图5B描绘了标准或高热量饮食下的小鼠生存曲线。高热量饮食下的小鼠寿命比标准饮食下的小鼠寿命短。高热量饮食加MgT下的小鼠寿命与标准饮食下的小鼠寿命相似。
图6A描绘了包含苏糖酸镁的控释片剂。图6B描绘了根据实施例6配制的包含苏糖酸镁的控释片剂的释放曲线。
发明详述
I.控释口服剂型
本发明提供了包含镁和苏糖酸盐或苏糖酸盐前体分子的组合物,其被配制用来延缓或控制释放,以提供在理想的时间段内足够高的生理有效的血清或血浆浓度,但速率又低至足以避免与高水平镁相关的不良事件。与高Mg含量有关的副作用包括腹泻。镁的控制释放对于降低和延迟血浆峰水平的同时维持生物利用度是十分理想的。因此,在将与制剂的立即释放有关的副作用最小化的同时,达到了生理有效的水平。此外,由于获得血清或血浆峰水平的时间延迟,以及治疗有效的血清或血浆水平时间延长,剂量频率减少到例如每天一次或两次剂量,从而增加受试者的顺应性和依从性。例如,通过使用延长体内达峰浓度时间的控释制剂,可减轻与施用镁相关的包括腹泻在内的副作用的严重程度和频率,从而减少镁浓度随时间的变化。减少浓度变化还降低了活性成分在其最大值时间点的浓度,并在给定时间内为治疗受试者提供了更为稳定量的镁,其可进一步实现用于适应症的增加剂量。
本发明范围内的控释可指任意一种缓释剂型。缓释剂型的非限制性的例子在Heaton等的2005/0129762的美国专利申请公开和Edgren等的2007/0128279的美国专利申请公开中有描述,其在此通过参考被引入。缓释制剂在本领域是已知的,其部分在Sawada等的2006/0292221的美国专利申请公开中有描述,在此通过参考被引入。出于本发明的目的,下列术语被认为与控释实质上相同:改进释放、连续释放、控制释放、延迟释放、贮库、逐步释放、长期释放、程序释放、延长释放、成比例释放、推迟释放、储库、延滞、缓慢释放、间隔释放、持续释放、缓释包衣(time coat)、定时释放、延迟作用、延长作用、分层缓慢作用、长效、延迟作用、重复作用、缓慢作用、持续作用、持续作用的药物和延缓释放。对这些术语的进一步讨论可参见Lesczek Krowczynski,Extended-Release Dosage Forms,1987(CRC Press,Inc.)。各种控释技术涵盖了非常广泛的剂型。控释技术包括但不限于物理体系和化学体系。
本文描述的组合物、试剂盒和/或方法对于本文描述的目的是有用的,例如维持、增强和/或改善健康、营养和/或受试者的其它病症和/或认知、学习和/或记忆功能,例如仅以举例方式的镁缺乏、轻度认知障碍(MCI)、阿尔茨海默式病(AD)、注意缺陷障碍(ADHD)、肌萎缩性侧索硬化症(ALS)或卢·格里格病(Lou Gehrig’s disease)、帕金森病、精神分裂症、糖尿病、偏头痛、焦虑、情感和高血压。
本发明的组合物可配制成缓慢释放或持续释放的形式,即在延长的时间内提供水平相对一致的苏糖酸镁。在一些实施方式中,镁反离子组合物和/或其它治疗剂可通过使用控释剂型联合或单独施用。在一种实施方式中,本发明提供了包含镁(Mg)和苏糖酸盐(T)的口服剂型,其中所述苏糖酸盐包含一种或多种苏糖酸盐或苏糖酸盐前体,其中所述口服剂型在溶出介质中具有体外溶出曲线,并且其中所述溶出曲线在使用美国药典II型(桨式)溶出系统于75rpm和37℃的温度下测定时,其范围为在约2小时内小于或等于5%,在约4小时内小于10%,在约6小时内小于40%,在约10小时内大于或等于60%,和在约12小时内大于或等于80%。在其它的实施方式中,所述溶出曲线在使用美国药典II型(桨式)溶出系统于75rpm和37℃的温度下测定时,其范围为在约2小时内小于5%,在约4小时内小于10%,在约6小时内小于40%,在约10小时内大于或等于60%,和在约12小时内大于或等于80%。在其它的实施方式中,所述溶出曲线在使用美国药典II型(桨式)溶出系统于75rpm和37℃的温度下测定时,其范围为在约2小时内小于5%,在约4小时内小于10%,在约6小时内小于40%,在约10小时内大于或等于60%,和在约12小时内大于或等于80%。在本文所述口服剂型的一些实施方式中,所述镁和苏糖酸盐被包封在片剂中。
在一些实施方式中,本发明控释口服剂型中的至少75%所述镁(Mg)和苏糖酸盐(T)以控释剂型提供。在一些实施方式中,控释口服剂型中的至少95%所述镁(Mg)和苏糖酸盐(T)以控释剂型提供。在一些实施方式中,所述口服剂型中的100%所述镁(Mg)和苏糖酸盐(T)以控释剂型提供。在一些实施方式中,溶出介质是盐溶液。在一些实施方式中,溶出曲线是零级,即溶出速率与浓度无关。
释放曲线,即在所需时间内镁释放的程度,可对给定的时间通过在控制条件下测定释放方便地确定,例如使用美国药典溶出装置。优选的释放曲线是减慢了镁向血流的摄取,同时还提供治疗有效水平的镁的那些。根据对于控释(“CR”)曲线的标准溶出试验指南,活性成分的溶出在一段时间内的给定间隔测定。建议最少有三个时间点,一般包括溶出曲线的早、中和晚阶段。最后的测量应不早于至少80%活性成分溶解的时间点(Guidance for Industry,“Extended Release Oral Dosage Forms:Development,Evaluation,and Application of In Vitro/In Vivo Correlations”,Food and Drug Administration,CDER,September 1997,第17页)。充分采样是重要的:例如在1、2和4小时以及随后的每2小时采样,直到80%活性成分被释放(Guidance for Industry,SUPAC-MR:Modified ReleaseSolid Oral Dosage Forms,”Food and Drug Administration,CDER,1997年9月,第6页)。优选的溶出装置是美国药典的装置I(篮式)或II(桨式),以认可的旋转速度应用,例如篮式为100rpm,桨式为50-75rpm(Guidance for Industry,“Extended Release Oral Dosage Forms:Development,Evaluation,and Application ofIn Vitro/In Vivo Correlations”,Food and Drug Administration,CDER,1997年9月,第4页)。控释剂型允许在延长的时间内释放活性成分。另一方面,在最初的30至60分钟内溶于溶液的物质被认为立即释放(“IR”)曲线。(“Dissolution Testing ofImmediate Release Solid Oral Dosage Forms”,1997年8月发行,IV-A部分)。所以,立即释放的固体口服剂型允许大多数或全部活性成分在短时间内释放,例如60分钟或更少。
主题组合物可包含活性成分,包括镁、苏糖酸盐或苏糖酸盐前体。在一个实施方式中,主题组合物包含镁反离子,如下式所示:
该组合物可以是在预防和/或治疗方面适合的或有利的。苏糖酸盐是维生素C或抗坏血酸的天然代谢产物,对动物无毒(Thomas等,FoodChem.17,79-83(1985))且与在动物中的生物效应(例如,促进维生素C的摄取)相关(Verlangieri等,Life Sci.48:2275-2281(1991))。
在一些实施方式中,苏糖酸盐包括苏糖酸盐和/或苏糖酸盐前体分子。苏糖酸盐可以是盐的形式。术语“苏糖酸盐前体”通常指当组合物溶于水性介质或在有酶或无酶的帮助下电离或水解而被摄入时,容易转化为苏糖酸盐的前体分子。前体可以是苏糖酸、苏糖酸的酯衍生物或苏糖酸酯,或者内酯化的苏糖酸。通常,本发明中使用的苏糖酸盐是指L-苏糖酸盐。例如,L-苏糖酸盐前体可以是L-苏糖酸、L-苏糖酸的酯衍生物或L-苏糖酸酯,或者内酯化的L-苏糖酸。在一些实施方式中,本发明使用D-苏糖酸盐或其前体。
在一些实施方式中,至少一部分所述镁(Mg)和苏糖酸盐(T)以MgT2的盐形式络合。在一些实施方式中,至少一部分所述镁(Mg)和苏糖酸盐(T)以MgT2的盐形式络合,其以重量等于至少约20mg的Mg的量存在。在一些实施方式中,所述苏糖酸盐(T)和所述镁(Mg)之间的摩尔比大于或等于约0.1至2。在一些实施方式中,镁(Mg)按重量以大于约1%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%或15%的量存在。在一些实施方式中,镁(Mg)按重量以大于约1%、5%或大于约7%的量存在。
本发明的组合物通常包含足量(如下进一步定义)的镁离子(下文称为“镁”)和苏糖酸盐或苏糖酸盐前体分子,其中镁或苏糖酸盐可以是也可以不是所述组合物中的苏糖酸镁形式。当镁不是苏糖酸镁的形式而是其它的镁盐时,其它的镁盐可以是任何合适的无机或有机镁盐。在本文,术语“合适的”通常指镁盐的阴离子是无毒的。合适盐的例子包括但不限于氯化镁、硫酸镁、氧化镁、醋酸镁、乳酸镁、柠檬酸镁、苹果酸镁、D-苏糖酸镁、葡萄糖酸镁、牛磺酸镁和吡酮酸(pidolate)镁。同样,当苏糖酸盐不是苏糖酸镁的形式时,其可以是包含其它无毒阳离子的其它苏糖酸盐形式。合适的无毒阳离子包括钾、钠、钙和铵。在一些实施方式中,合适的无毒阳离子是钾。一般情况下,本发明使用的术语“苏糖酸盐”包含苏糖酸盐及其前体,以举例的方式包括盐、酸、酯和内酯。
除苏糖酸镁外,组合物可包含至少一种含镁成分(MCC)或也用作本文的镁-反离子化合物。MCC的例子包括氨基酸的镁盐、醋酸镁、抗坏血酸镁、柠檬酸镁、葡萄糖酸镁、乳酸镁、苹果酸镁、吡咯烷酮羧酸镁和牛磺酸镁。本文公开的组合物的其它盐包括但不限于:酸加成盐,例如用盐酸、甲磺酸、氢溴酸、氢碘酸、高氯酸、硫酸、硝酸、磷酸、醋酸、丙酸、乙醇酸、乳酸、丙酮酸、丙二酸、丁二酸、顺丁烯二酸、富马酸、顺丁烯二酸、酒石酸、柠檬酸、苯甲酸、碳酸、肉桂酸、扁桃酸、甲磺酸、乙磺酸、羟基乙磺酸、苯磺酸、对甲苯磺酸、环己基氨基磺酸、水杨酸、对氨基水杨酸、2-苯氧苯甲酸和2-乙酰氧苯甲酸制得的那些酸加成盐。术语“盐”还可包括游离酸或游离碱的加成盐。所有这些盐(或其它类似的盐)可通过常规方式制备。所有的这些盐是可以接受的,条件是它们是无毒的并且不会显著干扰所需的药理活性。
本发明的MCC组合物可包含至少一种足以增强与MCC相关的元素镁生物利用度的非酸化奶成分。该成分的例子包括乳糖、脂肪酸或乳脂,和/或其例如足以实现这种增强的其它的有机成分。与至少一种MCC相关的元素镁用量和所述成分用量的质量比为约1至约5到约1至约3000。该组合物适合对受试者口服施用。
苏糖酸镁是一种镁反离子组合物的高度生物可利用形式。然而,可以以多种方式提供在体内获得这种苏糖酸镁。在一些实施方式中,受试者摄取苏糖酸镁。在其它的实施方式中,镁可与其它的补剂使用,导致体内镁反离子组合物的重构。不被理论所束缚,苏糖酸盐可促进任何形式的镁的细胞摄取,并且还可增强向脑和中枢神经系统的递送。因此,在一些实施方式中,提供不与苏糖酸盐络合的镁,并且对相同的受试者提供苏糖酸盐以增强吸收。例如,近乎同时服用葡萄糖酸镁和苏糖酸盐酸钾,以导致苏糖酸镁在体内的重构和/或增强镁摄取和/或镁向脑的递送。在其它的例子中,某些反离子可以是其它物质的代谢产物。例如,维生素C在人体代谢成苏糖酸根离子;因此,可被机体吸收的形式的镁和维生素C的摄取可导致苏糖酸镁在体内的重构。在人体被代谢成苏糖酸盐的其它物质的例子是抗坏血酸盐。因此,在本发明的一些实施方式中,可向受试者提供抗坏血酸镁,该物质在体内会代谢成镁和苏糖酸盐。本领域的技术人员能认识到,这些例子仅通过示例的方式来提供,镁化合物和次生化合物的其它组合可导致镁反离子组合物在体内的重构。
相对于包含单一镁反离子化合物的镁反离子组合物,包含一种以上镁反离子化合物的镁反离子组合物可以是合适的、有利的或理想的。在任意数目的特征或因素方面(例如含镁量、溶解度、适口性、镁生物利用度、生物可接受性等),一种以上镁反离子化合物的组合是合适的、有利的或理想的。在适口性方面,一种以上镁反离子化合物的组合可以是合适的、有利的或理想的。从维持和/或增强镁反离子化合物或几种镁反离子化合物的一种或多种属性方面来说,一种以上镁反离子化合物的组合可以是合适的、有利的或理想的。
苏糖酸盐与镁的摩尔比率的相对量可以被调节用于各种制剂。通常,苏糖酸盐与镁的摩尔比≥~1/5。由于每个MgT含有2个苏糖酸根,这意味着至少有10%Mg来自MgT。另外的90%可来自MgCl2或其它的Mg盐。在一些实施方式中,苏糖酸盐与镁的摩尔比≥~2/7。例如,该比率对应这样的营养制剂,在350mg Mg的建议每日供给量(RDA)中,其包含约50mg MgT形式的Mg和约300mg MgCl2或其它Mg盐形式的Mg。在其它的实施方式中,苏糖酸盐与镁的摩尔比约为2。在一些实施方式中,所述组合物中的所有苏糖酸盐均为苏糖酸镁的形式,其为所述组合物的有效成分。当所述镁和苏糖酸盐是组合物中单独化合物的每部分,并且所述组合物被溶解或口服摄取时,则至少部分镁和苏糖酸盐将由于离子交换反应在原位形成苏糖酸镁。在一些实施方式中,所有的镁和所有的苏糖酸盐均来自相同的苏糖酸镁化合物,例如使组合物的质量达到最小。在一些实施方式中,当苏糖酸盐与镁的摩尔比率小于2时,部分镁来自其它的镁化合物。在一些实施方式中,其它的镁化合物选自氯化镁、牛磺酸镁、乳酸镁、葡萄糖酸镁、柠檬酸镁和苹果酸镁。
在本发明给定剂型中所用镁的准确量取决于所述组合物的物理形式。根据一种实施方式,本发明提供了包含至少1重量%、2重量%、3重量%、4重量%、5重量%、6重量%、7重量%、8重量%、9重量%或10重量%或更多的元素镁的固体或半固体组合物。根据一种实施方式,固体或半固体组合物是包含至少20mg元素镁或至少50mg元素镁或至少80mg元素镁的小丸。
本发明的控释组合物具有很多优点。例如,本发明还可以减少施用频率。例如,本发明的控释组合物可用来以比即释制剂更低的频率施用镁(即每天一次(q.d.)相对于每天两次(b.i.d)或每天三次(t.i.d)),从而改善了受试者的顺应性和护理人员的方便性。在一些实施方式中,本文描述的组合物以更低的频率施用,例如每隔2天、每隔3天、每周或每月。这些组合物是特别有用的,因为它们从施用开始就提供生物有效量的镁,这进一步改善了顺应性和依从性,并且能在较短时间内达到有效的稳态镁浓度。此外,本发明的组合物借助于其设计,允许以更高的镁剂量安全地施用,再次增加了这些药物在各种适应症中的利用性。
与具有相同镁数量的即释(IR)制剂所观察到的相比,使用本发明提供的控释剂型,能以更低的速率将镁释放到受试者样品中。在一些实施方式中,控释制剂在规定时间内从施用到最大浓度以浓度变化测定的生物样品变化率小于IR制剂速率的约80%、70%、60%、50%、40%、30%、20%或10%。此外,在一些实施方式中,浓度随时间的变化率小于IR制剂速率的约80%、70%、60%、50%、40%、30%、20%或10%。在一些实施方式中,浓度随时间的变化率小于IR制剂速率的约5%。
