Application of Novel Natural Polymer for Controlling the Release of Fenoverine From Controlled Release Matrix Tablets

Kulkarni, Ajit S.; Mandhare, Trushali; Aloorkar, Nagesh H.

doi:10.22159/ijap.2017v9i2.16318

Cited by 5 publications

(3 citation statements)

References 1 publication

(2 reference statements)

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“…IR layer of HHN was prepared using a direct compression method. IR layer prepared by using a rotary tablet punching machine by using 8 mm flat punch on a 12-station rotary tablet machine [10,11]. SR layer of ISDN was optimized by using 3 2 full factorial designs and it was prepared using a direct compression method.…”

Section: Development Of Bilayer Tabletmentioning

confidence: 99%

Part Ii: Optimization of Isosorbide Dinitrate Sustained Release Layer in Antihypertensive Bilayer Tablet

et al. 2020

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Objective: Aim of the present study was the optimization of the sustained release (SR) layer of isosorbide dinitrate (ISDN) 40 mg and compressed with the immediate-release (IR) layer of hydralazine hydrochloride (HHC) 25 mg to decrease the dosing frequency and development of a novel b. i. d dosage form. Methods: Drug excipients compatibility study was carried out by FT-IR and a preliminary study was conducted for screening of polymer. The amount of HPMC K100M (X1) and the amount of Polyoxtm WSR303 (X2) were chosen as independent variables in 32full factorial designs. While % cumulative drug releases at 1 h (Q1) (Y1), % cumulative drug release at 2 h (Q2) (Y2), % cumulative drug release at 4 h (Q4) (Y3) and % cumulative drug release at 6 h (Q6) (Y4), were taken as dependent variables and statistically evaluation by using sigma plot 13.0. In the present study, according to the U. S. P. 2007 the following constraints were used for the selection of an optimized batch: Q1=15% to 30%, Q2=50% to 70%, Q4=65% to 85% and Q6>75%. 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 Q1, Q2, Q4, and Q6 were 084.583, 038.188, 057.719, and 118.396, respectively. All Calculated F values are greater than the tabulated value for all dependent variables. Prepared checkpoint batch selected from its desirability value 1 and it gives a 93.40±1.29 % drug release within 6 h. Conclusion: This bilayer formulation of anti-hypertensive drugs decreases the dosing frequency of HHC and ISDN.

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Section: Development Of Bilayer Tabletmentioning

confidence: 99%

Part Ii: Optimization of Isosorbide Dinitrate Sustained Release Layer in Antihypertensive Bilayer Tablet

et al. 2020

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“…Magnesium stearate and talc added to the above blend. The whole blend passed through 40# mesh and compressed using an 8 mm flat punch on a 12-station rotary tablet machine to form an IR layer [10,11]. SR layer of ISDN also post optimized using 3 2 full factorial designs and it was prepared using a direct compression method.…”

Section: Development 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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“…The obtained data were kinetically analyzed to determine the pattern of the drug release. For better characterization of the drug release behaviour for the systems studied and to understand the corresponding mechanism, Korsmeyer-Peppas semi-empirical model was applied [20][21].…”

Section: Preparation Of MDImentioning

confidence: 99%

Nano-Vesicles of Salbutamol Sulphate in Metered Dose Inhalers: Formulation, Characterization and in Vitro Evaluation

Arafa

Ayoub

2017

Int J App Pharm

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Objective: The present work was aimed to prepare niosomes entrapping salbutamol sulphate (SS) using reversed phase evaporation method (REV).Methods: Niosomes were prepared by mixing span 60 and cholesterol in 1:1 molar ratio in chloroform, SS in water was then added to organic phase to form niosomal SS. Formulations after evaporation of chloroform, freeze centrifuged then lyophilized, were evaluated for particles size, polydispersity index (Pdi), zeta-potential, morphology, entrapment efficiency (EE%) and in vitro release. For pulmonary delivery; metered dose inhalers (MDI) were prepared by suspending SS niosomes equivalent to 20 mg SS in hydrofluoroalkane (HFA). The metered valve was investigated for leakage rate, the total number of puffs/canister, weight/puff, dose uniformity and particle size. Results:The results showed spherical niosomes with 400-451 nm particles that entrapped 66.19% of SS. 76.54±0.132% SS release from niosomes that showed a controlled release profile for 8h. The leakage test was not exceeding 4 mg/3 d, the number of puffs were up to 200puffs/canister, the dose delivered/puff was 0.1 mg and 0.64-4.51μm niosomal aerosol. Conclusion:The results indicate an encouraging strategy to formulate a controlled drug delivery by entrapping (SS) in niosomes which could be packaged into (MDI) that met the requirements of (USP) aerosols guidelines which offering a novel approach to respiratory delivery.

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Application of Novel Natural Polymer for Controlling the Release of Fenoverine From Controlled Release Matrix Tablets

Cited by 5 publications

References 1 publication

Part Ii: Optimization of Isosorbide Dinitrate Sustained Release Layer in Antihypertensive Bilayer Tablet

Part Ii: Optimization of Isosorbide Dinitrate Sustained Release Layer in Antihypertensive Bilayer Tablet

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

Nano-Vesicles of Salbutamol Sulphate in Metered Dose Inhalers: Formulation, Characterization and in Vitro Evaluation

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