scholarly journals Surface Treatment of Glass Vials for Lyophilization: Implications for Vacuum-Induced Surface Freezing

Pharmaceutics ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 1766
Author(s):  
Francesco Regis ◽  
Andrea Arsiccio ◽  
Erwan Bourlès ◽  
Bernadette Scutellà ◽  
Roberto Pisano

Freeze-drying is commonly used to increase the shelf-life of pharmaceuticals and biopharmaceuticals. Freezing represents a crucial phase in the freeze-drying process, as it determines both cycle efficiency and product quality. For this reason, different strategies have been developed to allow for a better control of freezing, among them, the so-called vacuum-induced surface freezing (VISF), which makes it possible to trigger nucleation at the same time in all the vials being processed. We studied the effect of different vial types, characterized by the presence of hydrophilic (sulfate treatment) or hydrophobic (siliconization and TopLyo Si–O–C–H layer) inner coatings, on the application of VISF. We observed that hydrophobic coatings promoted boiling and blow-up phenomena, resulting in unacceptable aesthetic defects in the final product. In contrast, hydrophilic coatings increased the risk of fogging (i.e., the undesired creeping of the product upward along the inner vial surface). We also found that the addition of a surfactant (Tween 80) to the formulation suppressed boiling in hydrophobic-coated vials, but it enhanced the formation of bubbles. This undesired bubbling events induced by the surfactant could, however, be eliminated by a degassing step prior to the application of VISF. Overall, the combination of degasification and surfactant addition seems to be a promising strategy for the successful induction of nucleation by VISF in hydrophobic vials.

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).


2007 ◽  
Vol 544-545 ◽  
pp. 789-792 ◽  
Author(s):  
Li Zhang ◽  
Yu Bao Li ◽  
Pu Jiang Shi ◽  
Yi Zuo ◽  
Lan Wu

A novel nano-hydroxyapatite/chitosan (n-HA/CS) composite scaffold with high porosity was developed by a new method of emulsion-foaming/freeze-drying process and was characterized by means of infrared spectroscopy (IR), scanning electronic microscopy (SEM) and universal material testing machine. In addition, the porosity and density of the scaffold were also calculated. IR result shows that the characteristic absorption peaks belonging to both CS and HA are present in their composite, and the slight band-shifts and peak-decrease suggest that some interactions have taken place between the two phases of CS and n-HA in the composite. SEM photo displays that, with the dosage increase of Tween-80, the prepared scaffold shows highly porous and interconnected structure, in which macropores and micropores coexist. The calculated data demonstrate that the porosity of the scaffold is proportional to the content of the emulsifier, while the compressive strength is inversely. When 15wt% emulsifier used, the porosity of the scaffold can be up to 90% and the density is 0.453g/cm3, while the corresponding compressive strength is about 2.4MPa. The newly developed n-HA/CS composite scaffolds may serve as a good 3-D substrate for cell attachment and migration in bone tissue engineering.


Author(s):  
Alan S. Rudolph ◽  
Ronald R. Price

We have employed cryoelectron microscopy to visualize events that occur during the freeze-drying of artificial membranes by employing real time video capture techniques. Artificial membranes or liposomes which are spherical structures within internal aqueous space are stabilized by water which provides the driving force for spontaneous self-assembly of these structures. Previous assays of damage to these structures which are induced by freeze drying reveal that the two principal deleterious events that occur are 1) fusion of liposomes and 2) leakage of contents trapped within the liposome [1]. In the past the only way to access these events was to examine the liposomes following the dehydration event. This technique allows the event to be monitored in real time as the liposomes destabilize and as water is sublimed at cryo temperatures in the vacuum of the microscope. The method by which liposomes are compromised by freeze-drying are largely unknown. This technique has shown that cryo-protectants such as glycerol and carbohydrates are able to maintain liposomal structure throughout the drying process.


Polymers ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 772
Author(s):  
Estefanía Álvarez-Castillo ◽  
Carlos Bengoechea ◽  
Antonio Guerrero

The replacement of common acrylic derivatives by biodegradable materials in the formulation of superabsorbent materials would lessen the associated environmental impact. Moreover, the use of by-products or biowastes from the food industry that are usually discarded would promote a desired circular economy. The present study deals with the development of superabsorbent materials based on a by-product from the meat industry, namely plasma protein, focusing on the effects of a freeze-drying stage before blending with glycerol and eventual injection molding. More specifically, this freeze-drying stage is carried out either directly on the protein flour or after its solubilization in deionized water (10% w/w). Superabsorbent materials obtained after this solubilization-freeze-drying process display higher Young’s modulus and tensile strength values, without affecting their water uptake capacity. As greater water uptake is commonly related to poorer mechanical properties, the proposed solubilization-freeze-drying process is a useful strategy for producing strengthened hydrophilic materials.


Biomolecules ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 839
Author(s):  
Karina Jasińska ◽  
Bartłomiej Zieniuk ◽  
Dorota Nowak ◽  
Agata Fabiszewska

The study aimed to evaluate the impact of selected factors of the freeze-drying process on the hydrolytic and synthetic activity of the extracellular lipases of Y. lipolytica KKP 379 and to attempt the use of the crude enzyme preparation as a biocatalyst in the synthesis of geranyl 4-hydroxyphenylpropanoate. Antioxidant and antibacterial properties of the geranyl ester derivative were also investigated in order to evaluate their usefulness as a novel food additive. The studies confirmed that freeze-drying was an effective method of dehydrating yeast supernatant and allowed for obtaining lyophilizates with low water activity from 0.055 to 0.160. The type and concentration of the additive (2–6% whey protein hydrolyzate, 0.5% and 1% ammonium sulphate) had a significant effect on the hydrolytic activity of enzyme preparations, while the selected variants of drying temperature during the freeze-drying process were not significant (10 °C and 50 °C). Low yield of geranyl 4-hydroxyphenylopropionate was shown when the lyophilized supernatant was used (5.3%), but the yield of ester synthesis increased when the freeze-dried Y. lipolytica yeast biomass was applied (47.9%). The study confirmed the antioxidant properties of the synthesized ester by the DPPH• and CUPRAC methods, as well as higher antibacterial activity against tested bacteria than its precursor with 0.125 mM MIC (minimal inhibitory concentration) against L. monocytogenes.


2010 ◽  
Vol 65 (21) ◽  
pp. 5716-5727 ◽  
Author(s):  
Sajal M. Patel ◽  
Swetaprovo Chaudhuri ◽  
Michael J. Pikal

2017 ◽  
Vol 168 ◽  
pp. 1244-1250 ◽  
Author(s):  
Kenta Bando ◽  
Yasuki Kansha ◽  
Masanori Ishizuka ◽  
Atsushi Tsutsumi

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