在一些实施方式中,通过以相对成比例的方式增加达到最大浓度的时间,可减小浓度随时间的变化率。例如,将达到最大浓度的时间增加两倍可使浓度的变化率减少近2倍。因此,可提供镁使其以比即释(IR)剂型显著减小的速率达到其最大浓度。本发明的组合物可配制成提供通过24小时、16小时、8小时、4小时、2小时或至少1小时的最大浓度改变。浓度变化率相应减少的倍率为约0.05、0.10、0.25、0.5或至少0.8。在某些实施方式中,这可通过将小于约30%、50%、75%、90%或95%的镁在施用1小时内释放到血流中来实现。
任选地,控释制剂呈现出初始(例如从施用后2小时至施用后4小时)斜率小于相同剂量相同镁的IR制剂的斜率的75%、50%、40%、30%、20%或10%的血浆浓度曲线。给定个别受试者的精确斜率将根据苏糖酸镁组合物、递送的数量或其它因素(包括例如患者是否进食)而改变。对于如上提及的其它剂量,斜率直接随剂量改变。
通过使用本文所述缓释制剂或施用方法,在施用开始的3、5、7、9、10、12、15或20天过程中,镁在受试者中达到治疗有效的稳态血浆浓度。例如,当将本文所述制剂以基本恒定的日剂量(例如剂量范围为每天50mg至1000mg,优选100mg至800mg,更优选200mg至700mg的元素Mg)施用时,其达到稳态血浆浓度的时间为使用剂量逐步上升方案达到该血浆浓度所需时间的约70%、60%、50%、40%、30%或更少。
在一些实施方式中,用溶出试验在开始的1、2、4、6、8、10或12小时测定的本发明的镁释放速率,小于含相同镁的IR制剂速率的约80%、70%、60%、50%、40%、30%、20%或10%。在一些实施方式中,用溶出试验在开始的2-4小时测定的本发明的镁释放速率,小于含相同镁的IR制剂速率的约80%、70%、60%、50%、40%、30%、20%或10%。在一些实施方式中,用溶出试验在开始的2-4小时测定的本发明的镁释放速率,小于含相同镁的IR制剂速率的约5%。
本发明提供的控释剂型可采用各种形式。在一些实施方式中,本发明的补剂组合物以口服剂型施用,包括液体剂型(例如悬浮液或浆液)和口服固体剂型(例如片剂或散装粉末)。在一些实施方式中,剂型以片剂提供。本文使用的术语“片”通常指片剂、囊片、胶囊(包括软明胶胶囊)和锭剂。圆形片剂的平均片大小优选为约10mg至150mg元素Mg,而胶囊形状片剂的平均片大小为约20mg至200mg元素Mg。控释片剂通常分为三种类型:骨架、贮库和渗透体系。尽管这三种体系中的任一种都适用于本发明,但后两种体系具有包封相对大质量的更优化的性能,这可能是本发明所希望的。在一些实施方式中,缓释片剂基于贮库体系,其中含镁和苏糖酸盐的核被多孔膜包衣包封,其一经水化就使得苏糖酸镁扩散。人类使用的有效日剂量可以为约50至1000mg镁,其对应606至12119mg苏糖酸镁。如果镁和苏糖酸盐来自苏糖酸镁以外的化合物源,那么质量范围将发生改变。由于有效成分的结合质量通常为克数,因此高效的递送系统可提供最佳结果。
控释片剂的例子及其释放曲线见图6,其中所述片剂包含位于核内的作为镁组合物的苏糖酸镁、作为粘合剂的聚乙烯吡咯烷酮(PVA)、作为润滑剂的硬脂酸镁,以及位于包衣内的作为基质构成剂的聚乙酸乙烯酯(SR30D)、作为造孔剂的PVP、作为惰性粉末的滑石粉和TiO2、作为增塑剂的丙二醇和色淀染料。见实施例6和表1。上述制剂的片剂在24小时内呈现出零级释放曲线。
本发明进一步提供了制备本文所述口服剂型的方法。片剂用本领域已知的方法制备,并且可进一步包含合适的粘合剂、润滑剂、稀释剂、崩解剂、着色剂、调味剂、助流剂、熔融剂,其中许都种类在本领域是已知的。本发明的口服剂型可任选地具有膜包衣,用以保护镁反离子补剂组合物的组分免受水分、氧气和光线中一种或多种的影响,或掩盖任何不良味道或外观。合适的包衣剂包括例如纤维素、羟丙基甲基纤维素。在一些实施方式中,口服剂型包含多个封装在胶囊中的小珠。该形式可用作缓释制剂。也可将其它的片剂形式配制在缓释形式中。制备缓释片剂的方法在本领域是已知的,例如参见美国专利公开文本2006/051416和2007/0065512,或本文公开的其它参考文献。
在一些实施方式中,本发明的口服剂型通过将包含镁(Mg)和苏糖酸盐(T)的粉末与聚合物混合来制备,其中镁(Mg)和苏糖酸盐(T)均可以盐形式存在,所述聚合物的量足以产生包含镁(Mg)、苏糖酸盐(T)和聚合物的颗粒,其中所述颗粒的尺寸足以被12目的筛保留。在一些实施方式中,该方法进一步包含:使用12目筛过滤所述颗粒以除去未结合的苏糖酸盐;干燥颗粒;向所述颗粒中加入可接受量的润滑剂;将颗粒压制成大小在约100mg至2000mg之间的一种或多种小丸,并用包含聚乙烯吡咯烷酮、聚乙酸乙烯酯或丙二醇中一种或多种的聚合物包衣膜对所述一种或多种小丸包衣。在一些实施方式中,制备具有约10mg至约200mg的元素镁含量的小丸。在一些实施方式中,包含在剂型中的一种或多种形式的苏糖酸盐包括本文所述苏糖酸盐前体分子的苏糖酸盐。例如,前体可包含苏糖酸、苏糖酸酯或苏糖酸内酯。
在一些实施方式中,本文所述组合物使用标题为“Pharmaceuticalmultiple-units formulation”的美国专利4,606,909中描述的制剂制备。该文献描述了一种控释多单元制剂,其一经制剂(例如小丸或片)的崩解就向受试者的胃中提供多个各自被包衣或被装入微胶囊的单元(见例如第3栏第26行至第5栏第10行,以及第6栏第29行至第9栏第16行)。这些各自被包衣或被装入微胶囊的每个单元含有横截面基本均匀的核,该核含有难溶性活性物质的颗粒,且核被对胃内条件基本耐受但在当前的胃肠道条件下可溶蚀的包衣膜所包衣。
在一些实施方式中,本发明的组合物使用例如标题为“Deliverysystem”的美国专利4,769,027中公开的方法配制。因此,生理可接受物质(例如糖/淀粉、盐和蜡)的缓释制剂可用含镁的水渗透性聚合基质包衣,然后再用其内分散有水溶性颗粒致孔材料的水渗透性膜包衣。
在一些实施方式中,例如,如标题为“Drug delivery system andmethod of making the same”的美国专利4,897,268中所描述制备镁组合物,该专利涉及生物相容的、生物可降解的微囊递送系统。因此,可将镁配制成含有自由流动的球形颗粒掺合物的组合物,所述球形颗粒通过将大量镁各自装入到例如以不同速率生物降解的不同共聚物赋形剂的微胶囊中得到,从而以预定的速率将镁释放到循环中。这些颗粒中的一部分含有共聚物赋形剂使得核活性成分在施用后迅速释放,并因此在初期递送活性成分。第二部分颗粒含有赋形剂类型使得当第一部分的递送开始下降时,被包封的成分开始递送。第三部分成分可用另外的不同赋形剂包封,使得当第二部分的递送开始下降时其开始递送。递送速率可通过例如改变聚(D,L-丙交酯-共-乙交酯)包囊中丙交酯/乙交酯的比例而变化。可用的其它聚合物包括聚缩醛聚合物、聚原酸酯类、聚酰胺酯类、聚己内酯及其共聚物、聚碳酸酯类、多聚羟基丁酯及其共聚物、聚马来酰亚胺类(polymaleamides)、共聚草酸酯类(copolyaxalates)和多糖类。
在一些实施方式中,如美国专利5,395,626中所描述制备本发明的组合物,该专利描述了一种多层控释剂型。该剂型含有多个包衣颗粒,其中每个包衣颗粒在含镁的核周围有多个层,即含镁的核和至少一层含活性成分的其它层被控释屏障层覆盖,从而提供至少两层具有多层包衣颗粒中水溶性组合物的控释层。
在一些实施方式中,镁和苏糖酸盐使用例如标题为“Methods anddevices for providing prolonged drug therapy”的美国专利6,919,373、标题为“Osmotic delivery system,osmotic delivery system semipermeable bodyassembly,and method for controlling delivery rate of beneficial agents fromosmotic delivery systems”的美国专利6,923,800、标题为“Conversion ofliquid filled gelatin capsules into controlled release systems by multiplecoatings”的美国专利6,929,803,以及标题为“Minimally compliant,volumeefficient piston for osmotic drug delivery systems”的美国专利6,939,556中所描述的OROS技术来制备,它们全部在此通过参考被引入。该技术采用渗透作用提供高达24小时的精确控制递送,并且适用于许多化合物,包括难溶性的那些。OROS技术可以用于递送高剂量来满足高负载要求。通过定位到胃肠道的特定区域,OROS技术可提供对活性成分更加有效的吸收和增强的生物利用度。OROS的渗透驱动力和直到释放时间的活性成分保护消除了偶尔由胃pH和运动性引起的吸收和代谢差异。
用于持续长期递送的制剂在例如标题为“Gastric retention dosageform having multiple layers”的美国专利号6,797,283、标题为“System fordelaying drug delivery up to seven hours”的美国专利号6,764,697,以及标题为“Sustained delivery of an active agent using an implantable system”的美国专利号6,635,268中进一步提供,它们全部在此通过参考被引入。
在一些实施方式中,本发明的控释剂型包含多个小珠,其中每个小珠包括直径为约1μm至约1000μm的核,并且该核包括范围为约15至约350mg Mg/g剂型的含有镁或其盐的活性成分,其中剂型包括小于约2.5%的加合物,并且在剂型进入应用环境开始的约60分钟内,活性成分的溶出速率大于约80%。在一些实施方式中,在30分钟内的溶出速率大于约80%。
在一些实施方式中,每个小珠包括核和含镁的活性成分。镁的合适小珠形式可包含与可溶性成分混合的镁和苏糖酸盐,所述可溶性成分例如糖类(如蔗糖、甘露醇等),聚合物(如聚乙二醇、羟丙基纤维素、羟丙基甲基纤维素等),表面活性剂(月桂基硫酸钠、chremophor、吐温、司盘类、普流罗尼(pluronic)等)、不溶性助流剂成分(微晶纤维素、磷酸钙、滑石粉、煅制二氧化硅等)、包衣材料(合适包衣材料的例子有聚乙二醇、羟丙基甲基纤维素、蜡、脂肪酸等)、在合适材料中的分散体(例子有蜡、聚合物、生理可接受的油、可溶性物质等)或上述物质的组合。
根据一些实施方式,核包括糖球(空白丸心(nonpareil seeds))、微晶纤维素或甘露醇。在一些实施方式中,所述核是糖球,USP(PaulaurCranbury,N.J.)。在一些实施方式中,所述核的粒径为约1μm至约1000μm。在一些实施方式中,所述核的粒径为约300μm至约900μm。在一些实施方式中,所述核的粒径为约450μm至约825μm。在示例性的实施方式中,可对核进行包衣以避免核与活性成分之间的相互作用。例如,合适的包衣材料包括但不限于聚乙二醇、羟丙基甲基纤维素、蜡、脂肪酸等。
在一种实施方式中,所述球包含剂型的一部分,范围为约50mg/g至约500mg/g,优选为约60mg元素镁/g口服剂型(即60mg Mg/g)至约100mg元素镁/g口服剂型(即100mg Mg/g)。小珠的分数取决于剂型中使用的其它组分(如果有的话)的量。
所述核可用镁包衣,例如苏糖酸镁。在一种实施方式中,基于整个IR小珠的重量,苏糖酸镁的量为约150mg/g(或12.4mg Mg/g)至约950mg/g(或78.4mg Mg/g),优选约500至900mg/g(或41.2至74.3mgMg/g)。在其它的实施方式中,镁的量为约15至300mg/g,优选约25至约250mg/g。
在一种实施方式中,在对核包衣前向粘合剂和助流剂的混合物中加入苏糖酸镁。助流剂可选自但不限于微晶纤维素、磷酸钙、滑石粉和煅制二氧化硅。助流剂的使用量为1.5mg/g至约35mg/g。在一些实施方式中,助流剂为约1.5mg/g至约30mg/g。在一些实施方式中,助流剂为约2.5mg/g至约25mg/g。在其它的实施方式中,助流剂的范围为约5mg/g至约30mg/g。
粘合剂可选自但不限于聚维酮(PVP)、羟丙基甲基纤维素(HPMC,Opadry)、羟丙基纤维素(HPC)或其组合。在一种其中粘合剂是HPMC的实施方式中,粘合剂的量的范围为约15mg/g至约30mg/g,优选约15mg/g至约25mg/g。在其它的其中粘合剂是聚维酮的实施方式中,粘合剂的量的范围为1.5mg/g至约35mg/g,优选约5mg/g至约30mg/g。
活性成分和粘合剂/水/助流剂的混合物可通过例如用搅拌器混合至少15分钟、至少30分钟或至少1小时来制备。组分还可通过包括掺合、混合、溶出和蒸发的方法,或通过使用悬浮来合并。
活性成分/粘合剂/非活性物质混合物可沉积在核上、制湿团并挤出、制粒或喷雾干燥。在一种实施方式中,在应用所述混合物前,糖球先在约40℃至约55℃的范围内预热。核在应用于活性层前,任选地用约2%w/w至约10%w/w的密封包衣膜进行包衣。密封包衣膜可以是能将任意活性成分与核分开的任何可适用的包衣,例如聚合物包衣,如EudragitHPMC、HPC或其组合。为此,本发明组合物的溶出稳定性(即暴露于升高的温度时维持溶出曲线)也十分重要。
在一种实施方式中,糖球用本领域已知的流化床包衣器进行包衣,例如Glatt Powder Coater and Granulator GPCG3(Ramsey,N.Y.)。熟练掌握包衣条件,例如通常控制空气流速、喷雾速率和雾化压力是本领域的技术人员能了解或已知的。产品的温度范围可为约43℃至约51℃。空气流速的范围可为约5至约9m/s。喷雾速率的范围可为约9至约42gm/min。雾化压力的范围可为约1.5至约2.0bar。然后,将小珠在带包衣装置的流化床中约45℃至约50℃的温度下干燥至少5分钟。在一些实施方式中,小珠干燥至少15分钟,或至少30分钟。本领域技术人员能认识到,还可使用许多替代的操作条件和各种类型的仪器。
