HUE035492T2 - Törésnek ellenálló adagolási formák retardált hatóanyag-leadással - Google Patents
Törésnek ellenálló adagolási formák retardált hatóanyag-leadással Download PDFInfo
- Publication number
- HUE035492T2 HUE035492T2 HUE12001792A HUE12001792A HUE035492T2 HU E035492 T2 HUE035492 T2 HU E035492T2 HU E12001792 A HUE12001792 A HU E12001792A HU E12001792 A HUE12001792 A HU E12001792A HU E035492 T2 HUE035492 T2 HU E035492T2
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- minutes
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- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
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- B29C43/00—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
- B29C43/22—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of indefinite length
- B29C43/24—Calendering
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
- B29C45/0001—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor characterised by the choice of material
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- B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
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- B29K2105/0035—Medical or pharmaceutical agents
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- B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
- B29K2105/0005—Condition, form or state of moulded material or of the material to be shaped containing compounding ingredients
- B29K2105/0044—Stabilisers, e.g. against oxydation, light or heat
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
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- B29K2995/00—Properties of moulding materials, reinforcements, fillers, preformed parts or moulds
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Claims (5)
- As; EE z 4T§ WS fejétrpmszárnú európai caabédalem igénypontjainak magyár tördlfeear1, Adagolási forma, amely tartalmaz - fizloíégiásan Hatásos anyagot (A), - adok esetben egy vagy több feoiőgfosan elviselhető segédanyagot (8); - szintetikus pohmert tCi; és - adott esetben temtészetes, leíszinteukus vagy szintetikus viaszt (D). ahol az (A) anyag retardmétnxban van jele· ·; ahoi a retardmátrix a (C) polimert és/vegy az adott esetben jelenlevő {Dl viaszt tartalmazza retardmáfnx anyagként; ahol a (C) polimer polialkilén-oxid, amely a poiimetiíén-oxid, polfetlién-oxid, polspropiléa-oxid, ezek kopolirnerjei, ezek blokk-kopohmegei és ezek keveréke; köréből van kiválasztva, ahol a (C) polimer v-szkozltás szerint! átlagos molekulatömege legalább C\5 10y g/mol; és ahol az adagolási forma - törési szilárdsága legalább 400 N: és - fiziológiás körülmények között 5 éra után leadja az (A) anyag legfeljebb 08 %~át; azzal a megkötéssel, hogy az adagolási forma (1) nem olyan tabletta. amelynek törési szilárdsága legalább 500 N.: teljes tömege 300.0 mg; átmérője 10 mm és görbületi sugara 3 mm; amely 80 “C -ra méiegrfeft ás tablettánként 100 mg tramadohbldrokforldct és 200 mg, 7 000 000 rnolekulatömegö polietsién-oxióot tartalmazó keverékből felső bélyegzővel, alsó bélyegzővel és matricával rendelkező tablöttázö szerszámmal végzett préseléssel a prösnyemás legalább 18 másodpercig való lenntartásavai kapható, amely