Brusella abortus S-19 aşısının liyofilizasyon öncesi farklı liyoprotektanlar ile kritik formülasyon sıcaklıklarının araştırılması

Yıl 2019, Cilt: 30 Sayı: 1, 51 - 57, 30.06.2019

Mustafa Sencer Karagül , Buket Eroğlu

https://doi.org/10.35864/evmd.560109

Öz

Bu çalışmada, Brusella
(B.)abortus S19 aşı şuşu ile liyoprotektan karışımlarının termal analizi
yapılarak kritik formülasyon sıcaklıklarının belirlenmesi, karşılaştırmalı
sonuçlar ile liyofilizasyon optimizasyonu için istifade edilebilecek bilgilere ulaşılması
amaçlanmıştır. S19 aşısı ile 3 farklı liyoprotektan (mannitol, sukroz,
trehaloz) 3 farklı konsantrasyonda (%5, %10, %15) kullanılarak 9 farklı formülasyonun
analizi termal görüntüleme cihazı olan dondurarak kurutma mikroskopu (FDM) ve Diferansiyel
Termal Analiz (DTA) ile elektriksel direnç(Zsin) analizini sağlayan termal
analiz cihazı ile yapılmıştır. Termal analiz ve görüntüleme cihazların
kullanımıyla elde edilen kritik formülasyon sıcaklıkları ile liyoprotektan
tercihi ve konsantrasyonu arasındaki ilişki araştırılmıştır.  Aşı yarı mamulü ile liyoprotektan karışımları
için formülasyonların kritik sıcaklıklardaki kayda değer farklar, farklı liyoprotektan
kullanıldığında gözlenmiştir. Her liyoprotektanın farklı konsantrasyonları için
ise kurutma prosesinin yeni baştan dizayn edilmesini gerektiren farklar tespit
edilmemiştir. Bu açıdangelecek çalışmalar için oluşturulmuş temel bir reçete üzerinden
protektan madde konsantrasyonunun arttırılarak yapılacak liyofilizasyon
proseslerinin yürütülmesi verim ve stabiliteyi artırabilecektir.

Anahtar Kelimeler

B.abortus S-19, Liyofilizasyon, Liyoprotektan, Termal Analiz

Investigating the critical formulation temperatures of Brucella abortus S-19 vaccine with different liyoprotectants prior to liyophilisation

Öz

The aim of this study is to determine the critical temperatures
of formulations composed of B.abortus
S19 vaccine strain and liyoprotectants. It also attempts to obtain the necessary
information that may be beneficial for the optimisation of lyophilisation process
by the help of comparative results among formulations. Thermal analysis of 9
different formulations consisting of S19 strain and each of 3 lyprotectants
(mannitol, sucrose, trehalose) at 3 different concentrations (5%, 10%,15%) was carried
out by freze drying microscopy (FDM), differential thermal analysis (DTA), and electrical
impedance (Zsin) analysis. Correlations between liyoprotectant choice and liyoprotectant
concentration were investigated by the help of critical formulation temperatures
obtained through thermal analysis and screening instruments. Significant differences
in the critical temperature of vaccine with liyoprotectant formulation were observed
when a different liyoprotectant was used. However, differences that require the
redesign of the whole drying process were not observed at the different concentrations
of the same liyoprotectant. For this reason, 
in the quide of a baseline recipe, evaluation of the liyophilisation process
carried out through increasing the amount of liyoprotectant can be recommended to
increase stability and performance.

Anahtar Kelimeler

B.abortus S-19, Liyophilisation, Liyoprotectant, ThermalAnalysis

Kaynakça

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