一旦IR小珠形成本文提供的含苏糖酸镁的核,小珠可任选地用密封包衣膜进行额外包衣。密封包衣膜可以是聚合物或聚合物组合,它们可被设计为pH依赖性或非依赖性。在一个优选的实施方式中,用于密封包衣膜的聚合物选自但不限于HPMC(OpadryColorcon,PA)、HPC、EudragitRL、EudragitE100、EudragitE 12.5、EudragitE PO、EudragitNE(例如NE 30D或NE 40D),以及两种或多种前述物质的组合。这些聚合物在水性介质中是不溶的,但是与水性流体接触时表现为pH非依赖性的溶胀。在其它的实施方式中,IR小珠用在优选大于5的pH中可溶的pH依赖性的聚合物包衣。在IR小珠制剂中,密封包衣膜聚合物的量的范围为约0%w/w至约40%w/w,优选约0%w/w至约10%w/w,更优选约0%w/w至约3%w/w。
或者,出于美观、处理或稳定性目的,IR核可用能迅速崩解或溶解的包衣膜进行包衣。合适的材料有聚乙烯吡咯烷酮、羟丙基纤维素、羟丙基甲基纤维素、聚乙二醇、含游离氨基的聚甲基丙烯酸酯,它们每种可有或没有增塑剂,以及有或没有抗粘剂或填充剂。通常认为,加入核重量约3%的包衣材料能提供该尺寸范围的连续包衣。外包衣膜可以是选自但不限于HPMC(OpadryColorcon,PA)、HPC、EudragitRL、EudragitE100、EudragitE 12.5、EudragitE PO、EudragitNE及其混合物的聚合物。
通过渗透入到大量介质中并扩散通过聚合物层(其受聚合物渗透性和溶胀性质的控制),会发生活性剂(例如苏糖酸镁)自小珠的溶出。在一些实施方式中,改进释放的小珠与即释片剂型相比具有相近的生物等效AUC(曲线下面积,生物利用度的测量值),并且与即释片相比最大血浆浓度降低了至少25%。改进释放的小珠显示出良好的耐受性,并且能以范围很广的剂量施用。在一些实施方式中,当以单剂量施用时的最大血浆浓度小于即释片的约85%。在一些实施方式中,当以单剂量施用时的AUC在即释片的75%至130%内。该范围被认为与整个全身暴露等效。
控释制剂中的所有小珠都要求不会立即释放。这可防止剂量倾泻并可减少不良事件。在一些实施方式中,达到最大血浆浓度的平均时间范围为约5至约48小时,或约5至约36小时。在一些实施方式中,小珠具有在约4至约12小时内大于约70%至约80%的体外释放速率。在一些实施方式中,制剂具有在约2至约6小时内为约30%至约60%的释放速率。在一些实施方式中,在进入应用环境缓释的第一小时内,制剂具有约10%至约50%或者约10%至35%的释放速率。
在其它的实施方式中,本发明提供了包含即释(IR)组分和控释(CR)组分的复合剂型,其中即释组分包含第一种多个小珠,每个小珠包含占剂型约15至约350mg/g的第一种含镁或其盐的活性成分,其中约80%第一种活性成分在剂型进入应用环境后于开始的60分钟溶解;并且其中改进释放组分包含第二种多个小珠,每个小珠包含占剂型约15至约350mg/g的第二种含镁或其盐的活性成分,其中约70%至约80%第二种活性成分在剂型进入应用环境后于约4小时至约24小时内溶解。
复合剂型可组合成具有单相或多相曲线的单个剂型。组合物中的活性成分(例如苏糖酸镁)的量以mg/剂量测定,范围为约2.5mg至约100mg/剂量。优选地,所述剂量含有2.5mg至80mg活性成分。在其它的实施方式中,剂量为3、6、7、9、12、14、15、20、21、28、40或60mg。
包含IR和CR组分的组合物可包括用量约为本发明组合物约5%至90%的即释形式的镁。在一些实施方式中,即释部分为约10%至60%。在一些实施方式中,即释的镁含量为约15%至50%。镁的控释形式可组成活性成分的剩余部分。因此,最终的组合物在施用后提供一定量即释的镁,然后是其它量的缓慢/改进释放。本发明的组合物在任何给药间隔的血浆浓度/时间曲线中均可呈现出一个以上的峰,这取决于所用的特定活性成分、IR和CR组分的相对量、以及CR组分的溶出性质。因此,可得到具有特定释放曲线的组合物。
包含IR和CR组分的组合物可包括本领域已知的任何固体口服剂型。例如,本发明使用的固体剂型包括小珠。小珠是与剂量成比例的,即相同比例不同类型的小珠可用于不同的剂量,而不会显著改变活性成分随时间释放的百分比。例如,40mg剂量将递送两倍于20mg剂量的镁,生物利用度也成比例。使用不同量的小珠可得到不同的剂量。通过将具有不同溶出性质的一种或多种类型的小珠混合或者使用多层包衣作为聚合物层和随后的包衣膜上的额外的药物成分层以制备本领域技术人员熟悉的单一小珠,小珠可得到各种溶出性质。小珠还能具有范围很广的载药。例如,镁珠在小珠上的载药量高达500mg/g剂型,这取决于镁的形式、反离子等。本领域的技术人员将认识到,较高的载药允许更小的胶囊尺寸。
与即释片相比,将时间延长至最大血浆浓度与镁在应用环境中的释放速率相关。镁的释放速率取决于许多因素,包括固体剂型的组合物和溶出性质。通过使用含单一小珠或多个小珠类型组合的不同组合物,它们各自的释放速率可组合达到需要的血浆释放曲线。通过选择释放改进聚合物,以及将释放改进聚合物和粘合剂组合来赋予所得小珠不同的释放特性,可得到具有不同释放特性的小珠。如果需要,也可使用例如肠溶包衣的外包衣膜。
小珠或小珠混合物可例如以悬浮、填充到胶囊、压制成片或填充到小袋使用。一种或多种类型的改进释放的小珠可混合到一起或装入胶囊,或者撒入受试者的食物中。根据本发明,口服固体剂型可以是这些形式中的任意一种。优选地,所述剂型是胶囊。
在本发明的一种实施方式中,使用封装机将小珠配制成胶囊。为适应目标制剂的强度和填充重量,需要各种胶囊尺寸。对于约15mg至约630mg的填充重量,胶囊尺寸的范围为00至5。
剂型中IR和CR小珠的粒径取决于制备它们所用的技术。对于粉末技术(混合、喷雾干燥、分散等),粒径组分为亚微米至500μm;对于包衣技术(Wurster顶部喷雾、底部喷雾、喷雾干燥、挤出、成层等),为5至1700μm;对于制片技术,为1-40mm。
除包含镁和苏糖酸盐的活性成分外,本发明的口服剂型可包含任意量的生理可接受的赋形剂,部分取决于所使用的控释机理。“生理可接受的”包括施用于动物或人类后,不会产生不利、过敏或其它不良反应的分子实体和组合物,合适的例子是药学可接受的那些。“生理可接受的载体”包括任意和所有溶剂、分散介质、包衣、抗菌和抗真菌剂、等渗和吸收延缓剂等。用于生理活性物质的这类介质和物质在本领域是熟知的。除非任意的常规介质或物质与活性成分不相容,否则均可考虑用于苏糖酸镁组合物。补充的活性成分也可掺入到组合物中。“生理可接受的盐”包括酸加成盐,并且其与例如盐酸或磷酸的无机酸,或例如醋酸、草酸、酒石酸、扁桃酸等的这类有机酸形成。与游离羧基形成的盐还可来自无机碱,例如氢氧化钠、氢氧化钾、氢氧化铵、氢氧化钙或氢氧化铁,以及例如异丙胺、三甲胺、组氨酸、普鲁卡因等的这类有机碱。配制和施用的一般技术见“Remington:The Science and Practice ofPharmacy,第20版”,Lippincott Williams&Wilkins,费城,宾夕法尼亚州。这类制剂的例子有片剂、胶囊、小丸、粉末、颗粒、糖衣丸、凝胶、浆液、软膏、溶液、栓剂、注射剂、吸入剂和溶胶。
通过举例,使用本领域已知的其它方法可制备缓慢或改进释放的口服制剂。例如,本文提供的苏糖酸镁组合物的合适缓释形式可以是骨架片或胶囊组合物。合适的骨架形成材料包括例如蜡(例如巴西棕榈蜡、蜂蜡、石蜡、地蜡、虫胶蜡、脂肪酸和脂肪醇)、油、硬化油或脂肪(例如硬化菜籽油、蓖麻油、牛油、棕榈油和大豆油)和聚合物(例如羟丙基纤维素、聚乙烯吡咯烷酮、羟丙基甲基纤维素和聚乙二醇)。其它合适的骨架片材料有微晶纤维素、粉状纤维素、羟丙基纤维素、乙基纤维素与其它的载体和填充剂。片剂还可以含有颗粒、包衣粉末或小丸。片剂还可以是多层的。当活性成分(例如不同形式的镁和苏糖酸盐)具有明显不同的药代动力学曲线时,多层片是有利的。任选地,成品片剂可以是包衣的或未包衣的。
包衣组合物通常含有不溶的骨架聚合物(约占包衣组合物重量的15-85%)和水溶性材料(例如约占包衣组合物重量的15-85%)。任选地,可使用或包括肠溶聚合物(约占包衣组合物重量的1-99%)。合适的水溶性材料包括例如聚乙二醇、羟丙基纤维素、羟丙基甲基纤维素、聚乙烯吡咯烷酮、聚乙烯醇的聚合物,和例如糖(如乳糖、蔗糖、果糖、甘露醇等)、盐(如氯化钠、氯化钾等)、有机酸(例如延胡索酸、琥珀酸、乳酸和酒石酸)的单体材料,及其混合物。合适的肠溶聚合物包括羟丙基甲基纤维素醋酸酯琥珀酸酯、羟丙基甲基纤维素邻苯二甲酸酯、聚乙酸乙烯酯邻苯二甲酸酯、邻苯二甲酸醋酸纤维素、纤维素醋酸酯偏苯三酸酯、虫胶、玉米蛋白和含羧基的聚甲基丙烯酸酯。
根据包衣混合物的性质,例如主要组分或组分混合物的玻璃转变温度或者应用包衣组合物所使用的溶剂,包衣组合物可以是增塑的。合适的增塑剂可以包衣组合物重量的0至50%被加入,并且包括例如邻苯二甲酸二乙酯、柠檬酸酯、聚乙二醇、甘油、乙酰化甘油酯、乙酰化柠檬酸酯、癸二酸二丁酯和蓖麻油。如有需要,包衣组合物可包括填充剂。填充剂的用量可占包衣组合物总重量的1%至约99%,并且可以是例如二氧化硅、二氧化钛、滑石粉、高岭土、氧化铝、淀粉、粉末纤维素、MCC或波拉克林钾(polacrilin potassium)的不溶性材料。
包衣组合物能以于有机溶剂或水性溶剂或其混合物中的溶液或胶乳来应用。如果使用溶液,溶剂的量为基于溶解固体总重量的约25-99%。合适的溶剂有水、低级醇、低级的氯化烃类、酮类或其混合物。如果使用胶乳,溶剂的量为基于胶乳中聚合材料量的约25-97%。溶剂可主要为水。
本发明的组合物包括例如但不限于稀释剂、粘合剂、崩解剂、助流剂、润滑剂、着色剂、调味剂、溶剂、成膜聚合物、增塑剂、遮光剂、抗粘剂和抛光剂的赋形剂中的一种或任意组合。本发明的组合物可使用下列赋形剂中的任意一种或其组合配制。
表1:赋形剂
本文描述的镁组合物还可包括例如溶剂、分散介质、包衣、抗菌和抗真菌剂、等渗和吸收延缓剂等的载体。这类介质和物质用于药物活性物质的应用在本领域是熟知的。可接受的盐也可用于组合物,例如矿物盐,如盐酸盐、氢溴酸盐、磷酸盐或硫酸盐,以及有机酸的盐,如醋酸盐、丙酸盐、丙二酸盐或苯甲酸盐。组合物还可含有液体,例如水、盐水、甘油和乙醇,以及例如润湿剂、乳化剂或pH缓冲剂的物质。如标题为“Heterovesicular liposomes”的美国专利5,422,120、标题为“Vesicleswith Controlled Release of Actives”的PCT申请WO 95/13796、或标题为“Heterovesicular Liposomes”的WO 91/14445或欧洲专利EP 524,968B1中所描述的那些脂质体也可用作载体。
本发明的口服剂型可包含各种赋形剂。在本发明中用作可压缩性加强剂的表面活性剂通常包括各种生理可接受的,例如药学可接受的表面活性剂。合适的阴离子表面活性剂包括例如含有羧酸根、磺酸根和硫酸根离子的那些。含有羧酸根离子的那些有时被称为肥皂,通常由天然脂肪酸甘油酯在碱性溶液中皂化来制备。与这些表面活性剂相关的最常见的阳离子有钠、钾、铵和三乙醇胺。脂肪酸的链长范围为12至18。尽管有许多烷基硫酸酯可用作表面活性剂,一种特别优选的表面活性剂是HLB值为约40的月桂醇硫酸酯钠盐(sodium lauryl sulfate)。
在制剂领域中,月桂醇硫酸酯钠盐作为乳化剂使用,其用量最高达制剂重量的约0.1%。月桂醇硫酸酯钠盐是水溶性盐,其被制备成白色或奶油粉、晶体或片状,用作润湿剂和崩解剂。月桂醇硫酸酯钠盐又被称为十二烷基硫酸钠,实际上是主要由月桂醇硫酸酯钠盐组成的烷基硫酸钠混合物。月桂醇硫酸酯钠盐又称为硫酸月桂基酯钠盐。此外,月桂醇硫酸酯钠盐容易从商业来源(例如Sigma或Aldrich)以固体形式和溶液获得。月桂醇硫酸酯钠盐的溶解度约为每10ml水中1mg。椰子油的脂肪酸主要由月桂酸组成,被催化氢化后形成相应的醇。然后,用硫酸(硫酸化)将醇酯化,所得的烷基硫酸氢盐(烷基硫酸)通过控制pH条件与碱反应被转化为钠盐。
替代的阴离子表面活性剂包括多库酯盐,例如其钠盐。其它合适的阴离子表面活性剂包括但不限于烷基羧酸盐、酰基乳酸盐、烷基醚羧酸盐、N-酰基肌氨酸盐、多价烷基碳酸盐、N-酰基谷氨酸盐、脂肪酸、多肽冷凝物和硫酸酯。
在本发明的其它方面,两性(双亲/两亲性表面活性剂)、非离子表面活性剂和/或阳离子表面活性剂被包括在本发明的共处理(coprocess)组合物中。合适的非离子表面活性剂例如聚氧乙烯化合物、卵磷脂、乙氧基化的醇、乙氧基化的酯、乙氧基化的酰胺、聚氧丙烯化合物、丙氧基化的醇、乙氧基化的/丙氧基化的嵌段聚合物、丙氧基化的酯、链烷醇酰胺、氧化胺、多元醇的脂肪酸酯、乙二醇酯、二甘醇酯、丙二醇酯、甘油酯、聚甘油脂肪酸酯、司盘类(例如山梨醇酯)、吐温类(即蔗糖酯)、葡萄糖(右旋糖)酯和聚二甲硅氧烷。
其它合适的表面活性剂包括阿拉伯胶、苯扎氯铵、胆固醇、乳化蜡、单硬脂酸酯甘油酯、羊毛脂醇、卵磷脂、泊洛沙姆、聚氧乙烯和蓖麻油衍生物。本领域的技术人员还将进一步认识到,本发明使用的表面活性剂的名称和/或制备方法对于产品的有用性不是决定性的。
高极性分子也可用作可压缩性增强剂。这种高极性分子包括某些染料,特别是能结合到纤维素表面然后由于分子疏水部分(例如疏水尾)的存在而产生相对疏水环境的那些,它们“远离”纤维素表面并阻碍亲水表面对表面的纤维素相互作用,例如氢键。优选地,所述染料是生理(例如药学上)可接受被纳入固体剂型中的。
合适染料的例子包括刚果红(化学名:3,3’-[[1,1’联苯]-4,4’-二基双-(偶氮)]双[4-氨基-1-萘磺酸]二钠盐);FD&C红40号(又名为“诱惑红”)(化学名:6-羟基-5[(2-甲基-4-磺苯基)偶氮]-2-萘磺酸的二钠盐);FD&C黄5号(通用名:酒石黄(tartrazine))(化学名:5-氧代-(对磺苯基)-4-[(对磺苯基)偶氮]-2-吡唑啉-3-羧酸三钠盐);FD&C黄6号(通用名:日落黄FCF)(化学名:1-对磺苯基偶氮-2-萘酚-6-磺酸的二钠盐);胭脂红(Ponceau 4R)(化学名:2-羟基-1-(4-磺酸根合-1-萘偶氮)萘-6,8-二磺酸盐三钠);棕色HT(化学名:4,4’-(2,4-二羟基-5-羟甲基-3,3-亚苯基双偶氮)二(萘-1-磺酸盐)二钠);闪亮黑BN(化学名:4-乙酰氨基-5-羟基-6[7-磺酸根合-4-(4-磺酸根合苯基偶氮)-1-萘基偶氮]萘-1,7-二磺酸四钠);红色酸性染料(Carmoisine)(化学名:4-羟基-3-(4-磺酸根合-1-萘基偶氮)萘-1-磺酸二钠);蓝光酸性红(化学名:2-羟基-1-(4-磺酸根合-1-萘基偶氮)萘-3,6-二磺酸三钠);及其混合物。
其它可用作可压缩性增强剂的高极性分子包括任选的其它活性剂本身。例如,本领域的技术人员熟知的有某些类别的药物(例如抗精神病药物)本质上具有高极性,可根据用作本发明的可压缩性增强剂。
