HUE031293T2 - Gyógyszerkészítmények - Google Patents
Gyógyszerkészítmények Download PDFInfo
- Publication number
- HUE031293T2 HUE031293T2 HUE08848615A HUE08848615A HUE031293T2 HU E031293 T2 HUE031293 T2 HU E031293T2 HU E08848615 A HUE08848615 A HU E08848615A HU E08848615 A HUE08848615 A HU E08848615A HU E031293 T2 HUE031293 T2 HU E031293T2
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- Hungary
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- 239000008194 pharmaceutical composition Substances 0.000 title description 25
- 239000000203 mixture Substances 0.000 claims description 150
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 claims description 66
- 239000003826 tablet Substances 0.000 claims description 62
- 239000003795 chemical substances by application Substances 0.000 claims description 54
- 229910052742 iron Inorganic materials 0.000 claims description 31
- 239000002552 dosage form Substances 0.000 claims description 29
- 238000000034 method Methods 0.000 claims description 23
- 150000001720 carbohydrates Chemical class 0.000 claims description 21
- 235000014633 carbohydrates Nutrition 0.000 claims description 21
- 239000000796 flavoring agent Substances 0.000 claims description 21
- 210000000214 mouth Anatomy 0.000 claims description 21
- 239000004615 ingredient Substances 0.000 claims description 20
- 235000003599 food sweetener Nutrition 0.000 claims description 19
- 239000008187 granular material Substances 0.000 claims description 19
- 239000003765 sweetening agent Substances 0.000 claims description 19
- 239000000843 powder Substances 0.000 claims description 18
- 235000013355 food flavoring agent Nutrition 0.000 claims description 16
- 230000037406 food intake Effects 0.000 claims description 16
- 229920002678 cellulose Polymers 0.000 claims description 15
- 238000004519 manufacturing process Methods 0.000 claims description 14
- QJZYHAIUNVAGQP-UHFFFAOYSA-N 3-nitrobicyclo[2.2.1]hept-5-ene-2,3-dicarboxylic acid Chemical compound C1C2C=CC1C(C(=O)O)C2(C(O)=O)[N+]([O-])=O QJZYHAIUNVAGQP-UHFFFAOYSA-N 0.000 claims description 13
- 239000001913 cellulose Substances 0.000 claims description 13
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- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 12
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- 238000007907 direct compression Methods 0.000 claims description 10
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 10
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- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 6
- 239000008101 lactose Substances 0.000 claims description 6
- CVHZOJJKTDOEJC-UHFFFAOYSA-N saccharin Chemical compound C1=CC=C2C(=O)NS(=O)(=O)C2=C1 CVHZOJJKTDOEJC-UHFFFAOYSA-N 0.000 claims description 6
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 claims description 5
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- 108010011485 Aspartame Proteins 0.000 claims description 4
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- 150000002338 glycosides Chemical class 0.000 claims description 4
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims description 3
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- 235000014413 iron hydroxide Nutrition 0.000 claims description 2
- NCNCGGDMXMBVIA-UHFFFAOYSA-L iron(ii) hydroxide Chemical compound [OH-].[OH-].[Fe+2] NCNCGGDMXMBVIA-UHFFFAOYSA-L 0.000 claims description 2
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- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 claims 2
- 229920001817 Agar Polymers 0.000 claims 1
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 claims 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 1
- BPQQTUXANYXVAA-UHFFFAOYSA-N Orthosilicate Chemical compound [O-][Si]([O-])([O-])[O-] BPQQTUXANYXVAA-UHFFFAOYSA-N 0.000 claims 1
