Ukuze kuphathwe kahle izithako ezisebenzayo zemithi ezimpuphu (ama-API) nezi-excipients, ukugeleza okuhle kubaluleke kakhulu. Izimpuphu ezivame ukubambana noma ezibonisa ukungagelezi kahle zibeka izinselele ezinkulu ekuthuthweni nasekuphuzweni okunembayo. Ukufezekisa ukuhlanganiswa okufanayo phakathi kwama-API nezinye izithako zokwakheka kuyalimazeka lapho kukhona izinkinga zokubambana, ukunamathela odongeni, noma ukushajwa kukagesi.

Ukufakwa kwe-dosage encane (0.2-2%) ye-SYLOID® FP Silica kungathuthukisa kahle izakhiwo zokugeleza kwezinhlelo zokwelapha. Isakhiwo esiqondile se-SYLOID® FP Silica esinokungena kwemifantu sithuthukisa ukuxhumana okwakhiwe, ukulawulwa kokushaja, kanye nokwakhiwa kwamandla e-capillary, ngaleyo ndlela kunikeza izici ezinhle zokugeleza, ukusebenza kwe-glidant, kanye nemiphumela yokuvimbela ukuhlanganiswa kwezinhlelo.

I-SYLOID® 244FP, i-AL-1FP (emakethe ase-EU), kanye ne-63FP (emakethe ase-US) yizinto zokwelapha ezakhiwe nge-silica engokwemvelo. Zenziwa ngaphansi kwezimo eziqine kakhulu, ziqinisekisa ukuhlanzeka okungavamile kwezinto zamakhemikhali. I-W. R. Grace & Co.-Conn. iyona kuphela umkhiqizi we-SYLOID® FP Silica, enikeza ukulandelelwa okuphelele kwezinto ezisetshenzisiwe nokunakekelwa. Zonke izinhlobo ze-SYLOID® FP Silica ziqinisekisiwe ukuthi ziyahambisana nezimfuneko zakamuva ze-monograph ze-Silicon Dioxide ku-United States Pharmacopeia - National Formulary (USP-NF), i-Hydrated Silicon Dioxide ku-Japanese Pharmaceutical Excipients (JPE), kanye ne-Colloidal Hydrated Silica ku-European Pharmacopoeia (EP).

Ukuhamba kwezinto ezimpuphu kuthonywa yizinto eziningi, okubandakanya izici zemvelo zezinto zokusetshenziswa, ukusebenzisana phakathi kwezinhlayiya, izici zendawo ezithintana nazo, kanye nezimo ezahlukahlukene zemvelo. Izinselelo ezivame kakhulu ezihlobene nokuhamba ekwenziweni kwemithi zihlanganisa ukuminyana, ukunamathela odongeni, nokushaja ngogesi. Leli bhande liboniswa egrafini engezansi, ehambisana namandla adingekayo ukuze kuqale futhi kuqhubeke ukuhamba kwezinto ezimpuphu ngejubane lokuhamba kwezinto ezimpuphu.

Indawo Yokugeleza Kwamahhala Indawo Yokubambelela

Isithombe 1 Kudingeka amandla aphezulu okuqala ukuze umgubo omile uqale ukuhamba, futhi la mandla ayancipha njengoba umgubo uqhubeka nokuhamba. Ukuqina ngokuvamile kwenzeka esigabeni sokuqala esibonakala ngamandla aphezulu nesivinini esiphansi sokuhamba, kanti ukuhamba ngokukhululeka kuthuthukiswa njalo ngokwanda kwejubane lokuhamba.

Imikhiqizo yemithi ye-hygroscopic, njenge-API ezivela ezitshalweni, imithi elwa nokutheleleka, amafomu omisiwe, ama-probiotics, nezinye eziningi, ivame ukumunca umswakama womoya ngokuya nge-relative humidity (RH) yendawo, okuholela ekuhlanganeni kwezinhlayiya nokunamathela. Ukuqina kungase futhi kwenzeke lapho imigubo ingomiwe ngokuphelele, noma lapho umswakama udlulela ebusweni bezinhlayiya ngemuva kwesinyathelo sokomisa ezinqubweni zokugaya amanzi.

