Vacuum foam drying for preservation of LaSota virus: Effect of additives |
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Authors: | Sambhaji Pisal Gopal Wawde Shailendra Salvankar Sanjay Lade Shivajirao Kadam |
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Institution: | (1) Department of Pharmaceutical Biotechnology, Bharati Vidyapeeth Deemed University, Poona College of Pharmacy, Center for Advanced Research and Education (CARE), 411 038 Pune, India |
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Abstract: | The purpose of this research was to apply vacuum foam drying (VFD) for processing of LaSota virus and to screen formulation
additives for its stability. The aqueous dispersion of harvest containing sucrose or trehalose in combination with additive
(monosaccharides, polymers, N-Z-amine) was prepared. The diluted dispersions in vials were vacuum concentrated, foamed to
form a continuous structure, and vacuum dried. The products were evaluated for foam characteristics, residual moisture, virus
titer, x-ray diffraction pattern, and stability profile. The foamability increased with solid content in solutions. The foamability
of sucrose was enhanced with incorporation of N-Z-amine (10% and 15% wt/vol) and polyvinyl pyrrolidone (PVP K30, 3% wt/vol).
The fructose- or galactose-containing mixtures were deposited irregularly on the vial surface. The virus titer increased with
disaccharides in the formulation. Sucrose provided better protection than trehalose. Unlike lyophilization, N-Z-amine with
sucrose protected the virus from Millard’s Browning. Amino acids do not have a catalytic effect on hydrolysis of sucrose during
VFD. Monosaccharides were ineffective. A synergistic effect of PVP K30 or polyethylene glycol 6000 (3% wt/vol) with N-Z-amine
provided the maximum virus titer (6.97 and 7.15, respectively). This formulation retained the desired virus potency at 5°,
25°, and 40°C. The diffraction pattern revealed that a threshold concentration of N-Z-amine was required for inhibiting crystallization
of sucrose during VFD. VFD was successfully applied to produce a solid LaSota formulation. The products were amorphous and
did not devitrify on storage.
Published: July 21, 2006 |
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Keywords: | Foam drying LaSota virus additives stabilization |
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