PREPARATION AND CHARACTERIZATION OF FAST DISNTEGRATING TABLETS OF HYDRALAZINE HYDROCHLORIDE USING DESIGN OF EXPERIMENT TECHNIQUE

Kaur, R.,1 Sharma, G.,2 Nagpal, M., 3 Sidhu, S., 4 Jain, U. K.,5 Sharma, M.*6

Kaur, R.,1 Sharma, G.,2 Nagpal, M., 3 Sidhu, S., 4 Jain, U. K.,5 Sharma, M.*6 1 Pharmaceutics division, Chandigarh College of Pharmacy, Landran, Mohali, India 2 Pharmaceutics division, Chandigarh College of Pharmacy, Landran, Mohali, India 3 Pharmaceutics division, Chandigarh College of Pharmacy, Landran, Mohali, India 4 Pharmaceutics division, Chandigarh College of Pharmacy, Landran, Mohali, India 5 Chandigarh College of Pharmacy, Landran, Mohali, India 6 Pharmaceutics division, Chandigarh College of Pharmacy, Landran, Mohali, India

Abstract

Since the dose accuracy and patient’s compliance are important prerequisites for a long term treatment, there is a demand to develop a dosage form which can overcome difficulty in swallowing, inconvenience in administration while travelling, and increase patient’s acceptability. The present work was undertaken to develop fast disintegrating tablet of Hydralazine hydrochloride which will offer desired characteristics and intended benefits in hypertension. A 3² full-factorial experimental design was constructed to study the effect of type and concentration of superdisintegrant on disintegration time, wetting time and dispersion time. The tablets were prepared by direct compression technique. The ANOVA results confirmed that the studied response variables were strongly dependen on chosen factors (p<0.05). More than 90% of drug from optimized tablet was released within 5 minutes during in-vitro dissolution studies. The short term accelerated stability studies of selected formulation indicated that there was insignificant change in the drug content and percent drug released (p<0.05). It was concluded that FDT of hydralazine hydrochloride were formulated successfully.

Key words: Fast disintegrating tablets, optimization, superdisintigrants, dysphagia