CN116507327A - 可咀嚼调配物 - Google Patents
可咀嚼调配物 Download PDFInfo
- Publication number
- CN116507327A CN116507327A CN202180073292.XA CN202180073292A CN116507327A CN 116507327 A CN116507327 A CN 116507327A CN 202180073292 A CN202180073292 A CN 202180073292A CN 116507327 A CN116507327 A CN 116507327A
- Authority
- CN
- China
- Prior art keywords
- hydrochloride
- sodium
- composition
- dosage form
- acid
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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- 239000000203 mixture Substances 0.000 title claims description 63
- 238000009472 formulation Methods 0.000 title description 9
- -1 carbonate compound Chemical class 0.000 claims abstract description 375
- 239000002552 dosage form Substances 0.000 claims abstract description 137
- FSVJFNAIGNNGKK-UHFFFAOYSA-N 2-[cyclohexyl(oxo)methyl]-3,6,7,11b-tetrahydro-1H-pyrazino[2,1-a]isoquinolin-4-one Chemical compound C1C(C2=CC=CC=C2CC2)N2C(=O)CN1C(=O)C1CCCCC1 FSVJFNAIGNNGKK-UHFFFAOYSA-N 0.000 claims description 75
- 229960002957 praziquantel Drugs 0.000 claims description 75
- YZBLFMPOMVTDJY-CBYMMZEQSA-N moxidectin Chemical compound O1[C@H](C(\C)=C\C(C)C)[C@@H](C)C(=N/OC)\C[C@@]11O[C@H](C\C=C(C)\C[C@@H](C)\C=C\C=C/2[C@]3([C@H](C(=O)O4)C=C(C)[C@@H](O)[C@H]3OC\2)O)C[C@H]4C1 YZBLFMPOMVTDJY-CBYMMZEQSA-N 0.000 claims description 60
- 229960004816 moxidectin Drugs 0.000 claims description 60
- 230000000590 parasiticidal effect Effects 0.000 claims description 20
- 239000002297 parasiticide Substances 0.000 claims description 20
- 239000008188 pellet Substances 0.000 claims description 20
- WEQPBCSPRXFQQS-UHFFFAOYSA-N 4,5-dihydro-1,2-oxazole Chemical compound C1CC=NO1 WEQPBCSPRXFQQS-UHFFFAOYSA-N 0.000 claims description 19
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 18
- 239000003120 macrolide antibiotic agent Substances 0.000 claims description 16
- 229920000642 polymer Polymers 0.000 claims description 15
- 239000002245 particle Substances 0.000 claims description 13
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims description 12
- 239000008187 granular material Substances 0.000 claims description 11
- 239000011247 coating layer Substances 0.000 claims description 10
- 239000000758 substrate Substances 0.000 claims description 10
- 235000017557 sodium bicarbonate Nutrition 0.000 claims description 9
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims description 9
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- CKVMAPHTVCTEMM-ALPQRHTBSA-N milbemycin oxime Chemical compound O1[C@H](C)[C@@H](C)CC[C@@]11O[C@H](C\C=C(C)\C[C@@H](C)\C=C\C=C/2[C@]3([C@H](C(=O)O4)C=C(C)C(=N/O)/[C@H]3OC\2)O)C[C@H]4C1.C1C[C@H](C)[C@@H](CC)O[C@@]21O[C@H](C\C=C(C)\C[C@@H](C)\C=C\C=C/1[C@]3([C@H](C(=O)O4)C=C(C)C(=N/O)/[C@H]3OC\1)O)C[C@H]4C2 CKVMAPHTVCTEMM-ALPQRHTBSA-N 0.000 claims description 4
- 229940099245 milbemycin oxime Drugs 0.000 claims description 4
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 3
- MLBZKOGAMRTSKP-UHFFFAOYSA-N fluralaner Chemical compound C1=C(C(=O)NCC(=O)NCC(F)(F)F)C(C)=CC(C=2CC(ON=2)(C=2C=C(Cl)C=C(Cl)C=2)C(F)(F)F)=C1 MLBZKOGAMRTSKP-UHFFFAOYSA-N 0.000 claims description 3
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- HDKWFBCPLKNOCK-SFHVURJKSA-N 3-methyl-n-[2-oxo-2-(2,2,2-trifluoroethylamino)ethyl]-5-[(5s)-5-(3,4,5-trichlorophenyl)-5-(trifluoromethyl)-4h-1,2-oxazol-3-yl]thiophene-2-carboxamide Chemical compound S1C(C(=O)NCC(=O)NCC(F)(F)F)=C(C)C=C1C1=NO[C@](C(F)(F)F)(C=2C=C(Cl)C(Cl)=C(Cl)C=2)C1 HDKWFBCPLKNOCK-SFHVURJKSA-N 0.000 claims description 2
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- WTERNLDOAPYGJD-SFHVURJKSA-N monepantel Chemical compound C([C@@](C)(NC(=O)C=1C=CC(SC(F)(F)F)=CC=1)C#N)OC1=CC(C#N)=CC=C1C(F)(F)F WTERNLDOAPYGJD-SFHVURJKSA-N 0.000 claims description 2
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- 239000008186 active pharmaceutical agent Substances 0.000 claims 2
- AQXXZDYPVDOQEE-MXDQRGINSA-N Pyrantel pamoate Chemical compound CN1CCCN=C1\C=C\C1=CC=CS1.C1=CC=C2C(CC=3C4=CC=CC=C4C=C(C=3O)C(=O)O)=C(O)C(C(O)=O)=CC2=C1 AQXXZDYPVDOQEE-MXDQRGINSA-N 0.000 claims 1
- 150000004649 carbonic acid derivatives Chemical class 0.000 claims 1
- CHQKHXJPWDSTPY-UHFFFAOYSA-N fluprazine Chemical compound C1CN(CCNC(=O)N)CCN1C1=CC=CC(C(F)(F)F)=C1 CHQKHXJPWDSTPY-UHFFFAOYSA-N 0.000 claims 1
- 229950006789 fluprazine Drugs 0.000 claims 1
- 239000004480 active ingredient Substances 0.000 abstract description 31
- 239000007884 disintegrant Substances 0.000 abstract description 11
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 252
- 239000011734 sodium Substances 0.000 description 63
- 229910052708 sodium Inorganic materials 0.000 description 63
- 229940083542 sodium Drugs 0.000 description 63
- 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 description 62
- 239000002253 acid Substances 0.000 description 38
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 description 34
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 34
- 229960003179 rotigotine Drugs 0.000 description 30
- KFQYTPMOWPVWEJ-INIZCTEOSA-N rotigotine Chemical compound CCCN([C@@H]1CC2=CC=CC(O)=C2CC1)CCC1=CC=CS1 KFQYTPMOWPVWEJ-INIZCTEOSA-N 0.000 description 30
- QAOWNCQODCNURD-UHFFFAOYSA-L Sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 description 28
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 description 27
- 150000001875 compounds Chemical class 0.000 description 27
- VZCYOOQTPOCHFL-UPHRSURJSA-N maleic acid Chemical compound OC(=O)\C=C/C(O)=O VZCYOOQTPOCHFL-UPHRSURJSA-N 0.000 description 26
- 230000000895 acaricidal effect Effects 0.000 description 23
- 239000003795 chemical substances by application Substances 0.000 description 23
- HBCQSNAFLVXVAY-UHFFFAOYSA-N pyrimidine-2-thiol Chemical compound SC1=NC=CC=N1 HBCQSNAFLVXVAY-UHFFFAOYSA-N 0.000 description 22
- 239000000642 acaricide Substances 0.000 description 21
- 239000013543 active substance Substances 0.000 description 18
- 241001465754 Metazoa Species 0.000 description 16
- 229960004821 amikacin Drugs 0.000 description 16
- LKCWBDHBTVXHDL-RMDFUYIESA-N amikacin Chemical compound O([C@@H]1[C@@H](N)C[C@H]([C@@H]([C@H]1O)O[C@@H]1[C@@H]([C@@H](N)[C@H](O)[C@@H](CO)O1)O)NC(=O)[C@@H](O)CCN)[C@H]1O[C@H](CN)[C@@H](O)[C@H](O)[C@H]1O LKCWBDHBTVXHDL-RMDFUYIESA-N 0.000 description 16
- QLFZZSKTJWDQOS-YDBLARSUSA-N doramectin Chemical compound O1[C@@H](C)[C@H](O)[C@@H](OC)C[C@@H]1O[C@@H]1[C@@H](OC)C[C@H](O[C@@H]2C(=C/C[C@@H]3C[C@@H](C[C@@]4(O3)C=C[C@H](C)[C@@H](C3CCCCC3)O4)OC(=O)[C@@H]3C=C(C)[C@@H](O)[C@H]4OC\C([C@@]34O)=C/C=C/[C@@H]2C)/C)O[C@H]1C QLFZZSKTJWDQOS-YDBLARSUSA-N 0.000 description 16
- 229960003997 doramectin Drugs 0.000 description 16
- 238000000034 method Methods 0.000 description 16
- 239000005660 Abamectin Substances 0.000 description 14
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 14
- AFVFQIVMOAPDHO-UHFFFAOYSA-N Methanesulfonic acid Chemical compound CS(O)(=O)=O AFVFQIVMOAPDHO-UHFFFAOYSA-N 0.000 description 14
- AFJYYKSVHJGXSN-KAJWKRCWSA-N selamectin Chemical compound O1[C@@H](C)[C@H](O)[C@@H](OC)C[C@@H]1O[C@@H]1C(/C)=C/C[C@@H](O[C@]2(O[C@@H]([C@@H](C)CC2)C2CCCCC2)C2)C[C@@H]2OC(=O)[C@@H]([C@]23O)C=C(C)C(=N\O)/[C@H]3OC\C2=C/C=C/[C@@H]1C AFJYYKSVHJGXSN-KAJWKRCWSA-N 0.000 description 14
- 229960002245 selamectin Drugs 0.000 description 14
- ZKLPARSLTMPFCP-UHFFFAOYSA-N Cetirizine Chemical compound C1CN(CCOCC(=O)O)CCN1C(C=1C=CC(Cl)=CC=1)C1=CC=CC=C1 ZKLPARSLTMPFCP-UHFFFAOYSA-N 0.000 description 13
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 description 13
- ULGZDMOVFRHVEP-RWJQBGPGSA-N Erythromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)C(=O)[C@H](C)C[C@@](C)(O)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 ULGZDMOVFRHVEP-RWJQBGPGSA-N 0.000 description 13
- 238000004090 dissolution Methods 0.000 description 13
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- 229940079593 drug Drugs 0.000 description 12
- NYPJDWWKZLNGGM-UHFFFAOYSA-N fenvalerate Chemical compound C=1C=C(Cl)C=CC=1C(C(C)C)C(=O)OC(C#N)C(C=1)=CC=CC=1OC1=CC=CC=C1 NYPJDWWKZLNGGM-UHFFFAOYSA-N 0.000 description 12
- 150000003839 salts Chemical class 0.000 description 12
- 125000000217 alkyl group Chemical group 0.000 description 11
- 229960002587 amitraz Drugs 0.000 description 11
- QXAITBQSYVNQDR-ZIOPAAQOSA-N amitraz Chemical compound C=1C=C(C)C=C(C)C=1/N=C/N(C)\C=N\C1=CC=C(C)C=C1C QXAITBQSYVNQDR-ZIOPAAQOSA-N 0.000 description 11
- YKBZOVFACRVRJN-UHFFFAOYSA-N dinotefuran Chemical compound [O-][N+](=O)\N=C(/NC)NCC1CCOC1 YKBZOVFACRVRJN-UHFFFAOYSA-N 0.000 description 11
- 239000000796 flavoring agent Substances 0.000 description 11
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 10
- 239000002904 solvent Substances 0.000 description 10
- IBSREHMXUMOFBB-JFUDTMANSA-N 5u8924t11h Chemical compound O1[C@@H](C)[C@H](O)[C@@H](OC)C[C@@H]1O[C@@H]1[C@@H](OC)C[C@H](O[C@@H]2C(=C/C[C@@H]3C[C@@H](C[C@@]4(O3)C=C[C@H](C)[C@@H](C(C)C)O4)OC(=O)[C@@H]3C=C(C)[C@@H](O)[C@H]4OC\C([C@@]34O)=C/C=C/[C@@H]2C)/C)O[C@H]1C.C1=C[C@H](C)[C@@H]([C@@H](C)CC)O[C@]11O[C@H](C\C=C(C)\[C@@H](O[C@@H]2O[C@@H](C)[C@H](O[C@@H]3O[C@@H](C)[C@H](O)[C@@H](OC)C3)[C@@H](OC)C2)[C@@H](C)\C=C\C=C/2[C@]3([C@H](C(=O)O4)C=C(C)[C@@H](O)[C@H]3OC\2)O)C[C@H]4C1 IBSREHMXUMOFBB-JFUDTMANSA-N 0.000 description 9
- CPELXLSAUQHCOX-UHFFFAOYSA-M Bromide Chemical compound [Br-] CPELXLSAUQHCOX-UHFFFAOYSA-M 0.000 description 9
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- 125000003545 alkoxy group Chemical group 0.000 description 9
- MITFXPHMIHQXPI-UHFFFAOYSA-N benzoxaprofen Natural products N=1C2=CC(C(C(O)=O)C)=CC=C2OC=1C1=CC=C(Cl)C=C1 MITFXPHMIHQXPI-UHFFFAOYSA-N 0.000 description 9
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- ZOCSXAVNDGMNBV-UHFFFAOYSA-N 5-amino-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-4-[(trifluoromethyl)sulfinyl]-1H-pyrazole-3-carbonitrile Chemical compound NC1=C(S(=O)C(F)(F)F)C(C#N)=NN1C1=C(Cl)C=C(C(F)(F)F)C=C1Cl ZOCSXAVNDGMNBV-UHFFFAOYSA-N 0.000 description 8
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- DUEPRVBVGDRKAG-UHFFFAOYSA-N carbofuran Chemical compound CNC(=O)OC1=CC=CC2=C1OC(C)(C)C2 DUEPRVBVGDRKAG-UHFFFAOYSA-N 0.000 description 8
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- GGXQONWGCAQGNA-UUSVNAAPSA-N (2r,3r)-2,3-dihydroxybutanedioic acid;1-methyl-2-[(e)-2-(3-methylthiophen-2-yl)ethenyl]-5,6-dihydro-4h-pyrimidine Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O.CN1CCCN=C1\C=C\C1=C(C)C=CS1 GGXQONWGCAQGNA-UUSVNAAPSA-N 0.000 description 7
- OTPDWCMLUKMQNO-UHFFFAOYSA-N 1,2,3,4-tetrahydropyrimidine Chemical compound C1NCC=CN1 OTPDWCMLUKMQNO-UHFFFAOYSA-N 0.000 description 7
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- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 7
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- 239000005557 antagonist Substances 0.000 description 7
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- CGIGDMFJXJATDK-UHFFFAOYSA-N indomethacin 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 7
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- 125000004453 alkoxycarbonyl group Chemical group 0.000 description 6
- 125000003282 alkyl amino group Chemical group 0.000 description 6
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- SNPPWIUOZRMYNY-UHFFFAOYSA-N bupropion Chemical compound CC(C)(C)NC(C)C(=O)C1=CC=CC(Cl)=C1 SNPPWIUOZRMYNY-UHFFFAOYSA-N 0.000 description 6
- 125000001309 chloro group Chemical group Cl* 0.000 description 6
- KDLRVYVGXIQJDK-AWPVFWJPSA-N clindamycin Chemical compound CN1C[C@H](CCC)C[C@H]1C(=O)N[C@H]([C@H](C)Cl)[C@@H]1[C@H](O)[C@H](O)[C@@H](O)[C@@H](SC)O1 KDLRVYVGXIQJDK-AWPVFWJPSA-N 0.000 description 6
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Abstract
软可咀嚼剂型包含活性成分和作为崩解剂的碳酸盐化合物。
Description
技术领域
