METHOD FOR PRODUCING THE MICROCAPSULATED FORM OF A LIVE VIRAL VACCINE - European Patents

Patent Number: WO2004035028
Publication date: 2004-04-29
Inventor(s): SANDAKHCHIEV LEV STEPANOVICH [RU]; NECHAEVA ELENA AVGUSTOVNA [RU]; VARAKSIN NIKOLAI ANATOLYEVICH [RU]; RYABICHEVA TATYANA GENNADYEVNA [RU]; KOLOKOLTSOVA TAMARA DMITRIEVNA [RU]; MAZURKOVA NATALYA ALEKSEEVNA [RU]; VILESOV ALEKSANDR DMITRIEVICH [RU]; STANKEVICH RICHARD PETROVICH [RU]; ISIDOROV ROMAN VALERYEVICH [RU]
Applicant(s): G NAUCHNY TS VIRUSOLOGII I BIO [RU];; SANDAKHCHIEV LEV STEPANOVICH [RU];; NECHAEVA ELENA AVGUSTOVNA [RU];; VARAKSIN NIKOLAI ANATOLYEVICH [RU];; RYABICHEVA TATYANA GENNADYEVNA [RU];; KOLOKOLTSOVA TAMARA DMITRIEVNA [RU];; MAZURKOVA NATALYA ALEKSEEVNA [RU];; VILESOV ALEKSANDR DMITRIEVICH [RU];; STANKEVICH RICHARD PETROVICH [RU];; ISIDOROV ROMAN VALERYEVICH [RU]
Requested Patent: WO2004035028
Application Number: WO2002RU00465 20021017
Priority Number(s): WO2002RU00465 20021017
IPC Classification: A61K9/50; A61K39/145; A61K39/165
EC Classification: A61K9/00N10, A61K39/145, A61K39/165
Equivalents:
Cited Documents: US5807757; US5068104; EP0325359; US5648096; RU2127118
Abstract
The invention relates to microcapsule production and can be used for the pharmaceutical industry for producing vaccines and therapeutic preparations. The sizes of particles of the inventive microcapsulated form of a live viral vaccine ranges from 0.2 to 10.0 mkm and the shelf life thereof is equal to or higher than one year. The inventive method consists in preparing capsulated material in the form of a measles or influenza virus, dispersing said substance in a water-soluble charged polyelectrolyte, producing a coacervate for forming capsule membranes, introducing a hardener and in drying the thus produced capsules. The hardener is introduced into the charged polyelectrolyte simultaneously with the viral substance as far as the final concentration of the polyelectrolyte and which does not provoke a phase separation is obtained. The microcapsules are produced by the complex coacervation of the charged polyelectrolyte and the hardener which forms a complex by freezing a solution at a rate of 0.1-3.0 DEG C per minute till a temperature which is low than the glass transition temperature of an amorphous phase remaining after ice crystallisation, the drying process of the microcapsules being carried out with the aid of lyophilization. Before being frozen, a liquid stock is poured into ampoules which are filled with inert gas and sealed after the lyophylic drying.
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