所选表面活性剂的可用浓度范围部分地取决于其分子量,并且还取决于其起泡程度,特别是当待喷雾形成所需颗粒的搅动的浆液存在时。因此,对于本发明用除月桂醇硫酸酯钠盐外的表面活性剂与苏糖酸镁共处理的方面,应理解为表面活性剂所存在的量增强苏糖酸镁的可压缩性,但不会有显著抑制喷雾干燥的起泡程度。
在一种使用喷雾干燥步骤的实施方式中,将苏糖酸镁的水性分散体、可压缩性增强剂(augmenting agent)(例如表面活性剂或二氧化硅)与足量的热空气混合在一起,以产生液滴的蒸发和干燥。高度分散的浆液可以被泵送或雾化。其被喷雾到热滤空气流中,供应了用于蒸发的热量,并将干燥的产品传送到收集装置中。然后,空气被去除的水所耗尽。所得到的喷雾干燥粉末颗粒形状近球形,并且相对大小均匀,从而具有良好的流动性。共处理的颗粒无需均一或均匀。也可以使用其它的干燥技术,例如快速干燥、环干燥、微米干燥、托盘干燥、真空干燥、无线电频率干燥和可能的微波干燥。
或者,可将全部或部分赋形剂与活性成分进行湿法制粒。代表性的湿法制粒包括将新的赋形剂颗粒载入到合适的制粒机中,例如Baker-Perkins提供的那些,并与活性成分一起制成颗粒,优选使用水性制粒液体。在一些实施方式中,新型赋形剂总量的一部分与活性成分制粒,然后向制粒加入额外部分的新型赋形剂。在再其它的实施方式中,加入到赋形剂/活性成分颗粒中的额外部分新型赋形剂,可用本领域的技术人员通常使用的其它赋形剂替换,当然这取决于特定制剂的需要。
在本发明的其它实施方式中,向苏糖酸镁和/或可压缩性增强剂加入进一步的材料。这种附加的材料包括二氧化硅、非硅金属氧化物、淀粉、淀粉衍生物、表面活性剂、聚环氧烷、纤维素A醚、纤维素酯及其混合物等。可在水性浆液(并因此在产生的聚集的微晶纤维素赋形剂)中包括的进一步具体材料有三氧化二铝、硬脂酸、高岭土、聚二甲基硅氧烷、硅胶、二氧化钛、硅藻土、玉米淀粉、高直链淀粉玉米淀粉、高支链淀粉玉米淀粉、淀粉钠、乙醇酸、羟基化的淀粉、改性马铃薯淀粉及其混合物等。对本领域的技术人员显而易见的是,这些赋形剂可以以所需量被掺入。
除一种或多种活性成分外,还可在制备终产品前向新型赋形剂中加入本领域的技术人员已知的其它赋形剂。例如,如果需要,可在终产品(例如固体剂型)中加入任意通常接受的可溶或不溶性惰性填充剂(稀释剂)材料。这类惰性填充剂可包括单糖、双糖、多元醇、无机磷酸盐、硫酸盐或碳酸盐,和/或其混合物。合适惰性填充剂的例子包括蔗糖、葡萄糖、乳糖、木糖醇、果糖、山梨醇、磷酸钙、硫酸钙、碳酸钙、微晶纤维素、其混合物等。
有效量的任意通常接受的润滑剂(包括钙或镁皂)可任选地在加入镁时或在压制成固体剂型前的任何情形中添加。润滑剂可包含例如占固体剂型重量约0.5-3%中任意量的硬脂酸镁。在表面活性剂作为部分或全部可压缩性增强剂的实施方式中,不需要额外加入润滑剂。
全部混合物的量足以制得一批统一的片剂,然后在常规生产规模的制片机中于该机器的正常压制压力(例如约1500-10,000lbs/sq)下进行制片。混合物不应压制到这样的程度,即当暴露于胃液时难以水化。
本发明的片剂还可包含有效量的着色剂(例如二氧化钛、F.D.&C.和D.&C.染料;见Kirk-Othmer Encyclopedia of Chemical Technology,Vol.5,第857-884页,其在此通过参考被引入)、稳定剂、粘合剂、气味控制剂和防腐剂。
在一些实施方式中,镁(Mg)与选自氯离子、牛磺酸根、乳酸根、葡萄糖酸根、柠檬酸根、苹果酸根、琥珀酸根、硫酸根、丙酸根、氢氧根、氧化物、乳清酸根、磷酸根、硼酸根、水杨酸根、碳酸根、溴离子、硬脂酸根、氨基酸、丁酸根、天门冬氨酸根、抗坏血酸根、吡啶甲酸根、泛酸根、烟酸根、苯甲酸根、肌醇六磷酸根、酪蛋白酸根、棕榈酸根、丙酮酸根和苏糖酸根的阴离子络合。在一些实施方式中,口服剂型包含选自钙、钾、钠、铬、铁、硒、锌、锰、钼、钒和锂的金属离子。在一些实施方式中,组合物中加入了一种或多种抗氧剂,例如白藜芦醇、鞣花酸、槲皮素、硫辛酸或维生素C。
除上述列出的赋形剂外,本发明的口服剂型还含有一种或多种化学物质或者一种或多种从自然界中得到的提取物。下面列出的是根据本发明提供的营养成分和健康成分的例子。
能与苏糖酸镁混合的营养成分的例子包括:5-HTP(5-羟色胺)、7-酮基-DHEA(脱氢表雄酮)、醋酸盐、乙酰-L-肉碱、AE-941、α-胡萝卜素、α-羟酸、α-苯丙氨酸、α-酮戊二酸盐(或酯)、α-半乳糖苷酶、α-亚麻酸、α-硫辛酸、α-生育酚、SHA-10、雄烯二醇、雄烯二酮、精氨酸、天门冬氨酸(天门冬氨酸盐(或酯))、抗坏血酸、β-丙氨酸、β-丙氨酰-L-组氨酸、β-胡萝卜素、β-隐黄素、β-D-呋喃果糖苷酶、聚维酮碘(betadine)、β-葡聚糖、β-多糖、甜菜碱、β-谷甾醇、β-生育酚、BMS-214778、碳酸钙基质、磷酸钙、辛酸、角黄素、CDP-胆碱、螯合钙、胆钙化醇、胆碱、硫酸软骨素、胞二磷胆碱、柠檬酸、肌酸、隐黄质、半胱氨酸、D-泛酸钙、脱氢表雄酮、δ-生育酚、泛醇、右旋糖酐铁、DGL(解甘草甜素(deglycyrrhiziated licorice))、EA(去氢表雄酮)、腺苷钴胺(dibencozide)、二氯乙酸盐、二甲基甘氨酸、二甲基砜、丁二酸氢二钠虾青素、D,L-苯丙氨酸、DMAE(二甲氨乙醇)、D-甘露糖、DMSO(二甲基亚砜)、二十二碳六烯酸、多库酯钠(docusate sodium)、象牙烯宁(eburnamenine)-14-羧酸、EDTA(乙二胺四乙酸)、EFA(必需脂肪酸)、鞣花酸、二十碳五烯酸、葡萄糖酸铁、硫酸亚铁、5-羟色氨酸、类黄酮、叶酸类似物、叶酸盐(或酯)、叶酸、毛喉素(forskolin)、低聚果糖、GABA(γ-氨基丁酸)、氢溴酸加兰他敏、γ-胡萝卜素、γ-亚麻酸、γ-谷维素、γ-谷氨酰半胱氨酰甘氨酸、γ-生育酚、葡萄糖胺、硫酸葡萄糖胺、谷氨酰胺、谷氨酸、谷胱甘肽、甘油、甘油磷酸胆碱、甘氨酸、组氨酸、HMB(β-羟基-β-丁酸甲酯一水合物)、羟钴胺素、羟基柠檬酸、羟基甲基丁酸酯、羟基色氨酸、丁溴(东莨菪碱)(莨菪胺)、羟基赖氨酸、羟基脯氨酸、次黄嘌呤核苷、吲哚-3-甲醇、肌苷、烟酸肌醇酯、六磷酸肌醇酯、异抗坏血酸、异黄酮、异亮氨酸、乳酸、L-精氨酸、L-抗坏血酸、L-天门冬酰胺、L-肉碱、L-多巴、亮氨酸、L-苯丙氨酸、L-色氨酸、N-乙酰-2-苄基色胺(luzindole)、番茄红素、赖氨酸、苹果酸、mesoglycan、蛋氨酸、甲钴胺、甲基胍乙酸、二甲基砜、单不饱和脂肪酸、N-3脂肪酸、N-乙酰半胱氨酸、N-乙酰D-葡萄糖胺、N-乙酰-5-甲氧色胺、N-乙酰天门冬氨酸、NADH、烟酸、烟酰胺腺嘌呤二核苷酸、去甲二氢愈创木酸(NDGA)、二十八醇、辛酸、橄榄苦苷、Ω-3脂肪酸、Ω-6脂肪酸、Ω-9脂肪酸、PABA(对氨基苯甲酸)、潘氨酸、双泛酰硫乙胺、泛酸、羟泛酸、紫苏子醇、PGG-葡聚糖、乙酸苯酯、卵磷脂、磷脂酰丝氨酸、植物雌激素、植物甲萘醌、植物甾醇、多酚、多糖-K、多不饱和脂肪酸、聚维酮碘、钾、天冬氨酸钾、磷酸钾、聚乙烯吡酮碘、孕烯醇酮、孕酮、前维生素A、蝶酰谷氨酸、吡哆醇、吡哆醛-5-磷酸、槲皮苷、槲皮苷-3-鼠李葡萄糖苷、槲皮苷-3-芸香糖苷、奎宁、白藜芦醇、视黄醇、核黄素、核黄素-5-磷酸、水杨苷、水杨酸盐、SAM-e(S-腺苷甲硫氨酸)、谷甾烷、谷甾醇、谷甾醇葡萄糖苷、海藻酸钠、抗坏血酸钠、氯化钠、葡萄糖酸铁钠、碘化钠、苯乙酸钠、磷酸钠、山梨酸、豆甾醇、萝卜硫素、脱氧肾上腺素、丹宁酸、茶氨酸、可可碱、硫胺、硫辛酸、生育酚、生育三烯酚、三酰基甘油酯酶、枸橼酸胆碱(TRI)、曲克芦丁、色氨酸、酪氨酸、乙酰-L-酪氨酸、泛癸利酮、泛醌、熊果酸、松萝酸、缬氨酸、维生素A、维生素B1、维生素B12、维生素B2、维生素B3、维生素B5、维生素B6、维生素B9、维生素Bx、维生素C、维生素D、维生素D2、维生素D3、维生素E、维生素G、维生素H、维生素K、维生素M、维生素O、维生素Q10、木糖醇或玉米黄质。
作为可以掺入苏糖酸镁的草药或天然提取物的营养成分的例子包括:毛蕊花(毛蕊花)、麝香秋葵、相思豆、苦艾、虻田、洋槐、阿拉伯胶树、巴西莓、乙酰吗喃、金虎尾、菊苣(achicoria)、千叶蓍、胭脂树、西非荔枝果、附子、舟形乌头、水菖蒲、升麻、狝猴桃、猕猴桃、亚当针叶纤维、夹竹桃(adelfa)、有节莎草、印度枸桔、马栗树、非洲野生马铃薯、布枯、龙舌兰、剑麻、仙鹤草、agrimonia odorata、agrimoniaprocera、龙芽草、匍匐冰草、鳄梨病毒、丙氨酸、albahaca morada、albaricoque、albarraz、斗蓬草、alcusa、赤杨、苜蓿、阿尔加罗沃、藻胶、西草色素、alkanet tinctoria、洋葱、大蒜、韭菜、多香果、阿尔门德拉苦皮、almendra dulce、芦荟、巴巴多芦荟、好望角芦荟、库拉索芦荟、高山蔓越莓、大高良姜、良姜、药用蜀药、磷酸铝、捕蝇蕈、苋属植物、amargo、黄葵(麝香秋葵)、番麻、美国藜芦、美国木瓜、美国薄荷、美黄芩、美国缬草、美国白睡莲、美国红豆杉、对氨基苯甲酸、印度醋栗、阿密茴、缩砂、腰果、菠萝、凤梨、anapsos、牛舌草、里南苦油楝(andiroba)、穿心莲、anemone acutiloba、当归、angel′s trumpe、angostura trifoliata、anís estrellado、红木、刺果番荔枝、艾蒿、艾草、印楝、黄菊桔梗、黄菊扇贝、珊瑚虫类、抗癌酮(antineoplastones)、抗癌酮(antineoplastons)、AFA(水华束丝藻)、中华蜜蜂、意蜂、芹菜、大麻、苹果醋、杏子、花生、arbre fricassee、熊果苷、粗酒石、牛蒡、牛蒡子草、熊果属、熊果、槟榔、槟榔素、马兜铃属、杏、辣根、山金车、葛、arsenicum album、苦艾、青蒿素、北艾、节旋藻属螺旋藻、洋蓟、波罗蜜、日本青篱竹、阿魏、欧细辛、细辛、互生叶马利筋、岩衣藻、印度人参、亚洲人参、美国泡泡果、泡泡树、海藻、线状阿司巴拉妥、芦笋、露笋、白杨、香车叶草、aspérula olorosa、虾青素、astaxantina、北美山梗菜、黄蓍(astrágalo)、紫云英属、膜荚黄芪、颠茄、澳洲茶树油、秋水仙属、aveloz、燕麦提取物、鳄梨、印度楝、巴戟天、巴西棕榈树、侧孢毛旱地菊、三基数旱地菊、三翼酒神菊、假马齿苋、假马齿苋、硬皮橘、黄芩、ballota nigra、乳香、香脂草、竹子、班图郁金香、半夏厚朴汤、北美南部靛蓝、西印度草莓、伏牛花、牛蒡、山布枯、月桂树叶、月桂果实、熊葱、熊果、篷子菜、蜂花粉、蜂蜡、甜菜、bejuncode cerca、belcho(草麻黄)、癫茄、雏菊、膨润土、berberina、黄连素、具芒小檗、欧洲小檗、香柠檬油、β-艾叶、槟榔、水苏属植物、枫桦木、双歧杆菌、越桔、别敏、bing gan tang、桦木糖、兜铃、阿米芹、铋、苦杏仁、苦芦荟、苦灰、苦瓜(bitter gourd)、苦瓜(bitter melon)、酸橙、苦木、齿苋、胭脂树、biznaga、黑泻根、黑升麻、红醋栗、黑荚蓬、臭夏至草、黑桑、黑芥子油、黑胡椒、黑色种子、红茶、黑莓、黑樱桃、黑胡桃、墨角藻、水飞蓟、阿开木、血根草、蓝籽类叶牡丹、蓝旗根、blue rocket(乌头毒草)、蓝莓、蓝绿藻、bluperum、波耳多叶、兰草、琉璃苣子油、琉璃苣、borforsin、卡氏乳香树、乳香、齿叶乳香树、牛软骨、黄杨树、婆罗米、白菜油菜油、黑芥、甘蓝、巴西岩兰草、菠萝蛋白酶、高梁、木曼陀罗、泻根、b-谷甾醇、布枯、长叶车前、buckshornplantain、鼠李、荞麦、夏枯草、鳞基毛莨、柴胡、牛蒡、丁二醇、假叶树、款冬、黄杨、西洋玫瑰、仙人掌果、白千层油、calaguala、菖蒲、骨化三醇、金盏花、加州曼陀罗、花菱草、胡桐、牛初乳、茶、菜油甾醇、樟脑、加拿大大麻、cancer weed、大麻、菜籽油、斑蝥、荠菜、辣椒、苦油树、香菜、蒿子油、碳水化合物补剂、小豆蔻、豆蔻、cardo bendito、cardo lechero、番木瓜、肉碱、肌肽、角豆树、胡萝卜素、carqueja(酒神菊)、角叉菜胶、胡萝卜、红花、鼠李皮、腰果、七叶树、蓖麻油、蓖麻籽、冬虫夏草、阿拉伯茶、猫薄荷、猫爪草、洋大戟草、卡图巴、蓝升麻、辣椒、大麦、cebolla albarrana、北美香柏叶油、白屈菜、指甲花、疗病矢车菊(centaurea benedicta)、矢车菊、积雪草、龙舌兰(美国龙舌兰)、吐根、长角豆、马鹿、梅花鹿、鲸腊异丙酯、香茅、黄金菊、洋甘菊、小榭树、圣洁莓、淡紫花牡荆、白屈菜、昆诺藜、菊叶香藜、嚼用烟草、芡欧鼠尾草、繁缕、菊苣、红辣椒、月季、当归、枸杞、中国毛地黄、明胶、高良姜、人参、枸杞、八角茴香、中国茵蔯、chintul、苍术、壳聚糖、小球藻、红曲清醇、菊花、chrysanthemum vulgare、白杨素、金须茅属、菊苣、毒芹、苹果醋、美类叶升麻、肉桂、肉桂皮、美洲锡生藤、citrillus colocynthis、香茅草、瓜氨酸、酸橙树、酸橙、香柠檬、纤维柑橘、葡萄柚、橘子、麦角菌、clavo de olor、云蘑菇、丁香、石松、蛇床、钴维生素、古柯、红瓜果、香辣根、苍耳、椰子油、党参属、辅酶Q10、辅酶R、蓝升麻、cohosh negro、可乐果、秋水仙属、毛喉鞘蕊花、款冬、colubrina arborescens、紫草科植物、commifora mukul、没药、没药树、康德郎皮、金花菊属植物、欧毒芹、consuelda、苦配巴香脂、香胶树、黄连、珊瑚钙、冬虫夏草、云芝蘑菇、采绒革盖菌、虞美人、玉米穗丝、玉米糖胶、矢车菊、山茱萸、紫堇属、欧洲榛、育亨宾、艾菊、棉花子油、三角叶杨、茅草、欧洲防风、毒芹、豆科攀缘植物、西洋樱草(黄花九轮草)、蟹石、荚蒾皮、曼越橘、陇牛儿苗科、山楂、莳萝、石炭酸灌木、西葫芦、地中海柏木、姜黄、姜黄、姜黄色素、皱叶酸模、cusparia febrifuga、cusparia trifoliata、白藜芦醇、番荔枝、瓜尔豆、氰钴维生素、香茅属、菜蓟、节莎草、丝柏、cypripedium acaule、杓兰、甜菜碱、金雀儿、大黄甘草汤、雏菊、达米阿那、蒲公英、党参(或丹参)、枣椰树、香曼陀罗、datura sauveolens、曼佗罗、datura wrightii、胡萝卜、颠茄、丹醇、鹿天鹅绒、沙漠香菜、爪钩草、魔棒、地黄、dientede león、饮食、长寿的、食用纤维、饮食糖类、洋地黄、莳萝、dioscoreacommunis、dioscorea villosa L.