Stable dry powder composition comprising biologically active microorganisms and/or bioactive materials and methods of making

Abstract

The present invention relates to embedding live or dead microorganisms and/or bioactive materials in a protective dry formulation matrix, wherein the formulation includes the bioactive microorganism or material, a formulation stabilizer agent, and a protective agent. The formulation is prepared by dispersing all the solid components in a solution, with or without a vacuum, and cooling the solution to a temperature above its freezing temperature. The methods include a primary drying step of the formulation at a desired temperature and time period, and an accelerated secondary drying step under maximum vacuum and elevated temperature, to achieve a final desirable water activity of the dry material.

Description

CROSS-REFERENCE TO RELATED APPLICATION[0001]This application claims priority to U.S. Provisional Application Nos. 61 / 181,248 and 61 / 223,295 filed in the United States Patent and Trademark Office on May 26, 2009 and Jul. 6, 2009, respectively, the contents of which are hereby incorporated by reference herein for all purposes.BACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]The present invention is in the field of protection of bioactive microorganism and / or materials in high temperature and humid conditions. In particular, the invention relates to embedding live microorganisms and / or bioactive materials in a protective dry formulation matrix.[0004]2. Related Background Art[0005]Bioactive microorganisms, such as live or dead bacteria and viruses, or bioactive materials, such as proteins, vitamins, minerals, hormones and cells are generally unstable when stored under conditions of high temperature and humidity. For example, many commercially available probiotic bacteria ...

AI Technical Summary

Benefits of technology

[0023]In preferred methods, the formulation is mixed under vacuum at room temperature (e.g., from 20° C. to 30° C.). After mixing to homogeneity, the formulation is then cooled to a temperature above the freezing temperature of the formulation. Typically, the formulation is cooled to between −10° C. to +10° C., more preferably the formulation is cooled to between −5° C. and +5° C. In a preferred embodiment, the cooled formulation is then transferred to a drying chamber where heating is applied (20° C. or more) while controlling an initial vacuum pressure at a level to maintain the original pre-cooling temperature. Typically, the desirable vacuum pressure is below 7 Tor...

Problems solved by technology

Bioactive microorganisms, such as live or dead bacteria and viruses, or bioactive materials, such as proteins, vitamins, minerals, hormones and cells are generally unstable when stored under conditions of high temperature and humidity.

Other methods, such as spray drying, supercritical fluid drying, and desiccation are generally not suitable for sensitive bioactives such as live or attenuated bacteria and viruses because of the high drying temperatures used in these methods which result in significant damage to the microorganism itself.

In addition, they may not sufficiently dry the material to the specific residual moisture requirements for product stability, and thus an additional drying step by other means, may be required.

However, the requirement for sub-zero temperatures is energy intensive, and the low surface area to volume ratios of the frozen material necessitates the use of long drying time (up to several days per batch cycle).

For this reason, bioactive microorganism or materials such as viruses, bacteria, and cells that possess a cell wall or lipid membrane, pose significant challenges to the freeze-drying process.

However, such protective agents may not penetrate adequately into the cell to protect active components within the intracellular volume.

Therefore, a significant challenge...

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