I-SYLOID® FP Silica iyimpuphu ye-silica enezimbotshana eziningi, e-micronized. Lapho ingezwa kumafomula, ubukhulu bayo obuningi buyenza ikwazi ukumunca umswakama omkhulu, igcine umkhiqizo womile futhi yenze isiqiniseko sokuzinza kwefomula. Leli khono eliyingqayizivele liboniswa ngokucacile kuMfanekiso 2, okukhombisa amandla okumunca umswakama wezithako ezahlukahlukene ezithuthukisa ukuhamba ngaphansi kwezimo ezahlukene ze-RH. Isithako esihle kakhulu sokulawula umswakama singakhethwa ngokuya nge-RH yendawo ekhethekile yendawo yokukhiqiza nokugcina. Ukugcina amazinga aphansi omswakama kumafomula kuvimbela ukufuduka komswakama kuya kuma-API, ngaleyo ndlela kugcinwe ukuzinza kwamakhemikhali nezomzimba komkhiqizo wokugcina.

Isithombe 2 Indawo ethile ephezulu yokuphuma kanye ne-porosity yangaphakathi ye-SYLOID® FP Silica inikeza amandla aphezulu okuthola umswakama uma kuqhathaniswa nezinye izithako ze-silicon dioxide.

Ukuphusha okuqondile kunikeza izinzuzo eziningi kunezinye izindlela zokukhiqiza amaphilisi, okuhlanganisa ukuzinza okuthuthukisiwe kwe-formulation, izindleko zokukhiqiza eziphansi, nezinqubo zokusebenza ezilula. Nokho, ukuphumelela kokuphusha okuqondile kudinga ukuhlanganiswa kwe-API-excipient okunezici ezinhle kakhulu zokugeleza nokucindezelwa, okuyinselele eyaziwayo ekuthuthukisweni kwe-formulation. Inqubo yokuxuba i-glidant ezinyathelweni ezimbili inikeza isixazululo esisebenzayo sokulungisa ukuhlanganiswa okufanele okunjalo, ukufeza ukugeleza okuhle kakhulu kanye nezici zokucindezela ukuze kuphushwe okuqondile ngenkathi kugcinwa ukufana nokuzinza kwe-formulation kuyo yonke inqubo yokukhiqiza.

Ama-excipient e-SYLOID® FP Silica angasetshenziswa kuzo zombili izigaba zenqubo yokuhlanganisa i-glidant enezinyathelo ezimbili. Esigabeni sokuqala sokuhlanganisa i-API, i-SYLOID® AL-1FP (EU) noma i-SYLOID® 63FP (US) iyatuswa ukuze kuthuthukiswe ukuzinza kwe-API. Indawo yayo enkulu kakhulu eyenziwe nge-specific surface area yakha izibopho ze-hydrogen nama-molecule amanzi, iguqule amanzi akhululekile abe ngamanzi aboshiwe anokuzinza okuphezulu. Esigabeni sesibili sokuhlanganisa, i-SYLOID® 244FP isetshenziswa ukuvimbela ukubola nokuhlukana kwezinhlayiya ngesikhathi sokuhlanganisa nokucubungula okulandelayo. I-SYLOID® 244FP imunca inani elifanele lamanzi ukuze kufezeke ukuhlanganiswa kwe-powder okuhamba kalula, kanti ububanzi bayo bangaphakathi bugcina inani elanele lawo manzi aboshwe ngokomzimba ukuze kunikezwe izakhiwo zokubopha nokubopha ezibalulekile ekucubunguleni amaphilisi.