、diviner′s sage、山茱萸、dolichos pruriens、白云石、当归、D泛酸、D-苯丙氨酸、鸸鹋、茅膏菜属植物、胶粘藻科、烟斗藤、铁杉、紫锥花、狭叶松果菊、松果菊、蓝蓟属、接骨木、土木香、电胶质银、元素铁、小豆蔻、牛筋草、小豆蔻、偃麦草、鸸鹋油、enebrina、洋甘菊、英国长春藤、英国胡桃木、英国紫杉、麻黄、EGCG(表儿茶素酸酯)、柳兰、小花柳叶菜、淫羊藿、equinácea、问荆草、钙化醇、北美圣草、乌饭古柯、花菱草、escoba negra、espirulina、essiacestevia、桉树油、欧福尔比奥、eufrasia、丁香、贯叶佩兰、大戟属植物、大戟科、小米草属、酸果蔓、巴西莓、月见草油、evodia rutecarpa、小米草、荞麦、茴香(小茴香)、葫芦巴、发酵牛奶、阿魏、菊科植物、无花果、ficus inspida、无花果、旋果蚊子草、杂草、亚麻子和亚麻子油、fleet phospho-soda、快速灌肠剂、flor-essence蛤蟆菌、何首乌、洋地黄、草莓属、野草莓、龙眼、药鼠李、乳香、白蜡树属、法国玫瑰、乌头根(friar′s cap)、fructus barbarum、墨角藻、扶正解毒汤、五倍子酸、高良姜、雪花属、安古斯图拉树皮、车轴草、gallium aparine、具毒似翼藻、灵芝、藤黄纤体、莽吉柿、藤黄属植物、ácido hidroxicítrico、大蒜、garra del diablo(钩果草)、动物胶、凝花菜、素馨属、染料木黄酮、龙胆属的植物、龙胆紫、天竺葵、母菊、石蚕属植物、germanio、锗、三氧化二锗、麦芽、虎杖、gimnema、龙胆属的植物、姜、银杏树、人参、欧活血丹、朝鲜蓟、野生大豆、光果甘草、戈壁、梧次、秋麒麟草属植物、白毛茛、角孔珊瑚属、牛筋草、棉子酚、积雪草、gotu kola y fraccióntriterpénica total de lacentella asiática(TTFCA)、枸杞(枸杞)、gramilla、石榴、葡萄籽提取物、葡萄柚、草香豌豆、番荔枝、白屈菜、南姜、绿藜芦、绿茶、加纳籽、多叶奇果菌、胶草、弯曲胶草、常春藤、瓜尔胶、瓜拉拿、银胶菊、欧洲荚蒾、guggals、印度香胶树、阿拉伯树胶、阿拉伯胶、胶草、guru nut、匙羹藤、绞股蓝、金缕梅、hange koboku-to、haritaki、钩果草、印度大麻、山楂、榛子、穗花薄荷、常春藤、向日葵、菟葵、铁杉、大麻子油、獐耳细辛、独活、橘皮苷、木槿、hiedra terrestre、hierbacarmín、hierba de cabra en celo(淫羊藿)、hierba de limón(香茅)、hierbade san juan(贯叶连翘)、hierba de trigo(小麦)、高灌木红莓、沙棘提取物、零陵香、hochu-ekki-to、蜂蜜、金银花、hongo maitake、蝴蝶亚、大麦、苦薄荷、淫羊藿、七叶树、马板栗种子提取物、horse heal、山葵、问荆、厚朴(magnolia bark)、胡克斯配方、黄芪、huang-teng ken、啤酒花、蛇足石杉、石杉碱甲、透明质酸、乔木绣球、白毛茛、硫酸肼、积雪草总苷、软水草、贯叶连翘、hypoxis hemerocallidea、非洲马铃薯、柳薄荷、ignacia(或吕宋豆)、八角茴香、双花凤仙、impatiens pallida、硬皮橘、印度小蘖、印度无花果、相思子、鸡眼藤属植物、绿黎芦、印度蛇根木、路单利草、inula campana、土木香、吐根、药薯、依普黄酮、变色鸢尾、板蓝根、iscador、isphagula、常春藤、木菠萝、牙买加苦木科植物、日本紫杉、japanese sophora、茉莉、生姜、红豆、jervine alkaloids、凤仙花科凤仙花属植物、健脾温肾处方、绞股蓝、曼陀罗、有节莎草、荷荷巴油、短叶丝兰、胡桃、杜松、kan jang刺梧桐树胶、karkada、katuka、羽衣甘蓝、卡瓦胡椒(piper methysticum)、克非尔、巨藻、阿拉伯茶(catha edulis)、阿米芹(阿密茴,又称为维沙明)、激动素、猕猴桃、奇异果、黑底叶金丝桃、可乐果、高丽参、克力生物素、芸芝多糖、磷虾油、野葛、拉不拉多茶树、乳白蛋白、嗜酸乳杆菌、干酪乳杆菌、鼠李糖乳杆菌、植物乳杆菌、罗伊氏乳杆菌、乳酸菌、lactobaciloacidófilo、乳铁蛋白、羽衣草属、杓兰属、苦杏仁苷、大花紫薇、落叶松聚阿拉伯半乳糖、落叶松属、查帕拉尔橡树、矮橡林、山黧豆属、月桂树、laurus persea、薰衣草、卵磷脂、加茶杜香、ledum latifolium、喇叭茶、豆类、雷公藤、蜜蜂花、柠檬香草、蘑菇多糖、香菇、香菇、伦蒂斯科、欧益母草、腺茎独行菜、lepidium peruvianum chacón、小白屈菜、高良姜、lessertia frutescens、欧当归、左谷酰胺、地衣、欧亚甘草、木脂素类、女贞、酸橙、菩提花、菩提树、越橘、亚麻子油、亚麻、脂肪分解酵素、lirio azul、lirio de agua blanco(香睡莲)、地钱、L-正缬氨酸、北美山梗菜、槐豆、lomatium、lomatium dissectum、荜拨、忍冬.魔根属、魔根、lorenzo′s oil、荷花、马先蒿属、独活草、lucky nut、lúpulo、叶黄素、luteína、番茄、石松、蛇足石松、蔓越莓、羽裂地笋、地笋、美洲地笋、lysichiton americanu、麻黄、秘鲁人参(lepidium peruvianumchacón)、长寿饮食、madagascar jewel、茜草属的植物(染色茜草)、罗勒、神奇薄荷、木兰、木兰和半夏配方、银杏、灰树花、malpidnia glabra、西印度樱桃、红叶金虎尾、欧洲苹果、maltas malvavisco、mangaresa、柑桔、山竹果、manto de nuestra(羽衣草)、小苹果、MAP30、竹芋、maria pastora、万寿菊、大麻、marrubio blanco、欧夏至草、紫蜀葵、药蜀葵、蜀葵根、乳香(psitacia lentiscus)、洋甘菊、mauby bark、MCP(柑橘果胶)、绣线菊属植物、紫花苜蓿、互生叶白千层、白千层、白千层、褪黑激素、香蜂花、甲基萘醌类、唇萼薄荷、薄荷油、薄荷醇、墨西哥番薯、欧亚瑞香、微晶纤维素、微晶化钙、milenrama、绿玉树、水飞蓟、槲寄生、柑橘果胶、葫芦科苦瓜属苦瓜、罗汉果、红曲菌素K、紫红粬霉、舟形乌头、海巴戟、巴戟天、辣木属、黑桑、益母草、山乳香、牡丹、MSM(有机硫)、刺毛黧豆、艾蒿、铁青树碱、桑树、毛蕊花属、麝香子、芥末、月桂叶、蜡香桃木、没药、窄叶车前草、豆瓣菜、印度楝、中国莲、癌立消、猫薄荷、夹竹桃、荨麻、软骨素、粉蓝烟草、烟草、黑种草、诺丽果(海巴戟)、胭脂仙人掌属植物、北部花椒、戊氨酸、nuez de betel(槟榔)、肉豆蔻、马钱子、香睡莲、橡树皮、橡树苔、燕麦β-葡聚糖、燕麦麸/草、燕麦、罗勒、神罗勒、月见草、秋葵荚、松萝凤兰、油橄榄、夹竹桃、乳香、橄榄叶、橄榄油、olmo resbaladizo、北美刺人参、扭刺仙人掌、巴西棕油、牛至、俄勒冈葡萄、野马郁兰、鸟氨酸、虾黄素、羟基芦丁片、肠促胰液肽、牛胆抽提液、太平洋杉、塔状树、棕榈油、palma enana americana(锯叶棕)、柏马溴、人参、虞美人、药用墙草、荷兰芹、欧洲防风草、银胶菊、小白菊内酯、梅花、西番莲、欧防风属、欧洲防风、保哥果、巴西香可可、西非茜草科植物树、PC-SPES、花生油、果胶、马先蒿、pedra hume caá(myrcia salicifolia)、墙草属植物、绿玉树、薄荷油(唇萼薄荷)、牡丹、薄荷、薄荷油、白苏子、小长春花、鳄梨、紫蜂斗菜提取物、petasita、蜂斗菜、南欧大戟、波尔多树、佩奥特掌、非索那明(白芸豆)、菜豆数仁用杏品种、海枣、美国槲寄生、叶下珠属、physalis somnifera、植物-1、垂序商陆、牙买加苦木、牙买加苦树、胡黄连、pill-bearing spurge、众香树、茴芹、松树皮提取物、松花粉、滨海松、长叶松、卡瓦胡椒、胡椒属、黄连木、植物酯、芹叶车前草、车前、长叶车前、卵叶车前、胸膜炎、桃儿七、足叶草、一品红、毒葛、商陆、美洲商陆、poleo americano、甘蔗原素、虎杖、何首乌、白绒水龙骨提取物和anapsos、石榴、杨树、罂粟花、鸡母珠、美洲花椒、仙人镜、报春花、黄花九轮草、probeta、妇更美、丙帕锗、蜂胶、夏枯草、非洲李、巴旦杏、扁桃、杏仁油、杏、车前草、巴西榥榥木、葛根、蒙大拿变量葛根、葛根素、金虎尾属植物、胡薄荷酮、白头翁、南瓜、南瓜子油、石榴、车前叶蓝蓟、碧萝芷、非洲刺李、西洋梨、丙酮酸盐、青蒿、青蒿、青蒿素、庸医草、quaker bonnet、quakerbuttons、颤杨、苦木科植物、野胡萝卜花、水果皇后(芒果)、绒毛绣线菊、大花紫薇、白橡木、橡木皮层、麻栎属植乌毛蕨、quick-in-the-hand(凤仙花科凤仙花属植物)、quimsa-kuchu、藜麦、quinsu-cucho、茅草、冬凌草、镭杂草、当归、ranunculus bulbosus、榕叶毛茛、菜子油、覆盆子、蛇根木、红藻、红三叶草、红棕榈油、red sorrell、非洲李、红曲米、甘草酒、地黄、地黄根、榆绣线菊(spiraea ulmaria)、灵芝、凝乳酶、珀希鼠李、大黄、掌叶大黄、红景天、冰原红景天、杜香、大黄的叶柄、毒漆藤、黑茶镳子、米糠油、利口乐、roble blanco、罗马洋甘菊、罗梅罗、洛依柏丝、犬蔷薇、鸡母珠、rose haw、野玫瑰果、玫瑰月桂、洛神葵、艾菊、迷迭香、蜂王浆、雅黄、黑莓、覆盆子、绒毛覆盆子、ruibarbo、rumalon、皱叶酸模、假叶树、芸香、芦丁、黑麦草、锯叶棕、sábila、酒酵母、酵母菌、型链球菌、红花、鼠尾草、saiboku-to、柴胡清肝汤、salba银白杨、柳木类、鼠尾草、西班牙鼠尾草、熏衣草叶鼠尾草、鼠尾草油、丹参、鼠尾草、莎蔓芭亚蕨、sambucas nigra、檀香、血红根、血根碱、檀香、洋菝契、黄樟、接骨木(sambucusnigra)、锯棕榈、北五味子、五味子(schizandra berry)、五味子(schizandrae)、schizopeta、莨菪碱、金雀花、美黄芩、黄芩、半枝莲、侧花黄芩、沙棘、海藻、墨角藻、裸麦、分泌素、seersage、硫酸肼、海参、卷柏石松碱、番泻叶、丝氨酸、锯叶棕、香油、seso vegetal、shakuyaku-kanzo-to、大葱、鲨鱼软骨、生地黄、荠菜、荠菜、椎茸、紫草醌、小青龙汤、小柴胡汤、双黄连、山奈、梅花鹿、欧洲桦、蛋白银、水飞蓟素、西蒙得木、剑麻、臭菘草、榆树、菝葜浸膏、无烟烟草、蛇根草、欧洲荚蒾、大豆、一枝黄花、槐属、高粱、掌叶大黄、酸樱桃、酸橙汁、黄豆、大豆提取物、大豆麸皮、大豆蛋白、黄豆芽、大豆油、金雀花碱、菠菜、锗螺胺、螺旋藻、紫花欧瑞香、海葱、吕宋东、长角豆、金丝桃、水苏、药水苏、八角茴香、鹅肠草、刺梧桐、甜叶菊、stickleburr、刺荨麻、臭藜、吕宋果、马钱子、槐树、物质x、sulfato de condroitina、巴西人参(pfaffiapaniculata)、葵花籽油、萨瑟兰迪亚灌木、嚏根草、甜扁桃、sweet annie、甜罗勒、甜樱桃、甜橙、甘草、香车叶草、青蒿、白菖蒲、聚合草、康复力精、臭菘、通尿灵、塔马奴、酸豆、罗望子、黑蔓草、艾菊、菊蒿、橘子、艾菊、蒲公英、牛磺酸、茶树油、tejo、榄仁木、欧洲苦草、可可树、黄花夹竹桃、东方侧柏、雷公藤、百里香(thymus vulgaris)、枸杞、tilofora、toki-shakuyaku-san、毒漆藤(eastern poison ivy)、黄芪胶、粉蓝烟草、颤杨、刺蒺藜、巴西海木、三芥子油、红三叶、胡芦巴、豆科胡卢巴、三甲基乙醇胺、雷公藤、小麦、加拿大铁杉、TTFCA(积雪草的总三萜部分)、促吞噬素、tulsiholy basil、云芝、姜黄、达米阿那提取物、特纳草、松节油、款冬、娃儿藤属、印度娃儿藤、ukrainTM、红榆榆属/红榆、魔芋、钩藤属、绒毛钩藤、海葱、荨麻、须松萝、熊果叶、狭叶越桔、大果越桔、黑果越桔、越桔提取物、缬草、鹿茸、绒花、绒叶、绿藜芦、毛蕊花、马鞭草、鞭草、连理草、香根草(chrysopogonzizanioides)、欧洲绣球、黑山楂、vinagre de sidra de manzana、小蔓长春花、长春西汀、蓝蓟、virginia′s herbal E-TonicTM、白果槲寄生、黄荆、葡萄籽、白藜、山嵛菜、毒芹、西洋菜、冰草、麦麸/草、麦芽、小麦芽、乳清蛋白、白豆瓣、白锦葵、白栎、白胡椒、白檀香、白茶、白睡莲、wildarrach、野胡萝卜、野樱桃、野生姜、北美靛蓝、马郁兰、野迷迭香、野山芋、柳树皮、金缕梅、冬樱花、鹿蹄草、红纹马先蒿、西方雪果、苦艾、xango黄原胶、野油菜黄单胞菌、xhoba、西洋参、西藏胡黄连、仙草、仙灵脾、xianxao、小青龙汤、小柴胡汤、xukucao、血脂康、矢竹、yagona、山药、蘑菇、杨梅、麻醉椒、阳高那、蓍草、洋甘草、yashti madhuka、yavatikta、yege、黄涩、黄树皮、黄蜂蜡、黄甜菜、金黄雀花、皱叶酸模、黄色人参、黄马、黄印漆、黄色靛蓝、黄色茉莉花、黄花夹竹桃、黄罂粟、白毛茛、北美黄连、黄檀木、yellowsaunders、土木香、也门没药、yerba dulce、巴拉圭茶、圣草、红豆杉、yi zhu、淫羊藿、yinhsing、yodo、yogaraj guggul gum resin、育亨宾树皮提取物(育亨宾)、yongona、元胡索、丝兰、芦荟叶丝兰、狭叶丝兰、丝兰藜、yucca breifolia、丝兰王、小丝兰、紫花苜宿、yucca whipplei、云芝、美洲花椒、zapatilla de dama、玉米、zemaphyte、生姜或ZMATM。该组合物可用作营养补充剂、膳食补充剂、食品补充剂或作为食品添加剂。该组合物可制成片剂、胶囊、液体、冻干粉、粉末、结晶、气溶胶、浸渍到皮肤贴剂上的液体、软膏或栓剂。
在相关的实施方式中,镁反离子组合物还可含有其它的营养成分,其包括但不限于含钙物质(例如碳酸钙)、锡酯、羟基柠檬酸、维生素、矿物质、草药、香料及其混合物。可用作额外成分的维生素的例子包括但不限于维生素A(视黄醇)、维生素D(胆钙化醇)、维生素E族(α-生育酚和其它生育酚)、维生素K族(叶绿醌和甲基萘醌类)、硫胺素(维生素B1)、核黄素(维生素B2)、烟酸、维生素B6族、叶酸、维生素B12(钴胺素)、生物素、维生素C(抗坏血酸)及其混合物。终产品中维生素或多种维生素的量取决于特定的维生素。可用作附加成分的矿物质的例子包括但不限于钙、磷、铁、锌、碘、硒、钾、铜、锰、钼及其混合物。在维生素的情形中,终产品中存在的矿物质的量取决于特定的矿物质。对本领域的技术人员显而易见的是,关于其它营养成分的该列表仅通过举例方式提供,而不是限制性的。