Európai Gyógyszerkönyv szerint! tPő. For } v? v;rto hatóanyagleadás-meghatározásban hetéanyagleadés-vizsgálati közeget tartalmazó keverölapátes készülékben, 75 percenként forduiátszám (rpm) mellett leadja az (A) anyag 15 %-át 30 perc után, 52 %-át 240 perc után, 80 %-át 48Ö pere után és ÛÔ %-át 720 pere után; és ahol a vizsgálat kezdetekor a tablettát 800 mi, 1 ;2 pH-ju mesterséges gyomornedvbez adják, amelynek pH-ját lóg hozzáadásával 30 pere ufón 2,8-re, tovább; 00 pere után O.S-re, és ismét további 00 perc után 7,2're emelik, (2) nem olyan tabletta, amelynek törési szilárdsága legalább 800 N. teljes tömege 300,0 mg, átmérője 10 mm és görbületi sugara 8 mm; amely 80 '’C-ra melegített és tablettánként 100 mg iramadoí-hidrokiorídot és 200 mg, 7 000 000 moíekuíatómegü poíietüén-oxidol tartalmazó keverékből felső bélyegzővel, alsó bélyegzővel és matricával rendelkező tablettázé szerszámmal végzett préseléssel a presnyemás legalább 15 másodpercig való fenntartáséval kapható, ahol a keveréket a taplettézó szerszám matricájába töltik; amely Európai Gyógyszerkönyv szeunti /n v/ko hafeanyagfoadásmieghatározésban hatóanyagleadás-v-.zsgéiafi közeget tartalmazó kévéről apa tps készülékben, 75 percenkénti iörduíatszám mellett leadja az (A) anyag 15 %-át 30 perc után, 52 %-ât 240 parc után, 30 %»àt 430 perc után és 93 %--át 720 parc után; és ahol a vizsgálat kezdetekor a tablettái 600 ml, 1,2 pR-jú -nesterseges gyen^ornedvhez adják, amelynek pH'ját lúg hozzáadásával 30 perc után 2,3-re, további 80 perc után 8,5-re, és ismét további 80 perc után 7,2-re emelik; (3) nem olyan tabletta, amelynek törési szilárdsága legalább 500 ÎM, teljes tömege 150,0 mg átmérője 7 ncn; amely 80 'Ό-ra melegített és tablettánként 00 mg tramadoí-hidrokloridot és 100 mg, ? 000 000 moiekuiatömegű poiietüén-oxidöt tartalmazó keverékből felső bélyegzővel, első bélyegzővel ős matricával rendelkező tablettázó szerszámmal végzett préseléssel a présnyomás legalább 15 másodpercig való fenntartásával kapható; amely Európai Győgyszerkcnyv szerinti m vöm hatóanyagleadás-meghatározásban hafóanyegieadás-vizsgáíatí közeget tartalmazó keverölapátos készülékben, 75 percenkénti fordulatszám mellett leadja az (A) anyag 15 %~át 30 perc után, 62 %-át 240 pere után, 88 %-át 480 perc után és 09 %-áf 720 perc után; és ahol a vizsgálat kezdetekor a tablettát 500 mi, 1,2 pHgu mesterséges gyomornedvhez adlak, amelynek pH-'ját lúg hozzáadásával 30 perc után 2,3-re, további 90 perc után 6,6-re·, PC ismét további 60 perc után 7,2-ro emelik; (4) nem olyan tabletta, amelynek törési szilárdsága legalább 500 N, teljes tömege 300,0 mg, átmérője 13 mm és görbületi sugara 8 mm; amely 80 <:C-ra melegített és tablettánként 100 mg kamadokhidrokforidoh 20 mg xantántés 180 mgt 7 000 000 molekulatömegű pol-elilén-evldot tartalmazd keverékből felső bélyegzővek alsó bélyegzővel és matricává! rendelkező tablettázó szerszámmal végzett préseléssel a présnyornás legalább 15 másodpercig való fenntartásával kapható; amely Európai Gyógyszerkönyv szerinti ázvíác hatóanyagteadás-meghatározásben hatöanyegieadás-vízsgálati közeget tartalmazó keverölapátos készülékben, 75 percenkénti forduíatszám mellett leadja az (Aj anyag 14 %"ái 30 perc után, 54 %-át 240 perc-után, 81 %-át 480 perc után és 99 %-át 728 perc után; és áhel a vizsgálat kezdetekor a tablettát 600 mi, 1,2 pH-jú mesterséges gyémornedvhez. adják, amelynek pH-jál lúg hozzáadásával 30 perc után 2,3-re, további 90 perc után 6,6-re, és ismét további 80 perc után 7,2-re emelik; (5) nem olyan tabletta, amelynek törési szilárdsága legalább 500 N. teljes tömege '150,0 mg, hossza 10 mm és szélessége 5 mm, amely 90 :'C-ra melegített, tablettánként 50 mg tfcmaöol-hidrcklondot, 10 mg xantánf és 90 mg, 7 000 OöO molekulatömege polietilén--exídot tartalmazó keverékből felső bélyegzővel, alsó bélyegzővel és matricával rendelkező tablettázó szerszámmal végzett préseléssel a présnyemás legaiébe 15 másodpercig való fenntartásával kapható; amely Európa! Gyógyszerkönyv szerinti ,/p vére haíoanyagiéadáscnéghsfárözasean hatőanyagleadás-vizsgáiatí közeget tartalmazó kevérölapátoS: készülékben, 75 percenkénti fcrdolatszám mellett leadja az (Aj anyag 22 %-át 30 perc után, 50 %-át 120 perc után, 80 %-át 040 perc után, 90%'ét 300 perc utón, és 99 %>-át 480 perc után: és ahol a vizsgálat kezdetekor a tablettát SCO tói, 1,2 pHgu mesterséges gyomornedvhez adják, amelynek pH-jáf tép hozzáadásával 30 pere után 2,3-re. további 90 perc után 6,8-re, és -Ismét tôvâbbî 89 pere után 7,2-re emelik; (8) nem olyan tabletta, amatynák törési szilárdsága legalább 500 N, teljes tömege 150,0 mp, átmérője 10 mm és görbületi sugara 8 mm; amely 30 4C~ra. melegített és tablettánként 20 mg öxiködofehidmklöfldöt,· 20 mg xantánt és 110 mg, ? 000 000 meiekulatörnegü peiietüén-okidöt tartalmazó keverékből feléé bélyegzővel· alsó bélyegzővel és matricával rendelkező tabiettázó szerszámmal végzett préseléssel a présnyőmás legalább 15 rrsáscdpercsg való fers mártásával kapható; amely Európai Gyógyszerkönyv szerimi in vitro hatóam/agleadás-meghatározáshan. az Amerikai Gyógyszerkönyvben (USP-bern leírt. 6,8 pH-jú, foszfáttal puffereit hatóanyagláadás-vlzsgálatl közeged tartalmazó keverő! a paies készülékben 8? !'C-bn, 75 percenkénti fordulatszém mellett láádlá az (A)·· anyag 17 %-át 30 perc utam 51 %-át 240 perc utón, 90 %-át 480 perc után és 101,1 %-át 720 perc után; (7) nem olyan febtetta, amelynek törési szilárdságé legalább SÖÖ N, teljes tömege 344,2 mg, átmérője 10 mm és görbületi sugara 8 mm; amely úgy kapható hogy 0,2 mg butiihidrezitetóolt okiénak 98 %-os etanoiban, a kapott 7,7 %-os etanoios oldatot szárítják 40 X-on 12 óra hosszat 221 mg, 7 000 000 mcMekulatbmegű pohetllén-oxid jelenlétében, és ezt követően préselik egy 80 X-ra melegített és tablettánként 100 mg tramadoi-hidfökioriöol és 20 mg hidroxlpropümetücéllulözt tartalmazó keverékkel együtt felső bélyegzővel, aisé bélyegzővel és matricával rendelkező tabiettázó szerszám segítségével a présnyőmás legalább. 