The stability of the protein can be improved by introducing into the composition additives that interact with the protein in solution, making it stable, soluble and non-aggregated. It is known that the above types of instabilities that can have a strong impact on industrial viability and effectiveness of pharmaceutical proteins is x songsĬan be eliminated by introducing into the composition an additional molecules. Such changes include denaturation, adsorption on surfaces, aggregation and precipitation (Manning et al., Pharm. Physical instability rather implies changes in the protein structure of a higher order (second order and above). Physical instability, on the other hand, does not cause changes covalent bonds in proteins. Examples of problems caused by chemical imbalance, include deliciousa, racemization, hydrolysis, oxidation, beta-elimination and replacement of the disulfide bonds. Chemical instability causes a change in the protein due to the formation or cleavage of links. The destruction of proteins can be divided into two different classes, including chemical instability and physical instability. The main problem associated with the pharmaceutical protein compositions, is the overcoming of a certain instability of proteins. 61/004992, filed November 30, 2007, the contents of the priority application is incorporated into this description by reference. The amount of the invention also involves such compositions containing water and proteins which have a low osmolarity or hydrodynamic diameter which is less approximately by 50% thereof in a buffer solution in the given concentration with protein in the composition having a molecular weight more than approximately 47 kDa.ĮFFECT: invention provides protein stability in the solution.įor this application claims the priority of provisional patent application U.S. The aqueous composition under the present invention is rich in proteins and has the low conduction levels ensured by the low content of ionic excipients. SUBSTANCE: group of inventions refers to pharmaceutics, particularly an aqueous composition containing water and protein of molecular weight more than approximately 47 kDa, and to methods for preparing said composition.
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