除口服剂型外,本发明的组合物可通过任何可用和有效的递送系统施用于受试者。这类递送系统包括但不限于胃肠外、经皮、经鼻、舌下、经粘膜、动脉内或皮内施用模式的剂量单位制剂,其含有所需的常规的非毒性的生理可接受载体、辅料和载体,例如贮库或控释制剂。根据施用途径,本发明的镁组合物可配制成栓剂、洗液、贴剂或装置(例如皮下可植入的递送装置或吸入泵)。组合物可被优化用于特定类型的递送。
在本发明的一些实施方式中,镁和苏糖酸盐以气溶胶喷雾制剂从加压包、雾化器或干粉吸入器中递送。可用于雾化器的合适抛射剂包括例如二氯二氟甲烷、三氯氟甲烷、二氯四氟乙烷和二氧化碳。在加压气溶胶的情形中,剂量可通过提供阀确定,以递送规定量的化合物。
用于吸入或吹入的组合物包括于药学可接受的水性或有机溶剂或其混合物中的溶液和悬浮液,以及粉末。液体或固体组合物可含有以上列出的合适的赋形剂。优选地,本发明的组合物经口、经鼻或呼吸途径施用,以产生局部或全身作用。在可接受溶剂中的组合物可通过使用惰性气体被雾化。雾化溶液可直接从雾化装置中吸入,或者可将雾化装置连接到面罩、帐状物或间歇正压呼吸机上。溶液、悬浮液或粉末组合物可优选经口或鼻通过递送合适形式制剂的装置来施用。
在一些实施方式中,例如组合物可经鼻而不是通过吸入递送到筛板,能使活性剂从嗅觉通道递送到CNS,并减少全身施用。通常用于该施用途径的装置包括在标题为“Nasal delivery device”的美国专利6,715,485中。经该途径递送的组合物能增加CNS剂量或减少全身负担,从而降低与某些组合物相关的全身毒性风险。
组合物任选地可被配制成在容器中递送,提供连续、长期的递送,例如递送最高达30天、60天、90天、180天或一年。例如,所述容器可以生物相容性材料(例如钛)提供。长期递送的制剂特别适用于患有慢性病症的受试者,以确保改善的患者依从性并增加了组合物的稳定性。
根据另一个实施方式,本发明的组合物是包含至少20mg/L镁或至少40mg/L镁的液体或半液体。在一些实施方式中,本发明的组合物是包含至少5mg/L镁、至少10mg/L镁、至少20mg/L镁、至少30mg/L镁、至少40mg/L镁、至少50mg/L镁、至少60mg/L镁、至少70mg/L镁、至少80mg/L镁、至少90mg/L镁或至少100mg/L镁的液体或半液体。
或者,本发明的组合物可经皮施用。以经皮贴剂递送的制剂可使用本领域已知的方法进行,包括在例如美国专利5,186,938和6,183,770、4,861,800、6,743,211、6,945,952、4,284,444和WO 89/09051中一般描述的那些,它们全部在此通过参考被引入。贴剂特别适用于活性剂有吸收问题的实施方式。可制备贴剂用来控制皮肤渗透的活性成分在12小时、24小时、3天和7天时间内的释放。在一个实施例中,2倍日剩余量的苏糖酸镁被置于非挥发性流体中。优选的释放可以是12至72小时。
在一些实施方式中,例如,组合物可经鼻、口腔或舌下途径而不是经吸入递送到脑,能使活性剂通过嗅觉通道递送到CNS,并减少全身施用。通常用于该施用途径的装置包括在标题为“Nasal delivery device”的美国专利6,715,485中。经该途径递送的组合物能增加CNS剂量或减少全身负担,降低全身毒性风险,例如,腹泻。
以皮下可植入装置用于递送的组合物的制备可使用本领域已知的方法进行,例如在美国专利3,992,518、5,660,848和5,756,115中描述的那些。用于制备改进释放制剂的其它方法在例如美国专利5,422,123、5,601,845、5,912,013和6,194,000中有描述,它们在此均通过参考被引入。
II.用途
本发明提供了应用本发明所公开组合物的方法。在一些实施方式中,该用途包括施用本发明的口服剂型以提供各种健康益处。这样的组合物可包含至少一种镁反离子化合物。本文描述的镁反离子组合物可用于本文描述的各种应用和目的中的任意一种,例如维持、增强和/或改善受试者的健康、营养和/或其它病症,和/或认知、学习和/或记忆功能。镁缺乏可导致或与许多病理症状相关,例如食欲不振、恶心、呕吐、乏力、抽搐、心脏节律异常、糖尿病和/或心血管疾病。根据几项研究,镁缺乏可导致或可能与儿童的注意缺陷障碍(ADHD)及其相关症状有关(Kozielec等,Magnes.Res.10(2),143-148(1997)与Mousain-Bosc等,Magnes.Res.19(1),46-52(2006))。本文描述的镁反离子组合物可用来对患有镁缺乏、轻度认知功能障碍、阿尔茨海默氏症、注意缺陷障碍、ALS、帕金森氏症、糖尿病、偏头痛、焦虑症、情绪障碍和/或高血压的受试者施用,这仅仅是通过举例的方式。
镁是人体必需的矿物质,在许多生理功能中发挥作用。但是,普遍认为在工业化世界中至少有一半人没有从他们的饮食中获得足够的镁。有几种疾病,例如糖尿病和阿尔茨海默氏症(AD)与镁缺乏有关。因此,需要补充镁。建议的成人镁每日供给量(RDA)为约400mg。假设人们从饮食中获得40-50%所需镁,那么建议成人镁补剂的量通常为约200-250mg/天。有许多镁化合物被用作镁补剂。这些化合物包括例如氧化镁、柠檬酸镁、硫酸镁、氯化镁、葡萄糖酸镁、乳酸镁、吡酮酸镁和二甘氨酸镁。至少出于营养的目的,大多数商业镁补剂建议补充镁的量大约相同(即约250mg镁/天),其不考虑镁化合物的生物利用度和个体保留吸收的镁量的肾功能。有些镁补剂的供应商对于他们的产品建议更高的每日镁摄取,仍然没有考虑个体保留镁的肾功能。与镁缺乏相似的是,体内过量的镁(高镁血症)也会导致健康问题,例如神经肌肉抑郁症(neuromuscular depression)、低血压、心脏心律失常和呼吸麻痹。因此,保持血镁水平在正常范围内十分重要。本文公开了一种将镁水平控制到正常范围的特定区域的新型方法。在本发明的一些方面,该方法还提供了特殊的健康优势,例如增加记忆能力、增加寿命、减少抑郁症和减少神经疾病的症状,包括AD。
除用于营养外,镁补剂还用于治疗2型糖尿病。在一项研究中,糖尿病患者用每天近1g的镁治疗1个月(de Lordes Lima,等,DiabetesCare.21:682-6(1998))。该治疗使患者血清中的镁水平增加了约10%,但仅轻微改善了代谢控制。在另一项研究中,糖尿病患者用720mg/天的镁治疗3个月。同样,患者的血镁水平平均被提高了约10%(Eibl,等,Diabetes Care.21:2031-2(1995))。但是,用患者HbA1c水平评估的代谢控制没有改善。
已有报道镁离子通常可用于治疗痴呆(例如标题为“Methods fordiagnosing,monitoring and controlling the onset and progression of certaindementias and impeding memory loss or improving impairment of memory”的美国专利4,985,256)。Landfield和Morgan证实年轻的(9个月大)和年老的(25个月大)大鼠喂食含20%氧化镁的食物8天后,显示出某些认知功能改善的迹象(Landfield和Morgan,Brain Research,322:167-171(1984))。但是,认知功能的获得是暂时的,并且动物付出了腹泻和体重减轻的代价。事实上,由于副作用如此严重,使得研究者不得不使用替代喂养方案,对动物施用4天高Mg饮食,然后是2天常规饮食,然后回到高Mg饮食另外进行4天。
镁化合物还可用来影响骨密度。骨密度异常,包括但不限于骨质疏松症,可通过补充本发明的镁化合物来治疗。对受试者治疗可改善低骨密度的影响或作为对抗骨密度丢失的预防。骨密度可用本领域已知的任意方式测定,包括但不限于双能X射线吸光测定法(DEXA)、超声、定量计算断层照相法、单一的能源吸光测定法、磁共振成像、测量掌骨宽度和手X射线衍射分析。
如上所述,本文所述镁反离子组合物和/或方法可用于各种目的,例如维持、增强和/或改善受试者的健康、营养和/或其它病症,和/或认知、学习和/或记忆功能。受试者的这类病症的例子包括镁缺乏、轻度认知功能障碍、阿尔茨海默氏病、亨廷顿氏症、自闭症、精神分裂症、作为疾病或医学治疗(HIV疾病、癌症、化疗)的副作用的认知下降、抑郁症、老年痴呆症、注意缺陷障碍、肌萎缩性侧索硬化症(ALS)、帕金森氏病、糖尿病、心血管疾病(如高血压)、青光眼、偏头痛、焦虑、情绪和高血压,这些仅仅用于举例。镁补充剂还可用于维持、增强和/或改善因身体丢失镁而导致的病症,包括但不限于酗酒、厌食、贪食症、代谢综合征和营养不良。任何这类病症都可视为或定义为例如病理、精神病学、生理或医学病症或障碍。通常,术语“受试者”可以指任何动物。这类动物的例子包括但不限于冷血动物、温血动物、哺乳动物、驯化哺乳动物、灵长类动物、人类,并且被施用组合物的个体或患者是用于实验、诊断、营养和/或治疗目的。受试者或患者可以是健康、情绪、认知和/或营养状态正常、良好或优秀的受试者或患者,或者健康、情绪、认知和/或营养状态被损害的受试者或患者,包括异常的、较弱的、损害的、不健康的、受损的、病变的和/或营养缺乏的状态。受试者可以是任何年龄,包括高龄。
通常,术语“认知”是指获得、组织、理解、处理和/或使用信息或知识的过程。一般情况下,增强认知功能是指增强这类过程的任意方面,例如学习、进行心理活动、贮存、检索和/或使用信息和/或想法、记忆,和/或防止受试者认知状态的衰退。可使用各种标准试验来评估认知、认知功能和/或认知状态,并且可用来确定可有助于、受益于和/或需要维持和/或增强相同和/或监测相同治疗效果的受试者。合适试验的例子包括小型精神状态测试(Folstein,1975)、PROSPER神经心理测试电池组件(Houx,2002)等。也可用家族史、年龄和/或其它因素来确定可有利于有助于、受益于和/或需要维持和/或增强认知、认知功能和/或认知状态的受试者。
通常,关于用来对受试者机体施用例如组分、药剂、物质、材料、组合物等的两个或多个施用对象的术语“共同施用”,是指使用剂量和时间间隔进行施用,使得施用对象在小于最小量的时间间隔内一起出现在受试者机体内或在受试者机体的作用部位。时间间隔可以是任意合适的时间间隔,例如适宜的分钟、小时、天或周间隔。施用对象可同时施用,例如单个组合物的部分或其它。施用对象可几乎同时(例如彼此之间小于或等于约5分钟、约3分钟或约1分钟)或彼此在较短时间内(例如彼此之间小于或等于约1小时、30分钟或10分钟,或大于约5分钟到约1小时)施用。这样施用的施用对象可被认为在几乎相同的时间施用。本领域的普通技术人员能确定将施用对象施用于受试者机体的合适剂量和时间间隔,使得施用对象以大于受试者机体内的最小水平和/或以受试者机体内的有效浓度存在。当将施用对象共同施用于受试者机体时,任何施用对象可以是小于其单独施用所用有效量的有效量。术语“有效量”在本文中有进一步的描述,涵盖了小于有效量和通常有效量,以及事实上能有效引起特定状况、作用和/或反应的用量。为此,这类共同施用对象的剂量可以小于其单独施用时使用的剂量。任何这类施用对象的一种或多种作用可以是相加的或协同的。任何这类施用对象可在一个以上的时间施用。
通常,关于活性剂的术语“有效量”是指足以引起特定生物状况、作用和/或反应的活性剂的用量。以该方式有效的特定药剂的绝对量取决于各种因素,例如希望的生物学终点、药剂本身、受试者或靶向的其部分等。有效量的活性剂可单剂量或多剂量施用。有效量活性剂导致的生物状况、作用或反应的例子包括维持和/或改善受试者在涉及或关于认知功能任务中的行为、维持和/或改善受试者在测定某些与认知功能有关或相关测试中的行为、维持和/或改善认知功能的衰退速度(例如减缓)等。本文描述的组分可至少为有效量或至少使本文描述的任意相关特定目标或目的有效的用量。
通常,术语“生理可接受的”或“药学可接受的”指与动物或人类体内应用生物或药学相容的,例如由联邦监管机构或州政府批准,或在美国药典或其它普遍公认的药典中所列出的用于动物的,更特别是用于人类的。
本文所用的术语“治疗”以其所有的动词形式包括减轻或缓解受试者疾病的至少一个症状,所述疾病包括例如疼痛、阿尔茨海默氏病、血管性痴呆或帕金森病。术语“治疗”可指减轻或缓解受试者响应给定的刺激(例如压力、组织损伤、低温等)后所经历疾病表现出的强度和/或持续时间。例如,对于老年痴呆症,术语“治疗”可指减轻或缓解认知障碍(例如记忆和/或方向障碍)或整体功能障碍(日常起居活动,ADL)和/或减缓或扭转ADL中或认知的进行性恶化。在本发明的含义范围内,术语“治疗”还指阻止、延迟发作(即疾病临床症状的时期)和/或减小疾病发展或恶化的风险。本文使用的术语“保护”指适当地防止、延迟或治疗或所有受试者疾病的发展或继续或加重。在本发明的含义范围内,老年痴呆症与CNS紊乱相关,包括但不限于神经退行性疾病如阿尔茨海默氏病(AD)、唐氏综合症和脑血管性痴呆(VaD)。术语“治疗(treatment)”包括上述“治疗(treating)”的行为。
本文使用的术语“与剂量成比例的”是指活性成分的剂量和其生物利用度之间的关系。例如,如果剂量比例为相同组合物的两倍,则将递送两倍的活性成分并提供与一个剂量的剂型相同的生物利用度(例如AUC)。本发明的剂量比例适用于本文详细讨论的宽范围的剂量。
通常,与本文描述的镁反离子化合物关联使用的术语“元素镁”是指以游离离子存在的镁以及与一种或多种反离子结合的镁的总量。一般情况下,该术语不用来指与除镁反离子化合物外的其它物质相连的镁,所述镁反离子化合物可能是镁反离子组合物的成分(例如药物组合物、饮食补剂组合物、用镁反离子化合物补充的食品)。少量的镁可能天然存在于这类物质中或与这类物质相连。例如,果汁提取物或调味剂可能包含一部分从水果中得到的天然存在的镁。通常,与镁反离子化合物关联使用的术语“元素镁”不包括这类物质相关的镁。
本文使用的术语“含镁成分”(MCC)和“镁反离子化合物”可互换使用,并且它们可用于本文所述目的,例如维持、增强和/或改善受试者的健康、营养和/或其它病症,例如镁缺乏、糖尿病、情绪、注意缺陷障碍、ALS、帕金森病、焦虑、抑郁和/或偏头痛,和/或认知、学习和/或记忆功能,如MCI和/或AD。
已经证实,苏糖酸镁与通常用作镁补剂的镁化合物相比具有最高的生物利用度。迅速且高效地将镁从胃肠道递送到血液的能力使得该化合物成为药物应用的优秀候选药,例如治疗与镁缺乏相关的神经疾病或缺陷,或已知镁对其有效的那些疾病。参见标题为“MagnesiumCompositions,Methods of Using Same,and Associated Technology.”的美国专利申请12/054,373。例如,发现苏糖酸镁作为年轻动物的记忆增强剂或治疗与动物衰老或阿尔茨海默氏病(AD)相关的记忆减退有效。参见美国专利申请12/054,373。但是,对于用作饮食或营养补剂或用于一般性增强健康的组合物,其应有低的副作用并提供健康益处。不同于由健康专家对患有特定医学病症的患者开处方的药物组合物,饮食或营养补剂可由健康或不健康的人群服用,并且通常基于每日持续延长的时间,例如几个月、几年或者甚至一生。因此,当以有效剂量施用补剂时,提供充分的数据来支持长期安全性和饮食/营养补剂的益处十分重要。
