scholarly journals PRELIMINARY STUDY OF INSULIN DRY POWDER FORMULATION: CRITICAL PROCESS PARAMETERS ON SPRAY-FREEZE-DRYING AND CRITICAL MATERIAL ATTRIBUTE OF TREHALOSE AND INULIN AS STABILIZER

2021 ◽  
pp. 83-88
Author(s):  
CYNTHIA MARISCA MUNTU ◽  
SILVIA SURINI ◽  
CHRISTINA AVANTI ◽  
HAYUN ◽  
WOUTER HINRICHS
Keyword(s):  
Process Parameters ◽  
Freeze Drying ◽  
Time Lag ◽  
Physicochemical Characterization ◽  
Dry Powder ◽  
Critical Material ◽  
Atomization Process ◽  
Critical Process Parameters ◽  
Spray Freeze Drying ◽  
Critical Process

Objective: The aim of this study was to obtain recommendations about critical process parameters (CPP) and optimal ratio of trehalose and inulin as critical material attribute (CMA) on insulin dry powder formulation with spray-freeze-drying (SFD) method. Methods: Inulin dry powder was formulated with the SFD method, which consisted of an atomization process and freeze-drying (FD). SFD processes were optimized in order to obtain dry powder and CPP was analyzed. All seven variations of formulas proceeded with physicochemical characterization to obtain the optimal formula. Results: In the early optimization, there was a slight time lag between the atomization process and FD; as a result, some of the powder coagulated and crystallized. Another critical parameter was that the FD process should not be interrupted for at least 50 h of FD. Dry powder proceeded with physicochemical characterization, a formula without inulin showed semicrystalline properties, while six formulas had amorphous properties due to its combination. All formulas had a spherulite shape and rough surface. Five formulas with the combination of trehalose and inulin obtained dry powders with a diameter range of 30-43 μm, moisture content below 3.5% and high encapsulation efficiency (EE). Formula with the ratio of 1:1 (F4) showed optimal properties with moisture content and EE of 2.62% and 99.68%, respectively. Conclusion: This study concluded that there were two critical process parameters in the SFD method. There should be no time lag in SFD process and FD time which should not be interrupted. The optimal ratio for trehalose and inulin was shown by F4 with ratio of 1:1.

Freeze drying optimization of polymeric nanoparticles for ocular flurbiprofen delivery: effect of protectant agents and critical process parameters on long-term stability

2017 ◽  
Vol 43 (4) ◽  
pp. 637-651 ◽  
Author(s):  
Gladys Rosario Ramos Yacasi ◽  
Ana Cristina Calpena Campmany ◽  
María Antonia Egea Gras ◽  
Marta Espina García ◽  
María Luisa García López
Keyword(s):  
Process Parameters ◽  
Freeze Drying ◽  
Polymeric Nanoparticles ◽  
Term Stability ◽  
Long Term Stability ◽  
Critical Process Parameters ◽  
Critical Process

scholarly journals Intratracheal inoculation of AHc vaccine induces protection against aerosolized botulinum neurotoxin A challenge in mice

npj Vaccines ◽  
2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Changjiao Gan ◽  
Wenbo Luo ◽  
Yunzhou Yu ◽  
Zhouguang Jiao ◽  
Sha Li ◽  
...  
Keyword(s):  
Bronchoalveolar Lavage ◽  
Clostridium Botulinum ◽  
Freeze Drying ◽  
Botulinum Neurotoxin ◽  
Secretory Iga ◽  
Immune Protection ◽  
Dry Powder ◽  
Botulinum Neurotoxin A ◽  
Spray Freeze Drying

AbstractBotulinum neurotoxin (BoNT), produced by Clostridium botulinum, is generally known to be the most poisonous of all biological toxins. In this study, we evaluate the protection conferred by intratracheal (i.t.) inoculation immunization with recombinant Hc subunit (AHc) vaccines against aerosolized BoNT/A intoxication. Three AHc vaccine formulations, i.e., conventional liquid, dry powder produced by spray freeze drying, and AHc dry powder reconstituted in water are prepared, and mice are immunized via i.t. inoculation or subcutaneous (s.c.) injection. Compared with s.c.-AHc-immunized mice, i.t.-AHc-immunized mice exhibit a slightly stronger protection against a challenge with 30,000× LD50 aerosolized BoNT/A. Of note, only i.t.-AHc induces a significantly higher level of toxin-neutralizing mucosal secretory IgA (SIgA) production in the bronchoalveolar lavage of mice. In conclusion, our study demonstrates that the immune protection conferred by the three formulations of AHc is comparable, while i.t. immunization of AHc is superior to s.c. immunization against aerosolized BoNT/A intoxication.

scholarly journals Designing ultra-small nanostructured lipid carriers: critical process parameters

2020 ◽  
Author(s):  
Maria Mendes ◽  
João Basso ◽  
João Sousa ◽  
Alberto Pais ◽  
Carla Vitorino
Keyword(s):  
Process Parameters ◽  
Nanostructured Lipid Carriers ◽  
Critical Process Parameters ◽  
Critical Process

scholarly journals Application of Statistical Design to Assess the Critical Process Parameters of Ethanol Injection Method for the Preparation of Liposomes

2019 ◽  
Vol 18 (1) ◽  
pp. 103-111 ◽  
Author(s):  
Sayani Bhattacharyya ◽  
Bharani S Sogali
Keyword(s):  
Particle Size ◽  
Process Parameters ◽  
Particle Size Analysis ◽  
Polydispersity Index ◽  
Size Analysis ◽  
Ethanol Injection ◽  
Injection Method ◽  
Critical Process Parameters ◽  
Critical Process ◽  
Ethanol Injection Method

In the present study custom screening design was employed to observe the effect of four critical process parameters on particle size and polydispersity index of the liposomal formulation made by ethanol injection method. The four process parameters selected were lipid ratio, rate of injection, phase volume ratio and rotational speed of magnetic stirring. Eight different liposomal formulations were prepared using the design. The formulations were subjected to particle size analysis. The analysis was done at a significance level p<0.05 and found that the process parameters had significant effect on the particle size and polydispersity index of the formulations. The design was optimized for the individual responses with an overall desirability of more than 50%. Three batches of liposomes were formulated at optimized process parameters which matched the target as predicted by the design. Therefore, it can be concluded that the design was effective in production of nano sized stable monodisperse liposomes by ethanol injection method. Dhaka Univ. J. Pharm. Sci. 18(1): 103-111, 2019 (June)

scholarly journals Aeration and Shear Stress Are Critical Process Parameters for the Production of Oncolytic Measles Virus

2019 ◽  
Vol 7 ◽  
Author(s):  
Tanja A. Grein ◽  
Daniel Loewe ◽  
Hauke Dieken ◽  
Tobias Weidner ◽  
Denise Salzig ◽  
...  
Keyword(s):  
Shear Stress ◽  
Process Parameters ◽  
Measles Virus ◽  
Critical Process Parameters ◽  
Critical Process
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