title: Vacuum foam drying for preservation of LaSota virus: effect of additives.
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 degrees , 25 degrees , and 40 degrees 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.
authors.affiliation: Department of Pharmaceutical Biotechnology, Bharati Vidyapeeth Deemed University, Poona College of Pharmacy, Center for Advanced Research and Education, Pune-411 038, India. CAYT2002@rediffmail.com
authors.forename: Sambhaji
authors.initials: S
authors.lastname: Pisal
authors.forename: Gopal
authors.initials: G
authors.lastname: Wawde
authors.forename: Shailendra
authors.initials: S
authors.lastname: Salvankar
authors.forename: Sanjay
authors.initials: S
authors.lastname: Lade
authors.forename: Shivajirao
authors.initials: S
authors.lastname: Kadam
mesh_terms: D003890:Desiccation / Q000379:methods; D004187:Disaccharides / Q000737:chemistry / Q000494:pharmacology*; D004355:Drug Stability; D005612:Freeze Drying / Q000379:methods*; D011092:Polyethylene Glycols / Q000737:chemistry / Q000494:pharmacology*; D011309:Preservation, Biological / Q000379:methods*; D014618:Vacuum; D014780:Viruses / Q000187:drug effects*
chemical_list: D004187:Disaccharides; D011092:Polyethylene Glycols