Effect of Sodium Starch Glycolate on Formulation of Fexofenadine Hydrochloride Immediate Release Tablets by Direct Compression Method

Karim, Samira; Biswas, Abu Jafor; Bosu, A.; Laboni, Farhina Rahman; Julie, Azima Sultana; ., Md. Harun-or-Rashid

doi:10.3329/jsr.v10i1.32703

Cited by 6 publications

(3 citation statements)

References 5 publications

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“…The USFDA draft guidance document contains more information on the similarity factor (f2). The value of the similarity factor (f2) between 50 and 100 suggests that the two dissolution profiles are similar [17,18].…”

Section: Evaluation Of Bilayer Tabletmentioning

confidence: 99%

Part I: Optimization of Hydralazine Hydrochloride Immediate Release Layer in Antihypertensive Bilayer Tablet

et al. 2020

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Objective: Aim of the present study was the optimization of the immediate release (IR) layer containing hydralazine hydrochloride (HHC) 25 mg and compressed with a sustained-release (SR) layer of isosorbide dinitrate (ISDN) 40 mg to decrease the dosing frequency. Methods: In this study, Drug-excipients compatibility study was carried out by FT-IR and a preliminary trial was conducted for screening of super disintegrating agents. The amount of sodium starch glycolate (SSG) (X1) and the amount of ac-di-sol® (X2) was chosen as independent variables in 32 full factorial design while wetting time (WT) (Y1), disintegration time (DT) (Y2) and In vitro drug release at 15 min (Q15) (Y3) were taken as dependent variables. Multiple linear regression analysis, ANOVA, and graphical representation of the influence of factor by 3D plots were performed by using sigma plot 13.0. In the present study, the following constraints were used for the selection of an optimized batch: WT<16 s, DT<25 s, and Q15>90%. To validate the evolved mathematical models, a checkpoint batch was selected from its desirability value. Results: FT-IR spectra show that the drug and excipients were compatible with each other. The calculated F values found for WT, DT, and Q15 were 045.559, 077.100 and 278.760, respectively. All Calculated F values are greater than tabulated values for all dependent variables. Prepared checkpoint was selected from its desirability value 0.935 and it gives a 100% drug release within 30 min. Conclusion: These results confirm that the prepared HHC 25 mg IR layer is used for rapid control of hypertension.

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Section: Evaluation Of Bilayer Tabletmentioning

confidence: 99%

Part I: Optimization of Hydralazine Hydrochloride Immediate Release Layer in Antihypertensive Bilayer Tablet

et al. 2020

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“…Consequently, reducing the breakdown time improves the rate at which drugs dissolve. 7 The delivery of drugs with an immediate effect is preferred for those with extended biological half-lives. This research work focused on the selection of suitable superdisintegrating agent with for development of oral immediate release tablets of Trandolapril, in order to reduce the onset of action for management of high blood pressure.…”

Section: Introductionmentioning

confidence: 99%

Development and Characterization of Trandolapril Immediate Release Tablets Using Different Superdisintegrating Agents

Indurkhya¹,

PATEL²,

MASHEER³

2023

Curr. Res. Pharm. Sci.

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A potent non-sulfhydryl prodrug, trandolapril is transformed into the active substance, trandolaprilat, in the liver. For obese individuals with mild-to-moderate essential hypertension, Trandolapril is effective and safe. The elimination t1/2 of trandolapril and trandolaprilat are approximately 6 hours and 16–24 hours, respectively. The goal of present work is to develop the Trandolapril immediate release tablet using various superdisintegrants. Crospovidone, Sodium starch glycolate and Croscarmellose sodium in concentrations of 2%, 4%, and 6% were used as superdisintegrating agents for the optimization. Direct compression technique was used to make nine formulations (IRTR 1 to IRTR 9). The powder blends of all batches were evaluated for different parameters to know the powder flow characteristics and it was found that the powder blend had excellent flow and compressibility characteristics. Then, compressed tablets were tested for quality control parameters as per the IP. In formulation IRTR1-IRTR9, disintegration time was observed 30.23 to 71.67 Sec and more than 70% drug was released in 30 min. Thus, based on evaluation results, it is concluded that formulation of immediate release (IR) tablets of Trandolapril were successfully developed. Minimum disintegration time 30.23 seconds 90.56% drug release in 30 min was obtained with IRTR3. KEYWORDS: Trandolapril, Immediate release, Crospovidone, Sodium starch glycolate, crocarmellose sodium

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“…79 CCS: Croscarmellose, CP: Crospovidone, SSG: Sodium starch glycolate, LD: Ludiflash, DC: Direct compression, WG: Wet granulation, DS: Dissolution studies, DT: Disintegration time, WT: Wetting time, s: second, min: minutes.…”

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confidence: 99%

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2019

IJPSR

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The scenario of pharmaceutical drug delivery are expeditiously challenging, but conventional pharmaceutical dosage forms are still dominating. Immediate release dosage forms are those wherein ≥85% of labeled amount dissolves within 30 min. Superdisintegrants are used to improve the efficacy of solid dosage forms. The basic approach used in the formulation of the tablet is the use of superdisintegrants like croscarmellose, sodium starch glycolate, and crospovidone, etc. These superdisintegrants provide instantaneous disintegration of the tablet after administration in the stomach. Thus, decreasing the disintegration time which in turn enhances drug dissolution rate. The rapid disintegration may be due to the rapid uptake of water from the medium, swelling, burst effect and thereby promoting bioavailability. Tablets formulations are mostly preferred because of the low cost of manufacture, package, shipment, increased stability. Among various dosage forms used for oral drug delivery, tablets are one of the most successful and marketable drug delivery regimens as it provides several advantages over another form of dosage forms. This article provide an exhaustive account illustrating the significances of superdisintegrant in the immediate release of tablets and the mechanism of disintegration along with various conventional techniques and novel granulation technology used to prepare immediate-release tablets. INTRODUCTION: The Oral route is one of the most sought after route for the systemic effect due to its ease of ingestion, simple, safest, convenient, non-invasive, versatility and most importantly, patient compliance. Solid oral delivery systems are cheaply manufactured because they don't require sterile conditions 1. Although, increased focus and interest generated in the area of controlled release and targeted drug delivery system in recent years, tablet dosage forms that are intended to be swallowed whole, disintegrate, and release their medicaments fast and furiously in the gastrointestinal tract 2 .

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Effect of Sodium Starch Glycolate on Formulation of Fexofenadine Hydrochloride Immediate Release Tablets by Direct Compression Method

Cited by 6 publications

References 5 publications

Part I: Optimization of Hydralazine Hydrochloride Immediate Release Layer in Antihypertensive Bilayer Tablet

Part I: Optimization of Hydralazine Hydrochloride Immediate Release Layer in Antihypertensive Bilayer Tablet

Development and Characterization of Trandolapril Immediate Release Tablets Using Different Superdisintegrating Agents

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