Method of preparing biological materials and preparations produced using same

Abstract

Methods for preparing products containing moisture-sensitive materials, including biological materials such as proteins, peptides or live cells, comprising at least the steps: (i) providing a coating liquid comprising at least one active, a sugar polymer and a water soluble / miscible solvent; (ii) providing a quantity of microparticles comprising at least water soluble gel forming solid particles; (iii) fluidizing said quantity of microparticles within a processing chamber of a of a suitable apparatus to form a fluidized bed of said microparticles; (iv) spraying said coating liquid onto said fluidized bed from beneath the fluidized bed to coat said microparticles therewith under saturated moisture conditions; and (vi) allowing coated microparticles to dry, are described. Also described are compositions and uses.

Description

FIELD The present invention generally relates to a method of preparing biological materials, and particularly, but not exclusively, to a method of preparing biological proteins. BACKGROUND Many biological materials, such as proteins or whole cells, which may be useful in treatment and prevention of human and animal diseases or as food supplements, for example, are known to have a limited shelf life. This limitation is generally considered to be a result of protein instability at storage temperature, for example room temperature. The shelf life of certain proteins, and / or, cell cultures, may be extended by storing them at refrigeration temperatures (that is, 4° C. to 8° C.), however, even at such temperatures a shelf life of less than eighteen months is common. As will be appreciated, biologically active proteins are generally folded in a complex three dimensional manner which is unique to each protein. The proteins are generally organised on three levels; having a primary structu...

AI Technical Summary

Benefits of technology

The present invention provides a method for preparing biological materials, such as proteins and cells, in a stable and efficient manner. The method involves coating microparticles with a coating liquid containing an active, a sugar polymer, and a water soluble / miscible solvent. The coated microparticles are then fluidized in a processing chamber and sprayed onto a fluidized bed to form a fluidized bed. The method can further include additional coating steps to further coat the microparticles. The coated microparticles can be used for various applications such as injection, oral tablets, sustained release tablets, and skin washing solutions. The invention also provides a stable and room temperature stable product containing biological materials.

Problems solved by technology

It was discovered that running the experiment with a fluidisation rate set at 250 cubic meters of air / hour was not sufficient.

That a substantially high number of bacteria survived during these experiments did not elucidate why the tablets the inventors had previously produced were bacteria free.

The suppliers of the lactobacilli and bifidus cultures indicated that these bacteria are extremely temperature sensitive, and heat labile.

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