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Ph.D.
(Pharmacy)
DEVELOPMENT AND OPTIMIZATION OF GASTRO-RETENTIVE
FORMULATIONS OF HYDRALAZINE HYDROCHLORIDE

Ph.D. Scholar : Acharya Himanshu A
Research Supervisor : Dr. Rakesh P. Patel

Regi. No.: 13146021001
Abstract :
Hydralazine is a direct-acting smooth muscle relaxant used to treat hypertension by
acting as a vasodilator primarily in arteries and arterioles. The half-life of Hydralazine HCl
is very short, 2- 3 hours and frequency of dosing is 3-4 times a day. Hence, the patients
need to take frequent dosing and missing of dose may lead to chronical symptoms. To
avoid frequent administrations, the long acting floating oral dosage forms can be given
which can keep on delivering the drug at controlled rate for a specified period of time.
Hence to improve patient co-operation, the sustained release oral floating dosage form
may be useful option which once given to patient can continuously deliver the drug at
controlled rate without the need of taking tablets many times a day. This would improve
patient compliance and would improve the treatment / therapy. Different polymers like
HPMC K15M, Carbopol 940 and Sodium bicarbonate (Na2CO3) at different concentration
5%, 10%, 15% were used in order to study and get desired results. Several physical and
chemical characterizations were done in order to evaluate. In this research four different
dosage forms viz. floating effervescent tablets, mucho adhesive tablets, conventional
tablets and in-situ gel were prepared in order to understand the best dosage carrier. To
optimize the research work Box-Behnken design was used and results were interpreted
from contour plots and comparing to this trial batches with optimized batches in order to
achieve desire result and reproducibility. All the batches prepared were carefully evaluated
and noted. %CCPR (Drug Release) were carried on different intervals upto 24 hours.

Key words: Hydralazine, Floating oral dose, Box-Behnken, HPMC K4M, Carbopol 940,
Sodium Bicarbonate (Na2CO3)

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