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Original Research

Hydralazine HCl rapidly disintegrating sublingual tablets: simple dosage form of higher bioavailability and enhanced clinical efficacy for potential rapid control on hypertensive preeclampsia

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Pages 3753-3766 | Published online: 05 Nov 2018

Figures & data

Table 1 Composition and precompression evaluation of HHC sublingual tablet mixtures

Figure 1 DSC thermograms of HHC and its physical mixtures with (A) Avicel, (B) d-Mannitol, and (C) SSG.

Abbreviations: DSC, differential scanning calorimetry; HHC, hydralazine hydrochloride; SSG, starch sod-glycolate.
Figure 1 DSC thermograms of HHC and its physical mixtures with (A) Avicel, (B) d-Mannitol, and (C) SSG.

Figure 2 DSC thermograms of HHC and its physical mixtures with (A) Pharmaburst, (B) talc, and (C) saccharin sodium.

Abbreviations: DSC, differential scanning calorimetry; HHC, hydralazine hydrochloride; SSG, starch sod-glycolate.
Figure 2 DSC thermograms of HHC and its physical mixtures with (A) Pharmaburst, (B) talc, and (C) saccharin sodium.

Figure 3 FTIR spectra of HHC and its physical mixtures with (A) Avicel, (B) d-Mannitol, and (C) SSG.

Abbreviations: FTIR, fourier transform infrared spectroscopy; HHC, hydralazine hydrochloride; SSG, starch sod-glycolate.
Figure 3 FTIR spectra of HHC and its physical mixtures with (A) Avicel, (B) d-Mannitol, and (C) SSG.

Figure 4 FTIR spectra of HHC and its physical mixtures with (A) Pharmaburst, (B) talc, and (C) saccharin sodium.

Abbreviations: FTIR, fourier transform infrared spectroscopy; HHC, hydralazine hydrochloride.
Figure 4 FTIR spectra of HHC and its physical mixtures with (A) Pharmaburst, (B) talc, and (C) saccharin sodium.

Table 2 Characterization of the prepared HHC sublingual tablets

Figure 5 Dissolution profiles of HHC from sublingual tablets prepared using (A) SSG and (B) Pharmaburst in comparison to plain drug.

Abbreviation: HHC, hydralazine hydrochloride.
Figure 5 Dissolution profiles of HHC from sublingual tablets prepared using (A) SSG and (B) Pharmaburst in comparison to plain drug.

Figure 6 Mean plasma concentration–time curves of the prepared HHC sublingual tablet formula (F6) in comparison to conventional HHC oral tablets in rabbits.

Abbreviations: HHC, hydralazine hydrochloride; OHHC, oral test group; SHHC, sublingual test group.
Figure 6 Mean plasma concentration–time curves of the prepared HHC sublingual tablet formula (F6) in comparison to conventional HHC oral tablets in rabbits.

Table 3 The mean pharmacokinetic parameters of HHC after administration to rabbits by oral and sublingual routes

Table 4 CIs of the statistically calculated mean differences of calculated pharmacokinetic parameters

Figure 7 Bar chart of (A) BP of pregnant rats before and after treatment with l-NAME in comparison to non-pregnant rats. (B) The effect of HHC in different dosage forms on BP of pregnant rats.

Abbreviations: DBP, diastolic blood pressure; HHC, hydralazine hydrochloride; IVC, IV control group; IVHHC, IV test group; l-NAME, N(omega)-nitro-l-arginine methyl ester; NP, non-pregnant; NPT, non-pregnant treated; OC, oral control group; OHHC, oral test group; PT, pregnant treated; SBP, systolic blood pressure; SC, sublingual control group; SHHC, sublingual test group.
Figure 7 Bar chart of (A) BP of pregnant rats before and after treatment with l-NAME in comparison to non-pregnant rats. (B) The effect of HHC in different dosage forms on BP of pregnant rats.

Table 5 One-way ANOVA test for systolic blood pressure data

Table 6 One-way ANOVA test for diastolic blood pressure data