本公开涉及药物化学、药理学以及兽医和人类医学。更具体地,本公开涉及可咀嚼组合物,其可以用于递送一种或多种针对寄生虫或动物疾病具有活性的药剂。
背景技术
在医学领域,药物的口服施用是期望的,因为它通常可以在没有临床医生或兽医参与的情况下进行。可咀嚼剂型对于促进人和动物对药物产品的接受特别有用。然而,一些可咀嚼药物产品不具有期望的物理化学属性,如合适的崩解度和活性成分溶出度。因此,虽然软可咀嚼调配物是已知的,但是仍然需要具有改善的物理化学属性的软可咀嚼剂型。
附图说明
图1示出了洛替拉纳(lotilaner)、米尔贝肟(milbemycin oxime)和吡喹酮(praziquantel)从示例性可咀嚼组合物中的溶出。
图2示出了洛替拉纳、莫西菌素(moxidectin)和吡喹酮从示例性可咀嚼组合物中的溶出。
图3示出了洛替拉纳、莫西菌素、吡喹酮和双羟萘酸噻嘧啶(pyrantel pamoate)从示例性可咀嚼组合物中的溶出。
具体实施方式
本公开提供了与现有组合物相比具有改善的性质的可咀嚼组合物。所公开的软可咀嚼剂型包含至少一种活性成分和作为崩解剂的碳酸盐或碳酸氢盐化合物。碳酸盐或碳酸氢盐化合物的包含出乎意料地促进了有效剂型崩解和活性成分的治疗上有用的溶出。
当暴露于溶出介质时,常规压制片剂显示出崩解。为了增强药物释放,通常在片剂调配物中添加崩解剂。崩解剂遇湿膨胀并溶解,并且确保当片剂与生理介质接触时,迅速分解成更小的碎片,促进溶出。由剂型的快速崩解引起的立即药物释放往往对片剂的物理性质的变化更敏感。大多数崩解剂仅在干压缩之后例如在片剂制造期间有效。
由于软可咀嚼剂型通常既不是通过压制产生的,也不是在干燥条件下加工的,因此为这种类型的剂型鉴定有效的崩解剂具有挑战性。软可咀嚼剂型是基质的。最终产品的性质,例如药物释放,很大程度上取决于基质的物理性质。在暴露于液体溶出介质期间,基质剂型趋于随时间而侵蚀,其特征在于表面的持续降解导致基质大小的持续减小。侵蚀速度会受到不同基质性质的影响,如表面孔隙度、质地和润湿性。因此,存在这样的风险,例如由制造程序或储存内老化引起的基质性质的变化可能影响基质侵蚀速度,并且因此也影响药物释放。
所公开的软可咀嚼剂型,通过由碳酸盐或碳酸氢盐化合物促进的崩解机制,提供了优于现有软可咀嚼药物产品的益处,如快速释放、改善的药物暴露和对药物产品物理性质变化不太敏感的药物释放。软可咀嚼剂型储存稳定,并且对制造工艺以及活性成分和赋形剂的变化具有鲁棒性。
碳酸氢钠作为崩解剂的适用性在本文中针对包含不同类型的活性成分和赋形剂的多种软可咀嚼剂型进行了证明。不希望受理论的束缚,据信碳酸盐或碳酸氢盐化合物的崩解作用是由剂型与酸性溶解介质接触之后产生的二氧化碳触发的,促进剂型快速分解成更小的碎片,从而促进溶解。
通过开发目前公开的剂型,发现某些变量可以影响碳酸盐或碳酸氢盐化合物的崩解剂效率。这些变量包含调配物中的水含量;调配物中的亲脂性含量(例如,来自脂肪粉末);调配物中碳酸盐或碳酸氢盐崩解剂的含量;以及碳酸盐或碳酸氢盐化合物的粒度。基于本公开,本领域技术人员可以容易地管理这些变量,而无需过度的实验来产生在生理条件下具有合适崩解度和活性成分溶出度的可咀嚼剂型。
在优选的实施例中,本公开提供了软可咀嚼剂型,所述软可咀嚼剂型包含以下的组合:(i)异噁唑啉类杀寄生虫剂(例如,氟拉拉纳(fluralaner)、阿福拉纳(afoxolaner)、沙罗拉纳(sarolaner)或洛替拉纳);(ii)大环内酯类杀寄生虫剂(例如,米尔贝肟、莫西菌素、多拉菌素(doramectin)或塞拉菌素(selamectin));(iii)吡嗪异喹啉类杀寄生虫剂(例如,吡喹酮)和/或四氢嘧啶类杀寄生虫剂(例如,双羟萘酸噻嘧啶、酒石酸噻嘧啶(pyranteltartrate)、酒石酸莫仑太尔(morantel tartrate)或恩波酸奥克太尔(oxantelembonate))。本公开提供了含有上述活性物质的软可咀嚼剂型,其表现出有效的剂型崩解和这些活性成分在治疗上有用的溶解。还提供了含有这些活性物质的软可咀嚼剂型,其是可口的稳定的和可加工的。
1.定义
除非另有定义,否则本文所使用的所有技术术语和科学术语具有与本领域的普通技术人员通常所理解的含义相同的含义。在有冲突的情况下,将以本文档(包含定义)为准。虽然以下描述了优选的方法和材料,但是与本文所描述的那些类似或相当的方法和材料可以用于本发明的实施或测试中。本文所提及的所有出版物、专利申请、专利和其它参考文献均通过全文引用的方式并入。本文所公开的材料、方法和实例仅是说明性的,而不旨在是限制性的。
术语“向受试者施用”包含但不限于皮肤、皮下、肌内、粘膜、粘膜下、经皮、口服或鼻内施用。施用可以包含注射或局部施用。
术语“可咀嚼的”是指可以经口服用并且在吞咽之前被粉碎成更小的碎片的固体形式。
如本文所用,术语“包括(comprise(s))”、“包含(include(s))”、“具有(having)”、“具有(has)”“可以(can)”、“含有(contain(s))”和其变体旨在是不排除另外的行为或结构的可能性的开放式过渡性短语、术语或词语。除非上下文另外清楚地指明,否则单数形式“一个/种(a/an)”和“所述(the)”包含复数指示物。本公开也设想了“包括”、“由本文呈现的实施例或元件组成”和“基本上由本文呈现的实施例或元件组成”的其它实施例,无论是否明确地指出。
术语“盐”是指兽医或药学上可接受的有机酸和碱或无机酸和碱的盐。此类盐在本领域是众所周知的,并且包含在《药物科学杂志(Journal of Pharmaceutical Science)》,66,2-19(1977)中描述的那些。
本领域技术人员将会理解,本发明的某些化合物以异构体的形式存在。本发明的化合物的所有立体异构体,包含呈任何比率的几何异构体、对映异构体和非对映异构体,被设想为在本发明的范围内。
本领域技术人员还将会理解,本发明的某些化合物以互变异构体的形式存在。本发明的化合物的所有互变异构形式被设想为在本发明的范围内。
本发明的化合物还包含所有同位素变化,其中主要原子质量的至少一个原子被具有相同原子序数但原子质量不同于主要原子质量的原子替代。使用同位素变化(例如,氘、2H)可以提供更大的代谢稳定性。另外地,本发明的化合物的某些同位素变化可以并入放射性同位素(例如,氚、3H或14C),其可以用于药物和/或基底的组织分布研究。用如11C、18F、15O和13N等正电子发射同位素取代可以用于正电子发射断层扫描(PET)研究中。
术语“本发明的化合物(compounds of the invention)”和“本发明的化合物(acompound of the invention)”和“本发明的化合物(compounds of the presentinvention)”等包含本文所描述的式(I)的实施例和由式(I)所涵盖的其它更具体的实施例,以及本文所描述的例示性化合物和这些实施例中的每个实施例的盐。
术语“治疗(treating)”、“要治疗(to treat)”、“经治疗(treated)”或“治疗(treatment)”包含但不限于抑制、减缓、停止或逆转现有症状或疾病的进展或严重程度。
术语“控制(control)”、“控制(controlling)”或“控制(controlled)”是指包含但不限于降低、减少或改善症状、病症、病状或疾病的风险,以及保护动物免于症状、病症、病状或疾病。控制可以指治疗性、防治性或预防性施用。例如,幼虫或未成熟心丝虫感染将通过作用于幼虫或未成熟寄生虫来控制,防止感染发展为成熟寄生虫感染。
术语“预防”是指避免动物出现症状或疾病。
术语“受试者”和“患者”是指包含人和非人哺乳动物,如狗、猫、小鼠、大鼠、豚鼠、兔、雪貂、牛、马、绵羊、山羊和猪。应当理解,更具体的受试者是人。此外,更具体的受试者是哺乳动物宠物或伴侣动物,如狗和猫,以及小鼠、豚鼠、雪貂和兔。
术语“有效量”是指给予受试者期望益处的量,并且包含用于治疗或控制的施用。所述量将因个体受试者而异,并且将取决于许多因素,包含受试者的总体身体状况和要治疗的病状的潜在原因的严重程度、伴随治疗以及用于将期望的应答维持在有益水平的本发明化合物的量。
作为本领域技术人员,通过使用已知的技术和通过观察在类似情况下获得的结果,主治诊断医师可以容易地确定有效量。在确定有效量、剂量时,主治诊断医师要考虑许多因素,包含但不限于:患者物种;患者的大小、年龄和总体健康状况;所涉及的具体病状、病症、感染或疾病;病状、病症或疾病的程度或涉及程度或严重程度,个体患者的应答;所施用的特定化合物;施用模式;所施用的制剂的生物利用度特性;所选择的剂量方案;伴随药物的使用;以及其它相关情况。本公开的有效量,即活性成分治疗剂量,可以在例如0.5mg至100mg的范围内。技术人员可以确定具体的量。尽管这些剂量基于质量为约1kg至约20kg的受试者,但诊断医生将能够为质量超出此重量范围的受试者确定适当的剂量。本公开的有效量,即活性成分治疗剂量,可以在例如受试者的0.1mg至10mg/kg的范围内。预期给药方案为每日、每周或每月施用。
如本文所用,短语“口服生物利用度”和“口服施用时的生物利用度”是指施用于患者的给定量的活性物质的全身可用度(即,血液/血浆水平)。
如本文所用,术语“清除率”是指例如通过肾脏排泄从血液中去除物质,以血液或血浆的体积流量表示,其含有单位时间内去除的物质的量。
如本文所用,术语“半衰期”是指一半量的物质通过生物过程损失所需的时段。
如本文所用,术语“生物利用度”是指给定量的药物的生理可用度,不同于其化学效力。所述术语也可以指吸收到血流中的所施用的剂量的比例。
如本文所用,术语“动物”包含所有脊椎动物,包含人、伴侣动物和家畜动物。所述术语还包含处于所有发育阶段的个体动物,包含胚胎和胎儿阶段。伴侣动物包含但不限于狗和猫。家畜动物包含但不限于牛、骆驼、猪、绵羊、山羊和马。
如本文所用,术语“寄生虫”是指生活在宿主动物体内或体表上并且通过消耗宿主动物的营养而受益的害虫。所述术语涵盖害虫的生命周期的所有阶段。“体内寄生虫”是生活在宿主动物体内的寄生虫。“体外寄生虫”是生活在宿主动物体表的寄生虫。
术语“wt/wt”或“w/w”表示重量/重量。术语“%wt/wt”表示组合物的配方中的成分的重量百分比。
术语或“w/v”表示重量/体积。
术语“mg/kg”表示受试者(例如,伴侣动物,如狗或猫)的每千克体重的毫克数。
对于本文列举数值范围,明确地考虑了在其之间具有相同的精确程度的每个中间数字。例如,对于6至9的范围,除了6和9之外,设想了数字7和8;并且对于范围6.0至7.0,明确考虑了数字6.0、6.1、6.2、6.3、6.4、6.5、6.6、6.7、6.8、6.9和7.0。
2.调配物
本公开的软可咀嚼剂型包含活性成分和碳酸盐或碳酸氢盐化合物。软可咀嚼剂型任选地包含一种或多种可接受的赋形剂。术语“可接受的赋形剂”是指那些通常用于制备兽医和药物组合物的赋形剂,并且优选地在所用量下是纯的和无毒的。所述赋形剂通常是固体、半固体或液体材料,其总体上可以用作活性成分的媒剂或介质。可接受的赋形剂的一些实例可见于《雷明顿氏药物科学(Remington's Pharmaceutical Sciences)》和《药用赋形剂手册(Handbook of Pharmaceutical Excipients)》并且包含稀释剂、媒剂、载体、软膏基质、粘合剂、崩解剂、润滑剂、助流剂、甜味剂、调味剂、凝胶基质、缓释基质、稳定剂、防腐剂、溶剂、悬浮剂、缓冲剂、乳化剂、染料、推进剂、包衣剂等。应当理解,在某些实施例中,赋形剂可以发挥多种功能,这取决于例如所用量、组合物组成和制造工艺。
活性成分
在某些实施例中,活性成分包含针对寄生虫或害虫的活性成分。此类示例性活性成分包含但不限于阿福拉纳(afoxolaner)、氟拉拉纳(fluralaner)、洛替拉纳、沙罗拉纳(sarolaner)、阿苯达唑(albendazole)、坎苯达唑(cambendazole)、芬苯达唑(fenbendazole)、氟苯达唑(flubendazole)、甲苯咪唑(mebendazole)、奥芬达唑(oxfendazole)、帕苯达唑(parabendazole)、噻苯达唑(tiabendazole)、三氯苯咪唑(triclabendazole)、双甲脒(amitraz)、得米地曲(demiditraz)、氯舒隆(clorsulon)、克罗散泰(closantel)、氧氯叠氮(oxyclonazide)、碘醚柳胺(rafoxanide)、苯氰菊酯(cyphenothrin)、氟氯苯菊酯(flumethrin)、苄氯菊酯(permethrin)、环丙氨嗉(cyromazine)、得曲恩特(derquantel)、双苯酰草胺(diamphenetide)、地昔尼尔(dicyclanil)、呋虫胺(dinotefuran)、吡虫啉(imidacloprid)、烯啶虫胺(nitenpyram)、噻虫嗪(thiamethoxam)、阿维菌素(abamectin)、多拉菌素(doramectin)、埃玛菌素(emamectin)、依立诺克丁(eprinomectin)、伊佛霉素(ivermectin)、莫西菌素、塞拉菌素、米尔贝肟化物(milbemycin oxime)、艾默德斯(emodepside)、依西太尔(epsiprantel)、氟虫腈(fipronil)、氟佐隆(fluazuron)、氟六氟酮(fluhexafon)、茚虫威(indoxacarb)、左旋咪唑(levamisol)、氯芬奴隆(lufenuron)、氰氟虫腙(metaflumizone)、甲氧普林(methoprene)、莫奈太尔(monepantel)、莫仑太尔(morantel)、氯硝柳胺(niclosamide)、硝硫氰酯(nitroscanate)、硝碘酚腈(nitroxynil)、双苯氟脲(novaluron)、奥克太尔(oxantel)、吡喹酮、噻嘧啶(pyrantel)、吡丙腈(pyriprole)、吡丙醚(pyriproxyfen)、西萨普尼(sisapronil)、多杀菌素(spinosad)、乙基多杀菌素(spinetoram)和三氟苯嘧啶(triflumezopyrim)或上述任何一种的盐。
活性剂可以针对体外和/或体内寄生虫起作用。在一个实施例中,可咀嚼组合物包括针对体外寄生虫具有活性的化合物。在另一个实施例中,可咀嚼组合物包括针对体内寄生虫具有活性的化合物。在另外的实施例中,可咀嚼组合物包括针对体外寄生虫具有活性的至少一种化合物和针对体内寄生虫具有活性的至少一种化合物的组合。
活性剂可以是杀螨剂,并且例如可以选自:杀螨剂,如阿维菌素(abamectin)、多拉菌素(doramectin)、依立诺克丁(eprinomectin)、伊佛霉素(ivermectin)、弥拜菌素(milbemectin)、尼可霉素(nikkomycin)、塞拉菌素、四抗菌素(tetranactin)和苏云金素(thuringiensin);桥接的联苯杀螨剂,如偶氮苯(azobenzene)、苯螨特(benzoximate)、苯甲酸苄酯(benzyl benzoate)、溴螨酯(bromopropylate)、氯杀螨(chlorbenside)、杀螨醇(chlorfenethol)、杀螨酯(chlorfenson)、敌螨特(chlorfensulphide)、乙酯杀螨醇(chlorobenzilate)、丙酯杀螨醇(chloropropylate)、三氯杀螨醇(dicofol)、二苯砜(diphenylsulfone)、苯氧炔螨(dofenapyn)、除螨酯(fenson)、氟硝二苯胺(fentrifanil)、氟杀螨(fluorbenside)、丙氯诺(proclonol)、四氯杀螨砜(tetradifon)和杀螨硫醚(tetrasul);氨基甲酸酯杀螨剂,如苯菌灵(benomyl)、氯灭杀威(carbanolate)、甲萘威(carbaryl)、克百威(carbofuran)、苯硫威(fenothiocarb)、甲硫威(methiocarb)、速灭威(metolcarb)、蜱虱威(promacyl)和残杀威(propoxur);氨基甲酸肟酯杀螨剂,如涕灭威(aldicarb)、丁酮威(butocarboxim)、草氨酰(oxamyl)、抗虫威(thiocarboxime)和久效威(thiofanox);二硝基酚杀螨剂,如乐杀螨(binapacryl)、消螨酚(dinex)、消螨通(dinobuton)、敌螨普(dinocap)、敌螨普-4(dinocap-4)、敌螨普-6(dinocap-6)、邻敌螨消(dinocton)、硝戊酯(dinopenton)、硝辛酯(dinosulfon)、硝丁酯(dinoterbon)和DNOC(4,6-二硝基邻甲酚);甲脒类杀螨剂,如阿米曲士(amitraz)、杀虫脒(chlordimeform)、伊托明(chloromebuform)、伐虫脒(formetanate)和胺甲威(formparanate);螨生长调节剂,如四螨嗪(clofentezine)、苯氧炔螨(dofenapyn)、氟佐隆(fluazuron)、氟螨噻(flubenzimine)、氟环脲(flucycloxuron)、氟虫脲(flufenoxuron)和噻螨酮(hexythiazox);有机氯杀螨剂,如溴烯杀(bromocyclen)、毒杀芬(camphechlor)、除螨灵(dienochlor)和硫丹(endosulfan);有机锡杀螨剂,如三唑锡(azocyclotin)、三环锡(cyhexatin)和苯丁锡(fenbutatin oxide);吡唑类杀螨剂,如乙酰虫腈(acetoprole)、氟虫腈(fipronil)、吡螨胺(tebufenpyrad)和香草醛(vaniliprole);拟除虫菊酯杀螨剂,其包含:拟除虫菊酯杀螨剂,如氟丙菊酯(acrinathrin)、联苯菊酯(bifenthrin)、三氟氯氰菊酯(cyhalothrin)、氯氰菊酯(cypermethrin)、α-氯氰菊酯(alpha-cypermethrin)、甲氰菊酯(fenpropathrin)、氰戊菊酯(fenvalerate)、氟氰菊酯(flucythrinate)、氟氯苯菊酯(flumethrin)、氟胺氰菊酯(fluvalinate)、氟胺氰戊菊酯(tau-fluvalinate)和氯菊酯(permethrin),以及拟除虫菊酯醚杀螨剂,如苄螨醚(halfenprox);喹喔啉杀螨剂,如灭螨猛(chinomethionat)和克杀螨(thioquinox);亚硫酸酯杀螨剂,如克螨特(propargite);特窗酸杀螨剂,如螺螨酯(spirodiclofen);并且形成未分类的杀螨剂,如灭螨醌(acequinocyl)、磺胺螨酯(amidoflumet)、三氧化二砷(arsenous oxide)、灭虫脲(chloromethiuron)、氯氰碘柳胺(closantel)、克罗米通(crotamiton)、丁醚脲(diafenthiuron)、抑菌灵(dichlofluanid)、戒酒硫(disulfiram)、抗螨唑(fenazaflor)、喹螨醚(fenazaquin)、唑螨酯(fenpyroximate)、嘧螨酯(fluacrypyrim)、联氟螨(fluenetil)、甲硫酚(mesulfen)、MNAF(2-氟-N-甲基-N-1-萘乙酰胺)、氟蚁灵(nifluridide)、哒螨灵(pyridaben)、嘧螨醚(pyrimidifen)、舒非仑(sulfiram)、氟虫胺(sulfluramid)、硫和苯螨噻(triarathene)。
活性剂可以是杀虫剂,充当杀成虫剂或昆虫生长调节剂(IGR),并且可以例如选自不同的化学类别,如氯代烃、有机磷酸酯、氨基甲酸酯、拟除虫菊酯、甲脒、硼酸酯、苯基吡唑和大环内酯。杀成虫剂的代表包含吡虫啉、倍硫磷、氟虫腈、丙烯菊酯、溴氰菊酯、氰戊菊酯、氯菊酯和马拉硫磷。IGR的代表包含例如苯甲酰基苯脲(benzoylphenylureas),如除虫脲(diflubenzuron)、虱螨脲(lufenuron)、多氟脲(noviflumuron)、氟铃脲(hexaflumuron)、杀铃脲(triflumuron)和氟苯脲(teflubenzuron),或如苯氧威(fenoxycarb)、吡丙醚(pyriproxifen)、甲氧普林(methoprene)、烯虫炔酯(kinoprene)、烯虫乙酯(hydroprene)、环丙氨嗪(cyromazine)、噻嗪酮(buprofezin)和吡蚜酮(pymetrozine)等物质。杀虫剂包含新烟碱类杀虫剂,例如啶虫脒(acetamiprid)、噻虫胺(clothianidin)、呋虫胺(dinotefuran)、吡虫啉(imidacloprid)、烯啶虫胺(nitenpyram)、噻虫啉(thiacloprid)和噻虫嗪(thiamethoxam)。
在某些实施例中,软可咀嚼剂型包含异噁唑啉类杀寄生虫剂。异噁唑啉类杀寄生虫剂可以具有下式:
其中B1、B2、B3各自独立地是C-R或N;每个R独立地是H、卤素、氰基、-NO2、烷基、卤代烷基、烷氧基、卤代烷氧基、烷硫基、卤代烷硫基、烷基亚磺酰基、卤代烷基亚磺酰基、烷基磺酰基、卤代烷基磺酰基、烷基氨基、二烷基氨基或烷氧羰基;R1是C1-C3烷基或C1-C3卤代烷基;Y是任选取代的亚苯基、亚萘基、茚满基、5元或6元杂芳基或8-10元稠合杂双环基,其中任选取代基选自由以下组成的组:卤基、烷基、卤代烷基、环烷基、卤代环烷基、烷氧基、卤代烷氧基、烷硫基、卤代烷硫基、烷基亚磺酰基、卤代烷基亚磺酰基、烷基磺酰基、卤代烷基磺酰基、烷基氨基、二烷基氨基、-CN或-NO2以及NH2-C(=S)-;Q是T-NR2R3,基团(-CH2-)(-CH2-)N-R3、OH、NH2、烷氧基、卤代烷氧基、烷基氨基、卤代烷基氨基、二烷基氨基、卤代二烷基氨基、硫醇、烷硫基、卤代烷硫基、烷基亚磺酰基、卤代烷基亚磺酰基、烷基磺酰基、卤代烷基磺酰基、或任选取代的5元或6元碳环基、杂环基或杂芳基环;T是(CH2)n、CH(CH3)、CH(CN)、C(=O)或C(=S);R2是H、烷基、烯基、炔基、环烷基、烷基环烷基、环烷基烷基、烷基羰基或烷氧羰基;R3是H、OR7、NR8R9或Q1;或烷基、卤代烷基、烯基、卤代烯基、炔基、卤代炔基、环烷基、烷基环烷基、环烷基烷基、烷基羰基、烷氧基羰基、氨基羰基、烷基氨基羰基或二烷基氨基羰基,各自任选地被一个或多个独立地选自R4的取代基取代;或者R2和R3与其所连接的氮一起形成含有2至6个碳原子和任选地选自由N、S和O组成的组的一个另外原子的环,所述环任选地被1至4个独立地选自由烷基、卤素、-CN、-NO2和烷氧基组成的组的取代基取代;每个R4独立地是卤素;烷基、环烷基、烷氧基、烷硫基、卤代烷硫基、烷基亚磺酰基、卤代烷基亚磺酰基、烷基磺酰基、卤代烷基磺酰基、烷基氨基、卤代烷基氨基、二烷基氨基、二卤代烷基氨基、环烷基氨基、烷基羰基、烷氧基羰基、烷基氨基羰基、二烷基氨基羰基、卤代烷基羰基、卤代烷氧基羰基、卤代烷基氨基羰基、二卤代烷基氨基羰基、羟基、-NH2、-CN或-NO2;或Q2;每个R5独立地是卤素、烷氧基、卤代烷氧基、烷硫基、卤代烷硫基、烷基亚磺酰基、卤代烷基亚磺酰基、烷基磺酰基、卤代烷基磺酰基、烷基氨基、二烷基氨基、烷氧羰基、-CN或-NO2;每个R6独立地是卤素、烷基、卤代烷基、环烷基、卤代环烷基、烷氧基、卤代烷氧基、烷硫基、卤代烷硫基、烷基亚磺酰基、卤代烷基亚磺酰基、烷基磺酰基、卤代烷基磺酰基、烷基氨基、二烷基氨基、-CN、-NO2、苯基或吡啶基;R7是H;或烷基、烯基、炔基、环烷基、烷基环烷基或环烷基烷基,各自任选地被一个或多个卤素取代;R8是H、烷基、烯基、炔基、环烷基、烷基环烷基、环烷基烷基、烷基羰基或烷氧羰基;R9是H;Q3;或烷基、烯基、炔基、环烷基、烷基环烷基或环烷基烷基,各自任选地被一个或多个独立地选自R4的取代基取代;或者R8和R9与其所连接的氮一起形成含有2至6个碳原子和任选地选自由N、S和O组成的组的一个另外原子的环,所述环任选地被1至4个独立地选自由烷基、卤素、-CN、-NO2和烷氧基组成的组的取代基取代;Q1是苯环、5元或6元杂环、或8元、9元或10元稠合双环系统,任选地含有一至三个选自至多1个O、至多1个S和至多3个N的杂原子,每个环或环系统任选地被一个或多个独立地选自R5的取代基取代;Q2独立地是苯环或5元或6元杂环,每个环任选地被一个或多个独立地地选自R6的取代基取代;Q3是苯环或5元或6元杂环,每个环任选地被一个或多个独立地选自R6的取代基取代;并且n是1、2或3;其中所述星号表示碳原子是季碳原子。示例性异噁唑啉类杀寄生虫剂包含阿福拉纳、氟拉拉纳、洛替拉纳和沙罗拉纳。
在某些实施例中,软可咀嚼剂型包含驱肠虫剂。驱肠虫剂可以选自包含以下的体内驱虫剂和体内外杀虫剂:大环内酯类(macrocyclic lactones)、苯并咪唑类(benzimidazoles)、苯并咪唑前体类(pro-benzimidazoles)、咪唑并噻唑类(imidazothiazoles)、四氢嘧啶类(tetrahydropyrimidines)、有机磷酸酯类(organophosphates)、哌嗪类(piperazines)、水杨酰苯胺(salicylanilide)和环状缩肽类(cyclic depsipeptides)。示例性驱肠虫剂包含米尔贝霉素(例如,米尔贝肟)、阿维菌素(例如,伊维菌素、塞拉菌素、多拉菌素、埃普利诺菌素、莫西菌素和阿巴克丁)、苯并咪唑(例如,芬苯达唑、阿苯达唑和三氯苯达唑)、水杨酰苯胺(例如,氯桑特和羟考扎尼)、经取代的苯酚(例如,硝酰腈)、四氢嘧啶(例如,噻嘧啶、莫仑太尔、奥克太尔)、咪唑并噻唑(例如,左旋咪唑)、环辛缩肽(例如,艾默德斯)和吡嗪异喹啉(例如,吡喹酮)。
在某些实施例中,软可咀嚼剂型包含大环内酯类驱肠虫剂。大环内酯包含阿维菌素和其衍生物以及米尔贝霉素和其衍生物。驱肠虫剂的代表包含游离形式或生理学可接受的盐的形式的伊维菌素、多拉菌素、莫西菌素(moxidectin)、塞拉菌素、埃玛菌素、依普菌素、弥拜菌素、阿维菌素、米尔贝肟、奈马克丁(nemadectin)及其衍生物。
苯并咪唑类、苯并咪唑氨基甲酸酯和苯并咪唑前体类包含化合物,如噻苯咪唑(thiabendazole)、甲苯咪唑(mebendazole)、芬苯达唑(fenbendazole)、奥芬达唑(oxfendazole)、氧苯达唑(oxibendazole)、阿苯达唑(albendazole)、鲁苯达唑(luxabendazole)、奈托比胺(netobimin)、帕苯达唑(parbendazole)、氟苯达唑(flubendazole)、环苯达唑(cyclobendazole)、非班太尔(febantel)和硫菌灵(thiophanate)。咪唑并噻唑包含如四咪唑和左旋咪唑等化合物。四氢嘧啶包含如莫仑太尔和噻嘧啶等化合物。有机磷酸酯类包含化合物,如敌敌畏(dichlorvos)、哈洛克酮(haloxon)和敌百虫(trichlorfon)。哌嗪包含如哌嗪及其衍生物等化合物,例如二乙基氨基甲酰嗪。水杨酰苯胺类包含化合物,如氯氰碘柳胺、三溴沙仑(tribromsalan)、二溴沙仑(dibromsalan)、羟氯柳苯胺(oxyclozanide)、氯碘柳苯胺(clioxanide)、碘醚柳胺(rafoxanide)、溴硫柳酰胺(brotianide)和溴氟硝柳胺(bromoxanide)。环状缩肽包含由氨基酸和羟基羧酸作为环结构单元以及6至30个环原子组成的化合物,如PF1022A和艾默德斯。其它驱肠虫药的实例包含氯磺隆、奥沙尼喹、吡喹酮和莫奈太尔。
