Persistent discharge multiple particulate condition oral medicine form 机翻标题: 暂无翻译,请尝试点击翻译按钮。

源语言标题
(JP5654750) 持続​性​放出​マルチ​微粒子​状​経口​医薬​形態
公开号/公开日
JP5654750 B2 2015-01-14 [JP5654750]JP2009537610 A 2009-10-29 [JP2009537610] / 2015-01-142009-10-29
申请号/申请日
2009JP-0511528 / 2007-05-24
发明人
Ginberute Florence;Darugera Furederi;
申请人
FLAMEL TECHNOLOGIES;
主分类号
IPC分类号
A61K-009/16A61K-009/20A61K-009/48A61K-031/485A61K-047/02A61K-047/04A61K-047/14A61K-047/18A61K-047/32A61K-047/34A61K-047/36A61K-047/38A61K-047/42A61K-047/44A61P-023/00A61P-025/04
摘要
(JP5654750) Modified-release multimicroparticulate pharmaceutical form capable of maintaining the modified release of the active ingredient in an alcoholic solution and of withstanding attempts at misuse.
机翻摘要
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地址
代理人
代理机构
;
优先权号
2006FR-0004685 2006-05-24 2007WO-EP55069 2007-05-24
主权利要求
(JP5654750)  Claims machine translated from Japanese 1. Being the oral medicine form which obstructs the excess amount discharge under existing of alcohol, as for the aforementioned oral medicine form, At least the active ingredient of 1 types (AP) you could do discharge alteration, the particulate of reservoir type;   Poly- (meta) acrylic acid, poly- alkylene glycol, poly- alkylene oxide and poly- vinyl pyrolidone, at least viscous medicine V of 1 where it is chosen from the group which consists of gelatin, [natoriumuarugineto], pectin, [guaru], [kisantan], [karagenan] and Guerlain types: The methyl cellulose, the hydroxypropyl cellulose, the hydroxypropyl methyl cellulose, the hydroxyethyl cellulose, the carboxymethyl cellulose and those salts, the medicine D which is chosen from the building a bridge carboxymethyl cellulose and the group which consists of those blends;   Implication, As the particulate of the aforementioned reservoir type includes the aforementioned active ingredient, at the same time, makes the discharge alteration of AP secure, simultaneously it is the coating particulate which includes the coating layer R which grants the tolerance for pulverization vis-a-vis the coating particulate of AP, As for the aforementioned coating layer R, It is insoluble in the fluid of the alimentary canal, weight ratio 60% is between 90% vis-a-vis the weight of coating layer R, at least film formation characteristic of 1 types ([ko]) polymer A1;   It is soluble in the fluid of the alimentary canal, weight ratio 5% is between 40% vis-a-vis the weight of coating layer R, at least ([ko]) of 1 types polymer A2;   Weight ratio 1% is between 30% vis-a-vis the weight of coating layer R, at least plasticizer A3 of 1 types;   Implication, As for the aforementioned coating layer R, weight % with the mass amount ratio Tp which is displayed is the 30-60 with the dry standard for the total mass of the coating particulate, As for the aforementioned viscous medicine, the particulate of AP is form of the particulate which differs, The aforementioned medicine D exists in the blend of the particulate of AP, or it is one among the external components of monolith form, The aforementioned medicine form. 2. Medicine form, AP forms the complex whose solubility is little in the water or water alcoholic solution, to include also the deactivation medicine Q of 1 types at least, as for the aforementioned deactivation medicine Q, The anionic characteristic organic salt which is chosen from sodium dodecyl sulfate and [natoriumudokuseto];   The organic cation characteristic salt which is chosen from bromination [torimechirutetoradeshiruanmoniumu] and chloridation [benzoetoniumu];  And Strongly the acidic cation exchange resin, or it is strong according to the polarity of AP the basic anionic exchange resin;  And these blends The empty it is chosen, in claim 1 oral medicine form of statement. 3. Medicine D, exists in the ratio of 0.5%-30%w/w of total mass of the unit form, in claim 1 or 2 oral medicine form of statement. 4. Medicine D, exists in the ratio of 1%-20%w/w of total mass of the unit form, in claim 1 or 2 oral medicine form of statement. 5. Coating layer R, at least the interfacial active agent of 1 types and/or the lubricant of 1 types and/or the inorganic bulking agent of 1 types and/or furthermore includes the organic bulking agent A4 of 1 types, as for A4 weight ratio is 40% or less vis-a-vis the weight of coating layer R, either of the claim 1-4 in one section oral medicine form of statement. 