Abstract
This article presents the possibility of using of multiple regression analysis (MRA) and dynamic neural network (DNN) for prediction of stability of Hydrocortisone 100 mg (in a form of hydrocortisone sodium succinate) freeze-dried powder for injection packed into a dual chamber container. Degradation products of hydrocortisone sodium succinate: free hydrocortisone and related substances (impurities A, B, C, D and E; unspecified impurities and total impurities) were followed during stress and formal stability studies. All data obtained during stability studies were used for in silico modeling; multiple regression models and dynamic neural networks as well, in order to compare predicted and observed results. High values of coefficient of determination (0.950.99) were gained using MRA and DNN, so both methods are powerful tools for in silico stability studies, but superiority of DNN over mathematical modeling of degradation was also confirmed.
Highlights
IntroductionThis article presents the possibility of using of multiple regression analysis (MRA) and dynamic neural network (DNN) for prediction of stability of Hydrocortisone 100 mg (in a form of hydrocortisone sodium succinate) freeze-dried powder for injection packed into a dual chamber container
This article presents the possibility of using of multiple regression analysis (MRA) and dynamic neural network (DNN) for prediction of stability of Hydrocortisone 100 mg freeze-dried powder for injection packed into a dual chamber container
The goal of this work was to follow the chemical stabilities of HC 100 mg freeze dried power packaged in dual chamber vial, as a specific container closure system and to evaluate the possibility of using in silico method for prediction stability
Summary
This article presents the possibility of using of multiple regression analysis (MRA) and dynamic neural network (DNN) for prediction of stability of Hydrocortisone 100 mg (in a form of hydrocortisone sodium succinate) freeze-dried powder for injection packed into a dual chamber container. Hydrocortisone (HC), molecular weight 362.465, is a synthetic corticosteroid drug, (Figure 1) belonging to the group of corticosteroids, which are hydroxyl compounds (alcohols). They are relatively insoluble in water, and the sodium salt of the phosphate or succinate ester is generally used to provide water-soluble forms. Considering the chemical structure of this compound, it has been concluded that the most frequent reactions occur at the lateral dihydroxyacetone chain, as well as the transesterifications between the positions C17 and C21. Specified impurities of HC 21-HS are free HC and Hydrocor-
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