在某些实施例中,软可咀嚼剂型包含杀虫剂或杀螨剂。示例性杀虫剂和杀螨剂包含例如高灭磷(acephate)、啶虫脒(acetamiprid)、乙酰虫腈、阿米曲士、磺胺螨酯、阿维菌素(avermectin)、印楝素(azadirachtin)、谷硫磷(azinphos-methyl)、联苯菊酯(bifenthrin)、联苯肼酯(bifenazate)、噻嗪酮(buprofezin)、双三氟虫脲(bistrifluron)、噻嗪酮、卡巴呋喃(carbofuran)、巴丹(cartap)、溴虫腈(chlorfenapyr)、定虫隆(chlorfluazuron)、氯虫苯甲酰胺(chlorantraniliprole))、毒死蜱(chlorpyrifos)、甲基毒死蜱(chlorpyrifos-methyl)、环虫酰肼(chromafenozide)、噻虫胺(clothianidin)、丁氟螨酯(cyflumetofen)、氟氯氰菊酯(cyfluthiin)、β-氟氯氰菊酯、三氟氯氰菊酯、γ-三氟氯氰菊酯、λ-氯氟氰菊酯、氯氰菊酯、灭蝇胺(cyromazine)、溴氰菊酯(deltamethrin)、丁醚脲(diafenthiuron)、二嗪农(diazinon)、狄氏剂(dieldrin)、二氟脲(diflubenzuron)、四氟甲醚菊酯(dimefluthrin)、乐果(dimethoate)、呋虫胺(dinotefuran)、苯虫醚(diofenolan)、埃玛菌素、硫丹(endosulfan)、高氰戊菊酯(esfenvalerate)、乙虫腈(ethiprole)、苯硫威(fenothiocarb)、苯氧威(fenoxycarb)、甲氰菊酯(fenpropathrin)、氰戊菊酯(fenvalerate)、氟虫腈、氟啶虫酰胺(flonicamid)、氟虫双酰胺(flubendiamide)、氟氰戊菊酯、氟胺氰菊酯(tau-fluvalinate)、嘧虫胺(flufenerim)、氟虫脲(flufenoxuron)、地虫硫磷(fonophos)、氯虫酰肼(halofenozide)、氟铃脲(hexaflumuron)、氟蚁腙(hydramethylnon)、吡虫啉(imidacloprid)、茚虫威、异柳磷(isofenphos)、氯芬奴隆(lufenuron)、马拉松(malathion)、氰氟虫腙(metaflumizone)、聚乙醛(metaldehyde)、甲胺磷(methamidophos)、杀扑磷(methidathion)、灭多虫(methomyl)、甲氧普林(methoprene)、甲氧滴滴涕(methoxychlor)、甲氧苄氟菊酯(metofluthrin)、久效磷(monocrotophos)、甲氧虫酰肼(methoxyfenozide)、久效磷(monocrotophos)、烯啶虫胺(nitenpyram)、硝乙脲噻唑(nithiazine)、双苯氟脲(novaluron)、多氟脲(noviflumuron)、草氨酰(oxamyl)、对硫磷(parathion)、甲基对硫磷(parathiori-methyl)、苄氯菊酯(permethrin)、甲拌磷(phorate)、伏杀磷(phosalone)、亚胺硫磷(phosmet);磷胺(phosphamidori)、抗蚜威(pirimicarb)、丙溴磷(profenofos)、丙氟菊酯(profluthrin)、丙苯烃菊酯(protrifenbute)、吡蚜酮(pymetrozine)、氟虫腈(pyrafluprole)、除虫菊酯(pyrethrin)、啶虫丙醚(pyridalyl)、吡氟喹虫唑(pyrifluquinazon)、派瑞乐(pyriprole)、吡丙醚、鱼藤酮(rotenone)、利阿诺定(ryanodine)、乙基多杀菌素(spinetoram)、多杀菌素(spinosad)、螺螨酯(spirodiclofen)、螺甲螨酯(spiromesifen)、螺虫乙酯(spirotetramat)、硫丙磷、虫酰肼、氟苯脲、七氟菊酯(tefluthrin)、特丁磷(terbufos)、杀虫畏(tetrachlorvinphos)、噻虫啉、噻虫嗪(thiamethoxam)、硫双威(thiodicarb)、杀虫双(thiosultap-sodium)、唑虫酰胺(tolfenpyrad)、四溴菊酯(tralomethrin)、唑蚜威(triazamate)、敌百虫(trichlorfon)和杀铃脲(triflumuron)。
活性剂也可以是抗微生物活性成分,例如各种青霉素类、四环素类、磺胺类、头孢菌素类、头霉素类、氨基糖苷类、甲氧苄啶、二甲硝咪唑类、红霉素、弗氏菌丝素、呋喃唑酮,各种截短侧耳素,如硫胺素、沃尼妙林、各种大环内酯类、链霉素和针对原生动物起作用的物质,例如氯吡多、盐霉素、莫能菌素、卤夫酮、那拉霉素(narasin)和氯苯胍(robenidine)。
在某些实施例中,软可咀嚼剂型包含以下物质中的一种或多种:肾上腺素能剂;肾上腺皮质类固醇;肾上腺皮质抑制剂;醛固酮;烷化剂;拮抗剂;氨基酸;合成代谢;兴奋剂;止痛剂;镇痛激动剂和拮抗剂;麻醉剂;食欲减退剂;抗痤疮剂;抗肾上腺素剂;抗过敏剂;抗脱发剂;抗阿米巴;抗贫血剂;抗心绞痛剂;抗血管生成剂、抗焦虑剂;抗关节炎剂;抗哮喘剂;抗动脉粥样硬化剂;抗菌剂;抗生素;抗癌药;抗胆碱能药;抗凝血剂;抗惊厥药;抗抑郁药;抗糖尿病;抗腹泻;抗利尿;抗运动障碍药;止吐药;抗癫痫药;抗纤溶药物;抗真菌剂;抗出血剂;抗组胺药;抗高血钙剂、抗高胆固醇血症药;抗高脂血症;抗高血压药;抗高甘油三酯血症药;抗低血压药;抗感染药;消炎药;抗缺血剂;抗菌剂;抗微粒化药;抗有丝分裂药;抗真菌剂;抗恶心药;抗肿瘤药;抗中性粒细胞减少症药;减肥药;抗骨质疏松药、抗寄生虫剂;抗增殖药;安定药;抗逆转录病毒药物;抗吸收药;抗风湿药;抗脂溢性药;抗分泌药;解痉药;抗硬化剂;抗血栓形成药;抗肿瘤药;抗溃疡药;抗病毒剂;食欲抑制剂;双膦酸盐;血糖调节剂;支气管扩张剂;心血管药剂;中枢神经系统药剂;避孕药;胆碱能;集中辅助;镇静剂;诊断辅助设备;利尿剂;含DNA药剂、多巴胺能试剂;雌激素受体激动剂;生育剂;纤溶;荧光剂;自由氧自由基清除剂;胃酸抑制剂;胃肠运动效应器;糖皮质激素;谷氨酸能剂;毛发生长刺激剂;止血药;组胺H2受体拮抗剂;激素;低胆固醇血症;低血糖;降血脂;低血压;显像剂;免疫剂;免疫调节剂;免疫刺激剂;免疫抑制剂;白细胞介素,角质溶解;LHRH激动剂;情绪调节器;粘液溶解;散瞳;鼻减充血剂;神经肌肉阻断剂;神经保护;NMDA拮抗剂;非激素甾醇衍生物;促智剂;阿片类药物;拟副交感神经剂;纤溶酶原激活剂;血小板活化因子拮抗剂;血小板聚集抑制剂;含铂药剂、精神药物;放射性物质;raf拮抗剂,含RNA药剂,抗疥螨剂;硬化剂;镇静剂;镇静催眠药;选择性腺苷Al拮抗剂;选择性雌激素受体调节剂、血清素拮抗剂;血清素抑制剂;血清素受体拮抗剂;类固醇;兴奋剂;血栓剂;甲状腺激素;甲状腺抑制剂;拟甲状腺素;镇定剂;血管收缩剂;血管扩张剂;伤口愈合剂;黄嘌呤氧化酶抑制剂;等等。
在某些实施例中,软可咀嚼剂型包含以下物质中的一种或多种:阿巴卡韦(Abacavir)、硫酸阿巴卡韦(Abacavir sulfate)、阿巴西普(abatacept)、阿卡波糖(Acarbose)、对乙酰氨基酚(Acetaminophen)、阿昔洛韦(Aciclovir)、阿达木单抗(Adalimumab)、阿达帕林(Adapalene)、阿仑膦酸钠(Alendronate)、阿仑膦酸钠(Alendronate sodium)、阿夫唑嗪(Alfuzosin)、阿利吉仑(aliskiren)、别嘌呤醇(allopurinol)、爱维莫潘(alvimopan)、安贝生坦(ambrisentan)、氨基己酸(Aminocaproicacid)、盐酸阿米替林(Amitriptyline hydrochloride)、氨氯地平(amlodipine)、苯磺酸氨氯地平(amlodipine besylate)、阿莫西林(amoxicillin)、阿莫西林(amoxicilline)、安非他命(Amphetamine)、阿纳托唑(Anastrozole)、阿立哌唑(Aripiprazole)、阿莫达非尼(armodafinil)、阿扎那韦(Atazanavir)、阿替洛尔(atenolol)、阿托西汀(Atomoxetine)、阿托伐他汀钙(atorvastatin calcium)、阿托伐他汀(atorvastatin)、硫酸阿托品(Atropinesulfate)、氮卓斯汀(Azelastine)、阿奇霉素(azithromycin)、巴柳氮(Balsalazide)、苯那普利(Benazepril)、盐酸苯达莫司汀(bendamustine hydrochloride)、盐酸贝那普利(Benzepril hydrochloride)、贝伐单抗(bevacizumab)、比卡鲁胺(Bicalutamide)、比马前列素(Bimatoprost)、比索洛尔(Bisoprolol)、富马酸比索洛尔(Bisoprolol fumarate)、波生坦(Bosentan)、肉毒杆菌毒素(Botulin toxin)、布地奈德(Budesonide)、丁双胍(Buformin)、丁丙诺啡(Buprenorphine)、安非他酮(Bupropion)、氢溴酸安非他酮(bupropion hydrobromide)、盐酸安非他酮(Bupropion Hydrochloride)、卡麦角林(Cabergoline)、钙泊三醇(Calcipotriol)、骨化三醇(calcitriol)、坎地沙坦西酯(candesartancilexetil)、卡培他滨(Capecitabine)、甲巯丙脯酸(Captopril)、卡比多巴(carbidopa)、异丙基甲丁双脲(carisoprodol)、卡维地洛(Carvedilol)、卡泊芬净(Caspofungin)、头孢地尼(Cefdinir)、头孢哌酮钠(Cefoperazone)、头孢替安(Cefotiam)、头孢罗齐(cefprozil)、头孢呋辛(Cefuroxime)、塞来昔布(Celecoxib)、头孢氨苄(cephalaxin)、赛妥珠单抗(CertolizumabPegol)、西替利嗪(Cetirizine)、盐酸西替利嗪(Cetrizinehydrochloride)、西妥昔单抗(Cetuximab)、盐酸氯丙嗪(Chlorpromazine hydrochloride)、马来酸氯苯那敏(Chlorpheniramine maleate)、环索奈德(ciclesonide)、西司他丁(Cilastatin)、甲氰咪胍(cimetidine)、西那卡塞(Cinacalcet)、环丙沙星(Ciprofloxacin)、氢溴酸西酞普兰(citalopram hydrobromide)、克拉霉素(Clarithromycin)、克林霉素(Clindamycin)、克林霉素、盐酸克林霉素(clindamycin hydrochloride)、盐酸氯米帕明(Clomipraminehydrochloride)、盐酸可乐定(Clonidine hydrochloride)、氯吡格雷(clopidogrel)、硫酸氢氯吡格雷(Clopidogrel bisulfate)、邻氯青霉素钠(CloxacillinSodium)、复合阿莫西林-克拉维酸(Co-Amoxiclav)、磷酸可待因(Codeine phosphate)、秋水仙碱(Colchicine)、考来维纶(Colesevelam)、盐酸环苯扎林(cyclobenzaprinehydrochloride)、环磷酰胺(Cyclophosphamide)、环孢霉素(Cyclosporine)、达依泊汀α(darbepoetin alfa)、达非那新(Darifenacin)、DCRM 197蛋白、地氯雷他定(Desloratadine)、地氯雷他定(desloratidine)、乙酸去氨加压素(Desmopressin sulfate)、去羟米松(Desoximetasone)、地塞米松(dexamethasone)、双氯芬酸(Diclofenac)、枸橼酸乙胺嗪(Diethylcarbamazine citrate)、二氟泼尼酯(difluprednate)、苯海拉明(diphenhydramine)、双嘧达莫(Dipyridamole)、DL-甲硫氨酸、多西他赛(Docetaxel)、多奈哌齐(Donepezil)、多利培南(doripenem)、多佐胺(Dorzolamide)、多沙唑嗪(Doxazosin)、甲磺酸多沙唑嗪(doxazosin mesylate)、强力霉素(doxycydine)、屈螺酮(Drospirenone)、度洛西汀(Duloxetine)、度他雄胺(Dutasteride)、依库丽单抗(eculizumab)、依法韦仑(Efavirenz)、恩曲他滨(Emtricitabine)、依那普利(Enalapril)、马来酸依那普利(enalapril maleate)、依诺肝素钠(Enoxaparin Sodium)、依普沙坦(Eprosartan)、埃罗替尼(Erlotinib)、红霉素(Erythromycin)、促血红细胞生长素(Erythropoetin)、依他普仑(Escitalopram)、埃索美拉唑(esomeprazole)、雌二醇(estradiol)、雌激素(Estrogen)、右旋佐匹克隆(Eszopiclone)、依那西普(etanercept)、盐酸乙胺丁醇(Ethembutolhydrochloride)、乙琥胺(Ethosuximide)、乙炔雌二醇(ethynl estradiol)、依托孕烯(etonogestrel)、依托考昔(etoricoxib)、依曲韦林(etravirine)、艾塞那肽(Exenatide)、依替米贝(Ezetimibe)、依替米贝、因子VII、法莫替丁(famotidine)、法莫替丁、非诺贝特、非诺贝特、芬太尼、枸橼酸芬太尼、硫酸亚铁、非索非那定、盐酸非索非那定、非格司汀、非那雄胺、氟康唑、盐酸氟西汀、氟替卡松、氟伐他汀、叶酸、促卵泡素α、促卵泡素β、福莫特罗、福辛普利钠、加巴喷丁、加巴喷丁、吉西他滨、甘精胰岛素、格拉默、格列美脲、戈舍瑞林、醋酸组胺、人生长激素、盐酸肼屈嗪、氢可酮重酒石酸盐、羟基脲、盐酸羟嗪、伊班膦酸盐、伊马替尼、伊米苷酶、亚胺培南、咪喹莫特、硫酸茚地那韦、英夫利昔单抗、干扰素β-1a、异丙托铵、厄贝沙坦、伊立替康、异烟肼、硝酸异山梨酯、伊沙匹隆、氯胺酮、酮康唑、酮咯酸、乳糖酸盐、拉米夫定、拉米夫定、拉莫三嗪、醋酸兰瑞肽、兰索拉唑、拉帕替尼、拉罗匹普兰、拉坦前列素、来曲唑、亮丙瑞林、左旋沙丁胺醇、盐酸左旋咪唑、左乙拉西坦、盐酸左西替利嗪、左旋多巴、左氧氟沙星、左炔诺孕酮、左甲状腺素、左甲状腺素钠、利多卡因、利奈唑胺、二甲硝柳胺、赖诺普利、赖脯胰岛素、洛匹那韦、氯雷他定、劳拉西泮、氯沙坦钾、马拉维罗、马里诺、盐酸甲氯嗪、美洛昔康、美金刚、美罗培南、美他沙酮、二甲双胍、盐酸二甲双胍、美沙酮、甲氧基聚乙二醇-依泊汀β、哌甲酯、盐酸哌甲酯、美托洛尔、酒石酸美托洛尔、甲硝唑、甲硝唑、米格列醇、米诺环素、盐酸米诺环素、米氮平、莫达非尼、莫米松、孟鲁司特、孟鲁司特钠、吗啡、莫西沙星、霉酚酸酯、纳洛酮、萘普生钠、那他珠单抗、溴新斯的明、烟酸、烟酰胺、硝苯地平、硝呋替莫、盐酸尼罗替尼一水合物、呋喃妥因、盐酸去甲替林、制霉菌素、奥氮平、奥氮平、奥美沙坦、奥美沙坦酯、盐酸奥洛他定、奥马珠单抗、ω-3酸乙酯、奥美拉唑、昂丹司琼、阿片类药物、阿片类拮抗剂、奥利司他、奥司他韦、奥沙利铂、奥卡西平、盐酸奥昔替宁、盐酸羟考酮、紫杉醇、帕利珠单抗、泮托拉唑、扑热息痛、帕罗西汀、盐酸帕罗西汀、聚乙二醇化干扰素α-2a、培美曲塞、青霉胺、青霉素V钾、苯乙双胍、苯妥英钠、吡格列酮、哌拉西林、氯化钾、普拉克索、普伐他汀、普伐他汀钠、富马酸泼尼松龙喹硫平、普瑞巴林、磷酸伯氨喹、孕酮、异丙嗪、盐酸异丙嗪、盐酸丙酚醇、盐酸丙氧芬、伪麻黄碱、盐酸伪麻黄碱、溴吡斯的明、盐酸吡哆醇、喹硫平、富马酸喹硫平、盐酸喹那普利、雷贝拉唑、雷洛昔芬、雷替格拉韦、雷米普利、雷尼替丁、盐酸雷尼替丁、重组因子VIII、瑞他帕林、利莫那班、利塞膦酸盐、利塞膦酸钠、利培酮、利托那韦、利妥昔单抗、卡巴拉汀、酒石酸卡巴拉汀、利扎曲普坦、罗匹尼罗、罗格列酮、马来酸罗格列酮、罗苏伐他汀、轮状病毒疫苗、罗替戈汀、沙丁胺醇、硫酸沙丁胺醇、沙美特罗、二盐酸沙丙蝶呤、舍曲林、盐酸舍曲林、司维拉姆、七氟烷、西地那非、枸橼酸西地那非、辛伐他汀、辛伐他汀、西格列汀、丙戊酸钠、索利那新、生长抑素、生长激素、司他夫定、磺胺甲噁唑(Sulfomethoxazole)、舒马曲坦、琥珀酸舒马曲坦、他克莫司、他达拉非、枸橼酸他莫昔芬、坦洛新、盐酸坦洛新、替米沙坦、替马西泮、替莫唑胺、替西罗莫司、替诺福韦、盐酸特拉唑嗪、特比萘芬、特立帕肽、睾酮、盐酸四环素、沙利度胺、胸腺五肽、噻吗洛尔马来酸盐、噻托溴铵、替普拉那韦、托特罗定、酒石酸托特罗定、托吡酯、拓扑替康、曲马多、盐酸曲马多、曲妥珠单抗、盐酸曲唑酮、甲氧苄啶、阿拉昔洛韦、盐酸伐昔洛韦、丙戊酸钠、缬沙坦、万古霉素、伐地那非、伐尼克兰、文拉法辛、盐酸文拉法辛、盐酸维拉帕米、维格列汀、伏格列波糖、伏立康唑、华法林乙酰水杨酸钠、扎来普隆、齐多夫定、齐拉西酮、唑来膦酸盐、唑吡坦或其药学上可接受的盐;16-α氟代雌二醇、17-α二氢马列宁、17-α雌二醇、17-β雌二醇、17-羟基孕酮、1-十二烷基吡咯烷酮、22-氧骨化三醇、3-异丁基-γ丁酸、6-氟熊去氧胆酸、7-甲氧他克林、阿巴卡韦、硫酸阿巴卡韦、阿维菌素、阿巴诺基尔、阿巴他塞、阿贝卡米尔、阿比特龙、阿布鲁司特、阿布鲁司特钠、阿卡得辛、阿坎酸盐、阿卡波糖、醋丁洛尔、盐酸醋卡胺、醋氯啶、醋氯芬、醋氨苯砜、醋氨苯砜、乙酰谷酰胺铝、乙酰甘露聚糖、对乙酰氨基酚、乙酰唑胺、乙酰己胺、乙酰异羟肟酸、乙酰甲羟孕酮、马来酸乙酰吩嗪、乙酰砜钠、氯化乙酰胆碱、乙酰半胱氨酸、乙酰-L-肉碱、乙酰美沙朵、阿昔洛韦、阿昔洛韦、阿昔莫司、阿替酸盐、阿维菌素、阿克拉霉素、阿克拉霉素、阿克拉托铵、盐酸阿可达佐、阿考烟肼、吖啶琐辛、阿伐斯汀、阿克罗宁、阿克索胺、阿托地近、阿昔洛韦、酰基氟烯、盐酸阿达色林、阿达芬诺酯、阿达木单抗、阿达帕林、阿达色林、腺环戊醇(adecypenol)、腺环戊醇、阿德福韦、阿地米屈、腺苷蛋氨酸、腺苷、阿的纳唑仑、盐酸阿地芬宁、脂肪泊辛(adiposin)、阿多来新(Adozelesin)、阿屈非尼、肾上腺酮、二丙酸阿氯米松、阿布他明(airbutamine)、阿拉普利(alacepril)、阿来霉素、丙氨酸、阿拉丙酯、阿拉普肽(alaptide)、阿苯达唑、阿尔博拉布林(albolabrin)、沙丁胺醇、阿氯芬酸(Alclofenae)、铝克洛沙(Alcloxa)、阿地卡霉素(aldecalmycin)、阿地白介素、尿囊素铝、盐酸阿来他明、阿仑膦酸钠、阿仑膦酸钠、阿仑替莫、氢溴酸阿仑替莫、阿仑氯铵、阿来西定、阿法骨化醇、盐酸阿芬太尼、阿夫唑嗪、丙缩阿尔孕酮、阿糖脑苷酶、阿列氟烷、阿利那斯汀(alinastine)、阿立帕米(Alipamide)、阿利吉仑、尿囊素、二烯丙巴比妥、别嘌醇、阿洛咪啶、阿洛司琼、盐酸阿洛司琼、阿洛夫定、阿洛比汀、α-氨苯砜、阿匹地尔、阿普唑仑、盐酸阿普利洛尔、盐酸阿普利肟、前列地尔、阿尔司他丁钠、酒石酸阿坦色林、阿替普酶、噻嗪、奥曲肽、奥曲肽B、枸橼酸阿尔维林、阿维莫泮、阿伐昔普、醋酸阿莫地酮、盐酸金刚烷胺、氨莫司汀(ambamustine)、安波霉素、安贝生坦、安布替星、安布茶碱、安布赛特(Ambuside)、安西法尔(Amcinafal)、安西奈德、美西林(Amdinocillin)、匹美西林(Amdinocillin Pivoxil)、盐酸苯吲酮丙胺、阿洛米松(amelometasone)、阿米替林、阿米替林、醋酸阿米替龙、硫酸阿米西铵、安非他酮、氨芬酸钠、阿米妥唑、阿米环素、甲氧苄氨嘧啶、阿米妥、阿米沙星、阿米福汀、阿米卡星(Amilcacin)、盐酸阿米洛利、盐酸氨基克林、氨基苯甲酸钾、氨基苯甲酸钠、氨基己酸、氨基鲁米特、氨基马尿酸钠、氨基乙酰丙酸、氨茶碱、米诺环素、氨基水杨酸钠、氨基水杨酸、胺碘酮、盐酸阿米普洛、盐酸阿米喹辛、氨磺必利、双甲脒、盐酸阿米替林、氨来占诺、氨氯地平、苯磺酸氨氯地平、异戊巴比妥钠、阿莫地喹、盐酸阿莫地喹、阿莫罗芬、阿莫沙平、阿莫西林、氨氯苄、安非他明、硫酸安非他明、两性霉素、两性霉素B、氨苄青霉素、氨苄青霉素、硫酸安匹嗪、氨喹酯、氨利农、氨柔比星、安吖啶、淀粉酶、胰淀素、阿米硫霉素、醋酸阿那斯通、阿那格雷、阿那金娜、阿那奈、阿那瑞肽、醋酸阿那瑞肽、阿那曲唑、阿那唑林钠、安克罗德、穿心莲内酯、雄烯二酮、血管紧张素酰胺、阿尼肟、苯胺利定、盐酸阿尼西泮、阿尼西坦、阿尼洛酸、甲基溴异丙托品、茴香胺酶、阿尼扎芬、双炔失碳酯、拮抗剂D、拮抗剂G、安他瑞林、磷酸安替比林、安妥霉素、蒽林、蒽霉素雄激素、抗雌激素、抗肿瘤酮、安替比林、反义寡核苷酸、阿帕多林、阿帕凡特、阿帕西林钠、阿帕昔林、阿帕宗、阿哌地克林甘氨酸酯、阿哌昔林、盐酸阿扑吗啡、安普乐定、盐酸阿可乐定、安普霉素、安普林、盐酸安普林、抑肽酶、马来酸阿普他平、阿替加奈、无嘌呤核酸(apurinic acid)、无嘌呤核酸、阿雷地平、阿拉诺丁、阿伯前列素、阿贝卡星(arbekicin)、阿比多尔、盐酸阿布他明、阿氯非林(Arclofenin)、阿地肝素钠、阿加曲班、精氨酸、精氨酸加压素鞣酸盐、阿立多酮、阿立哌唑、阿莫达非尼、阿罗洛尔、阿匹酸、阿替夫林、阿利特富马酸盐、阿西马多林、阿斯帕拉酮、门冬酰胺酶、天冬氨酸、天冬氨酸、阿斯呋喃、阿司匹林、阿扑西林、阿司匹林、阿司咪唑、硫酸阿司米星、阿舒拉嗪、阿他美坦、阿扎那韦、阿替洛尔、阿替韦定、阿替帕美唑、马来酸阿替普辛、阿托利特、阿托莫西汀、阿托伐他汀、阿托伐他汀钙、阿托西班、阿托伐醌、抗癣青霉素(atpenin)B、苯磺酸阿曲库铵、阿莫司汀、阿曲肌醇、阿托品、硫酸阿托品、金诺芬(Auranofin)、金担子素A(aureobasidin A)、金硫葡糖、卑霉素、阿伏帕星、阿夫立定、尼扎替丁(Axid)、阿新司坦汀(axinastatin)1、阿新司坦汀2、阿新司坦汀3、阿扎苯胺、阿扎胞苷(Azacitidinie)、盐酸氮氯嗪、阿扎康唑、印楝素(azadirachtine)、二盐酸阿扎兰司他(Azalanstat Dihydrochloride)、富马酸阿扎克生(Azaloxan Fumarate)、马来酸阿札那托(Azanator Maleate)、阿扎硝唑、阿扎哌隆、阿扎利宾、氮丝氨酸、阿扎司琼、马来酸阿扎他定、硫唑嘌呤、硫唑嘌呤钠、氮杂毒素、氮杂酪氨酸、壬二酸、氮卓斯汀、阿折地平、阿折吲哚、阿塞替帕、阿齐利特、阿奇霉素、阿洛西林、唑亚胺、阿佐塞米、阿佐霉素、氨曲南、阿珠莫林钠(Azumolene Sodium)、盐酸巴氨西林、巴卡亭III、杆菌肽、巴氯芬、苦艾素A、苦艾素B、波淋菌素胺(bactobolamine)、勃来诺(balanol)、巴拉齐朋、巴尔希霉素(balhimycin)、巴洛沙星、巴柳氮、班伯霉素(Bambermycin)、班布特罗、硫酸丁酚胺、巴美菲林盐酸盐、班硝唑(Bamidazole)、宝藿苷(baohuoside)1、巴马斯汀、巴尼地平、巴西克(Basic)、巴西芬净、盐酸巴他必利(Batanopride Hydrochloride)、巴布司特(batebulast)、马来酸巴氮平(BatelapineMaleate)、巴马司他、白僵菌素、盐酸胺甲噻吨酮、贝卡普勒明、贝康唑、二丙酸倍氯米松、贝氟沙通、苄丝肼(Beinserazide)、贝磷地尔、颠茄碱(Belladonna)、贝洛酰胺、贝美司琼、贝米曲啶、贝莫拉旦、盐酸贝那利秦(Benapryzine Hydrochloride)、贝那普利、盐酸贝那普利、苯那普利拉、甲磺酸本达卡洛尔、盐酸苯达莫司汀、苄达酸、苄氟噻嗪、本芴醇、贝尼地平、贝诺睾酮、苯噁洛芬(Benoxaprofen)、苯噁洛芬、盐酸奥布卡因、苯哌利多、苯他西泮、苯替酪胺、贝奴司他(Benurestat)、苯溴马隆、盐酸贝那普利、苄索氯铵、盐酸苄替米特、苯咯溴铵、盐酸苄吲吡林、苯异噁唑、苯唑卡因、苯唑氯辛(benzochlorin)、盐酸苯佐他明、苄替哌、苯并咪唑克生(benzoidazoxan)、苯佐那酯、过氧化苯甲酰、苯甲酰星形孢菌素、苄喹酰胺、苄噻嗪、苄托品、甲磺酸苄托品、盐酸苄达明、苄青霉素酰聚赖氨酸、贝普利地尔、盐酸贝普利地尔、培拉克坦、贝前列素、贝福林、柏拉非农(berlafenone)、柏托沙米(bertosamil)、红霉素、贝西吡啶、甜菜碱(betaalethine)、倍他霉素B、倍他米松、倍他米隆、倍他洛尔、盐酸倍他洛尔、氯贝胆碱、硫酸苄甲胍、桦木酸、贝伐单抗、贝凡洛尔、盐酸贝凡洛尔、苯扎贝特、盐酸比拉米可、比阿培南、比卡鲁胺、盐酸比西发定、盐酸二氯地尔、比地索胺、二苯美伦、联苯苄唑、比卡林(bimakalim)、比马前列素、双米希尔(bimithil)、宾达利(Bindarit)、比尼霉素、比螺酮、博来霉素(bioxalomycin)、盐酸比培那醇、比哌立登(Biperiden)、盐酸苯柳胺酯、比立哌隆、比生群、比沙雷米、双氮丙啶亚精胺(bisaziridinylspermine)、双苯并咪唑A、双苯并咪唑B、双奈法德、甲氧丁喹乳酸盐、比索洛尔、富马酸比索洛尔、双吡啶硫酮镁硫酮(Bispyrithione Magsulfex)、双酰胺D、双酰胺K、双酰胺A、硫双二氯酚钠、比托特罗甲磺酸、比伐卢定、比折来新、硫酸博莱霉素、波尔定碱、勃雄二醇酯、勃拉睾酮、宝丹酮十一烯酸酯、勃来诺、勃金刚酯、波吲洛尔、波生坦、肉毒杆菌毒素、波克昔定、布雷菲德菌素、布雷弗拉特(breflate)、布喹那钠、溴他西尼、托西溴苄铵、盐酸布芬太尼、溴莫尼定、纤维蛋白酶、溴克立新、溴克利那、溴伏克辛、马来酸溴朵林、溴西泮、溴氯唑酮、菠萝蛋白酶、溴芬酸、溴吡二酮、溴隐亭、盐酸溴苯海拉明、溴克沙胺、溴哌利多、癸酸溴哌多、马来酸溴苯那明、溴哌酮、溴吡胺、溴替唑仑、马来酸布酰胺、布吲哚醇、盐酸布立嗪、布氯马酮、布地奈德、布地平、布多替坦、丁佛明、布美他尼、布那普司特、布那唑嗪、盐酸布诺洛尔、布吡酰胺、盐酸布比卡因、丁丙诺啡、盐酸丁丙诺啡、丁氨苯丙酮、氢溴酸安非他酮、盐酸安非他酮、氨基丁酸盐、醋酸布舍瑞林、盐酸丁螺环酮、白消安、丁巴比妥、布他西汀、盐酸布他克拉莫、布他必妥、布他本、枸橼酸布他米脂、布他拉嗪、布他前列素、布他膦酸四钠、布替萘芬、布替利嗪、丁硫氨酸亚砜胺、布替卡星、布替芬宁、硫酸布替松香、布替昔酯、丙酸布替考特、硝酸布康唑、丁酸酯、布托帕胺、盐酸布洛嗪、布托啡诺、盐酸布托沙胺、盐酸布替林、卡麦角林、放线菌素、卡地姆碘、咖啡因、胡桐内酯A、骨化二醇、钙泊三醇(Calcipotriene)、钙泊三醇(calcipotriol)、降钙素、骨化三醇、十一碳烯酸钙、钙磷酸蛋白C、卡普睾酮、坎苯达唑、卡姆纳姆钠(Cammonam Sodium)、卡莫格雷、金丝雀痘IL-2、坎地沙坦、坎地沙坦西酯、杀念菌素、坎沙曲、坎沙曲拉、卡格列波糖(Caniglibose)、坎利酸钾、坎利酮、卡培他滨、克冠酸钠、卡泊酸、硫酸卷曲霉素、卡罗单抗、辣椒素、甲巯丙脯酸、卡普脲、羧甲司坦(Car