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Fig. 2. HPLC chromatogram of diazepam Stability Studies. Stability study was carried out on optimized formula. The tablets were stored at 40+2°C/75+ 5% RH using saturated sodium chloride solution desiccator for 1 month, then the samples were evaluated for various physical tests and drug release study (27). Moreover, the study of drug—excipient interaction is one of the most important stability studies, and Fourier transform infrared — Figure 2 HPLC chromatogram of diazepam Stability Studies. Stability study was carried out on optimized formula. The tablets were stored at 40+2°C/75+ 5% RH using saturated sodium chloride solution desiccator for 1 month, then the samples were evaluated for various physical tests and drug release study (27). Moreover, the study of drug—excipient interaction is one of the most important stability studies, and Fourier transform infrared

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Fig. 1. Diazepam chemical structure The orodispersible tablets of DZ were prepared using superdisintegrant (SSG, Ac-Di-Sol, and crospovidone), sub- liming agent (AB, camphor), mannitol as a diluent, sodium saccharin as sweetening agent, alcoholic solution of poly- vinylpyrrolidone (PVP) in ethanol (10%, w/v) as binder and

Table I. Composition of Different Batches of ODTs of Diazepam administered to five healthy volunteers (21-35 years old), keeping the tablet in the oral cavity (on the tongue) for 1 min. The subjects then rinsed their mouths with distilled water. The rinsed water was then subjected to a quantitative assay using HPLC (Knauer, Germany) to determine the amount of diazepam remaining in the oral cavity. A washout period of 10 days before second trial was considered (25). Hardness. The crushing strength of the tablets was measured using a Monsanto hardness tester. Three tablets from each formulation batch were tested randomly and the average reading + SD was recorded.

Table II. Evaluation of the Prepared Orodispersible Tablets of Diazepam (Mean + SD)

Fig. 3. Diazepam release profile from different formulas and a commercial conventional tablet in phosphate buffer, pH 6.8, at 37+0.5°C

Table III. Micromeritics Properties of ODTs of Diazepam (Mean + SD, n=3)

Fig. 4. FTIR spectra of diazepam, physical mixture, and selected formula of orodispersible tablet of diazepam Because of disintegration of ODTs in saliva while still in the oral cavity, there can be pre-gastric absorption from some. Buccal, pharyngeal, and gastric regions are all areas of absorption of the many formulations. Any pre-gastric absorp- tion can be a great advantage to produce rapid onset and high

Table IV. Jn Vitro Dissolution Parameters of Diazepam in Phosphate Buffer, pH 6.8