SAIB(sucrose isobutyrate acetate) igiredhi remishonga yakawanda inoshanda excipient. Iyo viscous mvura inogadzirwa neinodzorwa esterification yeshuga yechisikigo (sucrose) ine acetic acid uye isobutyric anhydride. Iko musanganiswa unogadzirwa ne distillation uye yakanyanya kucheneswa kugadzirwa. Inogona kushandiswa seyakagadziriswa yekuburitsa mumiriri zvinhu, solvent / mutakuri uye kushandisa zvinodhaka inhibitor.

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SAIB chigadzirwa maitiro

SAIB yakanakisa solvent/carrier yehydrophobic API uye ine inononoka kuburitsa basa.

SAIB haina crystalline uye inoramba iine amorphous pane tembiricha yekamuri, iyo inokurudzira zvikuru chiyero chenguva dzose chekuendesa zvinodhaka;

SAIB haisi-polymeric uye haigwande kana kunaya kana yasangana nemvura yemumuviri ine mvura. SAIB inonyungudika mune zvakawanda organic solvents uye inowirirana nezvinhu zvakawanda; SAIB inogona kuparadzirwa mumvura nerubatsiro rweorganic solvents.

SAIB ine bioadhesive zvivakwa uye inogona kushandiswa kune transdermal, sublingual uye buccal chigamba zvikumbiro.

Product application

1. Kunonoka kusunungurwa

Mumufananidzo uri pamusoro, zvinogona kuonekwa kuti SAIB ine HLB kukosha kwe5, zvichiratidza kuti ndeye hydrophobic.

2. Yakashata mvura solubility API mhinduro

Hydrophobic SAIB yakanaka solvent/carrier ye API isina kunyungudika kwemvura, uye kushandiswa kweSAIB kunovandudza kunyungudika kwezvinodhaka zvisinganyunguriki.

3. Dzivirirai kushandisa zvinodhaka

Kushandiswa kweSAIB kunowedzera saizi yeopioid panguva yekugaya uye inokanganisa kutorwa kwezvinodhaka.

(1) Polymers (polyoxyethylene uye/kana hydroxypropyl methylcellulose) uye tocopherol acetate magranules akagadzirwa kubva kune doro solution yeSAIB. Kugadzirira kunorongedzerwa kunge Kusina Kupora / Kusapora kana kupisa-kupora / Kuporeswa (yakarapwa 90oC kwemaminetsi makumi matatu).

(2) Pseudoephedrine hydrochloride, mapolymers (polyoxyethylene uye/kana hydroxypropyl methylcellulose) uye tocopherol acetate magranules akagadzirwa kubva kune doro solution yeSAIB. Kugadzirira kunorongedzerwa kunge Kusina Kupora / Kusapora kana kupisa-kupora / Kuporeswa (yakarapwa 90oC kwemaminetsi makumi matatu).

Kuongororwa kwehupfu hwemhino kwakaratidza kuti SAIB kushandiswa kwakawedzera hupfu hwehupfu panguva yekukuya, uye kusvika ku47% yehupfu hwekukuya yakakura kupfuura 1mm.

Kuenzaniswa neboka rekutonga, chiyero chekuchera cheSAIB mumvura, 0.1% N HCl uye 0.1% N NaOH zvinonyungudutsa zvakaderera ne 41.3% -42.5%, 24.8% -26.1% uye 37.4% -50.6%, maererano. Kushandiswa kwezvinonyungudutsa zvinonyungudutsa zvinogadzira zvinonamira zvisaririra zvinonetsa kupfuura nenzira dzakasiyana dzekutonga (semuenzaniso, jekiseni, kupinza, kufefetera, nezvimwewo), kudzivirira kushandisa zvinodhaka.

mhedziso

Iko kushandiswa kweSAIB, pasina kupfekedza, kunogona kusanganiswa zvakananga neAPI kuti uwedzere kuburitswa kwezvinodhaka uye kuwana kusunungurwa kwakasimba.

Hydrophobic SAIB, iyo inogona kuparadzirwa mumvura nerubatsiro rwemakemikari emvura, inogona kushandiswa ne hydrophobic kana hydrophilic apis; SAIB inogona kuvandudza kunyungudika kweAPI nekunyungudika kwakashata kwemvura uye inonyungudutsa yakanakisa uye inotakura yeAPI isina kunyungudika kwemvura.

Kushandiswa kweSAIB kunodzivirira kushandiswa zvisina kunaka kwezvinodhaka nekuwedzera saizi yemushonga kana yavhurika, ichikanganisa kutorwa kwezvinodhaka, uye kuita kuti zviome kuti mushonga ubatwe nenzira dzakasiyana dzekutonga.

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