bocysteine)、卡醋胺、卡巴可、卡巴多司、卡马西平、过氧化脲、碳酰十二烷基硫酸酯、卡巴匹林钙、卡巴泽兰、卡佐霉素C、羧苄青霉素钾、羧苄索酮钠、卡贝替米、卡比托星、卡比多巴、卡比多巴-左旋多巴、马来酸卡比沙明、盐酸卡比芬、卡波氯醛、石炭酸品红、卡铂、卡前列素、卡巴韦、甲酰胺-氨基-三唑-1e、羧胺三唑、羧甲基化β-1,3-葡聚糖、盐酸卡布特罗、CaRest M3、枸橼酸双苯哌酯、卡立普多、卡金刚酸、卡莫司汀、CARN 700、卡尼达唑、卡罗沙宗、卡哌立肽、马来酸卡那嗪、卡罗芬、琥珀酸卡曲林、卡他唑酯、卡替洛尔、盐酸卡替洛尔、盐酸卡柔比星、卡维地洛、卡伏曲林、盐酸卡伏曲林、卡折来新、卡泊芬净、粟树精胺、卡芦莫南、西巴西坦、天蚕素B、西地芬戈、头孢克洛、头孢羟氨苄、头孢孟多、头孢假释、头孢三嗪、头孢氟钠、头孢唑啉、头孢卡品酯、头孢达肟戊酯、头孢地尼、头孢托仑酯、头孢吡肟、头孢他美、头孢酯、头孢克肟、头孢氟仑、盐酸头孢烷肟、头孢他唑、头孢明肟、头孢地嗪、头孢尼西钠、头孢哌酮、头孢哌酮钠、头孢拉尼、头孢噻利、头孢噻肟钠、头孢替坦、头孢替安、头孢西丁、头孢唑兰、头孢匹唑、头孢匹胺、头孢匹罗、头孢泊肟酯、头孢丙烯、头孢罗沙定、头孢磺啶、头孢他啶、头孢特仑、头孢布烯、头孢唑肟钠、头孢三唑、头孢呋辛、雷公藤红素、塞来昔布、塞利卡林、塞利洛尔、头孢霉素A、头孢三钠、头孢氨苄、头孢甘氨酸、头孢菌素、头孢噻吩钠、头孢匹林钠、头孢拉定、西曲拉明、西立伐他汀、蓝肽、西罗普利、西妥珠单抗、舍托肝素钠、棕胺苯酸钠、西他氯铵、盐酸塞他洛尔、切图佩拉酮(Cethuperazone)、西替地尔、西替利嗪、乙酰氯霉素、盐酸西曲酸酯、盐酸西替利嗪、西曲瑞克、西妥昔单抗、西吡氯铵、鹅去氧胆酸、敌退咳(Chlophedianol Hydrochloride)、氯醛甜菜碱、瘤可宁(Chlorambucil)、氯霉素、氯登妥因、利眠宁(Chlordiazepoxide)、葡萄糖酸氯己定、二氢卟酚、乙酸氯地孕酮、氯东方霉素A、盐酸氯普鲁卡因、氯磺丙脲、氯喹、磺酰胺氯代喹喔啉、氯噻嗪、氯烯雌醚、氯喔星、氯二甲苯酚、马来酸氯苯那敏(Chlorpheniramine Maleate)、氯苯甘油氨酯、马来酸氯苯那敏、氯丙嗪、盐酸氯丙嗪、氯磺丙脲、氯普噻吨、金霉素硫酸氢盐、氯噻酮、氯唑沙宗、考来烯胺树脂、盐酸色罗那、西苯唑啉、西卡前列素、盐酸环丙肾上腺素、环丙嗪多、环索奈德、环来他宁、环吡酮糖、环氯普洛尔、西多福韦、盐酸西多塞平、西芬林、西格列酮、盐酸西拉多帕、西兰司琼、西司他丁、西司他丁钠、西拉普利、西尼地平、甲磺酸西洛巴胺、西罗布拉啶、西罗芬净、西洛他唑、西马特罗、西咪替丁、溴化西美特罗、西那卡塞、西那卢卡司特、盐酸西南色林、马来酸肉桂哌乙酯、环桂氟胺、异炔诺、西尼必利、桂美君(Cinnamedrine)、桂利嗪、西诺西泮、西诺沙星、桂双哌酮、桂溴胺、辛喷他宗、辛曲胺、西奥特罗、西帕美茶碱、琥珀酸西曲马多、西普罗昔奈、西普罗贝特、环丙沙星、西前列素、西拉米多尔、西罗霉素、顺铂、西沙必利、苯磺酸顺阿曲库铵、西曲康唑、顺式卟啉、西替尼嗪、西酞普兰、氢溴酸西酞普兰、西替酰胺、胞磷胆碱、柠檬黄霉素α、克拉屈滨、盐酸氯胺羟喹、克拉霉素、黄嘌呤酰胺、克拉维酸钾、克拉唑仑、克拉唑胺、克雷伯必利、克雷马斯汀、马来酸克伦泰泽、溴化克林霉素、克林霉素、盐酸克林霉素、克雷奎诺、克雷克奈、克罗洛芬、氯巴唑、丙酸氯倍他索、丁酸氯倍他松、醋酸氯托隆、氯达诺酮、盐酸氯达松、氯屈膦酸、氯法齐明、氯氟硼酸酯、磷酸氯菲铵、醋酸氯奇石、磷酸氯马克林、醋酸氯美加酮、氯高铁龙、氯甲唑、氯米芬类似物、氯米诺、氯米酚、氯米帕明盐酸盐、氯硝西泮、氯硝丁、氯硝胺盐酸盐、氯帕胺、氯戊噻醇、盐酸氯哌酮、氯吡格雷、硫酸氢氯吡格雷、氯匹莫嗪、甲磺酸氯哌嗪、氯匹拉酸、氯普瑞醇、氯前列醇钠、氯噻嗪二钾、氯雷他定、氯雷索龙、盐酸氯丙烯酮、盐酸氯丙肾上腺素、氯苏龙、盐酸氯替敏、克罗散泰、乙酰甘氨酸氯西拉敏、氯噻嗪、马来酸氯噻肟酯丙酸氯替卡松、氯三唑、氯唑西林苄星、氯唑青霉素钠、氯氧喹、氯扎平、钴阿莫昔克、可卡因、可卡因、可待因、磷酸可待因、偕胺肟、秋水仙碱、科尔塞韦拉姆、科雷司汀、盐酸科尔斯蒂波尔、鞘氨醇、考福新(Colforsin)、棕榈胆磷、可利菌素甲磺酸钠、硫酸抗敌素、科里霉素A、科里霉素B、甲磺酸叔丁肾上腺素、康普瑞汀A4、复方伐他汀、芋头素、盐酸康吗啡酮(ConorphoneHydrochloride)、连续甾醇(contignasterol)、蛇毒解聚素、醋酸三氟米松、羊促肾上腺皮质激素(Corticorelin Ovine Tnflutate)、促肾上腺皮质素、醋酸可的松、可的伐唑、可托多松、科萨烷(cosalane)、科斯塔内酯(costatolide)、替可克肽(Cosyntropin)、可铁宁、可迈丁(Coumadin)、库马霉素、克仑布西定(crambescidin)、克伐他汀、克雷斯托(crisnatol)、克罗米屈钠(CromitrileSodium)、色甘酸钠、克罗米通、念珠藻素、葫芦苷(cucumariosid)、铜迈星、箭毒素(curacin)A、硫酸凝胶多糖(curdlan sulfate)、锔素(curiosin)、环己西林(Cyclacillin)、环佐辛、环唑嗪(cyclazosin)、胺氢趾唑、马来酸环己胺、环己嗪、环苯达唑、环苯沙比利、盐酸环苄沙比利、环布特A、环布特G、环己酮、环己酸环胍、环己酰胺、环戊烷蒽醌、环戊酰肼、盐酸环戊酯、盐酸环吩嗪、环磷酰胺、环拉坦、环丙烷、环丝氨酸、环辛、环孢菌素、环噻嗪、环噻唑霉素、环庚酰胺、卷曲霉素(cypemycin)、盐酸赛波那明、赛帕西泮、盐酸赛庚啶、盐酸赛普乐多、赛普罗酮、赛罗酰亚胺、半胱胺、盐酸半胱氨酸、胱氨酸、阿糖胞苷、盐酸阿糖胞苷酯、细胞松弛素B、细胞抑制素、达卡巴嗪、达昔单抗、达替米星、达维那霉素、达嗪、甲苯磺酸达乐达林、达氟司汀、达替帕林钠、达曲班、达伐他汀、达那泊胺、达那唑、达三唑仑、达普诺多林A、达匹唑唑、达匹坦、盐酸达泊西汀、氨苯砜、达托霉素、达贝波汀阿尔法、达格列酮钠、达非那素、达卢辛A、达洛地平、达西多明、盐酸柔红霉素、马来酸达唑洛尔、盐酸达唑匹尼、达美格雷、富马酸达唑普利、盐酸达昔西本、DCRM197蛋白、硫酸异喹胍、地西他滨(Decitabine)、去铁酮、地夫可特、脱氢胆酸、脱氢地丁(dehydrodidemnin)B、脱氢表雄酮、地拉普利、盐酸地拉普利、甲磺酸地拉韦定(Delavirdine Mesylate)、地来夸明(delequamine)、地发哌嗪、醋酸地马孕酮、地莫匹醇、翠雀花素(delphinidin)、地美溴铵(Demecarium Bromide)、地美环素、去甲环素、去甲西泮、去甲芬净、脱氧吡啶啉、去甲酮、去甲伪麻黄碱、去甲西霉素、去甲环素、硫酸皮肤素、去昔洛韦、去甲西诺酮丙酮、去呋喃酮、盐酸地西普胺、去甲鲁丁、去甲兰糖苷、地氯雷他定、去氯肾上腺素、去甲加压素、硫酸去甲加压肽、去甲孕酮、去甲肾上腺素、去甲氧基米松、去乙氧基胺碘酮、去甲氧皮质酮乙酸酯、酒石酸去甲铵、盐酸地烯醇、醋酸地替利酯、德伐匹德、地塞米松、右旋咪唑、马来酸右旋溴苯那敏、马来酸右氯苯那敏、盐酸德沙洛尔、右旋乙酰胺、盐酸右旋芬氟拉明、右旋异环磷酰胺、右旋西莫芬、右旋酮洛芬、右旋氯氟脲、右旋美托咪定、右旋甲铂、盐酸右旋噁唑醇、右旋泛醇、右旋培美洛、盐酸右旋普萘洛尔、右旋唑烷、右旋索他洛尔、2-硫酸糊精、右旋甲基苯丙胺、右旋美沙芬、盐酸右旋美沙芬、右旋甲状腺素钠、右旋维拉帕米、德扎胍、德扎酰胺、德扎西辛、盐酸双丙酮、环氯二胺、双帕胺、双三唑酸葡胺、三唑酸、双维啶、双西泮、双唑酮、盐酸二苯并平、二苯并噻吩、二布卡因、敌敌畏、二氯腙、二氯苯胺、二氯乙烯酮、双氯芬酸、双氯芬酸钠、双氯西林(Dicloxacillin)、双花青(dicranin)、双香豆素、盐酸双环胺、地达诺新(Didanosine)、膜海鞘素B、迪多克斯(didox)、己二烯雌酚、地诺孕素、枸橼酸乙胺嗪、二乙基异麦芽糖、二乙基降精胺(diethylnorspermine)、盐酸安非拉酮、己烯雌酚、盐酸地芬腈酰胺(DifenoximideHydrochloride)、地芬诺辛、醋酸双氟拉松、盐酸二氟沙星、盐酸二氟宁、二氟可龙、二氟米酮钠、二氟尼柳、二氟泼尼酯、地弗他酮、洋地黄、洋地黄毒苷、地高辛、盐酸二己威林、二氢雷西丁、二氢-5-氮胞苷、酒石酸二氢可待因、甲磺酸二氢麦角胺、二氢甾体酮、硫酸二氢链霉素、二氢速甾醇、狄兰汀、盐酸地洛伐、盐酸地尔硫卓、二甲法丹、盐酸二甲弗林、二甲羟萘、二甲丙脯醇、二甲二酮、马来酸二甲辛酯、二甲蓟酮、二甲基亚砜、二甲基高精胺、二甲基前列腺素Al、二甲基拉西坦、盐酸二噁胺、地诺前列素、地诺前列腺素酮、盐酸二噁唑醇、二噁霉素、苯海拉明、柠檬酸苯海拉明、二苯基螺霉素、盐酸二匹韦芬、二匹韦福林、二吡环酮、二苯菲酮、二丙基诺精胺、双嘧达莫、二吡硫酮、二吡酮、二红霉素、盘皮内酯、二磺酰亚胺、二磺芬、二吡喃、二噁草唑、二硫仑、二噻嗪、二甲氧基酮钠、马来酸二唑西平、DL-蛋氨酸、多巴酚丁胺、多巴酚胺、多巴酮、多西他赛、多康唑、多沙醇、多非立德、多拉司琼、多奈哌齐、多哌啶胺、多唑胺、多沙唑嗪、甲磺酸多沙唑辛、多西丁、屈螺酮、度洛西汀、度他雄胺、依巴斯汀(Ebastine)、依比拉肽(ebiratide)、乙溴替丁(ebrotidine)、依布硒(ebselen)、依卡派特(ecabapide)、依卡倍特(ecabet)、依卡曲尔(ecadotril)、脱皮甾酮(ecdisteron)、菊苣素(echicetin)、锯鳞血抑肽、腆依可酯(Echothiophate Iodide)、马来酸依氯那明(Eclanamine Maleate)、乙唑司特、依考莫司汀、益康唑、海鞘素722、依库丽单抗、依达拉奉、依达曲沙、依地福新、乙酸依地福龙、埃巴单抗(edobacomab)、依度尿苷、依决洛单抗(edrecolomab)、依酚氯铵(Edrophonium Chloride)、乙酸去甲氧孕酮(edroxyprogesteoneAcetate)、依法韦仑、依非加群、氟氯胺(eflomithine)、依福地平、乙呱仑(egualcen)、依兰群、依降钙素(eleatonin)、榄香烯(elemene)、依立曲坦、依高地平、依利罗地、依沙芦星、依尔替酸(eltenae)、衣鲁卡因、依美卡姆(emailcalim)、依美斯汀、盐酸依米丁、乙格列酯、依米托西盐、乙嘧替氟、依莫白介素、恩曲他滨、盐酸依那朵林、依奈西林(Enailciren)、依那普利、马来酸依那普利、依那扎群、恩环丙酯、甲磺酸恩屈嗪、恩甲羟松、安氟醚、恩格列酮、恩康唑、依尼前列素、恩莫单抗(Enlimomab)、恩洛铂、乙诺司特、依诺利康钠(EnolicamSodium)、依诺沙星(Enoxacin)、依诺沙星、依诺肝素钠、依诺肝素钠、依诺昔酮、磷酸恩哌罗林(Enpiroline Phosphate)、英洛菲林(Enprofylline)、恩普氨酯、恩他卡朋、肠抑素、恩韦拉登、恩韦肟、麻黄素、依匹西林、表甲雌三醇、肾上腺素、环硼肾上腺素、依匹哌啶、依匹唑、表柔比星(epirubicin)、盐酸差向四环素、依匹噻嗪、阿法依泊汀(Epoetin Alfa)、倍他依泊汀(Epoetin Beta)、依前列醇、依前列醇钠、环氧美沙酮(epoxymexrenone)、爱普列特、依普沙坦、依斯的明、马萘雌酮、马烯雌酮、厄布洛唑、厄多司坦、甲磺酸二氢麦角碱、马来酸麦角新碱、酒石酸麦角胺、埃罗替尼、艾生利特、厄索夫明、赤藓糖醇、丁四硝酯、红霉素、促血红细胞生长素、依他普仑、盐酸艾司洛尔、埃索美拉唑、盐酸依索比星、盐酸乙硫酰丙喹、艾司唑仑、雌二醇、雌莫司汀、氢溴酸氮杂炔雌醇、雌三醇、雌激素、雌激素、雌甾酮、雌激素、阿片类药物、易舒灵、依佐匹克隆、盐酸埃塔费德林、依那西普、依他尼达唑、依他洛尔、依他罗汀、盐酸依他唑酯、乙巴溴、乙西嗪、乙炔钠、乙炔酸、盐酸乙胺丁醇、香草二乙胺、油酸氨基乙醇、乙氯戊炔醇、盐酸乙胺丁醇、炔雌醇、乙碘化油、乙酰胺、硝酸乙胺、盐酸异丙丙烯嗪、乙酰亚胺、乙酰肟、乙氧乙醇、盐酸乙氧嗪、乙基苯丙胺、氯乙基、二乙二酸乙酯、雌烯醇乙酯、炔二醇、氯炔诺酮、雌二醇乙酯、双醋炔诺醇、依苯达唑、依替卡因、羟乙膦酸钠、羟乙磷酸、依替菲宁、盐酸乙替啶、乙索兰、法妥拉酸、氨基甲酸乙酯、盐酸乙福明、乙酰胺、炔诺孕酮、盐酸乙哌酮、乙氧基苷、乙氧丙啶、依托力昔布、盐酸乙苯噁啶、依托唑啉、依曲巴明、依曲韦林(etravirine)、依曲替酯、乙酸乙色胺、盐酸优卡托品、丁子香酚、盐酸优库平、伊韦霉素(eveminomicin)、依沙美肟、艾沙瑞林、盐酸已丙洛尔、依西美坦、艾塞那肽、依替米贝、依替米贝、因子VII、法曲唑、法利芬净、泛昔洛韦、法莫替丁、法莫匹啶、凡托法隆、盐酸凡特里酮、法罗培南、法昔多林、法舒地尔、法扎拉滨、非多托嗪、非巴酸、非巴酸、非比那克、非洛地平、费利加压素、芬那酰胺、芬那莫、芬苯达唑、芬布芬、芬吉特罗、芬氯芬酸、芬克罗宁、芬克洛、芬多沙、芬斯特雷、盐酸芬乙基林、盐酸芬氟拉明、芬加宾、芬酰亚胺、芬异瑞克斯、盐酸芬美托唑、芬美特罗、芬诺巴姆、硫酸芬辛亚胺、非诺贝特、非诺多潘、芬诺洛芬、芬诺特罗、芬匹龙、盐酸芬普利司特、芬前列素、芬喹酮、维甲酰酚胺、芬司匹利、芬太尼、枸橼酸芬太尼、芬替酸、芬替克洛、芬替康唑、盐酸非尼啶醇、非普地醇、吡磷铁钠、费里斯汀(ferristene)、铁氧嘧啶(ferrixan)、硫酸亚铁、四氧化三铁(Ferumoxide)、非莫西尔、盐酸非托西酯、非索非那定、盐酸非索非那定、富马酸非唑拉明、非西他滨、非阿尿苷、非莫择夫(fibmoxef)、纤维蛋白原、非格司亭、菲律平(Filipin)、非那雄胺、氟苯尼考(fiorfenicol)、费奥里芬(fiorifenine)、氟沙地尔(fiosatidil)、氟美西诺(fiumecinol)、氟桂利嗪(fiunarizine)、氟洛克生(fiuparoxan)、氟吡汀(fiupirtine)、氟红霉素(fiurithromycin)、氟曲马唑(fiutrimazole)、氟伐他汀(fiuvastatin)、氟伏沙明(fiuvoxamine)、马来酸黄酮地洛、黄酮吡哆醇(flavopiridol)、盐酸黄酮哌酯、夫拉扎酮、氟卡尼(flecamide)、氟丁特罗、氟罗沙星、氟辛克生、硫酸氟司洛尔、氟乙西泮、氟卓斯汀、氟罗布芬、夫洛非宁、氟地平、氟司喹南、氟氯西林、氟尿苷、氟啶酮(fluasterone)、氟扎可松、盐酸氟苯胺酯、氟苯达唑、氟西吲哚、氟二氯松、氟康唑、氟胞嘧啶、氟氘丙氨酸、磷酸氟达拉滨、氟氯达唑、氟代脱氧葡萄糖、氟多雷司、醋酸氟氢可的松、氟芬那酸、氟苯柳、氟马西尼、氟甲喹、氟美立酮、氟甲松、氟甲吗酮、氟甲氮平、氟氨雷司、氟鲁咪唑、氟甲氧缩松、氟硝唑、氟尼缩松、氟硝西泮、氟尼辛、氟骨化三醇(fluocalcitriol)、醋酸肤轻松、氟轻松、福可定丁酯、氟康唑、荧光素、盐酸氟柔红霉素、氟多巴、氟米龙、氟尿嘧啶、盐酸氟曲辛、氟西汀、盐酸氟西汀、氟甲睾酮、氟哌丁胺、醋酸氟哌龙、氟奋乃静癸酸酯、氟泼尼松龙、氟丙喹酮、氟前列醇钠、氟喹酮、盐酸氟拉多林、氟地奈德、盐酸氟西泮、氟比洛芬、氟雷托芬、氟他滨、氟乙酰胺、醋酸氟孕酮、氟乙基、氟己烯、氟哌隆、氟螺环烯、氟替卡松、氟替卡松丙酸酯、氟替卡松、氟伐他汀、氟伐他汀钠、氟嗪酰胺、叶酸、卵泡调节蛋白、卵泡抑素、促卵泡素α、促卵泡素β、氟美唑、甲磺酸福那嗪、福沙坦、福美司、福美司、福美司、福美司坦、福美司他、福莫特罗、福沙酯、福西泮、膦甲酸钠、磷霉素、膦甲酸钠、福辛普利、福辛普利钠、福辛普利拉、磷苯偶姻、福喹酮、福司地尔、福三霉素、福莫司汀、品红、呋莫西林、真菌霉素、呋喃唑酮、呋喃唑酮、呋喃唑酮、呋喃西林钠、呋喃布芬、呋喃唑酮、呋塞米、夫西地酸钠、夫西地酸、加巴喷丁、钆贝酸二甲葡胺、钆贝酸、钆布醇、钆喷酸胺、钆特沙芬林、钆喷酸二甲葡胺、钆特酸、钆特醇、钆特胺、加兰他敏、加丹司琼、盐酸加丹司琼、加拉碘铵、硝酸镓、戈洛帕米、加洛他滨、环苯丙胺、阿莫仑酸、更昔洛韦、甘尼瑞林、吉卡二醇、吉西他滨、吉美前列素、吉非罗齐、硫酸庆大霉素、龙胆紫、吉吡隆、盖斯克隆、孕二烯酮、孕酮己酸酯、孕三烯酮、盐酸吉伏曲林、吉立索泮、甘精胰岛素、格拉莫德、格拉默、蓝萼甲素A、格来色林、格列胺脲、格列波脲、嘧磺茴胺钠、格列氟胺(Glifiumide)、格列美脲、格列吡嗪、格洛莫南、胰高血糖素、谷氨酰胺酮、谷氨酰胺、格列本脲、格列本、格列普利、格隆溴铵、格列本脲、格列米丁钠、格列克酰胺、格列帕拉酰胺、Gold Au-198、促性腺激素(Gonadoctrinin)、戈那瑞林、促性腺激素类、戈舍瑞林、短杆菌肽、格拉司琼、格拉群、格雷帕沙星、灰黄霉素、愈创酯、愈创茶碱、胍那苯、醋酸胍那苯、硫酸胍那雷、胍西啶、硫酸胍乙啶、盐酸胍法辛、硫酸胍异喹、硫酸胍氯、盐酸胍辛、胍诺沙本、硫酸胍诺沙、硫酸胍氧芬、盐酸格司哌米司、哈拉西泮、哈西奈德、软海绵素B、卤倍他索丙酸酯、卤泛群、盐酸卤泛群、降脂酰胺、氢溴酸卤夫酮、海乐萌(halomon)、卤培米特、氟哌啶醇、卤泼尼松、卤孕酮、氯丙炔碘、氟烷、三合氯喹啉、哈霉素、哈托霉素(hatomamicin)、哈托莫鲁比金(hatomarubigin)A、哈托莫鲁比金B、哈托莫鲁比金C、哈托莫鲁比金D、肝素钠、合普素凡(hepsulfam)、调蛋白、海他西林、海特溴铵(HeterooiumBromide)、六氯酚过氧化氢(Hexachlorophene Hydrogen Peroxide)、六氟溴化物(Hexafluorenium Bromide)、六亚甲基二乙酰胺、海克西定、海索苯定、硫酸海索那林、己雷琐辛、磷酸组织胺、组氨酸、组织胞浆素、富组蛋白、醋酸富组蛋白、氢溴酸后马托品、盐酸胡喹嗪、人绒毛膜促性腺激素、人生长激素、氢化可的松、肼屈嗪盐酸盐、肼屈嗪聚苯乙烯、氢氯噻嗪、氢可酮重酒石酸盐、氢化可的松、氢氟噻嗪、氢吗啡酮盐酸盐、氢溴酸羟苯丙胺、硫酸羟氯喹、羟基苯那酸盐、己酸羟孕酮、羟基脲、盐酸羟嗪、羟甲香豆素、莨菪胺、金丝桃素、伊巴沙星、伊班膦酸盐、伊博加因、伊博泮、异丁司特、伊布芬酸、布洛芬、富马酸伊布利特、醋酸艾替班特、鱼石脂、亚可替定、伊达比星、艾多昔芬、碘苷、伊决孟酮、伊非曲班、异环磷酰胺、伊来西胺(Ilepeimide)、伊利马醌(illimaquinone)、伊莫福新(ilmofosin)、伊洛马司他、伊洛达普、伊潘立酮、伊洛前列素、盐酸伊马芬、伊马替尼、盐酸伊马佐丹、咪达普利、咪达嗪、咪唑吖啶酮、咪达碘、盐酸咪达卡巴、盐酸咪达啉、咪达脲、亚胺葡萄糖酶、盐酸咪洛沙、亚胺培南、盐酸丙咪嗪、咪喹莫特、盐酸丙咪脒、吲达可酮、吲达帕胺、盐酸吲达卡胺、盐酸吲达嗪、靛蓝磺酸钠、茚地那韦、硫酸茚地那韦、吲哚青绿、盐酸吲哚普利、吲哚利丹、吲哚美辛、吲哚美辛钠、吲哚美辛、吲哚美辛、吲哚美辛、盐酸吲哚美辛、吲哚美辛、盐酸英夫利昔单抗、伊诺考酮、伊诺加群、伊诺利单抗、烟酸肌醇酯、胰岛素、干扰素β-1a、吲四唑、盐酸因曲替林、碘苄胍、碘苯扎酸(Iobenzamic Acid)、碘比醇、碘、碘阿米洛利(iodoamiloride)、碘阿霉素、碘拉醇、碘美普尔、碘喷托、碘普罗胺、碘吡多(iopyrol)、碘赛特、碘昔兰、依帕利特、伊培沙宗、伊匹达克林、碘泊酸钙、甘薯苦醇、异丙托铵、异丙托溴铵、依普黄酮、伊普吲哚、伊普芬宁(Iprofenin)、异丙硝唑、异丙铂、盐酸异丙沙明、伊沙匹隆、厄贝沙坦、伊立替康、依沙星、依普拉酸、依舒拉汀、依替玛唑、依沙司坦、依沙索、伊斯博格雷、异帕米星、异苄唑、异丁苯、异卡巴肼、异康唑、异肾上腺素、异氟西汀、异氟哌酮乙酸酯、异氟烷、异氟磷酸盐、异高软海绵素B(isohomohalicondrinB)、异亮氨酸、盐酸异咪唑、盐酸异甲胺、异烟肼、碘化异丙酰胺、异丙醇、异丙基乌诺前列酮、盐酸异丙肾上腺素、异山梨醇、单硝酸异山梨醇酯、异替喹胺、异维甲酸、伊索克酸、异昔康、盐酸异舒普林、伊拉地平、依他美林、依他司琼、依他格雷、伊托必利、伊曲康唑、伊维菌素、伊沙匹隆、茉莉内酯、杰美沙星、杰索匹隆、交沙霉素、卡哈拉莱F(kahalalide F)、卡拉芬净(Kalafungin)、硫酸卡那霉素(KanamycinSulfate)、氯胺酮(ketamine)、酮色林(Ketanserin)、酮唑嗪(Ketazocine)、酮唑仑(Ketazolam)、酮噻草胺(Kethoxal)、富马酸酮替帕明(Ketipramine Fumarate)、酮康唑(Ketoconazole)、酮洛芬(Ketoprofen)、酮醇(Ketorfanol)、酮咯酸(ketorolac)、富马酸酮替芬(Fumarate)、吉他霉素(Kitasamycin)、盐酸拉贝洛尔、拉西地平、拉西地平、拉克替醇、拉克维菌素、乳糖酸盐、拉奈克、拉呋替丁、1-α羟基维生素D2、三乙酸片螺素-N酯、拉米夫定、拉莫三嗪、拉诺康唑、拉诺辛、兰吡立松、兰瑞肽、乙酸兰瑞肽(lanreotide acetate)、兰索拉唑、拉帕替尼、拉罗皮兰、拉坦前列素、侧生赤霉素(lateritin)、月桂氮酮、月桂基异喹啉氮鎓溴化物、琥珀酸拉伏替丁、拉扎贝胺、来西贝特、羊毛霉素(leinamycin)、来米地平、来明拉唑、来那西普、来尼喹新、来格司亭、仑哌隆、硫酸香菇多糖、莱普亭(leptin)、莱普妥斯新(leptolstatin)、乐卡地平、麦角腈、来立司琼、盐酸乙胺噁嗪酮、来曲珠利、来曲唑、亮氨酸、白霉素(leucomyzin)、亮丙瑞林、醋酸亮丙瑞林、亮丙瑞林、左沙丁胺醇、琥珀酸左安非他明、左旋咪唑、乳糖酸左多巴酚丁胺、左罗卡林、左乙拉西坦、左环丝氨酸、左旋倍他洛尔、左旋布比卡因、左旋卡巴斯汀、左旋肉碱、左旋西替利嗪、左旋西替利嗪二盐酸盐、左旋多巴、左旋羟丙哌嗪、左旋氧氟沙星、左旋呋喃它酮、左旋亚叶酸钙、醋酸左旋美沙啶、盐酸左旋美沙啶、左旋莫普洛尔、盐酸左旋南曲多、左旋去甲肾上腺素、左炔诺孕酮、萘磺酸左丙氧芬、左旋苯氧丙基青霉素钾、左美洛昔芬、酒石酸左啡诺、左西孟旦、左舒必利、左旋甲状腺素、左甲状腺素钠、盐酸左沙屈尔、来昔帕泛、来红霉素、利阿唑、赖苯普利、盐酸利达眯、利多卡因、利多芬、利多拉嗪、利法利嗪、利贝特、利非布洛、利那罗汀、林可霉素、利奈唑胺、利诺格列、利诺吡定、利诺曲班、林西多明、林曲普、林妥普利、碘甲腺原氨酸1-125、碘塞罗宁钠、复方甲状腺素(Liotrix)、利沙必利、二甲磺酸赖右苯丙胺、赖诺普利、赖脯胰岛素、利索克林酰胺(lissoclinamide)、硫酸利沙齐农、洛铂、氯苯扎利钠、洛布卡韦、洛卡酯葡甲胺(locarmate Meglumine)、碘卡葡胺、洛西他酸(locetamic Acid)、碘酰胺(lodamide)、氯德拉苯、碘地帕胺葡甲胺、碘地沙醇、碘安替比林I-131、碘胆固醇I-131、碘异丙基尿酸钠I-131、碘吡乙酸I-125、双碘喹啉、碘沙酸葡胺(IodoxamateMeglumine)、碘多沙胺、碘沙酸(Iodoxamie Acid)、盐酸洛非米唑、草酸洛芬太尼、盐酸洛非普胺、盐酸洛非他明I-123、盐酸洛非西定、洛格列酸、洛格列醇、洛格列胺、马钱子酸(loglycamic Acid)、洛格拉米(logulamide)、洛己基(lohexyl)、蚯蚓磷脂、洛美沙星、洛美利嗪、氯米芬(lomethin)I-125、盐酸氯甲萘满满、洛美曲索、洛蒙真菌素、氯诺昔康、洛莫司丁、氯萘帕林、氯那唑酸、氯尼达明、洛帕胺醇(lopamidol)、洛帕酸(lopanoic Acid)、盐酸洛哌丁胺、苯丙酸酯(lophendylate)、洛匹那韦、氯丙酸(loprocemic Acid)、碘普罗酸、碘吡多醇、洛比酮(lopydone)、氯碳头孢、盐酸氯雷胺、氯雷他定、氯雷西泮、氯氨酯、盐酸氯卡胺、氯雷唑、氯雷纳多、氯丁脲、氯甲安定、氯诺昔康、氯诺昔康、洛他胺、洛扎酮、氯沙坦、氯沙坦钾、洛塞法酸、洛塞酸、洛沙酮、洛沙三酮、洛舒胺葡甲胺、盐酸洛舒拉嗪、洛舒美酸、洛他苏、氯替泼诺、洛托酸、洛索洛芬钠(lothalamate Sodium)、洛他拉酸、氯罗兰、洛托酸、洛伐他汀、洛韦索尔、洛韦酯、洛沙酸钠、洛沙酸葡甲胺、洛沙酸、洛沙平、洛索利滨、洛索三嗪酸(loxotrizoicAcid)、芦贝鲁唑、盐酸甲硫恩酮、鲁非罗尼、甲磺酸卢罗司琼、勒托替康、镥、乙酸黄体瑞林、卢辛唑(luzindole)、阿朴酸钠、氨棕已胺、利迪卡霉素(lydicamycin)、利迪霉素、利奈孕酮、赖氨加压素、赖氨酸、利索茶碱(lysofylline)、溶葡球菌酶、马度米星、磺胺米隆、麦地宁2酰胺、水杨酸镁、硫酸镁、木兰醇、美坦辛、马来他姆、锦葵皂苷(mallotoaponin)、野梧桐色原烯、马洛替酯、马洛替酯、锰福地吡(mangafodipir)、马尼地平、马尼瓦霉素A、甘露醇、甘露糖抑制素A、手霉素E、手霉素F、马匹斯汀、马普替林、马拉维罗、马利马司他、屈大麻酚(Marinol)、马索罗酚(Masoprocol)、丝抑蛋白(maspin)、马斯托利德(massetolide)、美登素、琥珀酸马扎哌汀、马吲哚、甲苯咪唑、盐酸美贝维林、美布洛芬、美布他酯、盐酸美加明、盐酸氮芥、盐酸美克力嗪、甲氯环素、甲氯芬酸钠、甲氯喹啉酸、甲氯松二丁酸酯、盐酸美达西泮、甲羟孕酮、甲羟孕酮、甲羟孕酮、甲羟孕酮、盐酸美利嗪、甲芬那酸、甲芬尼地尔、盐酸甲芬诺酯、甲氧胺、盐酸甲氟喹、甲氟脲苷、磷酸甲洛米星钾、醋酸甲地孕酮、葡甲胺、甲路托、醋酸美仑孕酮、美洛昔康、美法仑、美金刚、盐酸美莫汀、盐酸甲萘胺、美诺通、美诺加林、美诺托品、硫酸美苯汀、美帕霉素、溴化美苯甲酯、盐酸哌替啶、硫酸美芬特明、美苯偶姻、甲氧苄氨嘧啶、盐酸甲哌卡因、甲丙氨酯、盐酸美普他酚、美喹多克斯、美来林钠、美巴龙、巯基嘌呤、氯化亚汞、美索洛普、美罗培南、美沙拉嗪、美沙拉嗪、美司他嗪、美司特龙、美司曲诺、盐酸美苏普林、盐酸美他洛尔、氯苯吡醇胺奥西那林(Metaproterenol