15 másodpercig történő fenntartásával; amely Európai Gyógyszerkönyv szerinti /n váró batóanyagteadás-meghatárpzásban hatóanyagieadás--vizsgáiati közeget tartafmazb keverbtópátos készülékben, 75 percenkénti forőuiatszám mellett leadja az (A) anyag 17 %-át 80 perc után, 59 %-át 240 perc után, 88 %-át 480 perc után és 98 %-át 720 perc után; és ahol a vizsgálat kezdetekor a tablettái 500 ml, 1,2 pH-ju mesterséges gyomornedvhez adják, amelynek pH-ját lég hozzáadásával 30 perc után 2,3-re, további 98 perc után 5,5-re, és ismét tovább! S8 perc után 7,2-re emelik; (8) hern olyan tabletta, amelynek törési szilárdsága legalább 500 N, teljes lomege 841,0 rag, átmérője 10 mm és görbületi: sugara 8 mm; amely egy 80 cC-ra melegített, tablettánként 108 mg tramadoi-bidroklorídot, 22:1 mg, 7 880 OöG molekula töm eg 8 polietiién-oxidet és 20 mg bidrexipropitmetilcéliuiázf tartalmazó keverékből felső bélyegzővel, alsó bélyegzővé! és rnathcávai rendelkező tabiettázó szerszámmal végzett préseléssel, a présnyőmás legalább 15 másodpercig történő fenntartásával kapható; amely Európa! Gyógyszerkönyv .szerinti tó vére hatöanyagíeadás-meghatározásban hatóanyagleadás·· vizsgálati közeget tartalmazó keverölspátos készülékben, 75 percenkénti tordulatszám mellett leadja az (A) anyag 16 %-át 30 perc után, 57 85-éf 248 perc istán, 64 %-át 480 perc után és 96 %-áf 720 perc után; és shot a vizsgálat kezdetekor a tablettát 806 ml, 1<2 pH-jú mesterséges gyomomedvhaz ártják, amelynek pH-jéi lúg hozzáadásával 38 perc után 2,3-re, további 90 pere után 8,5-re, és ismét további 00 perc után ?,2-re emelik; (6) nem olyan hiplanáhs tabletta, amelynek törési szilárdsága legalább 500 N, teljes tömege 336,6 mg; amely égy kapható, hogy 6,2 mg birtilhidmxitőluoit íeioidanaR 66 %ms ©tanúiban, a kapott 7,7 '%~os eianolos oldatot keverik 1§8 mg, 7 000 600 molekulatömege pokefilérwxöiddal nagysebességű keveröben 30 percig, ezt követően hozzáadnak 1 ?,8 mg, 7 000 000 moiekuiatömegö pölíefüén-oxidot és keverik 30 percig, és utána szárítják 46 cC on 12 óra hosszét; hozzáadnak 100 mg tramadol'hidrokloridot. 33,5 rng bídroxlpropiímetlloeilulózt és 33,6 mg peiietilénglikolt; és extradálják a keveréket kétcsigás extrnderben nitrogénatmoszféra alatt, 100 íordulaOparo csigasePesség mellett, 4 kg/ora teljesítménnyel. a termèkhôrnèrsèklet 126 "C és a köpenyhömérséklet 120 X; (10) nem olyan tabletta, amelynek törési szilárdsága legalább 600IM, teljes tömege 536,0 mg és átmérőié 12 mm; amely tablettánként 205 mg of trgmadei--hiörokiondöt és 361 mg, 7 000 000 möieküiátömagö peilehémdxlböi tartalmazó keverék préselésével 260 N erő és 28 Hz fekveneiájú, 60 % amplitúdó erősségű ultrahang-kezelés 0,6 másodpercig farté párhuzamos alkalmazásával kapható; amely Európai Gyógyszerkönyv .szerinti. m vibö haféanyagleadás-meghatárezásbari haíóanyagleedás--vizsgálai.i közegét tartaimazé süllyesztőé ksrverőlapátos készülékben, 75 percenkénti fordulatszám mellett leadja az (A) anyag 13 %-át 30 pere után, 51 %-át 240 perc után, 76 %-át 480 perc után és 100 %-át 720 pere után; és ahol hatóanyag-leadási vizsgáló közeg 600 mi gyomornedv, amelynek hőmérséklete 37 :’C és pH-ja 6,6; és (41} nem olyan tabletta, amelynek töress szilárdsága legalább 600 N, teljes tömege 300,6 mg, átmérője 10 mm és görbületi sugara 8 mm; amely tablettánként 100 mg tramadot-nídroklorídöt és 280 mg, 7 000 000 molekuiatömegö poiletliénmxldot tartalmazó keverék aráselésével - 9?0 N erő és 26 Hz frekvenciájú és ?5 % amplitúdó-erősségű ultrahang-kezelés 0.15 másodpercig tartó párhuzamos alkalmazásával, utána - 676 N erő és 20 Hz frekvenciájú és 