在一些实施方式中,本发明提供一种对有需要的受试者补充镁的方法。受试者可以是本文描述的任何动物。在一些实施方式中,所述受试者是人类。苏糖酸镁的即释制剂(及相关组合物)已被证实对许多设置有用,包括改善的认知功能和突触可塑性(标题为“Magnesiumcompositons and Uses Thereof for Cognitive Function”的美国专利申请12/054,367和标题相同的12/258,891),治疗神经疾病(标题为“Magnesium compositons and Uses Thereof for Neurological Disorders”的美国专利申请12/054,384)、代谢紊乱(标题为“Magnesium compositonsand Uses Thereof for Metabolic Disorders”的美国专利申请12/054,374)和延长寿命(标题为“Magnesium compositons and Uses Thereof forIncreasing Lifespan”的美国专利申请12/054,368)。
本发明提供了施用口服剂型的方法。在一些实施方式中,一种施用本文所述口服剂型的方法包括对受试者施用所述口服剂型一天一次(UID)、一天两次(BID)、一天三次、一天四次或一天超过6次。在一些实施方式中,施用本文所述口服剂型一周一次、一周两次、一周三次、一周四次、一周五次、一周六次或一周七次。在一些实施方式中,施用本文所述口服剂型一个月一次、一个月两次、一个月三次、一个月四次、一个月五次、一个月六次或一个月六次以上。
本文所述口服剂型可用来以连续的方式补充镁,例如终身。该剂型还可用来在一段时间内提供镁,例如足以治疗、控制或以其它方式使镁缺乏受益的时间。在一个实施方式中,本发明提供了一种对有需要的受试者补充镁的方法,该方法包括对所述受试者施用本文所述口服剂型至少一天两次,时间为1个月或更长、2个月或更长、3个月或更长、4个月或更长、5个月或更长、6个月或更长,或至少一天两次,时间为1年或更长。在一些实施方式中,一天一次施用足以提供优化的镁补充。
使用任何施用方案,例如本文所描述的那些,本发明提供了治疗与镁缺乏有关病症的方法,包括对有需要的受试者施用本文所述任何口服剂型。例如,所述病症可以为神经疾病、心血管疾病或代谢紊乱。其它受益于本发明的病症包括但不限于镁缺乏、轻度认知功能障碍、阿尔茨海默氏症,注意缺陷障碍、ALS、帕金森氏症、糖尿病、偏头痛、焦虑症、情绪障碍和/或高血压。本领域技术人员将理解的是,本发明的口服剂型和方法可以用于治疗能顺利地响应补镁的任何病症。
在其它的实施方式中,本发明的口服剂型施用于受试者的剂量为约4mg元素镁/kg/天至约8mg元素镁/kg/天,或约2mg元素镁/kg/天至约12mg元素镁/kg/天,或约2mg元素镁/kg/天至约10mg元素镁/kg/天,或约4mg元素镁/kg/天至约12mg元素镁/kg/天,或约6mg元素镁/kg/天至约12mg元素镁/kg/天,或约2mg元素镁/kg/天至约10mg元素镁/kg/天,或约4mg元素镁/kg/天至约10mg元素镁/kg/天,或约6mg元素镁/kg/天至约10mg元素镁/kg/天。最优的剂量取决于受试者。在一些实施方式中,受试者是人类。在该实施方式中,剂量可被优化治疗人类的病症。
在一些实施方式中,本发明的口服剂型施用于受试者的剂量小于约2mg元素镁/kg/天,小于约4mg元素镁/kg/天,小于约6mg元素镁/kg/天,小于约8mg元素镁/kg/天,小于约10mg元素镁/kg/天,小于约12mg元素镁/kg/天。在一些实施方式中,本发明的口服剂型施用于受试者的剂量大于约2mg元素镁/kg/天,大于约4mg元素镁/kg/天,大于约6mg元素镁/kg/天,大于约8mg元素镁/kg/天,大于约10mg元素镁/kg/天,或大于约12mg元素镁/kg/天。最优剂量取决于受试者。在一些实施方式中,受试者是人类。在该实施方式中,剂量可被优化治疗人类的病症。
在一些实施方式中,本发明提供了包含镁(Mg)和苏糖酸盐(T)的口服剂型,其中所述苏糖酸盐包含一种或多种苏糖酸盐或苏糖酸盐前体,其中所述口服剂型一经对受试者施用就易于被吸收或保留,当所述口服剂型以20mg/kg/天或更高的剂量施用时,使得至少约50%所述施用的镁被所述受试者吸收,或者至少30%施用于受试者的镁保留至少两天。
本文描述的镁形式对于其高生物利用度十分有利。施用方案和施用剂量取决于受试者生物可利用的镁的量。在一些实施方式中,大于约10%、20%、30%、40%、50%、60%、70%、80%或大于约90%所述施用的镁在所述受试者中被吸收。
在一些实施方式中,受试者吸收的镁的量与剂量成比例。例如,被吸收的镁的量与剂量成线性比例。在一些实施方式中,当所述口服剂型施用于受试者的量为约20mg/kg/天至约100mg/kg/天,或约20mg/kg/天至约90mg/kg/天,或约20mg/kg/天至约80mg/kg/天,或约20mg/kg/天至约70mg/kg/天,或约20mg/kg/天至约60mg/kg/天,或约20mg/kg/天至约50mg/kg/天,或约30mg/kg/天至约100mg/kg/天,或约40mg/kg/天至约100mg/kg/天,或约50mg/kg/天至约100mg/kg/天,或约60mg/kg/天至约100mg/kg/天,或约70mg/kg/天至约100mg/kg/天时,表现出被吸收的镁与剂量成比例地增加。
在一些实施方式中,本发明剂型中镁的溶出速率在约6至10小时内为约40-80%。
镁组合物有可能引起腹泻。事实上,镁化合物通常被用作轻泻剂,且氢氧化镁是俗称的非处方轻泻剂,其是Phillips’Milk of Magnesia的活性成分。此外,中国专利1200366A公开了将苏糖酸镁用作轻泻剂。但是,本发明表明大量常用镁补剂化合物中的苏糖酸镁引起腹泻的趋势最小。见实施例2和图1。
腹泻的发病率可通过以下来评估:向一组测试动物(例如大鼠或小鼠)提供一个剂量的苏糖酸镁或其前体,并且评价该组动物的腹泻发病率。在一种实施方式中,本发明提供了一种包含约30mg至2000mg镁(Mg)的口服剂型,其中所述口服剂型是控释制剂,并且其中一经施用于受试者大于40mg/天的所述口服剂型,就产生小于20%的腹泻发病率。发病率取决于特定的受试者、受试者的体重和所提供镁的生物利用度。例如,喂食含苏糖酸镁水溶液的小鼠的腹泻发病率取决于例如小鼠的血统、年龄或性别。
在一些实施方式中,当本发明的口服剂型以大于80mg/天的剂量施用时,提供小于50%、40%、30%、20%、10%或小于约5%的腹泻发病率。
在一些实施方式中,当以大于40mg/天的剂量向受试者施用至少约2、3、4、5、6天时,腹泻的发病率小于20%。在一些实施方式中,当以大于40mg/天的剂量向受试者施用至少约1周、或2周、或3周或以上时,腹泻的发病率小于20%。在一些实施方式中,当以大于40mg/天的剂量向受试者施用至少约1个月时,腹泻的发病率小于20%。
苏糖酸镁相对于其它形式的镁所具有的高生物利用度见图2A和B。例如,已报道最广泛应用的镁补剂氧化镁仅具有4%的生物利用度(Ranade VV,Somberg JC.Bioavailability and pharmacokinetics ofmagnesium after administration of magnesium salts to humans.Am J Ther.2001 Sep-Oct;8:345-57)。因此,长期服用相同建议量的使用苏糖酸镁的元素镁,受试者显示出比其它镁补剂更高的前所未及的血镁水平。苏糖酸镁还提供了优越的体内镁保留。图2C和D表明,尽管苏糖酸镁具有最大的镁吸收率,但是其血镁通过尿的排泄率与其它镁化合物相近。所以,测定镁化合物最终生物利用度的镁保留速率(吸收率-排泄率),苏糖酸镁比其它镁化合物高。因此,这使得苏糖酸镁是目前提高组织和其它体液内镁水平的最有效的化合物。事实上,在治疗24天后,苏糖酸镁显著增加小鼠脑中的镁水平(即脑脊液(CSF)中镁的浓度),而牛奶中的氯化镁和葡萄糖酸镁作用相对有限(图3)。这些数据表明,苏糖酸盐通常能促进镁进入脑。这种脑内镁的提高与动物认知功能的改善相一致。见标题为“Magnesium Compositionss,Methods of Using Same,and Associated Technology.”的美国专利申请12/054,373。
因此,本发明提供了一种提高受试者中枢神经系统内镁的方法,包括向所述受试者施用本文所述口服剂型。在一些实施方式中,口服剂型包含镁(Mg)和苏糖酸盐(T)的控释形式,其中所述苏糖酸盐包含一种或多种苏糖酸盐或苏糖酸盐前体。在一些实施方式中,施用口服剂型提供了受试者脑脊液内镁浓度的增加,其中与没有施用镁的基线相比,约10天后所述受试者的脑脊液中增加的镁浓度为增加约5%至增加约10%。在一些实施方式中,在施用所述口服剂型约10天后,所述脑脊液中增加的镁浓度范围为增加约1%至约10%,或增加约2%至约10%,或增加约3%至约10%,或增加约4%至约10%。在一些实施方式中,约10天后,所述受试者脑脊液中增加的镁浓度为增加约1%、2%、3%、4%、5%、6%、7%、8%、9%以上,或增加约10%以上。
本发明的组合物可提供如此高水平的镁而没有不良作用。在一些实施方式中,提供组合物,具有不良作用至少1个月、2个月、3个月、4个月、5个月或至少6个月。在一些实施方式中,提供组合物,具有不良作用至少1年、或2年、或5年、或20年、或20年或终生。例如,在年龄为15个月的正常雄性和雌性小鼠的余生中用苏糖酸镁治疗。见实施例4。结果表明,用镁治疗的动物具有正常的寿命(图4)。在这些实验中,镁日剂量(75mg/kg/天)的量对应用于增强正常年轻和衰老小鼠记忆以及AD小鼠在短期镁治疗实验中的有效剂量。见美国专利申请12/054,373,“Magnesium Compositions,Methods of Using Same,andAssociated Technology.”。数据表明,当以生理有效剂量使用时,苏糖酸镁没有长期毒性。
本发明的口服剂型进一步提供了对抗高热量饮食的保护健康的好处。在实验中,对10个月大、余生均为高热量饮食的小鼠给与该化合物。正如所预料的,具有高热量饮食加苏糖酸镁的动物组以及具有高热量饮食但没有苏糖酸镁(对照组#1)的其它动物组均随时间体重明显增加(图5A)。还如预期的是,高热量对照组(对照组#1)的动物死亡率远远大于喂食标准小鼠饮食(对照组#2)的动物(图5B)。但是,具有高热量饮食加苏糖酸镁的动物与具有标准饮食的动物寿命相近。众所周知的是,高热量饮食会导致肥胖,这反过来会导致各种健康问题,包括糖尿病和心血管疾病。图5的结果表明苏糖酸镁对代谢综合征和其它肥胖相关的健康问题有预防作用,从而使得该化合物除用作镁补剂外,还可用于一般健康增强的目的。
肥胖可导致许多严重的并发症。这些包括:II型糖尿病、不健康的胆固醇水平、心脏疾病(如动脉粥样硬化、心肌梗死、充血性心脏衰竭、血栓栓塞、心脏猝死、心绞痛或胸痛)、中风、高血压、睡眠呼吸暂停、呼吸障碍、肌肉骨骼疾病(例如骨关节炎、背痛)、胆囊疾病、脂肪肝疾病、癌症、哮喘、慢性头痛、曲张静脉、深静脉血栓形成、冠状动脉疾病、胃食管反流病(GERD)、胃灼热、抑郁症、疝气、胆结石、尿失禁、月经不规则、不孕不育、以及母亲和儿童增加的怀孕的危险。肥胖会导致许多人过早死亡。
在一种实施方式中,本发明提供了一种维持高热量饮食但没有高热量相关不良作用重大危险的方法,包括对受试者施用本文所述口服剂型。在一种实施方式中,口服剂型包含镁(Mg)和苏糖酸盐(T),其中苏糖酸盐包含一种或多种苏糖酸盐或苏糖酸盐前体。该口服剂型有效增加高热量饮食受试者的寿命。在一些实施方式中,向高热量饮食的受试者施用所述口服剂型会产生保护作用,使得所述受试者的寿命与中等体重受试者的平均寿命相当。
在一种实施方式中,本发明提供了一种包含镁(Mg)和苏糖酸盐(T)的口服剂型,其中所述苏糖酸盐包含一种或多种苏糖酸盐或苏糖酸盐前体,其中向受试者施用所述口服剂型提供对抗所述受试者高热量饮食不良作用的保护。不良作用包括但不限于动脉粥样硬化、心脏病、心肌梗死、中风、血栓栓塞、代谢综合征和糖尿病。本文还公开了各种肥胖引起的其它并发症。
本发明化合物的健康有益作用可在试验动物上测定,例如啮齿类动物,如小鼠或大鼠。见实施例5。在一些实施方式中,对于具有高热量饮食至少约60周的这类动物,口服剂型提高至少约10%、20%、30%、40%、50%或50%以上的生存率。在一些实施方式中,在较短时间内即可观察到生存率的提高。在一些实施方式中,对于具有高热量饮食至少约10周、20周、30周、40周或至少约50周的这类动物,口服剂型提高了显著量的生存率。本领域技术人员将会认识如何测定生存效果,例如使用Kaplan-Meier生存曲线分析。
III.试剂盒
本发明还提供了用于实施本发明的试剂盒。试剂盒可包括本文所述任意镁反离子组合物的至少一种成分或本文描述的任意镁反离子组合物。在一些实施方式中,试剂盒包括控释口服剂型的苏糖酸镁补剂或本文描述的任意变型。在一些实施方式中,试剂盒包括盛装所述口服剂型的瓶子或其它容器。在一些实施方式中,口服剂型被包含在泡罩包装中,以简化最终用户的健康和治疗方案。
实施例
实施例1方法
动物:成年雄性Sprague-Dawley大鼠获自中国北京维通利华。将大鼠单独安置在有自由获得的标准食物和水、12∶12h颠倒光线-黑暗周期的住所中,在晚上8:00打开光照。一旦达到和开始生物利用度实验(如下),给大鼠喂食含标准镁(0.15%)的商业颗粒饲料和随意的自来水。所有的实验方法由清华大学动物管理委员会批准。
不同镁制剂的治疗:将下列的镁制剂用于本实验中,苏糖酸镁(Magceutics Inc.,美国)、氯化镁和甘氨酸镁(Modern Eastern FineChemical,中国)、葡萄糖酸镁和柠檬酸镁(Sigma-Aldrich,德国)。乳糖获自Biobasic Inc(北京,中国)。为了供应给动物50mg/kg/天元素镁的剂量,将下述剂量的各种制剂溶于每日饮用量中:苏糖酸镁(606mg/kg/天)、氯化镁(196mg/kg/天)、葡萄糖酸镁(853mg/kg/天)、柠檬酸镁(310mg/kg/天)和甘氨酸镁(355mg/kg/天)。
