SAIB(sucrose isobutyrate acetate) ndi mankhwala grade multifunctional excipient. Ndi madzi a viscous okonzedwa ndi esterification ya shuga wachilengedwe (sucrose) ndi acetic acid ndi isobutyric anhydride. Ndi chisakanizo chopangidwa ndi distillation ndi kupanga oyeretsedwa kwambiri. Itha kugwiritsidwa ntchito ngati chida chothandizira kumasulidwa, zosungunulira / zonyamulira komanso zoletsa kugwiritsa ntchito mankhwala osokoneza bongo.

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Makhalidwe azinthu za SAIB

SAIB ndi chosungunulira / chonyamulira chabwino kwambiri cha hydrophobic API ndipo imakhala ndi ntchito yotulutsa pang'onopang'ono.

SAIB siimangirira ndipo imakhalabe amorphous kutentha kwa chipinda, zomwe zimalimbikitsa kwambiri kuchuluka kwa mankhwala osokoneza bongo;

SAIB si polymeric ndipo simaundana kapena kugwa madzi ikakumana ndi madzi am'thupi amadzimadzi. SAIB imasungunuka mu zosungunulira zambiri za organic ndipo imagwirizana ndi zida zambiri; SAIB imatha kumwazikana m'madzi mothandizidwa ndi zosungunulira zachilengedwe.

SAIB ili ndi bioadhesive properties ndipo itha kugwiritsidwa ntchito popanga transdermal, sublingual and buccal patch application.

Kugwiritsa ntchito mankhwala

1. Kuchedwetsa kumasulidwa

Pachithunzi pamwambapa, zikuwoneka kuti SAIB ili ndi mtengo wa HLB pafupifupi 5, kusonyeza kuti ndi hydrophobic.

2. Poor water solubility API solution

Hydrophobic SAIB ndi yabwino zosungunulira / chonyamulira kwa API ndi osauka madzi solubility, ndipo kugwiritsa ntchito SAIB kumapangitsa kusungunuka kwa malonda osasungunuka mankhwala.

3. Pewani kugwiritsa ntchito mankhwala osokoneza bongo

Kugwiritsa ntchito SAIB kumawonjezera kukula kwa ma opioid panthawi yopera ndikusokoneza kuchotsa mankhwala.

(1) Ma polima (polyoxyethylene ndi/kapena hydroxypropyl methylcellulose) ndi tocopherol acetate ndi ma granules opangidwa kuchokera ku njira ya mowa ya SAIB. Zokonzekerazi zimagawidwa ngati Osachiritsidwa / Osachiritsidwa kapena Ochiritsidwa / Ochiritsidwa (ochiritsidwa 90oC kwa mphindi 30).

(2) Pseudoephedrine hydrochloride, ma polima (polyoxyethylene ndi/kapena hydroxypropyl methylcellulose) ndi tocopherol acetate ndi ma granules opangidwa kuchokera ku njira ya mowa ya SAIB. Zokonzekerazi zimagawidwa ngati Osachiritsidwa / Osachiritsidwa kapena Ochiritsidwa / Ochiritsidwa (ochiritsidwa 90oC kwa mphindi 30).

Kuwunika kwa mphuno kwa mphuno kunasonyeza kuti kugwiritsa ntchito SAIB kumawonjezera kukula kwa ufa pa nthawi yopera, mpaka 47% ya kukula kwa ufa wogaya kuposa 1mm.

Poyerekeza ndi gulu lolamulira, kuchuluka kwa m'zigawo za SAIB m'madzi, 0.1% N HCl ndi 0.1% N NaOH zosungunulira zatsika ndi 41.3% -42.5%, 24.8% -26.1% ndi 37.4% -50.6%, motero. Kugwiritsa ntchito zosungunulira za organic m'zigawo kumapanga zotsalira zomata zomwe zimakhala zovuta kudutsa njira zosiyanasiyana zoyendetsera (monga jekeseni, kumeza, kufwenthera, ndi zina zotero), kupewa kugwiritsa ntchito mankhwala osokoneza bongo.

mapeto

Kugwiritsa ntchito SAIB, popanda zokutira, kumatha kusakanikirana mwachindunji ndi API kuti atalikitse kutulutsidwa kwa mankhwala ndikukwaniritsa kumasulidwa kosalekeza.

Hydrophobic SAIB, yomwe imatha kumwazikana m'madzi mothandizidwa ndi organic solvents, ingagwiritsidwe ntchito ndi hydrophobic kapena hydrophilic apis; SAIB ikhoza kupititsa patsogolo kusungunuka kwa API ndi kusungunuka kwamadzi kosakwanira ndipo ndi chosungunulira chabwino kwambiri komanso chonyamulira cha API chosasungunuka bwino m'madzi.

Kugwiritsiridwa ntchito kwa SAIB kumalepheretsa kugwiritsa ntchito mankhwala osokoneza bongo mwa kuonjezera kukula kwa tinthu tating'onoting'ono ta mankhwalawo pamene ali pansi, kusokoneza kuchotsa mankhwala osokoneza bongo, ndikupangitsa kuti zikhale zovuta kuti mankhwalawa alowe m'njira zosiyanasiyana.

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