Abstract
Objective: The aim of this study was to formulate a developed floating tablet of amlodipine using different concentrations and types of hydrophilic and hydrophobic polymers to be conserved in the stomach for modulating solubility and bioavailability, diminishes drug waste and decline side effects.Methods: Through this study, eleven innovative formulations of amlodipine floating tablets were prepared [mixture of amlodipine, sodium bicarbonate (NaHCO3), hydroxypropyl methylcellulose (HPMC) E50, HPMC K100M, ethylcellulose (EC) 5 mp. a. s.] by direct compression method. The pre-compressed mixtures were then evaluated for numerous parameters such as angle of repose, bulk density, tapped density, Carr's compressibility index and Hausner's ratio. After compression, tablets were subjected to several tests like; floating behavior of tablets, tablet thickness, hardness test, friability test, weight variation, in vitro dissolution test. In addition, the optimum formulation was evaluated for Fourier transform-infrared (FT-IR) and differential scanning calorimetry (DSC) tests. Results: From in vitro dissolution tests and kinetic assessments; F8 was selected as an optimum formula, depending on the R2 value of zero order kinetics (0.9915) and (n) value of Korsmeyer-Peppas (0.9635) which indicate purely relaxation zero order kinetic with good delaying in drug release that was reached to 14 h.Conclusion: It can be concluded that the developed formulation of a certain combination of low viscosity grades of HPMC and EC was considered an efficient floating tablet.
Highlights
Over 90% of the formulations manufactured today are ingested orally
The results showed that a non-significant effect (p>0.05) for increasing the concentration of sodium bicarbonate on drug release rate as showed in fig. 3
F8 was selected as an optimum formula, this is due to the (R2) and (n) value indicate purely relaxation zero order drug release with good delayed in drug release, and this will maximize the efficacy while minimizing dose frequency and toxicity [45]
Summary
Over 90% of the formulations manufactured today are ingested orally. This show that this class of formulation is the most popular worldwide and major attention of the researcher is towards this direction [1]. Oral delivery of drugs is the utmost chosen route of drug delivery due to the ease of administration; low cost of therapy, patient compliance, and flexibility in formulation [2]. Numerous trials have been made to conserve the dosage form in the stomach as a method of increment in the retention time. These trials involve presenting floating dosage forms (gas-generating systems and swelling or expanding systems), mucoadhesive systems, high-density systems, modified shape systems, gastric-emptying delaying devices and co-administration of gastric-emptying delaying drugs. The furthermost ordinarily used system is the floating dosage forms [6, 7]
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