镁吸收、排泄和保留的确定:将大鼠各自安置在代谢笼中12天,在这段时间内动物得到不含镁的食物。在第4天到第10天,动物得到含一种测试镁化合物的去离子水。从第11天到第12天,给大鼠喂食不含镁的食物和去离子水。在补镁期间(第4天到第10天),每天收集每只大鼠的尿液,并在第5天到第10天收集粪粒。汇集收集到的尿液和粪粒,并记录收集的每只大鼠尿液的总体积和粪便的总重量。使用电感耦合等离子体原子发射光谱仪(ICP-AES)分析所汇集的每只大鼠尿液和粪粒的镁含量,并确定尿液和粪便中的总镁含量(毫克)。
通过下列等式的线性回归斜率评估吸收、排泄和保留百分比:
吸收=(Mg摄取-Mg粪便)*100%/Mg摄取(等式1)
排泄=Mg尿液*100%/(Mg摄取-Mg粪便)(等式2)
保留=(Mg摄取-Mg粪便-Mg尿液)*100%/Mg摄取(等式3)
不同镁制剂的安全限度:为评估不同镁制剂的通便性质,将动物分成10组。每组通过饮水得到剂量为15到138mg/kg/天元素镁的具体镁制剂。溶于每日摄取水量的镁剂量基于~30ml/天/大鼠来确定。给动物供应4天补充镁的饮水,此后监测每组发生腹泻的动物的数目,并计算其占与动物总数的百分比。
脑脊液中的镁含量:对单独组的动物在基线(0天)和用不同镁制剂治疗的第12和24天评估脑脊液(CSF)中镁离子的含量。通过饮用水,用剂量为约50mg/kg/天元素镁的不同镁制剂对动物进行治疗。在每个采样点前,将大鼠用水合氯醛(400mg/kg,腹腔注射)麻醉,并通过使用直径为450μm的微针介入寰枕膜人工从小脑延髓池取50μl/动物CSF。收集CSF样品并在-20℃保存至进行镁测定。如上所述,测定镁的水平。
统计分析:将所有数据用正态分布模拟。使用95%置信区间的线性回归进行生物利用度分析。为确定动物的50%毒性剂量(TD50),使用95%置信区间的变量Hill-斜率分析最佳拟合的非线性回归。使用单向方差分析来分析脑脊液数据。使用GraphPad prism(5.00版,GraphPadsoftware Inc.)分析数据。小于0.05的P值被认为是显著的。
实施例2补镁对腹泻发病率的影响
图1显示喂食各种镁补剂的大鼠的腹泻发病率。当镁的剂量增加时,发生腹泻的动物百分比成比例增加。在较高剂量,苏糖酸镁(MgT)诱发腹泻的可能性较小。每种化合物的TD50(诱发50%动物腹泻所需的毒性剂量)如下:苏糖酸镁:131.5mg/kg/天,于牛奶中的葡萄糖酸镁(MgG+牛奶):119.1mg/kg/天,葡萄糖酸镁(MgG):99.7mg/kg/天,氯化镁(MgCl2):90.0mg/kg/天。将镁化合物添加到大鼠的饮用水中,从而模拟大鼠随着时间过去而饮水时镁化合物的缓释。
实施例3脑脊液中镁浓度([Mg2+]CSF)的提高
给小鼠喂食24天的氯化镁(MgCl2)、于牛奶中的葡萄糖酸镁(MgG+牛奶)和苏糖酸镁(MgT)。图3显示用不同镁制剂治疗后脑脊液中镁浓度([Mg2+]CSF)的提高。在治疗24天后,苏糖酸镁显著增加了小鼠脑脊液中镁的浓度,而氯化镁和于牛奶中的葡萄糖酸镁具有相对有限的作用。在第24天使用单向ANOVA(p<0.05),数据是显著的。
实施例4苏糖酸镁(MgT)对喂食正常食物的动物寿命的影响
10个月大的雄性和雌性小鼠购自中国北京维通利华实验动物技术有限公司。在开始实验前,给小鼠喂食5个月含普通镁(0.15%)的商业颗粒饲料(上海斯莱克实验动物有限公司)和随意的自来水。将四只雌性小鼠一起安置在能自由获得食物和水的12∶12h光明-黑暗周期的单独笼子中,光照在上午8:00开启。雄性小鼠单独饲养。在实验开始时,将苏糖酸镁(75mg/kg/天元素镁)添加到小鼠的饮用水中。使用Kaplan-Meier法绘制生存曲线,其包括每个时间点所有可用的动物。在实验开始时每组使用30只小鼠(图4A和B)。
实施例5苏糖酸镁(MgT)对喂食高热量饮食动物寿命的影响
9个月大的雌性小鼠购自中国北京维通利华实验动物技术有限公司。在开始实验前,给小鼠喂食1个月含普通镁(0.15%)的商业颗粒饲料(上海斯莱克实验动物有限公司)和随意的自来水。将四只雌性小鼠一起安置在能自由获得食物和水的12∶12h光明-黑暗周期的单独笼子中,光照在上午8:00开启。在实验开始时,部分小鼠通过添加氢化椰子油转换成高热量(HC)饮食,提供60%来自脂肪的热量(Baur等,2006Resveratrol improves health and survival of mice on a high-calorie diet.Nature 444,337-342)。部分喂食HC的小鼠通过其饮用水补充约45mg/kg/天元素镁的MgT补剂。在实验期间,基于周测定食物摄取和体重。使用Kaplan-Meier法绘制生存曲线,其包括每个时间点所有可用的动物。在实验开始时每组(即正常饮食、HC饮食、补充MgT的HC饮食)使用60只小鼠(图5A和B)
实施例6控释片剂的制备和释放曲线
为制备控释片剂,将苏糖酸镁粉碎并用80目筛过筛。将苏糖酸镁粉末与于95%乙醇中的15%聚乙烯吡咯烷酮(PVP)混合,每克苏糖酸镁粉末用0.3mL 95%乙醇。使用12目筛对所得颗粒过筛,除去任何未结合的苏糖酸镁。用加压空气在65℃干燥颗粒15分钟,然后再次使用12目筛过筛,除去任何未结合的碎片。向干燥颗粒中添加药学上可接受量的硬脂酸镁作为润滑剂(每克苏糖酸镁用~5mg)。在充分混合后,将润滑的颗粒压制成~1g大小的片剂。通过将223.67g 30%SR 30D(聚乙酸乙烯酯)(于水中)、6.7g聚乙二醇和19g PVP混合,然后加水至总量450g制得包衣液。还加入了药学适宜量的色淀染料和滑石粉或二氧化钛,以提供光保护和促进包衣工艺。将所得混合物充分搅拌形成均匀的悬浮液。在45-55℃使用上述的包衣液对片剂包衣,得到每片含~1g苏糖酸镁和70-90mg辅料的控释片剂。
在37℃、搅拌速率为75rpm的250mL生理盐水中测定上述制备的控释片剂的释放曲线。使用光谱法测定镁随时间的释放量(Raymond J.Liedtke和Gery Kroon Clin.Chem.30(11),1801-1804(1984))。释放曲线见表1。
表1.随时间释放的镁
时间(h) | %释放的镁 |
2 | 0 |
4 | 6.9 |
6 | 32.5 |
8 | 60.1 |
10 | 76.2 |
12 | 83.3 |
24 | 104.6 |
上述数据在图6B中绘制。
尽管本文已经显示和描述了本发明优选的实施方式,但是对本领域技术人员显而易见的是,这类实施方式仅通过举例来提供。许多变型、改变和替代方式目前对于本领域的技术人员而言是能发生的,而不会脱离本发明。应理解的是,在实施本发明时可使用本文描述的本发明实施方式的各种替代方式。下列的权利要求是为了确定本发明的范围以及在这些权利要求范围内的方法和结构,从而涵盖其等同物。
Claims (34)
1.一种包含镁(Mg)和苏糖酸盐(T)的口服剂型,其中所述苏糖酸盐包含一种或多种苏糖酸盐或苏糖酸盐前体,其中所述口服剂型在溶出介质中具有体外溶出曲线,并且其中所述溶出曲线在使用美国药典II型(桨式)溶出系统于75rpm和37℃的温度下测定时,其范围为在2小时内小于或等于5%,在4小时内小于10%,在6小时内小于40%,在10小时内大于或等于60%,和在12小时内大于或等于80%,其中所述苏糖酸盐前体包含苏糖酸、苏糖酸酯或苏糖酸内酯。
2.权利要求1的口服剂型,其中在所述口服剂型中的所述镁和苏糖酸盐被包封到片剂中。
3.权利要求1的口服剂型,其中至少部分所述镁(Mg)和苏糖酸盐(T)以MgT2的盐形式络合。
4.权利要求1至3之一的口服剂型,其中至少部分所述镁(Mg)和苏糖酸盐(T)以MgT2的盐形式络合,并以重量等于至少20mg Mg的量存在。
5.权利要求1的口服剂型,其中所述苏糖酸盐(T)和所述镁(Mg)之间的摩尔比大于或等于0.1至2。
6.权利要求1至3之一的口服剂型,其中所述镁(Mg)以大于1重量%的量存在。
7.权利要求1至3之一的口服剂型,其中所述镁(Mg)以大于5重量%的量存在。
8.权利要求1至3之一的口服剂型,其中所述镁(Mg)以大于7重量%的量存在。
9.权利要求1至3之一的口服剂型,其中所述镁(Mg)与选自氯离子、牛磺酸根、乳酸根、葡萄糖酸根、柠檬酸根、苹果酸根、琥珀酸根、硫酸根、丙酸根、氢氧根、氧化物、乳清酸根、磷酸根、硼酸根、水杨酸根、碳酸根、溴离子、硬脂酸根、氨基酸、丁酸根、天门冬氨酸根、抗坏血酸根、吡啶甲酸根、泛酸根、烟酸根、苯甲酸根、肌醇六磷酸根、酪蛋白酸根、棕榈酸根、丙酮酸根和苏糖酸根的阴离子络合。
10.权利要求1至3之一的口服剂型,进一步包含选自钙、钾、钠、铬、铁、硒、锌、锰、钼、钒和锂的金属离子。
11.权利要求1至3之一的口服剂型,进一步包含一种或多种选自白藜芦醇、鞣花酸、槲皮素、硫辛酸或维生素C的抗氧剂。
12.权利要求1至3之一的口服剂型,其中所述溶出曲线使用美国药典II型(桨式)溶出系统于75rpm和37℃的温度下测定时,范围为在2小时内小于5%,在4小时内小于10%,在6小时内小于40%,在10小时内大于或等于60%,和在12小时内大于或等于80%。
13.权利要求1至3之一的口服剂型,其中在所述口服剂型中有至少75%的所述镁(Mg)和苏糖酸盐(T)以控释剂型提供。
14.权利要求1至3之一的口服剂型,其中在所述口服剂型中有至少95%的所述镁(Mg)和苏糖酸盐(T)以控释剂型提供。
15.权利要求1至3之一的口服剂型,其中在所述口服剂型中有100%的所述镁(Mg)和苏糖酸盐(T)以控释剂型提供。
16.权利要求1至3之一的口服剂型,其中所述溶出介质是盐溶液。
17.权利要求1至3之一的口服剂型,其中所述溶出曲线是零级。
18.权利要求1至3之一的口服剂型,进一步包含与镁(Mg)和苏糖酸盐(T)混合的聚合物粘合剂。
19.权利要求18的口服剂型,其中所述聚合物包含聚乙烯吡咯烷酮。
20.权利要求1至3之一的口服剂型,其中所述口服剂型进一步包含药学上可接受量的硬脂酸镁。
21.权利要求1至3之一的口服剂型,其中所述口服剂型进一步包含聚乙烯吡咯烷酮、聚乙酸乙烯酯或丙二醇中的一种或多种。
22.权利要求1的口服剂型,其中所述苏糖酸盐包含一种或多种苏糖酸盐或苏糖酸盐前体,其中所述口服剂型有效增加高热量饮食受试者的寿命。
23.权利要求22的口服剂型,其中对高热量饮食受试者施用所述口服剂型产生保护作用,使得所述受试者的寿命与中等体重受试者的平均寿命相当。
24.权利要求1的口服剂型,其中所述口服剂型以1mg元素镁/kg/天至16mg元素镁/kg/天的剂量施用于人类受试者。
25.权利要求24的口服剂型,其中对于具有高热量饮食至少60周的受试者,口服剂型增加至少40%的生存率。
26.权利要求1的口服剂型,其中所述口服剂型包含镁(Mg)和苏糖酸盐(T),其中所述苏糖酸盐包含一种或多种苏糖酸盐或苏糖酸盐前体,并且其中所述口服剂型当施用于受试者时,在受试者的脑脊液中提供浓度增加的镁,其中与没有施用镁的基线镁浓度相比,在对所述受试者施用所述口服剂型10天后,在所述受试者脑脊液中增加的镁浓度范围为增加5%至增加10%。
27.权利要求1-26任一项所述的口服剂型在制备用于治疗与镁缺乏相关的病症的药物中的应用。
28.权利要求27的应用,其中所述病症选自神经疾病、心血管疾病和代谢紊乱。
29.权利要求1-26任一项的口服剂型在制备用于提高有需要的受试者中枢神经系统内镁的药物中的应用。
30.权利要求1-26任一项的口服剂型在制备用于保持高热量饮食但缺乏高热量相关不良作用的重大危险的药物中的应用。
31.权利要求1-26任一项的口服剂型在制备用于至少每天一次对有需要的受试者补充镁的药物中的应用。
32.权利要求1-26任一项的口服剂型在制备用于至少每天两次,时间为1个月或更长对有需要的受试者补充镁的药物中的应用。
33.一种制备权利要求1-26任一项口服剂型的方法,包括将含有镁(Mg)和苏糖酸盐(T)的粉末与聚合物混合,其中镁(Mg)和苏糖酸盐(T)均以盐形式存在,所述聚合物的量足以产生含有镁(Mg)、苏糖酸盐(T)和聚合物的颗粒,其中所述颗粒具有足以保留在12目筛上的尺寸。
34.权利要求33的方法,该方法进一步包括:
使用12目筛过滤所述颗粒以除去未结合的苏糖酸盐;
干燥颗粒;
向所述颗粒中加入药学上可接受量的润滑剂;
将颗粒压制成大小在100mg至2000mg之间的一种或多种小丸;和
用包含聚乙烯吡咯烷酮、聚乙酸乙烯酯或丙二醇中一种或多种的聚合物包衣膜对所述一种或多种小丸包衣。
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- 2010-07-01 US US12/829,361 patent/US8377473B2/en active Active
- 2010-07-01 WO PCT/US2010/040849 patent/WO2011003045A1/en active Application Filing
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2012
- 2012-12-27 HK HK12113395.0A patent/HK1172505A1/zh unknown
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2013
- 2013-01-08 US US13/736,679 patent/US8734855B2/en active Active
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2014
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US20110020443A1 (en) | 2011-01-27 |
US20130236542A1 (en) | 2013-09-12 |
EP2448413A4 (en) | 2013-02-13 |
CN102573496A (zh) | 2012-07-11 |
HK1172505A1 (zh) | 2013-04-26 |
US8734855B2 (en) | 2014-05-27 |
US20150064285A1 (en) | 2015-03-05 |
EP2448413A1 (en) | 2012-05-09 |
US8377473B2 (en) | 2013-02-19 |
WO2011003045A1 (en) | 2011-01-06 |
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