Polistirex)、重酒石酸间羟胺、美他沙酮、甲烯前列素、米非司酮(meterelin)、甲福明、氯醋甲胆碱、美他环素、美沙酮、醋酸甲脒、甲硫噻嗪、盐酸甲基苯丙胺、甲喹酮、醋甲唑胺、甲地拉嗪、乌洛托品、醋酸乌洛托品、乌洛托品、甲氧西林钠、甲巯咪唑、甲硫氨酸酶、甲硫氨酸、甲硫沙宗、盐酸甲硫沙酮、美索巴莫、美索比妥钠、甲福林、甲氨蝶呤、甲氨喋呤、甲氧沙酮、甲氧基聚乙二醇-依泊汀β、甲氧氟醚、甲氧肟胺、甲基氯噻嗪、甲基棕榈酸甲酯、甲基硝酸阿托品、甲基苄乙氯铵、甲基多巴、甲基多巴盐酸盐、亚甲蓝、马来酸甲基麦角新碱、甲基组胺、甲基肌苷一磷酸酯、哌醋甲酯、甲基强的松龙、甲基睾丸酮、二乙酸甲炔二醇酯、马来酸甲地尔酯、马来酸甲地尔酯、甲地酰胺、甲地平、甲地普利姆、甲地帕胺、甲地普洛尔、盐酸甲地唑啉、醋酸美托咪酯、甲氧氯普胺、碘化甲氧苄氨嘧啶、美托唑酮、美托吡嗪、美托普林、美托洛尔、酒石酸美托洛尔、美托嗪、甲硝呋酯、甲硝咪唑、甲硝哒唑钠、甲硝唑、甲脲地帕、美吡酮、甲羟色胺、盐酸美西律、甲羟戊酸钾、美洛西林、盐酸米安色林、米贝拉地尔、盐酸米贝拉地尔、米波隆、米歇尔胺B、咪康唑、微可林A、咪达氟、盐酸咪达唑仑、米多君、米非司酮、米夫贝特、米格列醇、米拉西胺、米拉美林、米屈肼、米仑哌酮、米立哌汀、米那普仑、米力农、米替福新、盐酸咪康唑、米那普林、米纳索龙、米诺环素、米诺环素、盐酸米诺环素、米诺地尔、盐酸米夫拉嗪、米考霉素、米普拉苷、米芬太尼、米立司亭、盐酸米林可霉素、马来酸米立司琼、米氮平、米索硝唑、米索前列醇、米丁度胺、米托卡星(Mitocarcin)、丝裂红素、米托洁林、米托胍腙、二溴卫矛醇、米托马星、丝裂霉素、丝裂萘酯、丝裂霉素、米托坦、米托蒽醌、氯化米瓦库铵、米伐泽罗、米沙普利、米西丁、咪唑斯汀、咪唑立宾、吗氯贝胺、莫达非尼、硫酸莫达林、莫地卡胺、莫昔普利、莫法罗汀、盐酸莫法吉兰、莫非唑拉克、莫格莫司汀、吗那宗、盐酸吗林酮、吗西多明、莫米松、马来酸莫那匹尔、莫能菌素、单辛精(Monoctanoin)、孟鲁司特、孟鲁司特钠、蒙特瑞林、莫匹达莫、莫拉西嗪、酒石酸莫兰泰尔、莫里西嗪、莫尼氟酸、吗啡、鱼肝油酸钠、莫沙帕明、莫沙必利、莫蒂利特(motilide)、莫维胺、拉氧头孢钠、莫沙佐辛、莫西沙星、莫西沙林、莫西沙唑、莫索尼定、腮腺炎皮肤试验抗原、莫唑林、马槟榔氧化物B、霉酚酸酯、霉酚酸、肉豆蔻酮(myriaporone)、大麻折尼、纳比隆、盐酸纳比坦、盐酸纳辛酸酯、萘丁美酮、N-乙酰地那林、那地得、那氟沙星、那洛尔、那屈肝素钙、那法曲替、那莫司他、萘法瑞林、萘夫西林钠、萘芬诺平、盐酸萘咪啶酮、萘福科特、苹果酸萘福明、盐酸萘福定、草酸萘福酯、盐酸萘替芬、萘哌地尔、那格列钒、纳吉斯蒂普(nagrestip)、盐酸纳布啡、萘啶酸钠、萘啶酸、纳美芬、盐酸纳美索恩、纳洛酮、纳曲酮、纳莫西酸、苯丙酸诺龙、盐酸南曲多、盐酸纳帕他定、纳帕地酸、盐酸纳帕美唑、纳帕维因、盐酸萘甲唑啉、萘普生、萘普生钠、萘普索、奈沙加群、盐酸萘喃吡醇、那拉霉素、那拉曲坦、纳托格司汀、纳沙普酶、那他珠单抗、那他霉素、那他普酶、盐酸纳沙高利特、奈必洛尔、尼布拉霉素、奈达铂、奈多罗米、盐酸奈法唑酮、盐酸奈氟齐特、盐酸奈福泮、马来酸奈勒扎林、盐酸奈莫唑林、奈莫柔比星、新霉素棕榈酸酯、溴化新斯的明、奈立膦酸、硫酸奈替米星、中性霉素、盐酸奈韦拉平奈哌齐(Nevirapin Nexeridine Hydrochloride)、尼克酸(Niacin)、硝溴生、盐酸尼卡地平、尼麦角林、灭绦灵、尼可地尔、尼克酰胺、烟醇、硝苯地平、硝呋米隆、硝呋啶、硝呋啶、硝呋地宗、硝呋太尔、硝呋太隆、硝呋达齐、硝呋酰胺、硝呋匹林醇、硝呋喹唑、硝呋噻唑、硝呋替莫、尼罗替尼、盐酸尼洛替尼一水合物、尼鲁米特、尼伐地平、尼氮酮、尼莫地平、尼泊罗定、尼拉沃林、尼利达唑、尼沙霉素、尼布替罗甲磺酸酯、尼辛、尼索地平、尼索西汀醋酸酯、硝唑尼特、硝唑尼特、尼特卡朋、盐酸硝普钠、盐酸硝胺、盐酸硝咪唑、硝西泮、尼群地平、硝基胞苷、硝基丹、呋喃妥因、呋喃西林、硝酸甘油、硝基甲苯、硝柳胺、枸橼酸硝米芬、一氧化二氮、硝基氧抗氧化剂、尼图林(nitrullyn)、尼伐可醇、双甲硝茚酮钠、尼扎替丁、诺贝拉汀、诺考达唑、诺加拉霉素、诺利溴铵、马来酸诺米芬辛、盐酸去甲乙酰甲羟孕酮、去甲肾上腺素重酒石酸盐、炔诺酮、去甲炔诺酮、诺氟拉、诺氟沙星、诺孕酯、炔诺孕酮、去甲炔诺酮、盐酸去甲替林、诺斯卡品、新生霉素尼尔雌醇、制霉菌素、双复磷、奥卡哌酮、盐酸奥芬太尼、奥西普隆、辛酸、奥他酰胺、盐酸奥替尼啶、二甲己胺、奥曲肽、磷酸奥克替林、氧氟沙星、奥福明(Ofornine)、奥克森酮(okicenone)、奥氮平、奥美沙坦、奥美沙坦酯、奥洛他定、盐酸奥洛他定、奥普利侬、奥沙拉嗪、奥沙拉嗪钠、奥瓦尼、奥马珠单抗、ω-3酸乙酯、奥美拉唑、奥那司酮、昂丹司琼、昂他唑司特、卵母细胞盐酸奥匹普拉莫、奥拉辛、硝酸奥康唑、奥格汀、奥利司他、奥玛铂、奥美定、奥硝唑、奥潘诺辛、奥芬那君、奥司他林、奥司他韦、奥坦泽帕德、苯唑西林钠、奥格雷酯、奥沙利铂、盐酸奥沙马林、奥沙米唑、奥沙姆尼喹、奥雄多隆、双羟萘酸奥桑特、盐酸奥沙普汀、奥沙普秦、奥沙巴唑、奥沙托咪、奥沙霉素、奥沙西泮、奥卡西平、奥塞隆、奥沙吖嗪、富马酸奥塞托隆、奥芬达唑、奥芬尼辛、奥苯达唑、奥昔康唑、奥昔帕明、奥昔膦酸、盐酸奥昔芬净、奥昔啡烷、肟莫南、肟莫南钠、奥哌咪酮、奥拉西坦、奥昔拉米、奥昔舒仑、盐酸奥美替丁、奥索地平、氧孕酮苯丙酸酯(OxogestonePhenopropionate)、氧喹酸、盐酸氧普洛尔、氧三茶碱、盐酸奥昔布宁、羟氯生、羟考酮、盐酸羟考酮、盐酸羟甲唑啉、羟甲吗啡酮、盐酸羟吗啡酮、奥昔普汀、羟苯丁酮、氧嘌呤醇、土霉素、催产素、奥扎格雷、奥兹利酮、紫杉醇、帕劳胺、帕尔地霉素、帕利那韦、帕利单抗、棕榈酰利佐辛、帕莫西酸钠、帕胺喹赛得、硫酸帕他洛尔、帕米格雷、帕米膦酸二钠、帕米膦酸、帕那普隆、帕那美新、人参三醇、泮考必利、泮库溴铵、帕尼培南、帕诺林(pannorin)、帕诺米芬、泛硫乙胺、泮托拉唑、盐酸罂粟碱、帕拉肌动蛋白、扑热息痛、对氯苯酚、三聚乙醛、醋酸对氨基米松、盐酸帕拉宁、溴化帕拉朋唑、双羟萘酸副玫瑰苯胺、帕苯达唑、盐酸帕康唑、帕雷戈酸、硫酸帕瑞肽、盐酸帕吉兰、帕那帕林钠、硫酸巴龙霉素、帕罗西汀、盐酸帕罗西汀、小白菊内酯、帕曲星、保洛霉素、泊泽尼普定(pazelliptine)、帕秦克隆、帕佐昔特、帕珠沙星、培氟沙星、培门冬酶、培戈汀、聚乙二醇干扰素α-2a、盐酸培兰色林、佩尔德辛(peldesine)、佩利奥米西佩雷汀(Peliomycipelretin)、盐酸培利酮、培美酸、五甲哌丙胺、培美曲塞、吡嘧司特、匹莫林、醋甲西林、硫酸喷布洛尔、喷昔洛韦、五氟利多、青霉胺、青霉素G苄星、青霉素G钾、青霉素G普鲁卡因、青霉素G钠、青霉素V肼屈嗪、青霉素V苄星、青霉素V钾、五氨酯、季戊四醇四硝酸酯、五夫苷、五脒、五吗啡酮、喷他莫司汀、甲基硫酸喷他哌啶、喷他佐辛、喷替酸、马来酸喷替平、喷替肽、喷替米星、喷替西酮钠、戊巴比妥、戊托酮、喷妥普利、戊聚糖、喷司他丁、己酮可可碱、戊替尼醇、戊曲唑、硫酸喷普霉素、喷司他丁、全氟吡酮、杠板归、杠板归、培高利特、马来酸哌己林、培里烯醇、培哚普利、培哚普利拉、氯菊酯、哌罗螺酮、奋乃静、非那胺、非那定、吩嗪霉素、盐酸非那吡啶、苯丁氮酮甘油酸钠、苯脲、盐酸苯环利定、酒石酸苯二甲肼、硫酸苯乙肼、苯乙双胍、盐酸苯甲肼、苯巴比妥、盐酸苯氧苄胺、苯丙香豆素、苯丝氨酸、苯琥珀醛、苯磺酰亚胺、苯特明、盐酸苯特明、甲磺酸酚妥拉明、苯羟茶碱、苯基氨基水杨酸盐、乙酸苯酯、苯丙氨酸、苯丙氨康唑、保泰松、盐酸去氧肾上腺素、盐酸苯丙醇胺、苯丙醇胺聚苯乙烯树脂(Phenylpropanolamine Polistirex)、盐酸非尼拉朵、苯妥英(Phenyloin)、苯妥英钠、毒扁豆碱、哌西那朵、毕西巴尼、三甲苯吡酸二乙醇胺(PicotrinDiolamine)、皮克洛夫(picroliv)、吡库特罗、匹多莫德、匹法明(Pifamine)、匹鲁卡品、吡西卡胺(pilsicamide)、匹马吉定、盐酸匹美汀、匹米前列素、匹莫苯丹、匹莫齐特、吡那地尔、泊来多林、匹多洛尔、匹嫩醇、匹诺伞素、盐酸匹诺昔平、吡格列酮、吡帕隆、哌哌酯、哌库溴铵、哌嗪、哌拉西林、哌拉西林钠、马来酸哌嗪、哌嗪、匹泊罗曼、匹泊磺凡、匹泊噻嗪棕榈酸酯、盐酸匹泊索兰、匹普唑林、盐酸匹喹酮、盐酸匹奎齐、吡拉西坦、盐酸吡兰达明、吡柔比星、吡兹莫南钠、吡唑酸、吡苄西林钠、醋酸吡布特罗、哌仑哌酮、盐酸哌仑西平、哌雷他尼、吡非尼酮、吡地西林钠、吡屈膦酸钠、吡前列素、吡曲西姆、盐酸吡利霉素、吡林多、吡马格雷、盐酸吡美诺、吡那滨、吡罗克酮、吡罗达韦、吡罗司特、酒石酸吡格列、吡罗酯、吡罗酰胺、盐酸吡罗蒽醌、吡罗昔康、吡罗昔酮、吡洛芬、吡喹唑、吡司多明、盐酸匹氨苄青霉素、匹伏普利、苯噻啶、胎盘素A(placetin A)、普卡霉素、普洛美坦、泊比司特乙二胺(Pobilukast Edamine)、普达非洛、太平洋漆树提取物、甲硫酸波尔定、壳聚糖、泊利涅酸钠(Polignate Sodium)、硫酸多粘菌素B、泊利噻嗪、泊那利司他、泊菲莫钠、泊菲霉素、氯化钾、碘化钾、高锰酸钾、聚维酮碘、普洛尔、氯解磷定、普拉克索、盐酸普拉西坦、盐酸普拉莫辛、普拉氯铵、马来酸普拉多林、普伐他汀、普伐他汀钠、普拉西泮、哌唑嗪、盐酸哌唑嗪、普那肼、普尼卡巴特、泼尼莫司汀、泼尼松龙、富马酸泼尼松龙喹硫平、强的松、泼尼松龙戊酸酯、普瑞巴林、琥珀酸孕烯醇酮、盐酸普瑞特罗、普尼拉明、盐酸普立地芬、普利酮、盐酸普利洛林、吡洛赛克、磷酸伯氨喹、普利米洛尔、普利米酮、普利尼维尔、普利诺米特氨丁三醇、普利诺沙丹、普利托沙星、盐酸丙咪嗪、盐酸丙地芬、丙磺舒、丙咪嗪钙、普罗布考、盐酸普鲁卡因胺、盐酸普鲁卡因、盐酸普鲁卡因、盐酸丙卡特罗、丙氯拉嗪、丙咪嗪、丙氯诺、盐酸酸丙氯拉嗪、盐酸普地利定、普罗度酸、盐酸普罗法朵、普罗加比、黄体酮、丙谷胺、胰岛素原(人)、脯氨酸、盐酸脯氨酸、盐酸丙嗪、异丙嗪、盐酸异丙嗪、盐酸普罗帕酮、丙帕锗、普尔安、溴丙胺太林、盐酸丙哌卡因、硝酸丙戊酯、丙戊茶碱、盐酸丙苯甲酸酯、丙哌卡因、丙丙丙嗪、丙酸、丙酰肉碱、丙吡胺、丙吡胺、丙哌维林、丙泊酚、盐酸丙酚醇、盐酸丙氧卡因、盐酸丙氧芬、盐酸普萘洛尔、丙硫胺、丙基双吖啶酮、丙基己啶、丙基碘酮、丙基硫氧嘧啶、普罗喹宗、丙利酸钾、盐酸内咯噁烷、海葱次苷、前列他林、蔓生素(prostratin)、硫酸鱼精蛋白、普罗泰格素(protegrin)、普罗瑞林、盐酸曲替林、丙吡唑、枸橼酸丙吡唑、丙咪嗪、酒石酸丙沙芬、普卢利沙星、伪麻黄碱、盐酸伪麻黄碱、嘌呤霉素、吡溴铵、双羟萘酸噻嘧啶、吡嗪酰胺、吡唑并呋喃、吡唑并吖啶、吡啶斯的明溴化物、盐酸吡哆醇、马来酸吡拉明、乙胺嘧啶、吡唑啉、吡啶硫酮钠、吡啶硫酮锌、盐酸焦戊酮、马来酸吡肟、吡咯卡因、盐酸吡咯烷酮、吡咯硝酮、双羟萘酸吡维铵、甲磺酸夸达佐辛(QuadazocineMesylate)、夸西泮(Quazepam)、喹齐酮(Quazinone)、夸唑定(Quazodine)、喹唑司特(Quazolast)、奎硫平(quetiapine)、富马酸喹硫平(quetiapine fumarate)、喹夫拉朋(quiflapon)、喹高利特(quinagolide)、喹那定蓝(Quinaldine Blue)、喹那普利(quinapril)、盐酸喹那普利(Quinapril hydrochloride)、盐酸喹唑嗪(Quinazosin Hydrochloride)、奎勃龙(Quinbolone)、喹他酯(Quinctolate)、乙酸喹地卡明(Quindecamine Acetate)、喹度溴铵(Quindonium Bromide)、盐酸喹洛雷(Quinelorane Hydrochloride)、炔雌醚(Quinestrol)、喹法米特(Quinfamide)、乙酸奎孕醇(Quingestanol Acetate)、奎孕酮(Quingestrone)、葡萄糖酸奎尼丁(QuinidineGluconate)、盐酸喹洛雷(QuinieloraneHydrochloride)、硫酸奎宁(Quinine Sulfate)、盐酸喹吡罗(Quinpirole Hydrochloride)、硫酸喹丙那林(Quinterenol Sulfate)、奎纽溴铵(Quinuclium Bromide)、奎奴普丁(Quinupristin)、马来酸喹哌嗪(Quipazine Maleate)、雷贝拉唑、雷贝拉唑钠、消旋酚、消旋肾上腺素、雷复尼特、雷洛昔芬、雷替格拉韦、雷替曲塞、拉马曲班、雷米普利、雷莫拉宁、雷莫司琼、雷奈酸、雷尼替丁、雷尼替丁、盐酸雷尼替丁、雷诺嗪、蛇萝芙木、雷卡那姆、盐酸雷卡那姆、雷卡西泮、重组因子VIII、瑞加韦单抗、瑞拉司亭、松弛素、雷洛霉素、盐酸瑞马米、盐酸瑞芬太尼、瑞前列醇、瑞莫必利、雷匹司特、雷莫霉素、盐酸雷复特罗、利血平、树脂增殖毒素、间苯二酚、瑞他帕林、去甲基化的瑞替利汀、网织红细胞、瑞复肝素钠、瑞复嗪酮、铼依替膦酸盐、根霉素、RI维他胺(retinamide)、利巴米诺、利巴韦林、利波腺苷、利卡司琼、利多格雷、利福布汀、利福美坦、利福美昔、利福酰胺、利福平、利福喷丁、利福昔明、利洛普司、利鲁唑、金刚乙胺、盐酸利马卡唑、利美索龙、氢溴酸利米特罗、利莫那班、利莫洛金、里奥地平、里奥前列素、利帕西泮、利匹沙坦、利塞膦酸盐、利塞膦酸钠、利塞膦酸、利什卡因、盐酸利什替利、利培酮、利培酮、利坦色林、瑞替培南、利托君、利托卢卡司特、利托那韦、利妥昔单抗、利伐斯汀、酒石酸利伐斯汀、利扎曲普坦、苯甲酸利扎曲普坦、盐酸罗卡斯特、罗库溴铵、罗多卡因、罗氟醚、罗格列胺、罗西替金、罗他霉素、罗塔米得(Roletamicide)、罗加米定、罗利普令、咯利普兰、罗利环素、罗咯定、氯马扎利、罗莫肽、罗硝唑、罗匹尼罗、盐酸罗匹妥英、罗哌卡因、罗匹嗪、罗喹美克、罗沙米星、罗格列酮、马来酸罗格列酮、罗索沙星、罗素伐他汀、轮状病毒疫苗、罗替戈汀、罗托沙敏、罗沙替丁(roxaitidine)、洛克沙砷、罗克吲哚、罗红霉素、鲁比津酮(rubiginone)B1、卢布氧基(ruboxyl)、芦氟沙星、卢帕他定(rupatidine)、芦他霉素、卢扎朵仑、沙丁胺醇、沙芬醇、沙丁胺醇、硫酸沙丁胺醇、柳胆来司、马来酸沙乙酰胺(SalethamideMaleate)、水杨醇、水杨酰胺、水杨酸葡甲胺、水杨酸、沙美特罗、沙那西定(Salnacediin)、水杨酰水杨酸、沙美利定、山帕曲拉、山环素、山费培南、氯化血根碱、沙培康唑、沙培沙坦、沙培林、二盐酸沙培林、沙奎那韦、盐酸沙拉沙星、乙酸沙拉新、肌肉叶绿醇A、沙格司亭、沙莫西林、沙匹西林、沙波格来、沙芦普酶、沙特力农、沙替格雷、沙妥莫单抗(satumomab pendetide)、司可芬净、氢溴酸东茛菪碱、盐酸司库扎平、西卡佛醇、西科巴比妥、硫唑酮、西吉兰、醋酸西格利特、盐酸司来吉兰、硫化硒、硒代蛋氨酸Se-75、赛福太、司美利特、生度米星、司莫地尔、司莫司汀、氯化赛帕松(SepazoniumChloride)、盐酸氯氟哌醇、司普立糖、盐酸塞罗西汀、乙酸丝拉克肽、马来酸麦角克索、丝氨酸、舍美他辛、醋酸舍莫瑞林、舍他康唑、舍吲哚、舍曲林、盐酸舍曲林、S-乙炔基尿嘧啶、塞替替林、司托哌隆、司维拉姆、司韦单抗、七氟烷、司佐胺、西波吡啶、盐酸西布曲明、硅雄酮、西地那非、枸橼酸西地那非、水飞蓟素(silipide)、西替普酶、硝酸银、西孟坦、辛曲秦、辛伐他汀、辛卡利特、西奈芬净、西硝地尔、辛纳比多尔(sinnabidol)、西帕曲近、西罗莫司、西索米星、西他列汀、西托糖苷、西佐喃(sizofuran)、索布佐生、淀粉硫酸钠、碘化钠I-123、硝普钠、羟丁酸钠、苯乙酸钠、水杨酸钠、丙戊酸钠、索利那新、索尔沃尔(solverol)、酒石酸索立哌汀、猪丙氨生长素、盐酸索金刚胺、生长调节素B、生长调节素C、生长激素抑制素、人蛋氨生长素、生长激素、猪诺生长素、牛度生长素、山梨糖醇、索里夫定、索他洛尔、盐酸索替瑞诺、司帕沙星、磷甲酸钠、磷磺酸、司帕索米、硫酸鹰爪豆碱、盐酸大观霉素、香料霉素D、司哌隆、甲磺酸螺旋多林、螺旋霉素、螺旋普利盐酸盐、螺旋普利拉、螺旋锗盐酸盐、螺内酯、螺内酯、螺铂、螺松、脾喷丁、海绵抑制素、镝双胺、角鲨胺、盐酸司他霉素、焦磷酸亚锡、硫胶体亚锡、司坦唑醇、司他托龙、星形孢菌素、司他夫定、斯替夫霉素、醋酸司他博龙、司替罗宁、碘化斯替巴嗪、司洛碘铵、针茅酰胺(stipiamide)、司替戊醇、斯托巴丁(stobadine)、硫酸链霉素、链霉素异烟肼、链霉黑素、链脲菌素、氯化锶Sr-89、苏西本(succibun)、琥巯酸、氯化琥珀胆碱、硫糖铝、硫糖钾酯、舒多昔康、舒芬太尼、苏福替定、硫西泮、舒巴坦匹酯、硝酸硫康唑、磺胺苯、磺胺苯甲酰胺、磺胺醋酰、磺胺嘧啶、磺胺嘧啶、磺胺多辛、磺胺林、磺胺甲嘧啶、磺胺二甲嘧啶、磺胺二甲嘧啶、磺胺甲噁唑、磺胺甲噁唑、磺胺间甲氧嘧啶、磺胺甲氧嘧啶、磺胺酸锌、磺胺硝氮、柳氮磺吡啶、磺胺嘧啶、磺胺甲氧嘧啶、盐酸磺胺甲氧嘧啶、磺肌苷、磺吡酮、磺异噁唑、磺甲噁唑、磺霉素、盐酸磺特罗、磺肟、舒林酸、舒马林、舒尼达唑、舒洛地尔、舒洛芬、舒洛培南、舒洛昔芬草酸盐、舒必利、舒前列酮、舒他西林、舒硫乙胺、舒妥普利、舒鲁司特、舒马汀、舒马曲坦、舒马曲坦琥珀酸盐、阳光西林钠、舒洛龙、舒洛芬、苏拉地他、苏拉明、舒福姆、马来酸舒里卡胺、舒利托唑、马来酸舒罗纳克林、硫酸舒利美、苦马豆素、西马卡林、三氯异氰尿酸、盐酸西咪替丁、盐酸他胺、盐酸他克林、他克莫司、他达拉非、盐酸他氨苄青霉素、他拉醇、他立霉素、他利莫司汀、他美辛、他尼氟酸、盐酸他奥普拉姆、他洛沙酯、盐酸他美他林、他莫西芬、枸橼酸他莫西芬、富马酸他帕明、坦洛新、盐酸坦洛新、盐酸坦达明、坦度螺酮、泰普根、他前列汀、他索沙坦、陶洛司汀、紫杉烷、紫杉烷类、琥珀酸他唑林、他扎司特、他扎罗汀、盐酸他齐福林、他唑巴坦、他唑芬龙、盐酸他唑洛尔、特布非龙、替布喹、替克洛占、替可加兰钠、替西白介素(Teecleukin)、替氟烷、喃氟啶、替加色罗、得理多、替考拉宁、替仑西平、碲吡啶鎓(tellurapyrylium)、替美司坦、替米沙坦、盐酸替洛蒽醌、盐酸替鲁地平、盐酸替马沙星、甲基硫酸艾马托品(Tematropium Methyl sulfate)、羟基安定、替美斯汀、替莫普利、替莫西林、替莫泊芬、替莫唑胺、替西罗莫司、替尼达普、替尼泊苷、替诺福韦、替诺沙、替诺昔康、替匹林多、替泊沙林、替普瑞特、特拉唑嗪、盐酸特拉唑嗪、特比萘芬、硫酸特布他林、特康唑、特非那定、特拉伏沙(terfiavoxate)、特格列德、特立帕肽、醋酸特立帕肽、特拉基伦、特利加压素、特罗地林、盐酸特罗沙林、特罗昔龙、特他洛尔、泰西康、泰西亚胺、睾丸酮、睾酮、丁卡因、四氯十氧化物、四环素、盐酸四环素、盐酸四氢唑啉、盐酸四咪唑、葡胺四唑司特、四唑胺(tetrazomine)、替曲膦、四羟醌、四氧普林、四氢甲吲胺、唐松青碱(thaliblastine)、沙利度胺、羟乙茶碱安妥明(Theofibrate)、茶碱、噻苯达唑、甲砜霉素、甲砜霉素、甲砜霉素、盐酸噻嗪西姆、氯化噻嗪胺、硫乙基哌嗪、替沃噻吨(Thiithixene)、硫汞苯磺钠、硫汞撒、噻可拉林(thiocoraline)、硫代麻黄碱(thiofedrine)、硫鸟嘌呤、噻马林醇(thiomarinol)、硫喷妥钠、噻普酰胺、硫利达嗪、噻替派、盐酸双苯乙硫酯、噻吩青霉素钾(ThiphencillinPotassium)、福美双、托扎啉酮、苏氨酸、凝血酶、血小板生成素、胸腺法新、胸腺五肽、胸腺三肽、盐酸甲状腺素、甲状腺素、噻克司特、噻克司特钠、噻加滨、替米啶、噻奈普汀、噻帕芬、盐酸噻帕米、盐酸噻拉米、噻唑呋林、替比司特钠、替勃龙、替布酸、替贝松丙酸酯、替卡博定、替卡西林甲酚钠、噻氯匹定、噻氯萘芬、替诺洛尔、替呋脲钠、替格氨双胆碱、替雌醇、盐酸替来他明、盐酸替利定、替利索罗、替诺罗苄美、盐酸替洛龙、替鲁膦酸二钠、替路膦酸、替米呋酮、醋酸噻吗布松、噻吗洛尔、噻吗洛尔马来酸盐、替比诺、替硝唑、替扎肝素钠、噻康唑、噻达唑嗪、噻多氯铵、盐酸噻哌酮、噻哌酸、盐酸噻螺酮、噻替丁、噻托铵、噻托溴铵、噻西唑、盐酸替喷托辛、替普拉那韦、替普瑞丹、盐酸替普瑞洛尔、替普那司特葡甲胺、盐酸替罗地尔、替奎赛德、盐酸替喹酰胺、替兰地啶、替拉扎明、替拉扎德、替罗非班、替罗帕胺、二氯化二茂钛、替沙诺、新戊酸替索考醇酯、盐酸替扎尼定、盐酸甲苄胺、妥布霉素、妥卡胺、妥康贝、盐酸托非那星、妥拉洛尔、妥拉唑胺、盐酸妥拉唑林、甲苯磺丁脲、托卡朋、托西酸盐、托法米得、托加比得、托利米酮、托林酸盐、托美汀、托萘酯、托聚维酮、托吡酰胺、托勒司他、托特罗定、托特罗定酒石酸盐、托姆鲁司特、盐酸托莫西汀、甲磺酸托纳佐辛、托吡酯、拓扑替康、盐酸拓扑替康、托普森汀、托普特龙、托喹嗪、托拉塞米、托瑞米芬、托塞米、托西芬、托舒沙星、全能干细胞因子(TSCF)、曲卡唑酯、特拉法明、曲拉奈德、曲马多、盐酸曲马多、盐酸曲马唑啉、群多普利、氨甲环酸、曲尼司特、转酰胺(Transcamide)、曲妥珠单抗、曲沙诺、盐酸曲唑酮、盐酸曲苯丁胺、盐酸曲芬太尼、曲洛西酸盐、马来酸曲西泮、醋酸曲斯托龙、维甲酸、三醋精、三乙酰尿苷、三芬净、曲安奈德、硫酸三唑嗪、氨苯蝶啶、三唑仑、三苄糖苷、三卡林、三乙酰胺、三氯甲叠氮、毛透明蛋白、曲西立滨、三硝酸酯(Tricitrate)、三氯酚哌嗪、三氯福司钠、曲恩汀、三苯格雷、三氟拉文(triflavin)、三氟洛辛、三氟巴占、三氟咪酯、三氟拉嗪盐酸盐、三氟哌利多、三氟丙嗪、三氟丙嗪盐酸盐、三氟尿苷、盐酸苯海索、三叶草烷、盐酸曲马唑嗪、曲美孕酮、酒石酸曲美普拉嗪、三甲双酮、甲氧苄啶、甲氧苄啶、曲美嗪、曲美曲塞、曲米帕明、曲莫前列醇、盐酸曲莫沙明、三油酸甘油酯、甲磺酸曲昔芬、曲帕酰胺、盐酸曲那明、盐酸曲普利啶、曲普瑞林、三硫酸嘧啶、三氯异氰尿酸钾、曲格列酮、三乙醇胺、三烯霉素、曲布地平、氨丁三醇、盐酸托潘色林、托吡卡胺、托品碱、托烷司琼、曲古霉素、曲伐沙星、曲呋啶、色氨酸、结核菌素、氯化筒箭毒碱、盐酸妥布氯唑、妥卡雷琐(tucarcsol)、妥洛特罗、妥罗雄脲、泰巴氨酯、泰乐菌素(tylogenin)、酪泮酸钠、酪氨酸、短杆菌素、酪氨酸磷酸化抑制剂(tyrphostin)、乌苯美司(ubenimex)、乌达西泮(Uldazepam)、十一碳烯酸(Undecylenic Acid)、尿嘧啶芥末(Uracil Mustard)、乌拉地尔(urapidil)、尿素(Urea)、脲地帕(Uredepa)、尿苷三磷酸(uridine triphosphate)、尿促卵泡素(Urofollitropin)、尿激酶(Urokinase)、熊去氧胆酸(Ursodiol)、伐昔洛韦(valaciclovir)、盐酸伐昔洛韦(Valacyclovir hydrochloride)、缬氨酸、戊诺酰胺(Valnoctamide)、丙戊酸半钠(Valproate semisodium)、丙戊酸、缬沙坦(valsartan)、伐米胺(vamicamide)、钒土(vanadeine)、万古霉素(Vancomycin)、缬美洛尔(vaminolol)、盐酸伐哌前列素(Vapiprost Hydrochloride)、伐普肽(Vapreotide)、伐地那非(Vardenafil)、瓦伦尼克林(Varenicline)、薇洛琳B(variolin B)、血管加压素、维库溴铵(VecuroniumBromide)、维拉雷琐(velaresol)、马来酸维吖啶(Velnacrine Maleate)、文拉法辛(venlafaxine)、盐酸文拉法辛(Venlafaxine hydrochloride)、盐酸维拉朵林(VeradolineHydrochloride)、藜芦胺(veramine)、盐酸维拉帕米(VerapamilHydrochloride)、维尔丁斯(verdins)、盐酸维立洛泮(Verilopam Hydrochloride)、维鲁司特(Verlukast)、维罗菲林(Verofylline)、维罗桑(veroxan)、维替泊芬(verteporfin)、维司力农(Vesnarinone)、甘草醇(vexibinol)、阿糖腺苷(Vidarabine)、维加巴因(vigabatrin)、维达列汀(vildagliptin)、盐酸维洛沙秦(Viloxazine Hydrochloride)、硫酸长春碱(VinblastineSulfate)、柠檬酸长春布明(vinburnine citrate)、乙烯福司(Vincofos)、长春考酯(vinconate)、硫酸长春新碱(Vincristine Sulfate)、长春地辛(Vindesine)、硫酸长春地辛(Vindesine Sulfate)、硫酸长春匹定(Vinepidine Sulfate)、硫酸长春甘酯(VinglycinateSulfate)、硫酸长春罗辛(Vinleurosine Sulfate)、长春瑞滨(vinorelbine)、长春西汀(vinpocetine)、长春培醇(vintoperol)、长春花碱(vinxaltine)、硫酸长春利定(VinzolidineSulfate)、维普罗斯托(Viprostol)、维及霉素(Virginiamycin)、绿黄菌素(Viridofulvin)、韦罗肟(Viroxime)、维他辛(vitaxin)、伏格列波糖(Voglibose)、伏拉佐辛(Volazocine)、伏立康唑(voriconazole)、伏氯唑(vorozole)、伏高利特(voxergolide)、华法林(Wafarin)、扎莫特罗、呫诺美林、异丙痒蒽酸钠、占替诺烟酸盐、珍米洛非班(xemiloflban)、联苯利平、联苯丁酸、希洛班(Xilobam)、希莫洛芬、希帕胺、甲磺酸佐尔啡诺、甲苯磺酸甲苯乙脒、盐酸赛拉嗪、盐酸赛洛唑啉、木糖醇、杨甘宾(yangambin)、扎比普利、扎考普利、扎鲁司特、扎西他滨、扎来普隆、扎罗螺酮、盐酸扎替丁、扎托普芬、扎那米韦、扎基伦、扎诺特龙、扎他克、扎鲁司特、扎替雷定、扎托司琼、马来酸扎托司琼、泽那司他、甲磺酸泽那辛、泽尼铂、折仑诺、齐多美辛、齐多夫定、齐罗硅酮、齐仑太尔、亚苄维C(zilascorb)、齐留通、盐酸齐美定、十一烯酸锌、嗪多群、盐酸齐诺康唑、净司他丁、盐酸苯丁磺喘宁、嗪维肟、齐拉西酮、佐波尔特、佐芬普利钙、佐芬普利拉、盐酸左拉明、盐酸左拉西泮、唑来膦酸、盐酸佐勒汀、佐米曲普坦、唑吡坦、佐美匹拉钠、佐美他平、盐酸佐尼克唑、唑尼沙胺、佐匹克隆、佐泊司他、佐巴霉素、盐酸佐柔比星、佐替平、珠卡赛辛以及其药学上可接受的盐。
在某些实施例中,基于剂型的总重量,软可咀嚼剂型可以包含范围为0.005%至80%(wt/wt)的活性成分。在某些实施例中,基于剂型的总重量,软可咀嚼剂型可以包含1%至50%(wt/wt)、5%至50%(wt/wt)、10%至50%(wt/wt)、15%至50%(wt/wt/)、20%至50%(wt/wt)、25%至50%(wt/wt)、30%至50%(wt/wt)、35%至50%(wt/wt)、40%至50%(wt/wt)、45%至50%(wt/wt)、1%至40%(wt/wt)、1%至35%(wt/wt)、1%至30%(wt/wt)、1%至25%(wt/wt)、1%至20%(wt/wt)、1%至15%(wt/wt)、1%至10%(wt/wt)、1%至5%(wt/wt)、10%至40%(wt/wt)、10%至30%(wt/wt)、10%至25%(wt/wt)、10%至20%(wt/wt)、10%至15%(wt/wt)、15%至30%(wt/wt)、15%至25%(wt/wt)或15%至20%(wt/wt)的活性成分。
在某些实施例中,对于每种活性成分,软可咀嚼剂型可以独立地提供每kg受试者0.001mg至1000mg,优选地每kg受试者0.01mg至100mg、更优选地每kg受试者0.1mg至50mg,并且甚至更优选地每kg受试者0.1mg至10mg的剂量。
在某些实施例中,对于每种活性成分,软可咀嚼剂型独立地包含0.01mg至1000mg活性成分,优选地0.1至500mg活性成分,更优选地0.5mg至100mg活性成分。
在优选的实施例中,软可咀嚼剂型包含活性成分的组合。在另一个优选的实施例中,软可咀嚼剂型包含异噁唑啉类杀寄生虫剂(例如,氟拉拉纳、阿福拉纳、沙罗拉纳或洛替拉纳)、大环内酯类杀寄生虫剂(例如,米尔贝肟、莫西菌素、多拉菌素或塞拉菌素)和吡嗪异喹啉类杀寄生虫剂(例如,吡喹酮)的组合。在另一个优选的实施例中,软可咀嚼剂型包含异噁唑啉类杀寄生虫剂(例如,氟拉拉纳、阿福拉纳、沙罗拉纳或洛替拉纳)、大环内酯类杀寄生虫剂(例如,米尔贝肟、莫西菌素、多拉菌素或塞拉菌素)和四氢嘧啶类杀寄生虫药(例如,双羟萘酸噻嘧啶、酒石酸噻嘧啶、酒石酸莫仑太尔或恩波酸奥克太尔)的组合。在另一个优选的实施例中,软可咀嚼剂型包含以下的组合:异噁唑啉类杀寄生虫剂(例如,氟拉拉纳、阿福拉纳、沙罗拉纳或洛替拉纳)、大环内酯类杀寄生虫剂(例如,米尔贝肟、莫西菌素或塞拉菌素)、吡嗪异喹啉类杀寄生虫剂(例如,吡喹酮)和四氢嘧啶类杀寄生虫剂(例如,双羟萘酸噻嘧啶、酒石酸噻嘧啶、酒石酸莫仑太尔或恩波酸奥克太尔)。
