Abstract
Objective: Aim of the present study was the optimization of the immediate release (IR) layer containing hydralazine hydrochloride (HHC) 25 mg and compressed with a sustained-release (SR) layer of isosorbide dinitrate (ISDN) 40 mg to decrease the dosing frequency.
 Methods: In this study, Drug-excipients compatibility study was carried out by FT-IR and a preliminary trial was conducted for screening of super disintegrating agents. The amount of sodium starch glycolate (SSG) (X1) and the amount of ac-di-sol® (X2) was chosen as independent variables in 32 full factorial design while wetting time (WT) (Y1), disintegration time (DT) (Y2) and In vitro drug release at 15 min (Q15) (Y3) were taken as dependent variables. Multiple linear regression analysis, ANOVA, and graphical representation of the influence of factor by 3D plots were performed by using sigma plot 13.0. In the present study, the following constraints were used for the selection of an optimized batch: WT<16 s, DT<25 s, and Q15>90%. To validate the evolved mathematical models, a checkpoint batch was selected from its desirability value.
 Results: FT-IR spectra show that the drug and excipients were compatible with each other. The calculated F values found for WT, DT, and Q15 were 045.559, 077.100 and 278.760, respectively. All Calculated F values are greater than tabulated values for all dependent variables. Prepared checkpoint was selected from its desirability value 0.935 and it gives a 100% drug release within 30 min.
 Conclusion: These results confirm that the prepared HHC 25 mg IR layer is used for rapid control of hypertension.
Highlights
Hypertension affects around half of the adult population worldwide, being one of the most common cardiovascular disorders (CVD)
From FT-immediate release (IR) spectra, we can conclude that the drug and excipients were compatible with each other and they were suitable to use for formulation [19]
Optimization of the IR layer of hydralazine hydrochloride (HHC) was performed by the overlay plot
Summary
Hypertension affects around half of the adult population worldwide, being one of the most common cardiovascular disorders (CVD) It occurs when the high cardiac output exerts pressure on the arterial wall as the blood flow increases. The combination consists of HHC 25 mg and ISDN 40 mg fixed-dose that functions as a nitric oxide enhancer and an antioxidant that helps to prevent tolerance to the prolonged use of nitrate. This combination balanced after-load and preload reduction with a lowering of ventricular filling pressure and systemic and pulmonic vascular resistance. The hemodynamic effects of the combination drug in heart failure include increased cardiac output [3, 4]
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