Abstract
Objective: The main objective of this study was to optimize the noneffervescent floating mini tablets (NEFT) formula of ranitidine hydrochloride (ranitidine HCl) using the simplex lattice design (SLD) with parameters, granule flow rate, hardness, friability, floating lag time and ranitidine HCl dissolution test (%).
 Methods: The material was prepared using the SLD model was cassava starch fully pregelatinized (CSFP), hydroxypropyl methylcellulose K4M (HPMC K4M), and magnesium stearate. The formula obtained was tested for critical parameters, namely flow rate, hardness, friability, floating lag time and ranitidine HCl dissolution test (%). The dissolution test was carried out by using the USP type II method (paddle method). The beaker is immersed in the water bath of temperature 37 °C. It is filled with 900 ml of 0.1 N HCl, and the apparatus was set at 75 rpm. The samples were taken in the interval of 10 min and estimated content by a spectrophotometer at 312 nm.
 Results: The optimum formula based on superimposed graphs of various contour plots with SLD. From the experimental data for all test parameters, the experimental results are approaching with the results of the prediction. The condition for optimum functional components in NEFT was 80 mg for CSFP, HPMC K4M 30 mg, and 10 mg magnesium stearate to obtain a yield of 7.85 kg hardness, 0.34 % friability, 15.27 floating lag time and 91.31 % ranitidine HCl dissolved.
 Conclusion: It can be concluded that the optimum formula using the Design-Expert® program the SLD concept is obtained in the range of 70-80 mg CSFP, 30-40 mg HPMC K4M, 0-10 mg magnesium stearate.
Highlights
Amylum as an excipient in pharmaceutical formulations is very widely used because it can be mixed with almost all drugs and is inert without causing chemical reactions [1]
Starch consists of water-soluble components as much as 20 % and water-insoluble parts as much as 80 % [6]
The IR spectra showed that there was no chemical interaction that caused the formation of a bond between ranitidine HCl and excipients in the formula
Summary
Amylum as an excipient in pharmaceutical formulations is very widely used because it can be mixed with almost all drugs and is inert without causing chemical reactions [1]. Amylum is often used as an excipient, such as binders. Amylose is a straight molecule, consisting of 250–300 Dglucose units and is uniformly linked by α-1,4-glucoside bonds, which tends to cause the molecule to be shaped like a helix [7,8,9]. Amylopectin consists of 1,000 or more glucose units, most of which is associated with α-1.4 bonds. When the colloidal solution is heated a sticky period occurs, this property is used as a binder. Amylose has the ability to expand when in contact with liquids, this property is used as a destroyer [14,15,16]
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