在又另一个优选的实施例中,软可咀嚼剂型包含洛替拉纳、莫西菌素和吡喹酮的组合。在又另一个优选的实施例中,软可咀嚼剂型包含洛替拉纳、莫西菌素、吡喹酮、噻嘧啶或其盐的组合。在又另一个优选的实施例中,软可咀嚼剂型包含沙罗拉纳、莫西菌素和噻嘧啶或其盐(例如,双羟萘酸噻嘧啶)的组合。在又另一个优选的实施例中,软可咀嚼剂型包含沙罗拉纳和塞拉菌素的组合。在又另一个优选的实施例中,软可咀嚼剂型包含氟拉拉纳和莫西菌素的组合。在又另一个优选的实施例中,软可咀嚼剂型包含阿福拉纳和米尔贝肟的组合。
在又另一个优选的实施例中,基于剂型的总重量,软可咀嚼剂型包含0.5%至25%(wt/wt)异噁唑啉(例如,洛替拉纳、沙罗拉纳、氟拉拉纳或阿福拉纳)、0.005%至1%(wt/wt)大环内酯(例如,莫西菌素、米尔贝肟、多拉菌素或塞拉菌素)和1%至10%(wt/wt)吡嗪异喹啉(例如,吡喹酮)的组合。
在又另一个优选的实施例中,软可咀嚼剂型提供了以下剂量:1mg/kg至100mg/kg异噁唑啉(例如,洛替拉纳、沙罗拉纳、氟拉拉纳或阿福拉纳)、0.001mg/kg至15mg/kg大环内酯(例如,莫西菌素、米尔贝肟、多拉菌素或塞拉菌素)和1mg/kg至100mg/kg吡嗪异喹啉(例如,吡喹酮)。
在又另一个优选的实施例中,基于剂型的总重量,软可咀嚼剂型包含0.5%至25%(wt/wt)异噁唑啉(例如,洛替拉纳、沙罗拉纳、氟拉拉纳或阿福拉纳)、0.005%至1%(wt/wt)大环内酯(例如,莫西菌素、米尔贝肟、多拉菌素或塞拉菌素)和5%至30%(wt/wt)四氢嘧啶(例如,双羟萘酸噻嘧啶、酒石酸噻嘧啶、酒石酸莫仑太尔或恩波酸奥克太尔)的组合。
在又另一个优选的实施例中,软可咀嚼剂型提供了以下剂量:1mg/kg至100mg/kg异噁唑啉(例如,洛替拉纳、沙罗拉纳、氟拉拉纳或阿福拉纳)、0.001mg/kg至15mg/kg大环内酯(例如,莫西菌素、米尔贝肟、多拉菌素或塞拉菌素)和1mg/kg至100mg/kg四氢嘧啶(例如,双羟萘酸噻嘧啶、酒石酸噻嘧啶、酒石酸莫仑太尔或恩波酸奥克太尔)。
在又另一个优选的实施例中,基于剂型的总重量,软可咀嚼剂型包含0.5%至25%(wt/wt)异噁唑啉(例如,洛替拉纳、沙罗拉纳、氟拉拉纳或阿福拉纳)、0.005%至1%(wt/wt)大环内酯(例如,莫西菌素、米尔贝肟、多拉菌素或塞拉菌素)、1%至10%(wt/wt)吡嗪异喹啉(例如,吡喹酮)和5%至30%(wt/wt)四氢嘧啶(例如,双羟萘酸噻嘧啶、酒石酸噻嘧啶、酒石酸莫仑太尔或恩波酸奥克太尔)的组合。
在又另一个优选的实施例中,软可咀嚼剂型提供了以下剂量:1mg/kg至100mg/kg异噁唑啉(例如,洛替拉纳、沙罗拉纳、氟拉拉纳或阿福拉纳)、0.001mg/kg至15mg/kg大环内酯(例如,莫西菌素、米尔贝肟、多拉菌素或塞拉菌素)、1mg/kg至100mg/kg吡嗪异喹啉(例如,吡喹酮)和1mg/kg至100mg/kg四氢嘧啶(例如,双羟萘酸噻嘧啶、酒石酸噻嘧啶、酒石酸莫仑太尔或恩波酸奥克太尔)。
在又另一个优选的实施例中,基于剂型的总重量,软可咀嚼剂型包含0.5%至25%(wt/wt)异噁唑啉(例如,洛替拉纳、沙罗拉纳、氟拉拉纳或阿福拉纳)、0.005%至1%(wt/wt)米尔贝肟和1%至10%(wt/wt)吡喹酮的组合。
在又另一个优选的实施例中,软可咀嚼剂型提供了以下剂量:1mg/kg至100mg/kg异噁唑啉(例如,洛替拉纳、沙罗拉纳、氟拉拉纳或阿福拉纳)、0.05mg/kg至3mg/kg米尔贝肟和1mg/kg至30mg/kg吡喹酮。
在又另一个优选的实施例中,基于剂型的总重量,软可咀嚼剂型包含0.5%至25%(wt/wt)洛替拉纳、0.005%至1%(wt/wt)米尔贝肟和1%至10%(wt/wt)吡喹酮的组合。
在又另一个优选的实施例中,软可咀嚼剂型提供了以下剂量:1mg/kg至100mg/kg洛替拉纳、0.05mg/kg至3mg/kg米尔贝肟和1mg/kg至30mg/kg吡喹酮。
在又另一个优选的实施例中,软可咀嚼剂型包含20-1,000mg洛替拉纳、0.1-150mg米尔贝肟和5-250mg吡喹酮。
在又另一个优选的实施例中,基于剂型的总重量,软可咀嚼剂型包含0.5%至25%(wt/wt)异噁唑啉(例如,洛替拉纳、沙罗拉纳、氟拉拉纳或阿福拉纳)、0.005%至1%(wt/wt)莫西菌素和1%至10%(wt/wt)吡喹酮的组合。
在又另一个优选的实施例中,软可咀嚼剂型提供了以下剂量:1mg/kg至100mg/kg异噁唑啉(例如,洛替拉纳、沙罗拉纳、氟拉拉纳或阿福拉纳)、0.001mg/kg至5mg/kg莫西菌素和1mg/kg至30mg/kg吡喹酮。
在又另一个优选的实施例中,基于剂型的总重量,软可咀嚼剂型包含0.5%至25%(wt/wt)洛替拉纳、0.005%至1%(wt/wt)莫西菌素和1%至10%(wt/wt)吡喹酮的组合。在又另一个优选的实施例中,基于剂型的总重量,软可咀嚼剂型包含14-16%(wt/wt)洛替拉纳、0.025%至0.045%(wt/wt)莫西菌素和3-5%(wt/wt)吡喹酮的组合。
在又另一个优选的实施例中,软可咀嚼剂型提供了以下剂量:1mg/kg至100mg/kg洛替拉纳、0.001mg/kg至5mg/kg莫西菌素和1mg/kg至30mg/kg吡喹酮。在又另一个优选的实施例中,软可咀嚼剂型提供了以下剂量:15mg/kg至45mg/kg洛替拉纳、0.025mg/kg至0.50mg/kg莫西菌素和1mg/kg至15mg/kg吡喹酮。在又另一个优选的实施例中,软可咀嚼剂型提供了以下剂量:20mg/kg至40mg/kg洛替拉纳、0.05mg/kg至0.10mg/kg莫西菌素和5mg/kg至10mg/kg吡喹酮。在又另一个优选的实施例中,组合物提供了以下剂量:20mg/kg至40mg/kg洛替拉纳、0.02mg/kg至0.04mg/kg莫西菌素和5mg/kg至10mg/kg吡喹酮。
在又另一个优选的实施例中,软可咀嚼剂型包含20-1,000mg洛替拉纳、0.001-200mg莫西菌素和5-250mg吡喹酮。在又另一个优选的实施例中,软可咀嚼剂型包含55-57mg洛替拉纳、0.1-0.2mg莫西菌素和13-15mg吡喹酮。在又另一个优选的实施例中,软可咀嚼剂型包含111-113mg洛替拉纳、0.2-0.3mg莫西菌素和28-30mg吡喹酮。在又另一个优选的实施例中,软可咀嚼剂型包含224-226mg洛替拉纳、0.5-0.6mg莫西菌素和56-58mg吡喹酮。在又另一个优选的实施例中,软可咀嚼剂型包含449-451mg洛替拉纳、1.1-1.2mg莫西菌素和113-115mg吡喹酮。在又另一个优选的实施例中,软可咀嚼剂型包含899-901mg洛替拉纳、2.2-2.3mg莫西菌素和227-229mg吡喹酮。
在又另一个优选的实施例中,基于剂型的总重量,软可咀嚼剂型包含0.5%至25%(wt/wt)异噁唑啉(例如,洛替拉纳、沙罗拉纳、氟拉拉纳或阿福拉纳)、0.005%至1%(wt/wt)莫西菌素和5%至30%(wt/wt)双羟萘酸噻嘧啶的组合。
在又另一个优选的实施例中,软可咀嚼剂型提供了以下剂量:1mg/kg至100mg/kg异噁唑啉(例如,洛替拉纳、沙罗拉纳、氟拉拉纳或阿福拉纳)、0.001mg/kg至5mg/kg莫西菌素和1mg/kg至30mg/kg双羟萘酸噻嘧啶。
在又另一个优选的实施例中,基于剂型的总重量,软可咀嚼剂型包含0.5%至25%(wt/wt)洛替拉纳、0.005%至1%(wt/wt)莫西菌素和5%至30%(wt/wt)双羟萘酸噻嘧啶的组合。
在又另一个优选的实施例中,软可咀嚼剂型提供了以下剂量:1mg/kg至100mg/kg洛替拉纳、0.001mg/kg至5mg/kg莫西菌素和1mg/kg至30mg/kg双羟萘酸噻嘧啶。
在又另一个优选的实施例中,软可咀嚼剂型包含20-1,000mg洛替拉纳、0.001-200mg莫西菌素和5-250mg双羟萘酸噻嘧啶。
在又另一个优选的实施例中,基于剂型的总重量,软可咀嚼剂型包含0.5%至25%(wt/wt)异噁唑啉(例如,洛替拉纳、沙罗拉纳、氟拉拉纳或阿福拉纳)、0.005%至1%(wt/wt)莫西菌素、1%至10%(wt/wt)吡喹酮和5%至30%(wt/wt)双羟萘酸噻嘧啶的组合。
在又另一个优选的实施例中,软可咀嚼剂型提供了以下剂量:1mg/kg至100mg/kg异噁唑啉(例如,洛替拉纳、沙罗拉纳、氟拉拉纳或阿福拉纳)、0.001mg/kg至5mg/kg莫西菌素、1mg/kg至30mg/kg吡喹酮和1mg/kg至30mg/kg双羟萘酸噻嘧啶。
在又另一个优选的实施例中,基于剂型的总重量,软可咀嚼剂型包含0.5%至25%(wt/wt)洛替拉纳、0.005%至1%(wt/wt)莫西菌素、1%至10%(wt/wt)吡喹酮和5%至30%(wt/wt)双羟萘酸噻嘧啶的组合。
在又另一个优选的实施例中,软可咀嚼剂型提供了以下剂量:1mg/kg至100mg/kg洛替拉纳、0.001mg/kg至5mg/kg莫西菌素、1mg/kg至30mg/kg吡喹酮和1mg/kg至30mg/kg双羟萘酸噻嘧啶。在又另一个优选的实施例中,软可咀嚼剂型提供了以下剂量:15mg/kg至45mg/kg洛替拉纳、0.01mg/kg至0.05mg/kg莫西菌素、1mg/kg至15mg/kg吡喹酮和1mg/kg至15mg/kg双羟萘酸噻嘧啶。在又另一个优选的实施例中,软可咀嚼剂型提供了以下剂量:20mg/kg至41mg/kg洛替拉纳、0.02mg/kg至0.041mg/kg莫西菌素、5mg/kg至10.4mg/kg吡喹酮和5mg/kg至10.4mg/kg双羟萘酸噻嘧啶。在又另一个优选的实施例中,软可咀嚼剂型提供了以下剂量:20mg/kg至40mg/kg洛替拉纳、0.02mg/kg至0.04mg/kg莫西菌素、5mg/kg至10mg/kg吡喹酮和5mg/kg至10mg/kg双羟萘酸噻嘧啶。
在又另一个优选的实施例中,软可咀嚼剂型提供了以下剂量:20.8-28.1mg/kg洛替拉纳、0.021-0.028mg/kg莫西菌素、5.28-7.13mg/kg吡喹酮和5.28-7.13mg/kg双羟萘酸噻嘧啶。在又另一个优选的实施例中,软可咀嚼剂型提供了以下剂量:20.8-40.2mg/kg洛替拉纳、0.021-0.040mg/kg莫西菌素、5.28-10.18mg/kg吡喹酮和5.28-10.18mg/kg双羟萘酸噻嘧啶。
在又另一个优选的实施例中,软可咀嚼剂型提供了以下剂量:20.0-40.9mg/kg洛替拉纳、0.020-0.041mg/kg莫西菌素、5.07-10.36mg/kg吡喹酮和5.07-10.36mg/kg双羟萘酸噻嘧啶。在又另一个优选的实施例中,软可咀嚼剂型提供了以下剂量:20-39.8mg/kg洛替拉纳、0.020-0.040mg/kg莫西菌素、5.07-10.09mg/kg吡喹酮和5.07-10.09mg/kg双羟萘酸噻嘧啶。在又另一个优选的实施例中,软可咀嚼剂型提供了以下剂量:20.8-39.8mg/kg洛替拉纳、0.020-0.040mg/kg莫西菌素、5.07-10.09mg/kg吡喹酮和5.07-10.09mg/kg双羟萘酸噻嘧啶。
在又另一个优选的实施例中,软可咀嚼剂型包含20-1,000mg洛替拉纳、0.001-200mg莫西菌素、5-250mg吡喹酮和5-250mg双羟萘酸噻嘧啶。在又另一个优选的实施例中,软可咀嚼剂型包含55-57mg洛替拉纳、0.05-0.06mg莫西菌素、13-15mg吡喹酮和13-15mg双羟萘酸噻嘧啶。在又另一个优选的实施例中,软可咀嚼剂型包含111-113mg洛替拉纳、0.1-0.2mg莫西菌素、28-30mg吡喹酮和28-30mg双羟萘酸噻嘧啶。在又另一个优选的实施例中,软可咀嚼剂型包含224-226mg洛替拉纳、0.2-0.3mg莫西菌素、56-58mg吡喹酮和56-58mg双羟萘酸噻嘧啶。在又另一个优选的实施例中,软可咀嚼剂型包含449-451mg洛替拉纳、0.4-0.5mg莫西菌素、113-115mg吡喹酮和113-115mg双羟萘酸噻嘧啶。在又另一个优选的实施例中,软可咀嚼剂型包含899-901mg洛替拉纳、0.85-0.95mg莫西菌素、227-229mg吡喹酮和227-229mg双羟萘酸噻嘧啶。
受保护活性成分
在某些实施例中,软可咀嚼剂型的一种或多种活性物质可以通过经活性物质涂覆的基底和/或含活性物质的基底掺入到剂型中。可以通过基底将活性物质掺入剂型中,以例如掩蔽不可口的成分的味道或保护不稳定的活性成分免于剂型基质中其它活性物质或赋形剂。
在优选实施例中,所述基底是团粒。软可咀嚼剂型的一种或多种活性物质可以通过经活性物质涂覆的团粒掺入到剂型中。示例性经活性物质涂覆的团粒包含:(i)团粒(例如,包含微晶纤维素);(ii)位于所述团粒的至少一部分之上的第一涂层,所述第一涂层包括一种或多种活性物质(例如,吡喹酮);以及任选地(iii)位于所述第一涂层的至少一部分之上的第二涂层,所述第二涂层包括生理学上可接受的聚合物(例如,甲基丙烯酸二甲氨基乙酯共聚物)。
用于产生团粒的合适的生理学上可接受的载体材料包含但不限于纤维素、淀粉、蔗糖、乳糖或其它不同类型的糖。由微晶纤维素制成的示例性团粒包含那些以商标(例如,/>CP203)或/>商标(例如,/>100(100-200μm)或/>200(200-355μm))可商购获得的团粒。
为了用活性成分涂覆团粒,可以将活性物质溶解在溶剂(例如,水、醇和其混合物)中,任选地与另外的组分一起,并通过喷雾法施涂于团粒。另外合适的溶剂是本领域技术人员已知的,易挥发的溶剂是优选的。在喷涂程序之后,可以去除挥发性组分(例如,在真空下)。在干燥工艺之后,可以进一步筛分团粒。
经活性物质涂覆的团粒可以进一步用包括生理上可接受的聚合物基质的次生层(例如,保护层)涂覆。合适的聚合物种类包含但不限于虫胶、基于纤维素、丙烯酸或甲基丙烯酸、马来酸酐、聚乙烯吡咯烷酮或聚乙烯醇的聚合物。也可以考虑其它聚合物,例如基于纤维素的聚合物,例如由邻苯二甲酸乙酸纤维素或乙酸纤维素-N,N-二正丁基羟丙基醚产生的聚合物。基于丙烯酸或甲基丙烯酸的聚合物的起始材料可以是甲基丙烯酸酯/甲基丙烯酸共聚物、2-甲基-5-乙烯基吡啶/甲基丙烯酸酯/甲基丙烯酸共聚物、甲基丙烯酸甲酯/甲基丙烯酸共聚物、甲基丙烯酸甲酯/甲基丙烯酸共聚物、甲基丙烯酸甲酯/马来酸酐共聚物或甲基丙烯酸甲酯/马来酸酐共聚物。
优选地使用基于丙烯酸或甲基丙烯酸的聚合物,例如具有低含量季铵基团的丙烯酸和丙烯酸酯的聚合产物,例如可从德国达姆施塔特的罗门公司(companyDarmstadt,Germany)以/>E、L或S的名称商购获得。/>E是甲基丙烯酸二甲氨基乙酯和中性甲基丙烯酸酯的阳离子聚合物。/>L和S是甲基丙烯酸和甲基丙烯酸甲酯的阴离子共聚物。/>E 100是在酸性pH值至多pH 5.0时溶解于胃液中的pH依赖性阳离子聚合物。高于pH 5.0时,它能够溶胀。呈粉末形式时,它被称为/>EPO并且可商购获得。/>EPO的优点是所述工艺可以在水性介质中进行,并且任选地不使用有机溶剂。
经活性物质涂覆的团粒的二次涂层可以通过将虫胶或聚合物溶解在溶剂或媒剂中,并将溶液或悬浮液喷洒到经活性物质涂覆的团粒上来实现。挥发性组分(例如,溶剂)可以随后被去除(例如,在真空下)。在干燥工艺之后,可以进一步筛分团粒。
用于第二聚合物的溶出的合适溶剂是例如相对易挥发的溶剂,例如以下中的一种或多种:甲醇、乙醇、异丙醇、丁醇、苯甲醇、乙二醇、丙二醇、苯酚、丙酮、乙酸、乙酸酐、硝基甲烷、乙二胺、乙酸溶纤剂,例如比率为1:1的丙酮-乙醇混合物。可以使用水性悬浮液或溶液,例如可以用来自水性悬浮液的EPO进行涂覆。根据此工艺,安全方面、环境保护和经济优势被最佳地组合。
任选地,可以将一种或多种材料施涂到含活性物质的双涂层团粒。例如,可以将亲水性热解二氧化硅(例如,200)施涂到双涂层团粒上。
在某些实施例中,当软可咀嚼剂型包含吡喹酮作为活性成分时,它通过双涂层团粒掺入到剂型中。用于产生此类双涂层吡喹酮团粒的工艺可以如下进行:(a)用吡喹酮涂覆直径例如为100-1000μm,优选地平均直径为200-250μm的中性味道、生理上可接受的固体团粒,(b)将(a)中获得的经吡喹酮涂覆的团粒进一步用包括生理上可接受的聚合物基质的次生层涂覆。
为了涂覆团粒,可以将吡喹酮溶解在合适的溶剂或媒剂(例如,纯化水、十二烷基硫酸钠(SDS)、聚乙烯吡咯烷酮)中,并通过喷雾法施涂于团粒。在喷涂程序之后,可以去除挥发性组分(例如,在真空下)。在干燥工艺之后,经吡喹酮涂覆的团粒可以筛分。经吡喹酮涂覆的团粒可以进一步用包括生理上可接受的聚合物基质的二次涂层(例如,用于掩味)涂覆。为了将二次涂层施涂到经吡喹酮涂覆的团粒上,可以将聚合物(例如,甲基丙烯酸二甲氨基乙酯共聚物,也被称为EPO)溶解或悬浮在合适的溶剂或媒剂(例如水、SDS、癸二酸二丁酯和多孔硅胶(例如,/>244FP二氧化硅))中,并通过喷雾法施涂到团粒。在喷涂程序之后,可以去除挥发性组分(例如,在真空下)。在干燥工艺之后,双涂层团粒可以筛分。
任选地,可以将一种或多种材料施涂到含吡喹酮的双涂层团粒。例如,可以将亲水性热解二氧化硅(例如,200)施涂到双涂层团粒上。
此类双涂层颗粒(例如,首先用吡喹酮涂覆,并且然后用聚合物基质涂覆)可以用一种或多种另外的活性物质(例如,异噁唑啉类杀寄生虫剂、阿维菌素或四氢嘧啶)或合适的药学上可接受的赋形剂(例如,填充剂、崩解剂、助流剂和/或润滑剂)进一步加工以获得共混物,用于进一步加工成最终的软可咀嚼剂型。
基于最终经活性物质涂覆的基底的重量,团粒中的吡喹酮的量可以为例如10-50%,20-40%,或25-35%。基于最终经活性物质涂覆的基底的重量,团粒中的吡喹酮的量可以为例如10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%、39%、40%、41%、42%、43%、44%、45%、46%、47%、48%、49%或50%。基于最终经活性物质涂覆的基底的重量,团粒中的吡喹酮的量可以为例如约30%。
根据一方面,可以调整所有赋形剂的粒度以接近经涂覆的团粒或双涂层团粒的平均直径,例如调整为大小为200μm至400μm、200μm至350μm或200μm至250μm,以避免下游剂型制造期间的分离。
优选地,在经活性物质涂覆的基底(例如,团粒)被掺入到可咀嚼剂型中的情况下,固体颗粒以均匀分布和含量均匀度的方式被包埋在剂型基质中。所公开的制造方法提供了可咀嚼剂型,其中此类颗粒具有均匀分布和含量均匀度。
碳酸盐或碳酸氢盐化合物
本发明的可咀嚼组合物包括碳酸盐或碳酸氢盐化合物。所述碳酸盐或碳酸氢盐化合物可以选自碳酸氢钠、碳酸钠、碳酸氢钠、碳酸钾、碳酸氢钾、甘氨酸碳酸钠、赖氨酸碳酸盐、精氨酸碳酸盐、碳酸钙、碳酸氢盐、碳酸锂、碳酸氢锂或其组合。在优选的实施例中,所述碳酸盐或碳酸氢盐化合物是碳酸氢钠。在优选的实施例中,所述组合物包括2.5至30%(wt/wt)的碳酸盐或碳酸氢盐化合物。在另外的实施例中,所述组合物包括2.5至30%(wt/wt)碳酸氢钠,优选地5至30%(wt/wt)碳酸氢钠,更优选地5至27%(wt/wt)碳酸氢钠。
在某些实施例中,基于剂型的总重量,软可咀嚼剂型包含0.5%至40%(wt/wt)碳酸盐或碳酸氢盐化合物,优选地碳酸氢钠。在某些实施例中,基于剂型的总重量,软可咀嚼剂型包含0.5%至25%(wt/wt)碳酸盐或碳酸氢盐化合物,优选地碳酸氢钠。优选地,基于剂型的总重量,软可咀嚼剂型包含3%至25%(wt/wt),更优选地3%至15%(wt/wt),更优选3%至10%(wt/wt),并且甚至更优选地3%至5%(wt/wt)的碳酸盐或碳酸氢盐化合物,优选地碳酸氢钠。
在某些实施例中,基于剂型的总重量,软可咀嚼剂型包含0.5%-25%、0.5%-24%、0.5%-23%、0.5%-22%、0.5%-21%、0.5%-20%、0.5%-19%、0.5%-18%、0.5%-17%、0.5%-16%、0.5%-15%、0.5%-14%、0.5%-13%、0.5%-12%、0.5%-11%、0.5%-10%、0.5%-9%、0.5%-8%、0.5%-7%、0.5%-6%、0.5%-5%、0.5%-4%、0.5%-3%、0.5%-2%、0.5%-1%、1%-25%、1%-24%、1%-23%、1%-22%、1%-21%、1%-20%、1%-19%、1%-18%、1%-17%、1%-16%、1%-15%、1%-14%、1%-13%、1%-12%、1%-11%、1%-10%、1%-9%、1%-8%、1%-7%、1%-6%、1%-5%、1%-4%、1%-3%、1%-2%、2%-25%、2%-24%、2%-23%、2%-22%、2%-21%、2%-20%、2%-19%、2%-18%、2%-17%、2%-16%、2%-15%、2%-14%、2%-13%、2%-12%、2%-11%、2%-10%、2%-9%、2%-8%、2%-7%、2%-6%、2%-5%、2%-4%、2%-3%、3%-25%、3%-24%、3%-23%、3%-22%、3%-21%、3%-20%、3%-19%、3%-18%、3%-17%、3%-16%、3%-15%、3%-14%、3%-13%、3%-12%、3%-11%、3%-10%、3%-9%、3%-8%、3%-7%、3%-6%、3%-5%、3%-4%、4%-25%、4%-24%、4%-23%、4%-22%、4%-21%、4%-20%、4%-19%、4%-18%、4%-17%、4%-16%、4%-15%、4%-14%、4%-13%、4%-12%、4%-11%、4%-10%、4%-9%、4%-8%、4%-7%、4%-6%、4%-5%、5%-25%、5%-24%、5%-23%、5%-22%、5%-21%、5%-20%、5%-19%、5%-18%、5%-17%、5%-16%、5%-15%、5%-14%、5%-13%、5%-12%、5%-11%、5%-10%、5%-9%、5%-8%、5%-7%、5%-6%、6%-25%、6%-24%、6%-23%、6%-22%、6%-21%、6%-20%、6%-19%、6%-18%、6%-17%、6%-16%、6%-15%、6%-14%、6%-13%、6%-12%、6%-11%、6%-10%、6%-9%、6%-8%、6%-7%、7%-25%、7%-24%、7%-23%、7%-22%、7%-21%、7%-20%、7%-19%、7%-18%、7%-17%、7%-16%、7%-15%、7%-14%、7%-13%、7%-12%、7%-11%、7%-10%、7%-9%、7%-8%、8%-25%、8%-24%、8%-23%、8%-22%、8%-21%、8%-20%、8%-19%、8%-18%、8%-17%、8%-16%、8%-15%、8%-14%、8%-13%、8%-12%、8%-11%、8%-10%、8%-9%、9%-25%、9%-24%、9%-23%、9%-22%、9%-21%、9%-20%、9%-19%、9%-18%、9%-17%、9%-16%、9%-15%、9%-14%、9%-13%、9%-12%、9%-11%、9%-10%、10%-25%、10%-24%、10%-23%、10%-22%、10%-21%、10%-20%、10%-19%、10%-18%、10%-17%、10%-16%、10%-15%、10%-14%、10%-13%、10%-12%、10%-11%、11%-25%、11%-24%、11%-23%、11%-22%、11%-21%、11%-20%、11%-19%、11%-18%、11%-17%、11%-16%、11%-15%、11%-14%、11%-13%、11%-12%、12%-25%、12%-24%、12%-23%、12%-22%、12%-21%、12%-20%、12%-19%、12%-18%、12%-17%、12%-16%、12%-15%、12%-14%、12%-13%、13%-25%、13%-24%、13%-23%、13%-22%、13%-21%、13%-20%、13%-19%、13%-18%、13%-17%、13%-16%、13%-15%、13%-14%、14%-25%、14%-24%、14%-23%、14%-22%、14%-21%、14%-20%、14%-19%、14%-18%、14%-17%、14%-16%、14%-15%、15%-25%、15%-24%、15%-23%、15%-22%、15%-21%、15%-20%、15%-19%、15%-18%、15%-17%、15%-16%、16%-25%、16%-24%、16%-23%、16%-22%、16%-21%、16%-20%、16%-19%、16%-18%、16%-17%、17%-25%、17%-24%、17%-23%、17%-22%、17%-21%、17%-20%、17%-19%、17%-18%、18%-25%、18%-24%、18%-23%、18%-22%、18%-21%、18%-20%、18%-19%、19%-25%、19%-24%、19%-23%、19%-22%、19%-21%、19%-20%、20%-25%、20%-24%、20%-23%、20%-22%、20%-21%、21%-25%、21%-24%、21%-23%、21%-22%、22%-25%、22%-24%、22%-23%、23%-25%、23%-24%或24%-25%的碳酸盐或碳酸氢盐化合物,优选地碳酸氢钠。
在某些实施例中,基于剂型的总重量,软可咀嚼剂型包含0.5%、1%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%或25%的碳酸盐或碳酸氢盐化合物,优选地碳酸氢钠。优选地,基于剂型的总重量,软可咀嚼剂型包含3%、4%或5%碳酸盐或碳酸氢盐化合物,优选地碳酸氢钠。
在某些实施例中,软可咀嚼剂型包含10mg至500mg碳酸盐或碳酸氢盐化合物,优选地碳酸氢钠。
在某些实施例中,本公开的组合物包含选定平均粒度的碳酸盐或碳酸氢盐化合物。虽然碳酸盐或碳酸氢盐化合物的存在促进了剂型的崩解和活性成分的溶出,但是已经发现,在某些实施例中,平均颗粒太大的碳酸盐或碳酸氢盐物质不能促进足够的剂型崩解和溶出。因此,在某些实施例中,用于制备可咀嚼组合物的碳酸盐或碳酸氢盐化合物,优选地碳酸氢钠的平均粒度小于或等于500μm、小于或等于450μm、小于或等于400μm、小于或等于350μm、小于或等于300μm、小于或等于250μm、小于或等于200μm、小于或等于150μm、小于或等于100μm、小于或等于50μm。在某些实施例中,用于制备可咀嚼组合物的碳酸盐或碳酸氢盐化合物,优选地碳酸氢钠的平均粒度为10-250μm、20-200μm、30-150μm或40-100μm。在某些实施例中,用于制备可咀嚼组合物的碳酸盐或碳酸氢盐化合物,优选地碳酸氢钠的平均粒度为约10μm、约20μm、约30μm、约40μm、约50μm、约60μm、约70μm、约80μm、约90μm、约100μm、约110μm、约120μm、约130μm、约140μm、约150μm、约160μm、约170μm、约180μm、约190μm或约200μm。
食用香料
