Sodium Stearyl Fumarate (SSF) Mankhwala Opaka | Kugwirizana Kwambiri ndi API, Njira Ina M'malo mwa Magnesium Stearate, GMP Giredi

Sodium Stearyl Fumarate (SSF) yathu ndi mafuta oyeretsera mankhwala opangidwa makamaka kuti agwiritsidwe ntchito pa mapiritsi ndi makapisozi. Mosiyana ndi magnesium stearate, imapereka kuyanjana kwabwino kwa API, kulimba pamene mafuta akupakidwa mopitirira muyeso, komanso palibe vuto lililonse pa kupezeka kwa bioavailability.Ndi mafuta ophikira madzi, osasungunuka pang'ono omwe amapereka kulimba kwabwino kwa piritsi pa mphamvu zofanana ndi kupsinjika ndipo amachepetsa nthawi yowonongeka.. Zimagwirizana ndi mankhwala a USP-NF, EP, ndi JP okhala ndi CDE registration (F20190000009) ndi chithandizo cha DMF (38822). Mlingo woyenera wogwiritsira ntchito: 0.5-3% w/w. Yabwino kwambiri pa mapiritsi othamanga kwambiri, mapiritsi otulutsa mphamvu, ndi mapangidwe okhala ndi ma API osagwirizana

Lumikizanani nafe

Tsatanetsatane wa Zamalonda

Mankhwala Opangira Mankhwala a Sodium Stearyl Fumarate (SSF)

Chidule cha Zamalonda

Sodium Stearyl Fumarate (SSF) ndi mafuta odzola omwe amagwiritsidwa ntchito kwambiri m'malo mwa mafuta achikhalidwe monga magnesium stearate ndi talc.Ndi mchere wa sodium wa stearyl fumaric acid, womwe umawoneka ngati ufa woyera mpaka woyera kwambiri wokhala ndi mphamvu zolimbitsa thupi zomwe zimathandiza kuti mafuta ochulukirapo akhale abwino mu mapiritsi ndi makapisozi..

Chidziwitso cha Zamalonda:

Dzina la Mankhwala:Sodium Stearyl Fumarate
Nambala ya CAS:4070-80-8
Nambala Yolembetsa ya CDE:F20190000009
Nambala ya DMF:38822
Kutsatira Malamulo a Pharmacopoeia:USP-NF, EP, JP
Fomula ya Maselo:C22H39NaO4
Kulemera kwa Maselo:390.53 g/mol

Zinthu Zofunika & Mapindu

1. Kugwirizana kwa API Yapamwamba

Kuthetsa mavuto okhudzana ndi magnesium stearate omwe amakumana nawo nthawi zambiri
Zomwe zanenedwa kuti sizikugwirizana ndi API ndi magnesium stearate ndi izi: Azathioprine, Cefaclor, Cilazapril, Clopidogrel, Diclofenac, Ibuprofen, Omeprazole, ndi zina zambiri.
Yabwino kwambiri pakupanga mankhwala komwe kusagwirizana kwa mankhwala ndi vuto

2. Kulimba mpaka Kupaka Mafuta Mopitirira Muyeso

Mosiyana ndi magnesium stearate, SSF imasunga magwiridwe antchito ngakhale ikagwiritsidwa ntchito nthawi yayitali.
Amapereka kuuma kwa mapiritsi nthawi zonse komanso kusweka popanda zotsatira za "mafuta ochulukirapo".

3. Kapangidwe ka Mapiritsi Olimbikitsidwa

Kuuma kwapamwambapa mphamvu zofanana za kupsinjika poyerekeza ndi mafuta ena odzola
Zovuta zochepa pa nthawi yopasuka- imasunga kusweka kwa mapiritsi mwachangu
Palibe zotsatira zoyipa pa bioavailability- kuonetsetsa kuti mbiri ya kutulutsidwa kwa mankhwala osokoneza bongo ikukhalabe yolondola

4. Chilengedwe Chokonda Madzi ndi Chosungunuka Mochepa

Mafuta osungunuka m'madzi - 0.5 mg/100 mL pa 25°C, ndikuwonjezeka kufika pa 20 g/100 mL pa 90°C
Zimapangitsa kuti pakhale zotsalira zochepa mu yankho, zomwe zimapangitsa kuti likhale labwino kwambirimapiritsi otulutsa mpweya
Zimawongolera ma profiles osungunuka a ma API osasungunuka bwino

5. Katundu Wabwino Kwambiri