Method for preparing ophthalmic preparation containing thymosin beta-4
AssigneeG-Treebnt Co., Ltd.
InventorsSi Young Lee, Sin Wook Kang, Ji Hye Sung, Tae Heum Um
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Abstract
The present invention relates to a method for manufacturing an ophthalmic preparation comprising thymosin β4. According to the inventive method, the manufacture of an ophthalmic preparation comprising thymosin β4 is carried out in the presence of an inert gas, thus the contact of thymosin β4 with oxygen is blocked and the oxidation of thymosin β4 can be prevented and the pharmacological activity of thymosin β4 maintains for long-term period. Therefore, the ophthalmic preparation prepared by the inventive method can maintain the pharmacological activity of thymosin β4 in a stable state for a long time.
Claims12
A method for manufacturing an ophthalmic product comprising thymosin β4 and a container, said method comprising:
- (i) providing a composition comprising (a) a thymosin β4 and (b) an excipient, wherein the composition is prepared by mixing (a) the thymosin β4 and (b) the excipient in the presence of an inert gas;
- (ii) filling the composition comprising the (a) thymosin β4 and the (b) excipient into the container;
- and
- (iii) sealing the container in the presence of an inert gas to give a sealed container containing the composition comprising the (a) thymosin β4 and the (b) excipient,
- wherein the (b) excipient comprises sodium chloride, potassium chloride, calcium chloride hydrate, magnesium chloride hexahydrate, sodium acetate hydrate, and sodium citrate hydrate,
- wherein the pH of the composition containing the (a) thymosin β4 and the (b) excipient ranges from 6.8 to 7.2, and
- wherein the ophthalmic product maintains at least about 92% purity under the condition of 25° C., 40% Relative Humidity (RH) for 12 months.
Dependencies are inferred from the claim text.