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- 229910052793 cadmium Inorganic materials 0.000 claims 1
- BDOSMKKIYDKNTQ-UHFFFAOYSA-N cadmium atom Chemical compound [Cd] BDOSMKKIYDKNTQ-UHFFFAOYSA-N 0.000 claims 1
- 235000012000 cholesterol Nutrition 0.000 claims 1
- OEYIOHPDSNJKLS-UHFFFAOYSA-N choline Chemical compound C[N+](C)(C)CCO OEYIOHPDSNJKLS-UHFFFAOYSA-N 0.000 claims 1
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- 239000011777 magnesium Substances 0.000 claims 1
- 229910052749 magnesium Inorganic materials 0.000 claims 1
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- JSPLKZUTYZBBKA-UHFFFAOYSA-N trioxidane Chemical compound OOO JSPLKZUTYZBBKA-UHFFFAOYSA-N 0.000 claims 1
- 125000000391 vinyl group Chemical group [H]C([*])=C([H])[H] 0.000 claims 1
- 229920002554 vinyl polymer Polymers 0.000 claims 1
- 229910021519 iron(III) oxide-hydroxide Inorganic materials 0.000 description 54
- CUPCBVUMRUSXIU-UHFFFAOYSA-N [Fe].OOO Chemical compound [Fe].OOO CUPCBVUMRUSXIU-UHFFFAOYSA-N 0.000 description 52
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- 239000000546 pharmaceutical excipient Substances 0.000 description 25
- 235000021317 phosphate Nutrition 0.000 description 25
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 23
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- 238000011068 loading method Methods 0.000 description 21
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Claims (9)
- !, Vp-ôiïl'hldi^Mdiîi. <m$y â· ;g^ôg>îss«rêsMiméiiy· teljés' tomegém vmmtkoxtaiva í 04113 f&as^Mæ&u ^ít#P· #: törten# adagolás ra alkalmat formában. ahol a vas-oxí-hidroxid mennyisége > 300 mg dózis formánként. 2. oâgÿ meoöjdiéglaínj a gfögpEeréiatof?^ teljes tömegére vonatkoztatva 10-80 tdmeg%-ban, tartalmazó gyogyszerkeszitrnöny. szájon át történő adagolás-ra alkalmas filmmel bevont dózis formában sértetlen lenyelésre vagy a szájüregben szétesni képes dózis formában. ebed a vas -oxí-hlclroxKi mennyisége > 3011 mg dózis formánként.
- 3. Az I. vagy 2, igénypont szerinti készítmény, ahoi a készítmény legalább egy szénhidrátot és/vagy huminsavai tartalmaz. 4. A 3. igénypont szctanti készítmény, ahol a szénhidrátot az. alábbiakat tartalmazó csoportból választjuk: mono-, dl- vagy pohsxachamt mint agarőz, dexírán. dextrin, dextrán származékok, cellulóz és eelMöz szlrmaiokok, szaoharóz, maMz és laktósg élópyósénrsMeltn-réz. dextrán és keményítő.
- 5. Az előző igénypontok blopelytko szerinti készítmény, áhol a vasmxidMdmxid béta s as-οχidddroxtáot tariaImaz.
- 6. Az előzd igénypontok bármelyike szerinti készítmény, ahol a készítményben a vss-oxi-hidroxid a készítmény teljes tömegére vonatkoztatva 30 - 65 % (íömegdömeg) mennyiségben van jelen. ?. Az előző igénypontok bármelyike szerinti készítmény, ahol a szénhidrát és'vagy kéliinsav összesen 1 - 50 % (tömeg/tőmeg). előnyösen 5 - 30 % {tömeg/tömagjf mennyiségben van jelen a készítmény teljes tömegére vonatkoztatva. A Az előző Igénypontok bármelyike szerinti készítmény, amely továbbá égy vágy több izeallő szert, édesítőket, ixíoiozőkat éAvagy színezékeket tartalmaz, 9. A 8. igény pora szerinti készítmény, ahol az édesítő szer egy iennészmes vagy nem-természetes édesítőszer, amelyet cukrok, poiiubk, aszpartám, szukralöz, aeesznltámln-K, es/sagv szacharin közel és az iztbkozö szett & glikozidok közöl,, rmnt neohesxperidm-dihidrokalkon, glicirrizln, glutamát közöl választjuk. 10. A 8. vagy 0. Igénypont szerinti készítmény, ahol édesítő szer 0,01 - 2,> Ά (unneg/ídmeg), és az Izíbkozó szer 0,1 ·· 10 ppm mennyiségben van jelen, mindegyik a készítmény teljes tömegére vonatkoztatva, 11. Λ 8. igénypont szerinti készítmény, ahol oz ízesítő szer a készítmény teljes tömegére vonatkoztatva 0,0! -10.% Ctömeg/tömegb elbnydsen 0,1 - 5: % ÇippsegAômcig Jegelő* nyőr-ebbon 0.1 - 1 % ttőmeg/tömegt van jelen.