本发明的可咀嚼组合物可以包括调味剂以改善适口性。具体地,所述组合物可以包括肉类调味品。示例性食用香料包含但不限于调味品、Desiccated Pork LiverPowderTM、/>356、/>400、PC-0125、/>调味品,例如/>鸡肉烹制干香料、/>肉切碎型干香料、/>肝型干香料和/>鸡皮和肉干香料。示例性实施例中使用的肉或牛肉调味品可以是天然来源的或人工调配的,以具有肉或牛肉风味。天然调味品通常由干的和粉碎的或粉末状的肉制成,这些肉可以从驯养的肉类动物获得,包含牛,如奶牛或公牛、猪、鹿、绵羊、山羊,家禽,可以包含火鸡、鸡、鸭等。非动物的,通常是植物来源的调味品,包含大豆、花生、水果、甜味剂、蜂蜜、糖、枫糖浆和果糖、欧芹、芹菜、薄荷、留兰香、大蒜等。
在某些实施例中,可咀嚼组合物包含天然食用香料。在某些实施例中,可咀嚼组合物包含合成食用香料。在某个实施例中,可咀嚼组合物包含天然食用香料和合成食用香料的组合。
在示例性实施例中,基于剂型的总重量,组合物中可以任选地包含例如浓度为0.5%至40%(wt/wt)的食用香料。在优选的实施例中,调味品是肉切碎型干香料或/>肝型干香料。在优选的实施例中,基于剂型的总重量,组合物包括0.5至20%(wt/wt)调味品,优选0.5至10%(wt/wt)调味品,更优选地0.5至7%。在另外的实施例中,基于剂型的总重量,所述组合物包括的0.5至10%(wt/wt)/>肉切碎型干香料或/>肝型干香料。
润湿剂
示例性润湿剂包含但不限于甘油、丙二醇、鲸蜡醇、单硬脂酸甘油酯、藻酸铵、乳酸钠、山梨醇、三醋精、木糖醇、转化糖、多元醇、聚乙二醇、聚甘油、黄原胶、角叉菜胶、藻酸盐、环甲基硅酮、透明质酸钠、乳酸钠、痕量锡(tracetin)、三乙醇胺、玉米糖浆和其混合物。在一些实施例中,润湿剂可以包括多于一种油,包含但不限于一种或多种脂肪,天然脂肪和合成脂肪两者。用作软咀嚼物成分的油可以是饱和或不饱和液体脂肪酸、其甘油酯衍生物或植物或动物来源的脂肪酸衍生物、或其混合物。典型的动物脂肪或油的来源是鱼油、鸡油、牛油、精选白油脂、优质蒸制猪油以及其混合物。然而,其它动物脂肪也适用于软咀嚼物。植物脂肪或油的合适来源可以源自棕榈油、棕榈氢化油、玉米胚芽氢化油、蓖麻氢化油、棉籽油、大豆油、橄榄油、花生油、棕榈油精油、椰子油、可可脂、人造黄油、黄油、起酥油和棕榈硬脂油以及其混合物。另外地,动物或植物油或脂肪的混合物适用于基质。
在示例性实施例中,基于剂型的总重量,组合物中可以任选地包含例如浓度为约1%至约25%(wt/wt)、约1%至约20%(wt/wt)、约1%至约15%(wt/wt)或约5%至约15%(wt/wt)的润湿剂。更典型地,组合物将含有约1%至约10%(wt/wt)的润湿剂。
表面活性剂
本发明的可咀嚼组合物可以包括表面活性剂。表面活性剂(surfactant)(也被称为表面活性剂(surface-active agent))是一种降低两种液体之间或液体与固体之间界面处的表面张力的组分。合适的表面活性剂可以存在于《雷明顿:药学科学与实践(REMINGTON:THE SCIENCE AND PRACTICE OF PHARMACY)》(第20版,麦克出版公司(MackPublishing Co.),2001)中。示例性表面活性剂包含但不限于甘油单油酸酯、聚氧乙烯脱水山梨醇脂肪酸酯、包含脱水山梨醇单油酸酯(20)的脱水山梨醇酯、聚乙烯醇、包含聚山梨醇酯20和聚山梨醇酯80的聚山梨醇酯、d-α-生育酚聚乙二醇1000琥珀酸酯(TPGS)、维生素E TPGS(D-α-生育酚聚乙二醇1000琥珀酸酯)、十二烷基硫酸钠(SLS)、环氧乙烷和环氧丙烷的共聚物(例如,如泊洛沙姆124、188、338和407等泊洛沙姆以及/>F87等)、聚乙二醇蓖麻油衍生物,包含聚氧乙烯35蓖麻油(/>EL)、聚氧乙烯40氢化蓖麻油(RH 40)、聚氧乙烯60氢化蓖麻油(/>RH60);丙二醇单月桂酸酯甘油酯,包含辛酸/癸酸甘油酯(/>MCM)、聚乙二醇化甘油酯(/>如/>44/14)、PEG 300辛酸/癸酸甘油酯(/>767)、PEG400辛酸/癸酸甘油酯/>PEG 300油酸甘油酯(/>M-1944CS)、PEG 300亚油酸甘油酯(/>M-2125CS);聚乙二醇硬脂酸酯和聚乙二醇羟基硬脂酸酯,包含聚氧乙烯8硬脂酸酯(PEG 400单硬脂酸酯)、聚氧乙烯40硬脂酸酯(PEG 1750单硬脂酸酯)、PEG3350等。聚乙二醇硬脂酸酯(polyethylene glycol stearate)(同义词包含聚乙二醇硬脂酸酯(macrogol stearate)、聚氧乙烯硬脂酸酯(polyoxylstearate)、聚氧乙烯硬脂酸酯(polyoxyethylene stearate)、乙氧基化硬脂酸酯;CAS编号9004-99-3、9005-08-7)是混合的聚氧乙烯聚合物的单硬脂酸酯和二硬脂酸酯的混合物。聚乙二醇羟基硬脂酸酯是羟基硬脂酸与聚乙二醇的单酯和二酯的混合物。可以用于组合物的一种聚乙二醇羟基硬脂酸酯是聚乙二醇12-羟基硬脂酸酯。所述组合物可以包含表面活性剂聚乙二醇15 12-羟基硬脂酸酯(来自BASF的/>HS 15),12-羟基硬脂酸的单酯和二酯与15摩尔环氧乙烷的混合物。所述组合物可以包含聚氧乙烯35蓖麻油(/>EL)作为表面活性剂。所述组合物可以包含聚氧乙烯40氢化蓖麻油(/>RH 40)或聚氧乙烯60氢化蓖麻油(/>RH60)作为表面活性剂。
在示例性实施例中,基于剂型的总重量,组合物中可以任选地包含例如浓度为约0.1%至约10%(wt/wt)、约1%至约10%(wt/wt)或约5%至约10%(wt/wt)的表面活性剂。更典型地,表面活性剂可以以约0.1%至约5%(wt/wt)或约1%至约5%(wt/wt)的浓度存在。在优选的实施例中,所述组合物包括0.5至10%表面活性剂。在优选的实施例中,所述组合物包括十二烷基硫酸钠。在另外的实施例中,所述组合物包括0.5至5%(w/w)十二烷基硫酸钠,更优选地约1至2%(w/w)十二烷基硫酸钠。
溶剂
示例性溶剂包含但不限于无水甘油(CAS 56-81-5)、各种等级的液体聚乙二醇(PEG),包含PEG 200、PEG 300、PEG 400和PEG 540;碳酸丙烯酯;丙二醇;甘油三酯,包含但不限于辛酸/癸酸甘油三酯、辛酸/癸酸/亚油酸甘油三酯(例如,810和812)、辛酸/癸酸/琥珀酸甘油三酯、丙二醇二辛酸酯/二癸酸酯等;水、山梨醇溶液、辛酸/癸酸甘油酯和聚乙二醇化甘油酯/>或其组合。另外的示例性溶剂包含中链甘油三酯(MCT)和被称为长链甘油三酯(LCT)的植物油。中链长度脂肪酸的甘油三酯,被称为中链甘油三酯或MCT,可以通过用碳链长度为C8或C10的脂肪酸酯化甘油来合成。MCT通常作为C8(辛酸(octanoic acid)或辛酸(caprylic acid))和C10(癸酸(decanoic acid)或癸酸(capric acid))脂肪酸甘油酯的混合物,与少量(每一种<1%)的C6(己酸(hexanoic acid)或己酸(caproic acid))和C12(十二烷酸或月桂酸)脂肪酸甘油酯一起商购获得。
在示例性实施例中,基于剂型的总重量,组合物中可以任选地包含例如浓度为约1至约50%(wt/wt)的溶剂。在其它实施例中,溶剂的浓度将为约1至约40%(wt/wt)、约1至约30%(wt/wt)或约1至约20%(wt/wt)。更典型地,溶剂将以约5%至约20%(wt/wt)或约5%至约15%(wt/wt)的浓度处于组合物中。
在某些实施例中,可咀嚼组合物不包含作为溶剂添加的水。已经发现,在某些实施例中,向调配物中添加水降低了碳酸盐或碳酸氢盐崩解剂的效率。不希望受理论的束缚,据信添加的水可以与可咀嚼调配物中存在的碳酸盐或碳酸氢盐反应,由此减少可用于与生理介质反应的碳酸盐或碳酸氢盐化合物含量,并且因此减少剂型崩解和溶出。
填料
本发明的可咀嚼组合物可以包括填料。示例性填料包含但不限于玉米淀粉、预糊化玉米淀粉、大豆蛋白粉、玉米芯、玉米蛋白粉、含水或无水磷酸氢钙、微晶纤维素(MCC)和含水或无水乳糖。淀粉组分可以包括任何来源的淀粉,并且可以在软咀嚼物中作为粘合剂。组合物中使用的淀粉组分可以是未改性的,或衍生的和/或预糊化的。可以用作用于衍生化的基础淀粉的淀粉包含普通玉米、蜡质玉米、马铃薯、木薯、大米等。用于淀粉的合适类型的衍生剂包含但不限于,环氧乙烷、环氧丙烷、乙酸酐和琥珀酸酐,以及其它食品认可的酯或醚,单独或相互组合引入此类化学物质。
本发明的可咀嚼组合物可以包括亲水性填料。“亲水性填料”是用于增加组合物质量的亲水性组分。合适的亲水性填料包含但不限于甘露醇、乳糖、蔗糖、山梨醇和葡萄糖。
在示例性实施例中,基于剂型的总重量,组合物中可以任选地包含例如浓度为约5%至约80%(wt/wt)、约10%至约70%(wt/wt)、约10%至约60%(wt/wt)、约10%至约50%(wt/wt)或约10%至约40%(wt/wt)的填料。更典型地,填料可以以约30%至约70%(wt/wt)、约30%至约60%(wt/wt)、约30%至约50%(wt/wt)或约35%至约55%(wt/wt)的浓度存在。
成形剂
示例性成形剂包含但不限于聚乙二醇(PEG)、微晶蜡、鲸蜡醇和聚乙烯吡咯烷酮(PVP)。根据组合物的期望的稠度,可以使用不同分子量的PEG(例如,高于或低于PEG8000,但优选地高于600)。
在示例性实施例中,基于剂型的总重量,组合物中可以任选地包含例如浓度为组合物的约2%至约30%wt/wt的成形剂。
粘合剂
本发明的可咀嚼组合物可以包括粘合剂。粘合剂是一种增加粘结性的组分。合适的粘合剂可以存在于《雷明顿:药学科学与实践》(第20版,麦克出版公司,2001)中。
示例性粘合剂包含但不限于聚乙烯吡咯烷酮(例如,聚维酮和K-29/32)、交联聚乙烯吡咯烷酮(交联聚维酮)、各种等级的聚乙二醇,包含PEG 3350、PEG 4000、PEG 6000、PEG 8000以及甚至PEG 20,000等;乙烯基吡咯烷酮和乙酸乙烯酯的共聚物(例如,共聚维酮),如BASF以商品名/>VA 64销售的产品等;淀粉,如马铃薯淀粉、木薯淀粉或玉米淀粉;糖蜜、玉米糖浆、蜂蜜、枫糖浆和各种类型的糖;羟丙基纤维素(HPC)、羟丙基甲基纤维素(HPMC)和藻酸盐。
在示例性实施例中,组合物中可以任选地包含例如浓度为约1%至约30%(wt/wt)的粘合剂。更典型地,基于剂型的总重量,组合物将包含浓度为约1%至约20%(wt/wt)、约1%至约15%(wt/wt)、约1%至约10%(wt/wt)、约5%至约15%(wt/wt)、约5%至约10%(wt/wt)或约1%至约5%(wt/wt)的粘合剂。
抗氧化剂
本发明的可咀嚼组合物可以包括抗氧化剂。“抗氧化剂”是作为防腐剂来增加如果暴露于氧气中是不稳定的活性成分的稳定性的组分。合适的抗氧化剂可以存在于《雷明顿:药学科学与实践》(第20版,麦克出版公司,2001)中。合适的抗氧化剂包含但不限于2;/>PG;/>s-1;BHA(2-叔丁基-4-甲氧基苯酚);BHT(2,6-二叔丁基-4-甲基苯酚);焦亚硫酸钠还原剂;抗氧化剂增效剂,如生育酚(α-生育酚、β-生育酚或δ-生育酚、生育酚酯、α-生育酚乙酸酯)、没食子酸烷基酯、丁基化羟基茴香醚、丁基化羟基甲苯、无水和含水柠檬酸、乙二胺四乙酸和其盐、卵磷脂、酒石酸、抗坏血酸、棕榈酸抗坏血酸酯、富马酸、苹果酸、抗坏血酸钠、偏亚硫酸氢钠、没食子酸正丙酯、单硫代甘油、白藜芦醇、槲皮素、苯甲酸、二甲基硫脲(DMTU)、橙皮素、四氢姜黄素、四氢去甲氧基姜黄素和Trolox(N-乙酰半胱氨酸,6-羟基-2,5,7,8-四甲基苯并二氢吡喃-2-羧酸)。在优选的实施例中,抗氧化剂是BHA。
在示例性实施例中,基于软可咀嚼剂型的总重量,抗氧化剂可以例如以约0.01至约2.0%(wt/wt),特别优选地约0.05至约1.0%或约0.1%至约0.2%(wt/wt)的浓度任选地包含在组合物中。在优选的实施例中,所述组合物包括0.01至0.2%(w/w)抗氧化剂。在另外的实施例中,所述组合物包括0.01至0.2%(w/w)BHA,优选地约0.1%BHA。
防腐剂
示例性防腐剂包含但不限于对羟基苯甲酸酯(对羟基苯甲酸甲酯和/或对羟基苯甲酸丙酯)、苯扎氯铵、苄索氯铵、苯甲酸、苯甲醇、溴硝醇、对羟基苯甲酸丁酯、西曲溴铵、氯己定、氯丁醇、氯甲酚、甲酚、对羟基苯甲酸乙酯、亚胺脲、对羟基苯甲酸甲酯、苯酚、苯氧基乙醇、苯乙醇、乙酸苯汞、硼酸苯汞、硝酸苯汞、山梨酸钾、苯甲酸钠、丙酸钠、山梨酸、硫柳汞、抗坏血酸、钙。
在示例性实施例中,基于剂型的总重量,组合物中可以任选地包含例如浓度为约0.01至约5.0%(wt/wt)、约0.01至约2%(wt/wt)或约0.05至约1.0%(wt/wt)的防腐剂。
稳定剂
示例性稳定剂包含但不限于硬脂酸镁、柠檬酸和柠檬酸钠。pH稳定剂(也被称为缓冲剂)包含例如乙酸/乙酸盐、苹果酸/苹果酸盐、柠檬酸/柠檬酸盐、酒石酸/酒石酸盐、乳酸/乳酸盐、磷酸/磷酸盐、甘氨酸/甘氨酸盐、tris、谷氨酸/谷氨酸盐和碳酸钠。
在某些实施例中,软可咀嚼剂型可以包含稳定剂和稳定剂的组合,以防止或减少大环内酯(例如,莫西菌素或多拉菌素)的降解。合适的稳定剂包含甘油缩甲醛、氨基糖(例如,氨基葡萄糖、氨丁三醇、葡甲胺等)、乙二醇醚、改性淀粉,例如羟丙基淀粉磷酸酯;纤维素衍生物(例如,羟丙基甲基纤维素(HPMC)、乙基纤维素、羟丙基甲基纤维素乙酰琥珀酸酯、羧甲基纤维素等);和非离子三嵌段共聚物(例如,泊洛沙姆-101、泊洛沙姆-108、泊洛沙姆-124、泊洛沙姆-188、泊洛沙姆-215、泊洛沙姆-284、泊洛沙姆-338、泊洛沙姆-407等),所有这些都可以用于使大环内酯物理稳定。在某些实施例中,可以用稳定剂和任选地至少一种抗氧化剂的组合来稳定大环内酯(例如,莫西菌素)。例如,可以将大环内酯如莫西菌素用羟丙基甲基纤维素和葡甲胺稳定,并且进一步用抗氧化剂(例如,BHT)稳定。
在示例性实施例中,基于剂型的总重量,组合物中可以任选地包含例如浓度为约0.1至约5%(wt/wt)、约0.1至约3%(wt/wt)或约0.1至约2%(wt/wt)的稳定剂。
润滑剂
示例性润滑剂包含但不限于各种分子量范围的聚乙二醇,包含PEG 3350(陶氏化学公司(Dow Chemical))和PEG 4000、玉米油、矿物油、氢化植物油(STEROTEX或LUBRITAB)、花生油和/或蓖麻油。在某些实施例中,润滑剂是包括中链甘油三酯(MCT)或丙二醇脂肪酸酯(包含辛酸/癸酸甘油三酯)的中性油。以商标已知的中性油的非限制性实例包含/>810、/>812、/>818、/>829和/>840。另外的润滑剂包含被称为长链甘油三酯(LCT)、硬脂酸镁(MgSt)、硬脂酸和硬脂酰富马酸钠的植物油。
在示例性实施例中,基于剂型的总重量,组合物中可以任选地包含例如浓度为约1%至约50%(wt/wt)、约1%至约20%(wt/wt)、约1%至约15%(wt/wt)、约1%至约10%(wt/wt)或约1%至约5%(wt/wt)的润滑剂。
助流剂
示例性流动性助剂或助流剂包含但不限于二氧化硅(CARBOSIL)或硅胶(SYLOID)、滑石、淀粉、钙、硬脂酸盐、硬脂酸镁和硅酸铝镁(NEUSILIN)。
在示例性实施例中,基于中组合物的重量,组合物中可以任选地包含例如浓度为约约0.01至约25%的助流剂。
适口性增强剂
本发明的可咀嚼组合物可以包括一种或多种适口性增强剂。本发明的可咀嚼组合物可以包括氯化钠作为适口性增强剂。在优选的实施例中,所述组合物包括1至2%(w/w)氯化钠,优选地约1.5%(w/w)氯化钠。
甜味剂
本发明的可咀嚼组合物可以包括甜味剂以进一步改善适口性。可以使用任何天然糖,包含糖果糖、麦芽糖醇、木糖醇、山梨醇、甘露醇、乳糖、右旋糖、蔗糖、葡萄糖或果糖,或其任何混合物。也可以使用人工甜味剂,包含糖精、阿斯巴甜、安赛蜜和在优选的实施例中,甜味剂是/>在优选的实施例中,所述组合物包括0.5至5%(w/w)甜味剂,优选地0.5%至2%(w/w)甜味剂,更优选地约1%(w/w)甜味剂。在另外的实施例中,所述组合物包括约1%(w/w)/>
着色剂
本发明的可咀嚼组合物可以包括着色剂。着色剂可以选自偶氮染料、有机或无机颜料或天然来源的着色剂。在优选的实施例中,所述组合物包括0.05至0.25%(w/w)着色剂。
增塑剂
本发明的可咀嚼组合物可以包括增塑剂。“增塑剂”是一种用于增加组合物的塑性性质的组分。合适的增塑剂包含但不限于甘油、醇(如三氯叔丁醇或山梨醇)、二醇(如聚乙二醇或丙二醇)、邻苯二甲酸酯(如邻苯二甲酸二乙酯)、羊毛脂(lanolin)、羊毛脂(woolfat)、液体石蜡、凡士林、苯甲酸苄酯、三醋精、聚(乳酸-共-乙醇酸)(PLGA)、甲基丙烯酸酯、乙酰柠檬酸三丁酯、蓖麻油、癸二酸二丁酯、柠檬酸三丁酯、柠檬酸三乙酯或9-45K NF,或其任何组合。在优选的实施例中,增塑剂是甘油。在优选的实施例中,所述组合物包括2至30%(w/w)增塑剂。在另外的实施例中,所述组合物包括2至30%(w/w)甘油,优选地3至23%(w/w)甘油,更优选地6至20%(w/w)甘油。
另外的崩解剂
示例性另外的崩解剂包含但不限于纤维素、羧甲基纤维素钙、羧甲基纤维素钠、波拉克林钾、淀粉、羟丙基淀粉、玉米淀粉、膨润土、铝硅酸镁盐、预糊化淀粉、改性淀粉、乳糖一水合物、交联羧甲基纤维素钠、微晶纤维素、羟丙基纤维素、甘氨酸、交联聚维酮、硅酸镁铝、淀粉羟乙酸钠、瓜尔胶、胶体二氧化硅、聚乙烯吡咯烷酮(聚维酮)、海藻酸、海藻酸钠、海藻酸钙、甲基纤维素和壳聚糖。
在示例性实施例中,基于剂型的总重量,所述组合物中可以任选地包含例如浓度为一种或多种崩解剂的0%(wt/wt)至约10%(wt/wt)、约1%(wt/wt)至约10%(wt/wt)、约1%(wt/wt)至约7%(wt/wt)、约1%(wt/wt)至约5%(wt/wt)或约2%(wt/wt)至约4%(wt/wt)的另外的崩解剂。
在某些实施例中,软可咀嚼剂型中唯一的崩解剂是碳酸氢钠。在某些实施例中,软可咀嚼剂型不包含碳酸氢钠以外的另外的崩解剂。
3.制备方法
本公开的组合物可以根据本领域技术人员已知的方法制造。例如,干法共混、干法制粒、湿法制粒、直接压制和熔融挤出的方法可以用于制造所公开的组合物。
在示例性实施例中,可以通过制备固体成分的粉末共混物,向粉末共混物中添加液体成分并制粒,以及挤出制粒的粉末共混物以提供挤出物来制造组合物。在另一个示例性实施例中,可以通过制备固体成分的粉末共混物,向粉末共混物中添加液体成分并制粒,以及挤出制粒的粉末共混物以提供挤出物来制造组合物。
在另一个示例性实施例中,组合物可以通过以下制造:制备固体成分的粉末共混物[例如,称量粉末材料,使粉末材料通过筛子,混合粉末材料(例如,在搅拌机中)];制备液体成分的液体溶液(例如,称量液体材料,合并液体成分);制粒(例如,将粉末共混物倒入Hobart行星式混合器中,在搅拌下,将液体添加到粉末共混物中进行制粒);以及挤出颗粒(例如,将最终的制粒的共混物转移到挤出机中,并通过模具挤出)。
在另一个示例性实施例中,组合物可以根据以下程序制造:(a)制备粉末共混物:将粉末材料称重并通过筛子(例如,1000μm筛)。将粉末倒入到瓶中(例如,玻璃瓶)并在搅拌机中混合合适的时间(例如,用Turbula搅拌机混合15分钟),(b)制粒:将粉末共混物倒入到混合器(例如,Hobart行星式混合器)的碗中。将液体成分称重并制备成液体溶液。在搅拌下,将液体溶液添加到粉末共混物中进行制粒,(c)挤出:将最终的制粒的共混物转移到挤出机(例如,Gabler挤出机DE40)中,并通过模具(例如,13mm圆形模具)挤出。挤出物可以被切割成单个单元,并且在选定的条件下包装和储存。在某些实施例中,用于产生可咀嚼组合物的挤出机可以是来自加布里勒有限公司(GABLER GmbH)的螺杆直径为40mm并且螺杆长度L/D比为10D的DE40/10D型共旋转双螺杆挤出机。在某些实施例中,来自哈克公司(Haake)(随后赛默飞世尔(ThermoFisher))的冷却器/加热器可以用于将挤出机的双层夹套维持在40℃。
在另一个示例性实施例中,组合物可以根据以下程序制造:使用箱式搅拌机将活性药物成分和着色剂与淀粉预共混。将预共混物和剩余的固体材料转移到箱式搅拌机的滚筒中。例如,共混15分钟。将粉末共混物筛分,并转移到箱式搅拌机的滚筒中。例如,共混15分钟。将粉末共混物筛分并转移到K-Tron粉末进料器中。混合甘油,任选地与抗氧化剂溶液和/或水混合,并转移到液体进料器的罐中。设定挤出工艺参数并启动挤出机。将液体混合物泵送到挤压机中。将粉末共混物计量添加到挤出机中。开始自动切割工艺。调整挤出机的切割装置,以获得适当重量的可咀嚼剂型。在挤出之后收集可咀嚼剂型,并转移到托盘中。将可咀嚼剂型在环境条件下固化至少24小时。固化之后,包装可咀嚼剂型。
在另一个示例性实施例中,组合物可以通过以下来制造:使干成分共混以提供咀嚼混合物;向咀嚼混合物中添加液体组分(例如,油、润湿剂或溶剂),并且使干成分/液体成分混合物共混以形成完全共混的混合物。在共混之后,所得的软咀嚼混合物可以通过搅拌机从端口排出到合适的容器中,用手或优选地用成形机加工成单独的剂量单位。可以使用各种成形设备,但是特别优选地使用的是为产生模制食品而开发的模制机器。例如,合适的成形设备包含由福迈斯公司(Formax Corporation)制造的福迈斯F6TM模制机器。每批可咀嚼剂型可以散装包装,或者,优选地,每个软咀嚼物然后单独包装以便储存。合适的包装材料的实例包含HDPE瓶、泡罩或箔/箔包装。
当调配物中包含活性物质涂覆的团粒时,优选地此类团粒在制造期间与干成分一起计量添加。
在另一个示例性实施例中,共混、研磨/筛分、挤出和混合的步骤可以采用表1中列出的设备来完成。
4.调配物性质
所公开的组合物可以通过一种或多种性质来表征。例如,组合物的特征可以由酸度、粘附性、咀嚼性、内聚性、断裂压缩、压缩挤出、崩解、溶出、亲脂性含量、水分含量、适口性、pH、弹性、表面孔隙率、质地、水分活性或湿润性表征。
崩解
本公开提供了具有快速崩解特性的可咀嚼组合物。所公开的组合物的崩解可以根据欧洲药典(European Pharmacopoeia)6.0的崩解方法2.9.1(测试B)进行评估。
如按照欧洲药典8.0的崩解方法2.9.1(测试B)确定的,本公开的优选组合物在水中崩解时间少于50分钟和/或在0.1M HCl中崩解时间少于30分钟。如按照欧洲药典8.0的崩解方法2.9.1(测试B)确定的,本公开的更优选组合物在水中崩解时间少于25分钟和/或在0.1M HCl中崩解时间少于20分钟。如按照欧洲药典的崩解方法2.9.1(测试B)确定的,本公开的又更优选组合物在水中崩解时间少于15分钟和/或在0.1M HCl中崩解时间少于15分钟。
如按照欧洲药典6.0的崩解方法2.9.1(测试B)确定的,在水中测量的所述组合物的崩解时间可以小于或等于60分钟、小于或等于55分钟、小于或等于50分钟、小于或等于45分钟、小于或等于40分钟、小于或等于35分钟、小于或等于30分钟、小于或等于25分钟、小于或等于20分钟、小于或等于15分钟或小于或等于10分钟。如按照欧洲药典6.0的崩解方法2.9.1(测试B)确定的,在水中测量的所述组合物的崩解时间可以为60分钟、59分钟、58分钟、57分钟、56分钟、55分钟、54分钟、53分钟、52分钟、51分钟、50分钟、49分钟、48分钟、47分钟、46分钟、45分钟、44分钟、43分钟、42分钟、41分钟、40分钟、39分钟、38分钟、37分钟、36分钟、35分钟、34分钟、33分钟、32分钟、31分钟、30分钟、29分钟、28分钟、27分钟、26分钟、25分钟、24分钟、23分钟、22分钟、21分钟、20分钟、19分钟、18分钟、17分钟、16分钟、15分钟、14分钟、13分钟、12分钟、11分钟或10分钟。
如按照欧洲药典6.0的崩解方法2.9.1(测试B)确定的,在0.1M HCl中测量的所述组合物的崩解时间可以小于或等于60分钟、小于或等于55分钟、小于或等于50分钟、小于或等于45分钟、小于或等于40分钟、小于或等于35分钟、小于或等于30分钟、小于或等于25分钟、小于或等于20分钟、小于或等于15分钟或小于或等于10分钟。如按照欧洲药典6.0的崩解方法2.9.1(测试B)确定的,在0.1M HCl中测量的所述组合物的崩解时间可以为60分钟、59分钟、58分钟、57分钟、56分钟、55分钟、54分钟、53分钟、52分钟、51分钟、50分钟、49分钟、48分钟、47分钟、46分钟、45分钟、44分钟、43分钟、42分钟、41分钟、40分钟、39分钟、38分钟、37分钟、36分钟、35分钟、34分钟、33分钟、32分钟、31分钟、30分钟、29分钟、28分钟、27分钟、26分钟、25分钟、24分钟、23分钟、22分钟、21分钟、20分钟、19分钟、18分钟、17分钟、16分钟、15分钟、14分钟、13分钟、12分钟、11分钟或10分钟。
在某些实施例中,如按照欧洲药典6.0的崩解方法2.9.1(测试B)确定的,在水中测量的,在40℃和大气压下,在铝箔袋、铝泡罩包装或类似的储存容器中储存至少5天、至少10天、至少15天、至少20天、至少25天、至少30天、至少35天、至少40天、至少45天或至少50天之后,所述组合物的崩解时间可以小于或等于60分钟、小于或等于55分钟、小于或等于50分钟、小于或等于45分钟、小于或等于40分钟、小于或等于35分钟、小于或等于30分钟、小于或等于25分钟、小于或等于20分钟、小于或等于15分钟或小于或等于10分钟。如按照欧洲药典6.0的崩解方法2.9.1(测试B)确定的,在水中测量的,在40℃和大气压下,在铝箔袋、铝泡罩包装或类似的储存容器中储存至少5天、至少10天、至少15天、至少20天、至少25天、至少30天、至少35天、至少40天、至少45天或至少50天之后,所述组合物的崩解时间可以为60分钟、59分钟、58分钟、57分钟、56分钟、55分钟、54分钟、53分钟、52分钟、51分钟、50分钟、49分钟、48分钟、47分钟、46分钟、45分钟、44分钟、43分钟、42分钟、41分钟、40分钟、39分钟、38分钟、37分钟、36分钟、35分钟、34分钟、33分钟、32分钟、31分钟、30分钟、29分钟、28分钟、27分钟、26分钟、25分钟、24分钟、23分钟、22分钟、21分钟、20分钟、19分钟、18分钟、17分钟、16分钟、15分钟、14分钟、13分钟、12分钟、11分钟或10分钟。
在某些实施例中,如按照欧洲药典6.0的崩解方法2.9.1(测试B)确定的,在0.1MHCl中测量的,在40℃和大气压下,在铝箔袋、铝泡罩包装或类似的储存容器中储存至少5天、至少10天、至少15天、至少20天、至少25天、至少30天、至少35天、至少40天、至少45天或至少50天之后,所述组合物的崩解时间可以小于或等于60分钟、小于或等于55分钟、小于或等于50分钟、小于或等于45分钟、小于或等于40分钟、小于或等于35分钟、小于或等于30分钟、小于或等于25分钟、小于或等于20分钟、小于或等于15分钟或小于或等于10分钟。如按照欧洲药典6.0的崩解方法2.9.1(测试B)确定的,在0.1M HCl中测量的,在40℃和大气压下,在铝箔袋、铝泡罩包装或类似的储存容器中储存至少5天、至少10天、至少15天、至少20天、至少25天、至少30天、至少35天、至少40天、至少45天或至少50天之后,所述组合物的崩解时间可以为60分钟、59分钟、58分钟、57分钟、56分钟、55分钟、54分钟、53分钟、52分钟、51分钟、50分钟、49分钟、48分钟、47分钟、46分钟、45分钟、44分钟、43分钟、42分钟、41分钟、40分钟、39分钟、38分钟、37分钟、36分钟、35分钟、34分钟、33分钟、32分钟、31分钟、30分钟、29分钟、28分钟、27分钟、26分钟、25分钟、24分钟、23分钟、22分钟、21分钟、20分钟、19分钟、18分钟、17分钟、16分钟、15分钟、14分钟、13分钟、12分钟、11分钟或10分钟。