6. A1 group below: Ethyl cellulose and cellulose acetate, (The copolymer of meta) acrylic acid and alkyl ester, the copolymer, ethylacrylate, methyl methacrylate of acrylic acid ester and the methacrylic acid ester which at least possess one four class ammonium bases and the copolymer of [torimechiruanmonioechirumetakurireto], Poly- vinyl acetate, And those blends;   From it is selected, A2 group below: Poly- acrylamide, poly- - [N]-biniru amide and poly- vinyl pyrolidone (PVP) and poly- - the nitrogen content which is chosen from the group which includes [N]-biniru lactam ([ko]) the polymer, Water soluble derivative of cellulose, Poly- vinyl alcohol (PVA), Poly- alkylene oxide, Polyethylene glycol (PEG), And those blends;   From it is selected, A3 group below: Cetyl alcoholic ester, Subordinate group below: Acetylation glyceride, it is chosen from [guriserirumonosuteareto], [guriserirutoriaseteto] and [guriserirutoribuchireto], the glycerine and those ester, Subordinate group below: It is chosen from dibutyl phthalate, diethyl phthalate, dimethyl phthalate and the dioctyl phthalate, phthalate, Subordinate group below: It is chosen from [asechirutoribuchirushitoreto], [asechirutoriechirushitoreto], [toribuchirushitoreto] and [toriechirushitoreto], [shitoreto], Subordinate group below: It is chosen from [jiechirusebaketo] and [jibuchirusebaketo], [sebaketo], Agitation Pate, [azereto], Benzoate, Vegetable oil, [humareto], [mareeto], [okisareto], [sukushineto], Butyrate, Cetyl alcoholic ester, [maroneto], Castor oil, And those blends;   From it is selected, A4 group below: It is chosen from the alkaline metal of the fatty acid or the subordinate group of the alkaline earths metal salt, the anionic characteristic interfacial active agent, Poly- oxy ethylation oil, Polyoxyethylene - polyoxypropylene copolymer, Poly- oxy ethylation sorbitan ester, Poly- solvate, Poly- oxy ethylation castor oil derivative, Steering rate, [suteariruhumareto], [guriserorubeheneto], Talc, Colloid silica, Titanium oxide, magnesium oxide, Bentonite, Crystallite characteristic cellulose, Kaolin, Silica aluminum, And those blends, From it is selected, in claim 1 or 5 oral medicine form of statement. 7. Concerning each component A1 of coating layer R, A2 and A3, (total mass A1+A2+A3+A4 % as,) that mass m, Concerning A1, 60<=m<=80;   Concerning A2, 5<=m<=25;   Concerning A3, 2<=m<=20 It supports, in claim 1 oral medicine form of statement. 8. Component A4, is weight ratio 20% or less of total weight of coating layer R, in claim 5 oral medicine form of statement. 9. Coating layer R weight % with is displayed with dry standard, the mass amount ratio Tp for the total mass of the coating particulate is the 40-60, either of the claim 1-8 in one section oral medicine form of statement. 10. Viscous medicine V polymer below group: Polyethylene glycol, Polyethylene oxide, And those blends From it is selected, either of the claim 1-9 in one section oral medicine form of statement. 11. It is impossible, the particulate of viscous medicine V and the particulate of AP resembles to have the density which size it is distributed and resembles, to separate mutually due to the screen applying in claim 1 oral medicine form of statement. 12. Medicine form, exists with tablet unit form, At least, medicine D of 1 types exists in the ratio of 1%-30%w/w of total mass of unit form, the said form furthermore includes the compressed *** shape medicine, either of the claim 1-11 in one section oral medicine form of statement. 13. Medicine form, exists with gelatin capsule unit form, At least, medicine D of 1 types exists in the ratio of 0.5%-20%w/w of total mass of unit form, either of the claim 1-11 in one section oral medicine form of statement. 14. Medicine form, at least, The particulate of AP which was covered with the coating which possesses tolerance in pulverization;   Ion-exchange resin;   Polyoxyethylene;   Methyl cellulose, It includes, either of the claim 1-13 in one section oral medicine form of statement. 15. Medicine form, at least, The particulate of AP which was covered with the coating which possesses tolerance in pulverization;   Ion-exchange resin;   Polyoxyethylene;   Methyl cellulose;   Hydroxyethyl cellulose, It includes, either of the claim 1-14 in one section oral medicine form of statement. 