Embonisweni yokukhiqiza imithi nokudla egxile ekunembeni, ukukhethwa ngakunye kwe-excipient kuthinta ngqo ukuphepha komkhiqizo, ukuzinza, nokusebenza kwawo. I-SYLOID® AL-1FP silicon dioxide kaGrace iyinto ebalulekile eqinisekiswe kakhulu. Ikhishwe ngomhla zingama-28 kuSepthemba, 2023, le Certificate of Analysis ingaphezu kombiko wekhwalithi—yisiqinisekiso esicacile sokusebenza okungajwayelekile komkhiqizo kanye nokuhambisana okungenamibandela.

I-SYLOID® AL-1FP ihambisana ngokuqinile namazinga omhlaba aphezulu kakhulu. Isitifiketi siqinisekisa ukuhambisana okugcwele nezinga elisha kakhulu le-USP/NF le-Silicon Dioxide kanye nezidingo ze-JPE ze-Hydrated Silicon Dioxide. Ukulawulwa kwayo kwezinto ezingcolile kubalulekile: i-sulfate ≤0.5%, i-chloride ≤0.1%, kanye nezinsimbi ezisindayo (Cd<0.5mg/kg, As<0.5mg/kg, Pb<1mg/kg, Hg<0.1mg/kg) zingaphansi kakhulu kwemikhawulo yokuphepha yamazwe ngamazwe, zihambisana ngokuphelele neziqondiso ze-ICH Q3D.

Iphinde ihlangabezane nezindinganiso eziphathimandla zezithako zokudla, okuhlanganisa i-FCC kanye ne-EU Regulation (EU) No. 231/2012 ye-E551 (i-silicon dioxide). Lokhu kuhambisana okuphindwe kabili kwenza kube yisithako esithembekile sezidakamizwa kanye nesithako sokudla esiphephile, okuvumela ukusetshenziswa okungenamihawu ezimbonini ezahlukene.

Idatha yokuhlaziya yesitifiketi igqamisa izakhiwo ezinhle kakhulu ze-SYLOID® AL-1FP emzimbeni nasemazingeni ezinto ezithinta ukusebenza kwayo:

: Okuqukethwe yi-SiO₂ kufinyelela ku-99.4%, kudlula isidingo esincane esingu-99.0% ukuze kube nokungaguquguquki okungenakuqhathaniswa.

: Usayizi ovamile wezinhlayiya ezingu-7.4 μm, ungaphakathi kobubanzi obungu-6.5–8.1 μm bokusasazeka okufanayo nokugeleza okuhle kakhulu.

: I-pH engu-5.0 (ngaphakathi kuka-4.0–6.0) inikeza indawo ethambile, ezinzile yamafomula azwelayo.

: Okusele kwesikrini esimanzi (>42 μm) <0.01% (kuhlangabezana nomkhawulo); ukulahlekelwa ngokomisa (0.6%) nokubasa (6.3%) kulawulwa ngokuqinile ukugwema izinkinga zokuzinza.

Lezi zinketho eziklanyelwe zenza i-SYLOID® AL-1FP i-excipient ebalulekile ekwenziweni kwemithi nokudla.

Njengama-silica asintetikhi anama-pore-volume aphansi, anama-surface-area aphezulu, i-SYLOID® AL-1FP yenza kahle ekumunceni komswakama—ilawula umswakama omncane ngisho nasezingeni eliphansi lokujwayela komswakama. Lokhu kuvikela ama-API azwela emswakameni, kucisha ukubola, futhi kwandisa impilo yeshalofu nomphumela womkhiqizo.

Emithini, yenza njengosizo olungcono lokugeleza (luthuthukisa ukucubungula impuphu) kanye nesinqamuli (sivikela ama-antibiotic azwela). Ekukhiqizeni ukudla, isebenza njenge-anti-caking agent, ivimbela ukuhlanganiswa futhi igcina izakhiwo ezigeleza kalula emikhiqizweni eyimpuphu.

Isekelwe uhlelo oluqinile lokuphatha ikhwalithi lukaGrace, i-SYLOID® AL-1FP yenziwa ngokuhambisana ne-EXCIPACT-GMP futhi inesitifiketi se-DQS (Isitifiketi. Cha. 415602 EXCI). UGrace uqinisekisa ukuhlolwa kwebatch njalo ngenyanga ukuze kuqinisekiswe ukuhambisana okuqhubekayo. Izikhombo ezicacile—inombolo yoku-oda, inombolo yebatch (1000404214), nosuku lokukhiqiza (Septhemba 9, 2023)—ziqinisekisa ukulandelelwa okuphelele.

Phakathi kwezidingo zekhwalithi ezikhulayo, ukuhambisana okungenakuqhathaniswa kwe-SYLOID® AL-1FP, ukusebenza okunembayo, nokusebenza okuthembekile kwenza kube ukukhetha okuthembekile kwabakhiqizi. Kungaphezu kwe-excipient—kuyisivikelo esibalulekile sekhwalithi yomkhiqizo nempilo yomphakathi.

Izindaba nolwazi olukhishwe yiZhonglian Chemical lunikezwa ngenhloso yokwazisa kuphela futhi luhloselwe kuphela ukubhekisela nokuxhumana phakathi kochwepheshe bemboni. Aluqinisekisi ukunemba nokuqedela kolwazi olunjalo. Akufanele usebenzise lolu lwazi ukufaka esikhundleni sokwahlulela kwakho okuzimele; ngakho-ke, uzobhekana nezingozi ezivela kunoma yikuphi ukusetshenziswa kolwazi, futhi iZhonglian Chemical ngeke ibe nesibopho. Uma kwenzeka kukhona ukwephulwa, sicela uxhumane nathi ukuze kususwe.