溶出度
所公开的组合物的溶出度可以根据欧洲药典2.9.3.“固体剂型的溶出度测试(Dissolution Test for Solid Dosage Forms)”进行评估。所公开的组合物可以在60分钟内释放至少30%、至少35%、至少40%、至少45%、至少50%、至少55%、至少60%、至少65%、至少70%、至少75%、至少80%、至少85%、至少90%或至少95%的活性成分,如根据欧洲药典2.9.3确定的。所公开的组合物可以在45分钟内释放至少30%、至少35%、至少40%、至少45%、至少50%、至少55%、至少60%、至少65%、至少70%、至少75%、至少80%、至少85%、至少90%或至少95%的活性成分,如根据欧洲药典2.9.3确定的。所公开的组合物可以在30分钟内释放至少30%、至少35%、至少40%、至少45%、至少50%、至少55%、至少60%、至少65%、至少70%、至少75%、至少80%、至少85%、至少90%或至少95%的活性成分,如根据欧洲药典2.9.3确定的。所公开的组合物可以在15分钟内释放至少60%、至少65%、至少70%、至少75%、至少80%、至少85%或至少90%的活性成分,如根据欧洲药典2.9.3确定的。表2提供了所公开的组合物的欧洲药典2.9.3溶出度测试的相关参数。
亲脂性含量
在某些实施例中,本公开的组合物包含亲脂性含量(例如,通过脂肪粉末和/或食用香料提供的)以增强适口性。虽然亲脂性材料(例如,脂肪粉末)的存在可以增强适口性,但是已经发现太高的亲脂性含量会阻碍合适剂型崩解和活性成分溶出。不希望受理论的束缚,据信剂型中过量的亲脂性含量会通过限制生理介质接触剂型内的碳酸盐或碳酸氢盐化合物而阻碍快速崩解和溶出。因此,在某些实施例中,本公开提供了具有被配置成平衡适口性和崩解剂性能的有利的亲脂性含量的组合物。在某些实施例中,基于剂型的总重量,软可咀嚼剂型包含0%-15%、0%-14%、0%-13%、0%-12%、0%-11%、0%-10%、0%-9%、0%-8%、0%-7%、0%-6%、0%-5%、0%-4%、0%-3%、0%-2%、0%-1%、1%-15%、1%-14%、1%-13%、1%-12%、1%-11%、1%-10%、1%-9%、1%-8%、1%-7%、1%-6%、1%-5%、1%-4%、1%-3%、1%-2%、2%-15%、2%-14%、2%-13%、2%-12%、2%-11%、2%-10%、2%-9%、2%-8%、2%-7%、2%-6%、2%-5%、2%-4%、2%-3%、3%-15%、3%-14%、3%-13%、3%-12%、3%-11%、3%-10%、3%-9%、3%-8%、3%-7%、3%-6%、3%-5%、3%-4%、4%-15%、4%-14%、4%-13%、4%-12%、4%-11%、4%-10%、4%-9%、4%-8%、4%-7%、4%-6%、4%-5%、5%-15%、5%-14%、5%-13%、5%-12%、5%-11%、5%-10%、5%-9%、5%-8%、5%-7%、5%-6%、6%-15%、6%-14%、6%-13%、6%-12%、6%-11%、6%-10%、6%-9%、6%-8%、6%-7%、7%-15%、7%-14%、7%-13%、7%-12%、7%-11%、7%-10%、7%-9%、7%-8%、8%-15%、8%-14%、8%-13%、8%-12%、8%-11%、8%-10%、8%-9%或9%-10%脂肪粉末含量(wt/wt)。
适口性
本公开提供了可口的组合物。如根据兽用药品委员会(Committee forMedicinalProducts for Veterinary Use,CVMP)2015年2月生效的《兽用药品适口性演示指南(Guideline on the demonstration of palatability of veterinary medicinalproducts)》[EMA/CVMP/EWP/206024/2011(2014)]测量的,组合物的适口性可以大于或等于60%、大于或等于65%、大于或等于70%、大于或等于75%、大于或等于80%、大于或等于85%、大于或等于90%或大于或等于95%。如根据兽用药品委员会(CVMP)2015年2月生效的《兽用药品适口性演示指南》[EMA/CVMP/EWP/206024/2011(2014)]测量的,组合物的适口性可以为约60%、约61%、约62%、约63%、约64%、约65%、约66%、约67%、约68%、约69%、约70%、约71%、约72%、约73%、约74%、约75%、约76%、约77%、约78%、约79%、约80%、约81%、约82%、约83%、约84%、约85%、约86%、约87%、约88%、约89%、约90%、约91%、约92%、约93%、约94%、约95%、约96%、约97%、约98%、约99%或约100%。
稳定性
本公开提供了储存稳定的组合物。所述组合物可以具有可接受的物理和化学稳定性,提供至少12、13、14、15、16、17、18、19、20、21、22、23、24、25、26、27、28、29、30、31、32、33、34、35或36个月保质期。
质地
本公开提供了可咀嚼的组合物。可咀嚼意指组合物可以被动物咀嚼,它不应该太脆以至于当动物咀嚼组合物时会破裂或折断,也不应该太软以至于当动物咀嚼组合物时会完全变形。对于本公开的优选组合物,在室温下,挤出后1小时,直径为8mm的球体以1毫米/秒的速度穿入组合物2mm所需的峰值力介于5与40N之间,更优选地介于5与25N之间,最优选地介于10与25N之间。
可咀嚼调配物的质地(柔软度/硬度)可以通过例如使用质地分析仪类型TA-XT2iHR/25来测量,所述分析仪可从稳定微系统有限公司(Stable Micro Systems Ltd.)(总部:英国拉马斯路维也纳大楼的稳定微系统有限公司(Stable Micro Systems Ltd.,ViennaCourt,Lammas Road;UK))商购获得。测量以1毫米/秒的速度推动球体穿入可咀嚼组合物1或2mm所需的峰值力(单位为N)。球体的直径为8mm。可以在挤出后的选定时间(例如,1小时)进行测量。
含量均匀度
本公开提供了具有含量均匀度的组合物。含量均匀度可以根据欧洲药典2.9.40(剂量单位的均匀度)进行评估。
5.使用方法
本公开的组合物可以用于治疗和/或控制动物的体外寄生虫感染或侵袭。所述组合物可以用作杀外寄生物剂,具体地用作杀螨剂和杀虫剂。所述组合物具体地可以用于兽医学、家畜饲养和公共健康维护领域:防治寄生在脊椎动物,具体地是温血脊椎动物,包含伴侣动物、家畜、家禽和冷血脊椎动物如鱼上寄生的螨虫、昆虫和桡足动物。体外寄生虫的非限制性实例包含:蜱(例如,硬蜱种(Ixodes spp.)(例如,蓖子硬蜱(I.ricinus)、六角硬蜱(I.hexagonus)))、扇头蜱种(Rhipicephalus spp.)(例如,血红扇头蜱(R.sanguineus))、牛蜱种(Boophilus spp.)、花蜱种(Amblyomma spp.)(例如,美洲花蜱(A.americanum)、海湾花蜱(A.maculatum)、特里斯特花蜱(A.triste)、微小花蜱(A.parvum)、卡真钝绥螨(A.cajennense)、卵圆钝眼蜱(A.ovale)、椭斑花蜱(A.oblongoguttatum)、金黄色钝眼蜱(A.aureolatum)、卡延钝眼蜱(A.cajennense))、璃眼蜱种(Hyalomma spp.)、血蜱种(Haemaphysalis spp.)、矩头蝉种(Dermacentor spp.)(例如,变异革蜱(D.variabilis)、安氏革蜱(D.andersoni)、边缘革蜱(D.marginatus)、钝缘蜱种(Ornithodorus spp.)等);螨(例如,皮刺螨种(Dermanyssus spp.)、疥螨种(Sarcoptesspp.)(例如,山羊疥螨(S.scabiei))、痒螨种(Psoroptes spp.)(例如,牛痒螨(P.bovis)、耳螨种(Otodectes spp.)、足螨种(Chorioptes spp.)、蠕形螨种(Demodexspp.)、(例如,毛囊脂螨病(D.folliculorum)、犬蠕形螨(D.canis)和皮脂蠕形螨(D.brevis)等):咀嚼和吮吸虱子(例如,畜虱种(Damalinia spp.)、毛虱种(Linognathus spp.)、姬螯螨种(Cheyletiella spp.)、(Haematopinus spp.)、水牛盲种(Solenoptes spp.)、啮毛虱种(Trichodectes spp.)、猫虱种(Felicola spp.)等);跳蚤(例如,隐翅种(Siphonapteraspp.)、栉头蚤种(Ctenocephalides spp.)等);叮咬苍蝇、蠓和蚊子(例如,斑虻种(Tabanidaespp.)、血蝇种(Haematobia spp.)、家蝇种(Musca spp.)、螫蝇种(Stomoxys spp.)、皮蝇种(Dematobia spp.)、锥蝇种(Cochliomyia spp.)、墨蚊种(Simuliidae spp.)、蠓种(Ceratopogonidae spp.)、毛蠓种(Psychodidae spp.)、伊蚊种(Aedes spp.)、库蚊种(Culexspp.)、按蚊种(Anophles spp.)、绿蝇种(Lucilia spp.)、白蛉种(Phlebotomus spp.)、罗蛉种(Lutzomyia spp.)等);床虱(例如,麦蛾属和麦蛾科的昆虫);以及蛴螬(例如,牛皮蝇(Hypoderma bovis)、纹皮蝇(H.lineatum);以及桡足动物(例如,管口纲中的海虱,包含海虱属和鱼虱属)。
本公开的组合物可以用于治疗和/或控制体内寄生虫,例如蠕虫(例如,吸虫、绦虫和线虫),包含心蠕虫、蛔虫、钩虫、鞭虫、吸虫和绦虫。胃肠蛔虫包含例如奥斯特线虫(包含受抑制的幼虫)、竖琴奥斯特线虫(O.lyrata)、柏氏血矛线虫(Haemonchusplacei)、似血矛线虫(H.similis)、捻转血矛线虫(H.contortus)、犬弓蛔虫(Toxocaracanis)、狮弓蛔虫(T.leonina)、猫弓蛔虫(T.cati)、艾氏毛圆线虫(Trichostrongylus axei)、蛇形毛圆线虫(T.colubriformis)、长刺毛圆线虫(T.longispicularis)、肿孔古柏线虫(Cooperiaoncophora)、点状古柏线虫(C.pectinata)、有斑古柏线虫(C.punctata)、苏尔纳巴达古柏线虫(C.surnabada)(麦克马斯特古柏线虫(syn.mcmasteri))、匙突古柏线虫(C.spatula)、猪蛔虫(Ascaris suum)、红色猪圆线虫(Hyostrongylus rubidus)、牛仰口线虫(Bunostomum phlebotomum)、牛毛细线虫(Capillaria bovis)、羊仰口线虫(B.trigonocephalum)、乳突类圆线虫(Strongyloides papillosus)、兰氏类圆线虫(S.ransomi)、辐射节线虫(Oesophagostomum radiatum)、有齿节线虫(O.dentatum)、哥伦比亚节线虫(O.columbianum)、长尾节线虫(O.quadrispinulatum)、鞭虫种(Trichurisspp.)等。其它寄生虫包含:钩虫(例如,犬钩虫(Ancylostoma caninum)、猫钩虫(A.tubaeforme)、巴西钩虫(A.braziliense)、狭头钩虫(Uncinaria stenocephala))、肺蠕虫(例如,牛肺虫(Dictyocaulus viviparus)和后圆线虫种(Metastrongylus spp));眼虫(例如,眼线虫种(Thelazia spp.));寄生期蛴螬(例如,牛皮蝇、纹皮蝇、人皮蝇(Dermatobia hominis))、肾虫(例如,猪肾虫(Stephanurus dentatus));螺旋蠕虫(例如,嗜人锥蝇(Cochliomyiahominivorax)(幼虫));丝虫总科和盘尾丝虫科的线状丝虫。盘尾丝虫科中的线状丝虫的非限制性实例包含布鲁格丝虫属(即,马来布鲁丝虫(B.malayi)、彭亨布鲁丝虫(B.pahangi)、帝纹布鲁丝虫(B.timori)等)、吴策线虫属(Wuchereria spp.)(即,班氏吴策线虫(W.bancrofti)等)、恶丝虫属(Dirofilaria spp.)(犬恶丝虫(D.immitis)、匐行恶丝虫(D.repens)、熊恶丝虫(D.ursi)、细恶丝虫(D.tenuis)、斯佩坦恶丝虫(D.spectans)、卢特雷恶丝虫(D.lutrae)等)、棘唇线虫属(Dipetalonema spp.)(即,隐现棘唇线虫(D reconditum)、三叶棘唇线虫(D.repens)等)、盘尾丝虫属(Onchocerca spp.)(即,吉氏盘尾丝虫(O.gibsoni)、喉瘤盘尾丝虫(O.gutturosa)、旋盘尾丝虫(O.volvulus)等)、丝绒虫属(Elaeophora spp.)(伯氏丝绒虫(E.bohmi)、伊拉非丝绒虫(E.elaphi)、波尔丝绒虫(E.poeli)、矢形纹丝绒虫(E.sagitta)、施氏丝绒虫(E.schneideri))、曼森线虫属(Mansonella spp.)(即,奥氏曼森线虫(M.ozzardi)、常现曼森线虫(M.perstans)等)以及罗阿丝虫属(Loa spp.)(即,罗阿丝虫(L.loa))。
本公开的组合物可以用于治疗和/或控制具体地蠕虫,其中体内寄生线虫和吸虫可能是哺乳动物和家禽的严重疾病的原因。这种症状的典型线虫是:丝虫(Filariidae)、丝状虫(Setariidae)、血矛线虫(Haemonchus)、毛圆线虫(Trichostrongylus)、胃线虫(Ostertagia)、细颈线虫(Nematodirus)、古柏线虫(Cooperia)、蛔虫(Ascaris)、仰口线虫(Bunostonum)、结节线虫(Oesophagostonum)、夏伯蒂亚(Charbertia)、鞭虫(Trichuris)、圆线虫(Strongylus)、毛样线虫(Trichonema)、网尾线虫(Dictyocaulus)、毛细线虫(Capillaria)、盲肠虫(Heterakis)、弓蛔虫(Toxocara)、禽蛔虫(Ascaridia)、尖尾线虫(Oxyuris)、钩口线虫(Ancylostoma)、钩虫(Uncinaria)、弓蛔虫(Toxascaris)和副蛔虫(Parascaris)。吸虫具体地包含片形吸虫科(Fasciolideae),尤其是肝片形吸虫(Fasciolahepatica)。
线虫属、古柏线虫种和结节线虫种的某些寄生虫寄生在宿主动物的肠道中,而血矛线虫种和奥斯特线虫种的其它寄生虫寄生在胃中,并且网尾线虫种的寄生虫寄生在肺组织中。这些科的寄生虫可以在内部细胞组织和器官,例如心脏、血管、淋巴管和皮下组织中发现。特别显著的寄生虫是犬的心丝虫,犬恶丝虫(Dirofilaria iminitis)。
可以通过本公开的组合物治疗和/或控制的寄生虫包含来自绦虫纲(绦虫)的寄生虫,例如中带绦虫科,尤其是中带绦虫属,具体地线中殖孔绦虫(M.lineatus):复孔绦虫科(Dipylidiidae),尤其是犬复孔绦虫(Dipylidium caninum)、乔伊种,具体地帕斯夸利乔伊绦虫(Joyeuxiella pasquali)和复孔绦虫种(Diplopylidium spp.),以及带绦虫科(Taeniidae),尤其是豆状带绦虫(Taenia pisformis)、獐绦虫(Taenia cervi)、羊绦虫(Taeniaovis)、水泡绦虫(Taeneia hydatigena)、多头带绦虫(Taenia multiceps)、巨颈绦虫(Taeniataeniaeformis)、连续带绦虫(Taenia serialis)和棘球绦虫种(Echinococcusspp.),最具体地是水疱绦虫(Taneia hydatigena)、卵带绦虫(Taenia ovis)、多棘带绦虫(Taeniamulticeps)、连续带绦虫(Taenia serialis);细粒棘球绦虫(Echinococcusgranulosus)和多房棘球绦虫(Echinococcus multilocularis)。
此外,本公开的组合物可以用于治疗和/或控制人类致病寄生虫。其中,消化道中出现的典型代表是钩虫属、板口线虫属、蛔虫属、类圆线虫属、旋毛虫属、毛细线虫属、鞭虫属和蛲虫属。本公开的组合物也适用于对抗来自龙线虫科的线虫属、盘尾丝虫属和罗阿丝虫属的寄生虫,以及具体地感染胃肠道的类圆线虫属和旋毛虫属的寄生虫。
由本公开的组合物治疗和/或控制的特定寄生虫是心丝虫(犬恶丝虫)。此类治疗的特定受试者是狗和猫。
本公开的组合物可以用于治疗和/或控制蜱感染(六角硬蜱、蓖麻硬蜱和血红扇头蜱、网纹革蜱),用于治疗和/或控制跳蚤感染(猫栉首蚤和犬栉首蚤)。
本公开的组合物可以用于治疗和/或控制成年跳蚤和预防新的跳蚤感染(猫栉首蚤):治疗和/或控制蜱感染[变异矩头蜱(美洲狗蜱)、肩突硬蜱(黑腿蜱)、血红扇头蜱(棕色狗蜱)、美洲钝眼蜱(孤星蜱)、网纹革蜱、蓖子硬蜱和六角硬蜱];通过降低未成熟成虫(L5)脉管圆线虫的感染水平来治疗和/或控制8周龄及以上并且体重4.4磅(2kg)或以上的狗的线虫病:心丝虫病(犬恶丝虫)、血管圆线虫病、成年钩虫(犬钩虫)、成年蛔虫(犬弓蛔虫、狮弓蛔虫)和成年鞭虫(犬鞭虫)感染,以及绦虫(犬复孔绦虫、豆状带绦虫、多房棘球绦虫和细粒棘球绦虫)感染。
本公开提供了一种用于治疗寄生虫的方法,所述方法包括:向有需要的受试者施用包含有效量的活性成分和碳酸氢钠的可咀嚼组合物,所述方法任选地进一步包括有效量的至少一种另外的活性化合物。
本公开提供了一种用于控制寄生虫的方法,所述方法包括:向有需要的受试者施用包含有效量的活性成分和碳酸氢钠的可咀嚼组合物,所述方法任选地进一步包括有效量的至少一种另外的活性化合物。
本公开提供了用于治疗寄生虫的可咀嚼组合物的制造,所述组合物包含活性成分和碳酸氢钠。在某些实施例中,本公开提供了用于控制寄生虫的可咀嚼组合物的制造,所述组合物包含活性成分和碳酸氢钠。
本公开提供了用于在疗法中使用的本发明的可咀嚼组合物。本公开提供了用于控制动物体内或体表的寄生虫的本发明的可咀嚼组合物,所述可咀嚼组合物包括有效量的针对寄生虫具有活性的一种或多种药剂。本公开进一步提供了用于预防和/或治疗由寄生虫传播的疾病的本发明的可咀嚼组合物,所述可咀嚼组合物包括有效量的针对寄生虫具有活性的一种或多种药剂。
本公开提供了本发明的可咀嚼组合物用于制造用于控制动物体内或体表的寄生虫的药物的用途,所述可咀嚼组合物包括有效量的针对寄生虫具有活性的一种或多种药剂。本公开进一步提供了本发明的包括有效量的针对寄生虫具有活性的一种或多种药剂的可咀嚼组合物用于制备用于预防和/或治疗由寄生虫传播的疾病的药物中的用途。
本公开提供了一种控制有需要的动物体内或体表寄生虫的方法,所述方法包括施用本公开的可咀嚼组合物,所述组合物包括有效量的对寄生虫具有活性的一种或多种药剂。本公开进一步提供了一种预防和/或治疗有需要的动物的由寄生虫传播的疾病的方法,所述方法包括施用本公开的可咀嚼组合物,所述组合物包括有效量的对寄生虫具有活性的一种或多种药剂。
本公开提供了本公开的可咀嚼组合物在控制动物体内或体表的寄生虫的用途,所述可咀嚼组合物包括有效量的针对寄生虫具有活性的一种或多种药剂。
本公开的组合物可以与一种或多种其它活性化合物或疗法组合,用于治疗一种或多种病症、疾病或病状,包含治疗寄生虫。本公开的组合物可以与一种或多种用于治疗寄生虫或其它病症的化合物或疗法组合同时、依次或单独施用。
6.实例
本发明具有多个方面,通过以下非限制性实施例展示。
实例1
表1示出了七种可咀嚼调配物(LS7_01、02、04、05、06、07和08),其含有作为活性物质的洛替拉纳、吡喹酮和米尔贝肟,以及作为崩解剂的碳酸氢钠,以及一种不含碳酸氢钠的参照调配物(LS_03)。
碳酸氢钠以0.5%至4.0%的水平添加。评估调配物中碳酸氢钠的有效水平,以影响合适的药物从调配物中释放出来。
表1.含碳酸氢钠的可咀嚼调配物
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根据以下程序制备所有八种调配物。将粉末材料称重并通过1000μm筛子。将粉末倒入玻璃瓶中,并用Turbula搅拌机混合15分钟。将粉末共混物倒入到Hobart行星式混合器的碗中。将液体成分称重并制备成液体溶液。在搅拌下,将液体添加到粉末共混物中进行制粒。将最终的制粒的共混物转移到Gabler挤出机DE40中,并通过13mm圆形模具挤出。挤出物被切割成单个单元,并且在定义的条件下包装和储存。
根据表2中所描述的溶出程序对所有八种调配物进行了评估。可咀嚼调配物中碳酸氢钠的水平显著影响所有三种活性成分(洛替拉纳、吡喹酮、米尔贝肟)的药物释放。如图1所示,调配物中的碳酸氢钠含量越高,药物释放越快。高于3.0%时,检测不到进一步的增加。在存在3%碳酸氢钠的情况下,约80%的活性成分在30分钟之后释放。
表2.可咀嚼调配物的溶出度测试
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实例2
在实验室稳定性研究中评估了表3的调配物(LS_01-08)。将样品装入密封的铝袋中,并在25℃/60%rH和40℃/75%rH的受控条件下储存。根据表2的程序,在1、3、4和6个月的时间点评估溶出度曲线。包含3%或4%碳酸氢钠的调配物在所有储存条件下显示出稳定的、不随时间变化的溶出度曲线。碳酸氢钠的崩解作用在老化调配物中是有效的,在加速条件下以3%或更高的碳酸氢钠水平储存6个月。
表3.含碳酸氢钠的可咀嚼调配物
根据以下程序制备所有四种调配物。将所有粉末材料称重并通过1000μm筛子。将粉末倒入玻璃瓶中,并用Turbula搅拌机混合15分钟。将粉末共混物倒入到Hobart行星式混合器的碗中。将液体成分称重并制备成液体溶液。在搅拌下,将液体添加到粉末共混物中进行制粒。将最终的制粒的共混物转移到Gabler挤出机DE40中,并通过13mm圆形模具挤出。挤出物被切割成单个单元,并且在定义的条件下包装和储存。
如根据表2的评估的,可咀嚼调配物中的碳酸氢钠的水平显著影响所有三种活性成分的药物释放。调配物中的碳酸氢钠含量越高,药物释放越快。高于3.0%时,检测不到进一步的增加。在存在3%碳酸氢钠的情况下,约80%的活性成分在30分钟之后释放。
实例3
表4示出了含有作为活性物质的洛替拉纳、莫西菌素和吡喹酮以及作为崩解剂的碳酸氢钠的可咀嚼调配物。吡喹酮通过双涂层团粒(经吡喹酮涂覆的微晶纤维素基底,以及EPO掩味二次涂层)存在于LS14_04中。包含200-400μm较大粒度级分的碳酸氢钠的LS14_03中的活性成分的药物释放受到不利影响。图2示出了LS14_04表现出所有活性成分的快速溶出。
表4.含碳酸氢钠的可咀嚼调配物
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实例4
表5示出了含有作为活性物质的洛替拉纳、莫西菌素、吡喹酮掩味团粒和双羟萘酸噻嘧啶以及作为崩解剂的碳酸氢钠的可咀嚼调配物。碳酸氢钠以4.0%的水平添加。评估所述调配物的崩解和溶出性能。图3示出了LS16_04表现出所有活性成分的快速溶出。
表5.含碳酸氢钠的可咀嚼调配物
实例5
表6示出了含有作为活性物质的洛替拉纳、莫西菌素、吡喹酮掩味团粒和莫奈太尔以及作为崩解剂的碳酸氢钠的可咀嚼调配物。碳酸氢钠以4.0%的水平添加。
表6.含碳酸氢钠的可咀嚼调配物
应当理解,前述详细描述及所附实施例仅是说明性的,且不应被视为对本发明之范畴之限制,本发明之范畴仅由所附申请专利范围及其等同物来限定。
对揭示之实施例之各种改变及修改对于本领域中熟习此项技术者来说将显而易见。在不脱离本发明之精神及范畴之情况下,可进行此类改变及修改,包含但不限于与本发明之化学结构、取代基、衍生物、中间体、合成、组合物、调配物或使用方法相关的彼等改变及修改。
Claims (17)
1.一种可咀嚼兽用组合物,其包括:
活性药物成分;以及
碳酸盐化合物。
2.根据权利要求1所述的组合物,其中所述碳酸盐化合物是碳酸氢钠。
3.根据权利要求2所述的组合物,其包括0.5%至40.0%(wt/wt)碳酸氢钠。
4.根据权利要求2或权利要求3所述的组合物,其包括1.0%至4.0%(wt/wt)碳酸氢钠。
5.根据权利要求1至4中任一项所述的组合物,其包括异噁唑啉类杀寄生虫剂作为活性药物成分。
6.根据权利要求1至5中任一项所述的组合物,其包括洛替拉纳(lotilaner)、氟拉拉纳(fluralaner)、阿福拉纳(afoxalaner)或沙罗拉纳(sarolaner)。
7.根据权利要求1至6中任一项所述的组合物,其包括大环内酯类杀寄生虫剂。
8.根据权利要求1至7中任一项所述的组合物,其包括莫西菌素(moxidectin)或米尔贝肟(milbemycin oxime)。
9.根据权利要求1至8中任一项所述的组合物,其包括吡喹酮(praziquantel)。
10.根据权利要求1至9中任一项所述的组合物,其包括双羟萘酸噻嘧啶(pyrantelpamoate)。
11.根据权利要求1至10中任一项所述的组合物,其包括莫奈太尔(monepantel)。
12.根据权利要求1至11中任一项所述的组合物,其中所述碳酸盐化合物,优选地碳酸氢钠的平均粒度为10-250μm、20-200μm、30-150μm或40-100μm。
13.根据权利要求1至12中任一项所述的组合物,其中所述碳酸盐化合物,优选地碳酸氢钠的平均粒度为30-150μm。
14.根据权利要求1至13中任一项所述的组合物,其中所述碳酸盐化合物,优选地碳酸氢钠的平均粒度为40-100μm。
15.根据权利要求9至14中任一项所述的组合物,其中所述吡喹酮作为经吡喹酮涂覆的团粒掺入到剂型中。
16.根据权利要求15所述的组合物,其中所述经吡喹酮涂覆的团粒包括:(i)团粒基底(例如,包含微晶纤维素);(ii)位于所述团粒的至少一部分之上的第一涂层,所述第一涂层包括吡喹酮;以及任选地(iii)位于所述第一涂层的至少一部分之上的第二涂层,所述第二涂层包括生理学上可接受的聚合物(例如,甲基丙烯酸二甲氨基乙酯共聚物)。
17.一种可咀嚼兽用组合物,其包括:
0.5%至25%(wt/wt)异噁唑啉(例如,洛替拉纳、沙罗拉纳、氟拉拉纳或阿福拉纳);
0.005%至1%(wt/wt)莫西菌素;
1%至10%(wt/wt)吡喹酮;
5%至30%(wt/wt)双羟萘酸噻嘧啶;以及
1.0%至10.0%(wt/wt),优选地1.0%至5.0%(wt/wt),更优选地4.0%(wt/wt)碳酸氢钠。
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