scholarly journals Beyond freeze-drying of biologics: vacuum-foam drying and spray freeze-drying

Author(s):  
S. Ohtake ◽  
A. Langford ◽  
B. Balthazor ◽  
B. Bhatnagar ◽  
S. Tchessalov ◽  
...  

The complexity of biotherapeutics in development continues to increase as our capability in discovery and recombinant technology improves. While safety and efficacy remain the two critical aspects of all therapeutics, ensuring adequate stability is a challenge. Freeze-drying is a commonly-used processing technique to enhance the stability of biotherapeutic products, although the lengthy process time and low energy efficiency have led to the search for, and evaluation of, next-generation drying technologies, including spray freeze-drying and vaccum-foam drying. Both processes result in dosage forms that vary considerably from those produced by lyophilization and possess physical properties that may be deemed superior for their intended applications. Keywords: vacuum-foam drying; spray freeze-drying; lyophilization; biotherapeutics; stabilization

Pharmaceutics ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 1023
Author(s):  
Ji Young Yu ◽  
Piyanan Chuesiang ◽  
Gye Hwa Shin ◽  
Hyun Jin Park

Liposomes have been utilized as a drug delivery system to increase the bioavailability of drugs and to control the rate of drug release at the target site of action. However, the occurrence of self-aggregation, coalescence, flocculation and the precipitation of aqueous liposomes during formulation or storage can cause degradation of the vesicle structure, leading to the decomposition of liposomes. To increase the stability of liposomes, post-processing techniques have been applied as an additional process to liposomes after formulation to remove water and generate dry liposome particles with a higher stability and greater accessibility for drug administration in comparison with aqueous liposomes. This review covers the effect of these techniques including freeze drying, spray drying and spray freeze drying on the stability, physicochemical properties and drug encapsulation efficiency of dry liposomes. The parameters affecting the properties of liposomes during the drying process are also highlighted in this review. In addition, the impact of using a protective agent to overcome such limitations of each process is thoroughly discussed through various studies.


2016 ◽  
Vol 66 (2) ◽  
pp. 207-218 ◽  
Author(s):  
Narges Poursina ◽  
Alireza Vatanara ◽  
Mohammad Reza Rouini ◽  
Kambiz Gilani ◽  
Abdolhossein Rouholamini Najafabadi

Abstract Spray freeze drying was developed to produce dry powders suitable for applications such as inhalation delivery. In the current study, the spray freeze drying technique was employed to produce inhalable salmon calcitonin microparticles. Effects of the carrier type, concentration of hydroxyl propyl-β-cyclodextrin and the presence of Tween 80 on the chemical and structural stability, as well as on the aerosol performance of the particles were investigated. The results indicated that hydroxyl propyl-β-cyclodextrin had the most important effect on the chemical stability of the powder and strongly increased its stability by increasing its concentration in the formulation. Chemically stable formulations (over 90 % recovery) were selected for further examinations. Fluorescence spectroscopy and circular dichroism suggested that the formulations were structurally stable. Aerosol performance showed that the Tween-free powders produced higher fine particle fraction values than the formulations containing Tween (53.7 vs. 41.92 % for trehalose content and 52.85 vs. 43.06 % for maltose content).


2017 ◽  
Vol 2017 ◽  
pp. 1-7 ◽  
Author(s):  
Yuqi Pang ◽  
Xu Duan ◽  
Guangyue Ren ◽  
Wenchao Liu

Microencapsulation is widely used to minimize the oxidation of fish oil products. This study compared the effects of different drying methods, for example, spray drying (SD), freeze drying (FD), and spray freeze drying (SFD) on the microencapsulation of fish oil. Spray drying (SD) is the most common method for producing fish oil microcapsules, and it has low operation cost and short processing time, while the product yield and quality are poor. Freeze drying (FD) can be used to produce oil microcapsules with high quality, but it takes long time and high overall cost for drying. Spray freeze drying (SFD) is a new method for the preparation of microcapsules, which combines the SD and FD processes to obtain high quality powder. The yield of powder reached 95.07% along with porous structure by SFD. The stability and slow-release property of SFD products were better than those of SD and FD, which showed that SFD improved product storage stability and potential digestibility.


npj Vaccines ◽  
2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Changjiao Gan ◽  
Wenbo Luo ◽  
Yunzhou Yu ◽  
Zhouguang Jiao ◽  
Sha Li ◽  
...  

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.


1976 ◽  
Vol 4 (1) ◽  
pp. 1-5
Author(s):  
E M Scott ◽  
W Woodside

The effect of suspending media on the stability of pseudorabies virus upon freeze-drying and subsequent storage was studied. A variety of media was tested, including: sodium glutamate; sucrose; lactose; lactalbumin hydrolysate; peptone; a combination of sucrose, dextran, and glutamate; and various combinations of sucrose, glutamate, and potassium phosphates. Suspending media containing glutamate, either alone or in combination with sucrose and either dextran or phosphates, afforded the greatest degree of protection during the freeze-drying process and upon storage. Some possible functions of these additives in preventing injury to the virus during freezing and drying have been suggested.


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