- 12. Az előző igénypontok bármelyike szerinti készítmény., amely továbbá égy vagy több kötőanyagot mint ,vupe?deziníegránsnkat, sikosítokat. out ms-harisokat tartalmaz. 13,. A 12. igénypont szeriöd kéMMéőyj sltölA §w^ëtâmMi%0Miû az aläbbfäkböi llfö csoportból válaszljttk: térhálósított p>liyinil.^itrfîlidotiPkÿ biédoiiiott tebésyfíők.it mbdto suou eolhdözok:, H. A O·,· -vagy 13* "igénypont zzoriot! készlbfiénjy ahol a ^öpörd^lötogÄs p l|-szitpÄy teljes tdmogéro voMtköZíatvs 0,1 - 1.0% (tŐmegAÖmegh fl^pyBssp. ChS - 8 3¾ (db meg/tömeg}, meg előnyösebben 2,5 -1 % (tömeg/tömegt mennyiségben van jelen. 15. A 12. igénypont szerinti készítmény, ahol a síkosáét ax alábbiakból álló csoportból választjuk: magnéziutn-szlearál, szilkium-dinxKi származékok, mint kolloid szil idom-dioxld, pirogén szilk-um'dkndd. hidratált nátrium-sziliko-aiumináb kolloid szílikon-dioxid, talk um es ezek keverékei, előnyösen magnézium-szivaréi, kellőid sxilkium-dioxid, vagy tálkám. 1:6. A í 2, vagy '1.5, Igénypont saormtj kêsdnsppyï:|ltDl a AköPÖé s készítmény teljes lötpegete vonaikoptatvp 0,0.1 - IÛ 50 Ctöntégltömég), előnyösén 0*3 - 5 % (iimlgAÖöieg) menynyi cégben van lelett,
- 17. Az előzd igénypontok bármelyike szerinti készítmény, aotcly tartalmaz a készítmény teljes tömegére vonatkoztatva vas-οχi·hidruxidot lő - B0 % ítőrneg/tömeg) mennyi' ségben, legalább egy szénhidrátot és/vagy Uummaavat 1,l-! - 30 % ítömegdömeg) teljes mennyiségben, adott esetben egy vagy több kötőanyagot 1,0 - 30 % Ctömeg/tőrneg) teljes mennyiség-ben, egy vagy több ízibkoxót 0,1 - 10 ppm teljes mennyiségben, és vagy egy vagy több ízesítőt 0,01 10 % (tötneg/tömeg) teljes mennyiségben. 18. A 17. igénypont szerinti készítmény: amely egy vagy több szuperöe/imegtrinit tartalmaz (él - 10 tömeg% (íömog/íőmeg) teljes mennyiségben,10. Az előzd igénypontok bármelyike szerint) készítmény sértetlen lenyelésre vagy a szájüregben gyorsan, szétesni képes dózis tonnában, mim rágótabletta vagy pirula, száraz. pO' rok, szemcsék, kapszulák vagy zacskók, amelyek ezeket a szemcséket, ostyákat vagy pasztillákat tartalmazzák.
- 20, A z előző igeőypbntók: blMtelylke: szári bt! köszlttbiny álkaíPtázásá biporfezlatétbiá kezeilkém szplgáló gyógyszer előállítására.
- 21, Az előző igénypontok bánnelyike szerinti készítmény alkalmazása krônjJçgs vese elégtelenségben szenvedő belezek kezelésére szolgáló gyógyszer előállításúm.
- 22, Eljárás az. előző Igénypontok bármelyike szerinti készítmény előállítására tabletta alakban közvetlen préseléssel vagy száraz granulálásiak Ikk Eljárás az előző Igénypontok bármely tke szerinti készítmény előállítására tabletta alakban, ahol egy vizes sxuszpenxiót. amely a végső készítmény nőies tömegére vonatkozóan legalább az összetevők 90 %-át (tömeg.·törneg) tartalmazza, készítőnk, amelyet ezután porlaszt' va szárítunk egy íolyől.épes por nyerésére, amelyet adott esetben összekeverünk a maradék ösz-szelevökkel és oxulàn tablettává n;cselünk, 24. A 23. igénypont szerinti eljárással előállított tabletta. 2$. Tabbua, amdy egs adott eMtbea jafeotévû tabfetta iayoaai tttmagdt kivéve, a táBlotia késaí today tebts iftMágété -mMÛêMâWâ 40 - bS 44 (tÔMeg/têîÉèg)vas« otoMbiytodot, S -IC) % {i§xm$Wm®g$ :ﻜa>%%fee« s^ebarbto ési - ,%ÏÏ. %|ttefg/tppe.gf mennyiségben kenum?· ind nmatmam
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