Ukuma nosayizi wezinhlayiyana kunomthelela omkhulu ekuhambeni kwamaphampu ngokukhululeka, ukuthambekela kokuhlukana, nokuhlanganiswa okuhlanganisiwe. Ngokuvamile, izinhlayiyana ezijikelezayo zibonisa izici zokuhamba ezingcono kunezinhlayiyana ezingezona ezijikelezayo, kanti izinhlayiyana ezinkulu zisebenza kangcono kunezincane ekuhambeni. Ngaphezu kwalokho, ukusabalala okuhlanganisiwe kosayizi wezinhlayiyana kunomthelela ekuthuthukiseni ukuziphatha kokuhamba. I-SYLOID® FP Silica inokuhlukana kosayizi wezinhlayiyana okuncane, okulawulwa kahle, okubalulekile ekugcineni ukuhlanganiswa okuhlanganisiwe ezinqubweni zokuqondisa ukuqondisa.

Ukuhlukaniswa kwe-SYLOID® FP Silica particles kuvikela kahle ukuhlukaniswa futhi kuthuthukisa kakhulu izici zokuhamba kwezinhlanganisela ezine-micronized APIs noma ezinye izithako ezine-micronized. Lokhu kuthuthukiswa kokuhamba akugcini nje ngokwenza kube lula ukucubungula imithi kodwa futhi kuletha nezinzuzo ezithile ezinqubweni zokuhlanganisa nokuhlanganisa ngaphambi kokuhlanganiswa.

Izinga lokushisa eliphakeme linomthelela omubi ekuthambekeni kokukhululeka kwepowder futhi lingadala ukuhlanganiswa okukhulu. Lo mthelela ubonakala kakhulu ezinhlelweni ezine-oyela nezinto ezine-lipid, lapho ngisho nokwanda okuncane kokushisa kungaholela ekuhlanganiseni okukhulu. Ukushintsha kwezinga lokushisa kungashintsha amandla okuthola umswakama kwezinto futhi kudale ukuhlanganiswa phezu kwezindawo ezibandayo, kokubili okuthinta ukuhlanganiswa.

Ukugcinwa isikhathi eside kwemikhiqizo yemithi epakishwe ngaphansi kwengcindezi, ikakhulukazi uma ihambisana namazinga aphezulu omswakama, kungaholela ekubeni izinto zibe yimihume ngenxa yokuminyana kwezinhlayiya nokuhlanganiswa kwazo.

Izinto ezibopha, izinto ezimunca umswakama, kanye nezimixwayo ezinamafutha ngokwemvelo zivame ukubambana. Imikhiqizo eyenziwe nge-lyophilized ne-freeze-dried (isibonelo, ama-probiotics, ama-peptides) ivame ukuba nezinkinga zokushajwa kukagesigesi ngesikhathi sokucubungula. Ezinkingeni zikagesigesi, isakhiwo esinemingxuma kanye namandla e-capillary e-SYLOID® 244FP enza ukuthi ukungathathi hlangothi kukagesigesi kube kahle, kunciphise ukuziphatha kukagesigesi futhi kunciphise ukunamathela kwezinhlayiya zomlotha ezintweni zokucubungula. Ezimixwayo ezithambekele ekunamatheleni ezindaweni zokucubungula, ukwengezwa komlotha we-silica okhutshwe kahle njenge-SYLOID® FP Silica kwakha ungqimba oluvikelayo phezu kwezinye izithako, kunciphise ukunamathela futhi kuvimbele ngempumelelo ukubambana nokunamathela odongeni.

*Ngeminye imininingwane eningiliziwe ngendlela yokuxuba i-glidant enezinyathelo ezimbili, sicela ucele inothi lethu lesicelo elizinikezele.

I-Equation kaWashburn ingasetshenziswa ukuze kubikezelwe ngempumelelo ukuhlanzeka kwepowder yezokwelapha. Izicelo zayo ezingaba khona ekuthuthukiseni ifomula zifaka phakathi ukubalwa kwe-kinetics yokukhululwa kwemithi, ukuthuthukiswa kokwakheka kwefomula, nokunquma izitayela zokunamathela ngesikhathi sokukhiqiza.

I-Washburn Equation: $$L^2=(C \times r) \times \gamma \times cos\Phi / 2 \times \et$$

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