DEVELOPMENT AND OPTIMIZATION OF GASTRO-RETENTIVE FORMULATION OF HYDRALAZINE HCL
Journal Title: International Journal of Pharmaceutical Sciences and Drug Research - Year 2016, Vol 8, Issue 5
Abstract
Hydralazine hydrochloride has a half-life of 2 to 4 hours with an oral bioavailability of 26-50%. Since hydralazine has a demethylating effect on various suppressor genes, it can be used in various types of cancer to support chemotherapy. The purpose of this study was to optimize and evaluate floating tablets of hydralazine hydrochloride designed to prolong the gastric residence time and to provide controlled release of the drug for 24 h. The floating tablets of hydralazine hydrochloride were prepared by the wet granulation method. Polymers of hydroxy propyl methyl cellulose (HPMC K100M), HPMC K15M, carbopol 940 and sodium bicarbonate were used as the release retarding agents. This study investigated utility of a 3-factor, 3-level Box-Behnken design and optimization process for floating tablet of Hydralazine with 5 replicates of center points. Amount of HPMC K4 (Hydroxy Propyl Methyl cellulose), amount of sodium bicarbonate were selected as the independent variables whereas total floating time (TFT), T90, % cumulative drug release at 24 hours, and T20, Q1 were selected as dependent variables. Non-Fickian diffusion release transport was confirmed as the release mechanism for the optimized formulation and the predicted values agreed well with the experimental values. Drug excipient compatibility studies were investigated by FTIR, DSC and XRD. The produced tablets exhibited good floating time and controlled drug release over a period of 24 h. The resultant data were critically analyzed to locate the composition of optimum formulations. All predicted values of response variables of optimized formulation demonstrated close agreement with the experimental data during optimization procedure.
Authors and Affiliations
Himanshu A Acharya, Rakesh P Patel
Keywords
Related Articles
- EP ID EP625197
- DOI 10.25004/IJPSDR.2016.080502
- Views 94
- Downloads 0
VALIDATED RP-HPLC METHOD FOR THE DETERMINATION OF IVABRADINE HYDROCHLORIDE IN PHARMACEUTICAL FORMULATION
A simple, rapid, precise, and accurate RP-HPLC method for the estimation of Ivabradine Hydrochloride an anti-anginal agent, both as a bulk drug and in pharmaceutical formulation was developed. The chromatographic separat...
A CLINICAL STUDY ON RISK FACTORS AND APPROPRIATENESS OF ANTIBIOTIC PRESCRIBING FOR INFECTIVE EXACERBATION OF OBSTRUCTIVE AIRWAY DISEASE IN OLD AGED PATIENTS
Medication Appropriate Index (MAI) is used to assess the quality of antibiotic prescribing. The aim of the study to determine the risk factors of obstructive airway disease and to assess the appropriateness of ongoing an...
METHOD DEVELOPMENT AND VALIDATION OF DAPAGLIFLOZIN IN API BY RP-HPLC AND UV-SPECTROSCOPY
In the present study, two analytical methods were developed for the estimation of Dapagliflozin in API. Method A: RP-HPLC method, Method B: UV spectroscopic method. In method A, the drug showed linearity in the range of...
SELECTIVE CYTOTOXIC ACTIVITY OF SYNTHETIC NATURAL CYCLOPEPTIDES ON HCT11 & B16F10 CELLS
Peptides are natural messenger molecules of human body and hence ideal lead compounds for the initiation of drug discovery research. They are the important organic compounds with potent biological activities. Peptides fu...
ANTIOXIDANT ACTIVITIES OF INCLUSION COMPLEXES OF 2-(BENZOTHIAZOLYL-2’) HYDRAZONO-3-PHENYL 5-ARYLIDENE- 4- THIAZOLIDINONE DERIVATIVES WITH Β-CYCLODEXTRIN
The present study focused on the preparation and antioxidant studies of inclusion complexes of some compounds of 4-Thiazolidinone derivatives with β-cyclodextrin. The inclusion complex has been prepared in order to incre...