32,5 % amplitúdó-erősségű ultrahang-kezelés 0,55 másodpercig tartó párhuzamos alkalmazásával, és utena -- 870 N erő 2.3 másodpercig történő alkalmazásával kapható; amely Europa· Gyógyszerkönyv szerinti ír? váró hatöanyagíeadás-m eg tatarozásban süllyesztés kevemlapàtos készülékben. ?5 percenkénti l'ordulatszám mellett leadja az (A) anyag 17,1 %-éf 30 perc után, 00,0 %-át 240 perc után, 64 %-át 480 perc után és 94,2 %-át 720 perc után; és ahoi hatóanyag-leadást vizsgáié közeg 600 mi gyemornedv, amelynek hőmérséklete 37 «C és pidga 8,8. .2. Az 1, Igénypont szerinti adagolási fonna, ázzál; jellemezve, hogy nem tartalmaz, pszlchotrop hatásé anyagot,
- 3, ÄZ 1 . vagy 2. igénypont szerinti adagolási forrna, azzai jellemezve, hogy törési szilárdsága legalább 800 M. 4» Az alázó igénypontok egyike szerinti adagolási forma, azzal jellemezve, hogy tabletta formában van,
- 8, Az előző igénypontok egyike szerinti adagolási tonna, azzal jellemezve, hegy nerc tartalmaz sem tfamadolmldrokloridot, sem ozlkodon-hidrokloridot,
- 6, Az előző Igénypontok egyike szerinti adagolási forma, -azzal jellemezve, hogy az (A) anyag gyógyászati anyag, amely a táplálkozási rendszer és anyagcsere betegségeinek kezelésére és megelőzésére alkalmas szerek; a ver és á vérképző szemek betegségeinek kezelésére és megelőzésére alkalmas szerek; a kartlíovászkoiáns rendszer betegségeinek kezelésére ás megelőzésére alkalmas szerek; derrcatológia szerek; az progenitalis rendszer és nerc! hormonok betegségeinek kezelésére és megelőzésére alkalmas szerek; szisztémás hormonkészítmények a nemi hormonok és Inzulinok kivételével; fertőzés elleni szerek szisztémás alkalmazásra; ántlneopiáziás és Immunmodoláiészerek; az izom és a vázrendszer betegségeinek kezelésére és megelőzésére alkalmas szerek; ez Idegrendszer betegségeinek kezelésére és megelőzésére alkalmas szerek; parazita elleni szerek, inszektlcidek és repeiienssk; a iégzöszervrendszer betegségeinek kezelésére és megelőzésére alkalmas szerek; érzékszervek betegségeinek kezelésére és megelőzésére alkalmas szerek; általános dietetikus és mdioterápiás szerek körébői van kiválasztva.
- 7. Eljárás az "-6, igénypontok egyike szerinti adagolási forma előállítására, amely tartalmazza a következő lépésekét; (a) összekeverjük az (A) komponenst, adott esetben a (B.) komponenst, a (C) komponenst és adott esetben a (0) komponenst; (P) adott esetben előformáijuk az (a) lépésben kapott keveréket, előnyösen az (a) lépésben kapott keverékre gyakorolt hö- és/vagy erőhatás alatt, ahol a bevezetett bő mennyisége előnyösen nem elegendő ahhoz, hogy a (€) komponenst, lágypláspentjálg melegítse; (o) keményítjük a keveréket bő és erő hatása alatt, ahol a hö hővezetése történhet az erő hatása alatt és/vagy előtt, és a bevezetett hő mennyisége elegendő ahhoz, hogy a (0) komponenst legalább lágyoláspontjáig melegítse; (d) adott esethon egységekre osztjuk a keményített keveréket; (e) adott esetben formáljuk az adagolási formát; és tf) adott eséthor; fii,mbévenattal tétjük el. 8. A 7 igénypor« szerinti aijérás. azzal jellemezve, hogy a <c) lépésben kétcsigás extruclert vagy bolygö^engeres extfudert alkalmazunk
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