16. It exists with form of the gelatin capsule which was covered with the medicine D where the aforementioned medicine form designates the sodium carboxymethyl cellulose or the hydroxyethyl cellulose as the foundation, in claim 13 oral medicine form of statement. 17. Active ingredient below: [asetoruhuin], acetyl - ***.alpha.-mechiruhuentaniru and [asechirujihidorokodein], acetyl meta doll, [aruhuentaniru] and allyl professional gin, ***.alpha.-sechiru meta doll, I [mepurojin], I meta doll, ***.alpha.-mechiruhuentaniru, ***.alpha.-mechiruchiohuentaniru and I professional gin, [anirerijin], atropine, [butoruhuanoru] and [benzechijin], benzyl morphine, ***.beta.-hidorokishihuentaniru, ***.beta.-hidorokishi methyl - 3 - [huentaniru], ***.beta.-sechiru meta doll, I [mepurojin], I meta doll, I professional gin, [bejitoramido], [bupurenoruhuin], [jiokisahuechirubuchireto] and [shikurazoshin], canna bis, [setobemidon] and [kuronitazen], codeine and coca, cocaine, [kodokishimu], [dezoshin], [jimenokisadoru], [jiokisahuechirubuchireto], [desomoruhuin], [dekusutoromoramido], [dekusutoropuropokishihuen], [jianpuromido], [jiechiruchiamubuten], [jihuenokishin], [jihidorokodein], [jihidoroetoruhuin], [jihidoromoruhuin] and [jimenokisadoru][jimehueputanoru], [jimechiruchiamubuten], [jihuenokishireto], [jipipanon], [dorotebanoru], [eputazoshin], [etoheputajin], [echirumechiruchiamubuten], [etonitazen], [ekugonin], ephedrine and [echirumechiruchiamubuten], ethyl morphine, [etonitazen], [etoruhuin], [etokiserijin], [huentaniru], [hurechijin] and heroin, hydro codon, hydro mol phenol, hydro mol phone, [hidorokishipechijin], [isometadon], [ketobemidon], [rebaroruhuan], [rohuentaniru], [rebometoruhuan], [rebomoramido], [rebohuenashirumoruhuan], [reboruhuanoru] and [meputajinoru], meperidine, [metazoshin], methadone, [mechirudesoruhuin], [mechirujihidoromoruhuin] and [mechiruhuenideto], methyl - 3 - [chiohuentaniru], methyl - 3 - [huentaniru], [metopon], [moramido] and mol ferri gin, morphine, [mirohuin], [narubuhuin], narceine, [nikomoruhuin], [norureboruhuanoru], [norumetadon], [naroruhuin] and [norumoruhuin][nikokodein], [nikojikodein], [nikomoruhuin], [noruashimetadoru], [norukodein], [norureboruhuanoru], [norumetadon], [norumoruhuin], [norupipanon] and the opium, the oxy codon, the oxy mol phone, [papaberetsumu], [huenadokison], [huenoperijin], [puromedoru], [puroperijin], [puropiramu] and [puropokishihuen], para - [huruorohuentaniru], [pentazoshin], [pechijin], [huenamupuromido], [huenazoshin], [huenomoruhuan], [huenoperijin], [horukojin], [piminojin], [piritoramido], [puroheputajin], [puropuranororu], [puroperijin], [puropiramu], [rasemetoruhuan], [rasemoramido], [rasemoruhuan], [remihuentaniru], [suhuentaniru], [tebakon], [tebain], [chiohuentaniru] and the Chilean gin, [torimeperijin] and [toramadoru] and the salt which those can allow pharmacology, it is selected from ester, the hydrate, the multiformity and isomer and those blends,Either of claim 1-16 in one section oral medicine form of statement. 18. AP, the hydrochloric acid oxy codon, the sulfuric acid morphine, the hydrochloric acid oxy mol phone and the hydrochloric acid hydro mol phone, is the pain reliever which is selected from the hydrochloric acid hydro codon and the group which consists of hydrochloric acid [toramadoru], either of the claim 1-17 in one section oral medicine form of statement.
法律状态
(JP5654750) LEGAL DETAILS FOR JP2009537610  Actual or expected expiration date=2027-05-24    Legal state=ALIVE    Status=GRANTED     Event publication date=2007-05-24  Event code=JP/APP  Event indicator=Pos  Event type=Examination events  Application details  Application country=JP JP2009511528  Application date=2007-05-24  Standardized application number=2009JP-0511528     Event publication date=2009-10-29  Event code=JP/A  Event indicator=Pos  Event type=Examination events  Published application  Publication country=JP  Publication number=JP2009537610  Publication stage Code=A  Publication date=2009-10-29  Standardized publication number=JP2009537610     Event publication date=2012-03-26  Event code=JP/A977  Event type=Examination events  Report on retrieval  Effective date of the event=2012-03-26  JAPANESE INTERMEDIATE CODE: A971007     Event publication date=2012-04-11  Event code=JP/A131  Event indicator=Neg  Event type=Examination events  Notification of reasons for refusal  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专利类型码
B2A
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