Formulation and Evaluation of Fast Dissolving Tablets of Nifedipine (original) (raw)
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Formulation and Evaluation of Fast Dissolving Tablet of Nifedipine
2020
In the present study, there was an attempt to make rapidly dissolving tablets using the direct dissolution method containing Nifedipine-Mannitol solid dispersion. The main objective of the work was to prepare nifedipine solid dispersion with Mannitol to initiate action. The solid dispersion was prepared by the solvent evaporation method and evaluated for cumulative drug release. FDT was formulated by a direct compression method using different super Disintegrants such as CCS and SSG in different ranges (1–3 %). Preformation studies were performed on the powder mixture for tablets. The flow properties (F1 – F18) of the mixture were evaluated by determining the Carr's index, the Hausner ratio, and the angle of view. Condensate density, tapped density, Carr's index, Hausner ratio and representation of angles. The formulated tablets were evaluated for thickness, hardness, stability, weight variation, wetting time, drug content uniformity, dissolution time, and invitro dissolutio...
Journal of Applied Pharmaceutical Science, 2015
The aim of this study was to assess the dissolution properties of twelve sustained release (SR) nifedipine tablet brands, including 20 mg and 30 mg innovator brands, for possible generic substitution. The tablet brands were purchased from retail pharmacies in the Kumasi Metropolis, Ghana. The weight uniformity, drug content and in vitro dissolution of the tablets in phosphate buffer pH 6.8 were evaluated. The dissolution data were compared using the similarity (f2) and difference (f1) factors, and the USP acceptance criteria for SR tablets. The kinetics of drug release from the tablets was also evaluated. All the brands passed the weight uniformity test. Nine brands (75 %) passed the drug content test while three brands (25 %) failed. The two innovator nifedipine SR brands passed all the tests undertaken. Comparison of the dissolution data using f1 and f2 showed that all three 30 mg nifedipine SR brands were dissimilar to the innovator brand. Also, two 20 mg nifedipine SR brands (28.6 %) were similar or bioequivalent with the innovator 20 mg brand while five brands (71. 4 %) were dissimilar. Three (75 %) 30 mg and four (50 %) 20 mg nifedipine SR brands exhibited appropriate drug release profiles based on the USP acceptance criteria. Drug release from the twelve tablet brands mostly followed the Higuchi kinetic model (58.3 %) followed by the Hixson-Crowell model (16.7 %). Only one brand (N7) exhibited constant drug release kinetics. Results from the study have shown that switching or substituting brands of SR nifedipine for patients should be guided by a critical assessment of the dissolution data using appropriate evaluation techniques.
The influence excipients on the dissolution profiles of nifedipine tablets
Scripta Scientifica Pharmaceutica, 2014
Currently a large number of generic drugs are registered in Ukraine for medical use. The advantage of generic drugs is the relatively cheapness compared to innovative medicines, because the creation and registration of generic drugs require less research and, consequently, less material costs, which are nec-ABSTRACT PURPOSE: Study of dissolution profiles of nifedipine tablets from different manufacturers to further assess of their equivalence in vitro, as well as study of the dependence of the dissolution profile on the adjuvants composition. MATERIAL AND METHODS: 3 buffer media with pH 1.2 (hydrochloric acid buffer); 4.5 (acetate buffer); 6.8 (phosphate buffer) was used. The absorptions were observed at 343. RESULTS: The dissolution profiles of nifedipine tablets from different manufacturers have been studied and have been founded that the percentage of nifedipine release from the sample B is higher than from "Corinfar", and the percentage of nifedipine release from "Corinfar" is higher than from the sample A. Adjuvants composition of nifedipine tablets have been studied. It is founded that the inclusion of surfactants, solubilizers and emulsifiers into tablets contribute to increasing of active substance release from the dosage form. CONCLUSIONS: Found that the introduction of surfactants into tablets, solubilizers and emulsifiers help to increase the release of active substance from the dosage form.
Acta Pharmaceutica, 2015
With the increased reliance on in vitro dissolution testing as an indicator of in vivo drug behavior and the trend towards the in silico modeling of dosage form performance, the need for bioperformance dissolution methodology development has been enhanced. Determination of the in vivo drug delivery profile is essential for the bioperformance dissolution test development and in vitro/in vivo correlation modeling, as well as the understanding of absorption mechanisms. The aim of this study was to compare different methods in terms of their usefulness and applicability in deciphering in vivo delivery of nifedipine administered in modified release dosage forms. A detailed survey of publications on nifedipine pharmacokinetics was done and used to identify the magnitude of food effect. In vitro dissolution testing was performed under various experimental conditions. Obtained results indicate the potential for using the developed in silico model coupled with discriminative in vitro dissolution data for identification of the in vivo drug product behavior.
International Journal of Research in Pharmaceutical Sciences, 2020
Nifedipine has a bioavailability of 45-56 percent and a 2-hour elimination half-life. It has a 50 percent kidney excretion rate and a 5-15 percent bile excretion rate. The intention of this research is to invent and evaluate Nifedipine loaded ODT and to prove the enhancement of bioavailability. The 23 factorial optimization design exposed about the outcome of independent variable on dependent variable throughout the formulation of Nifedipine ODT. From the records, it was accomplished that there was a good correlation between Disintegration time, Dissolution rate and super disintegration concentration. The formulation F4 (Nifedipine ODT) has achieve the goal of ODT drug delivery with desired release characteristics, cost-effective, decreased dose, effective administration and hence improved patient compliance. The invivo pharmacokinetic studies reveals that increase in AUC0-∞; decrease in Tmax; increase in Cmax in Nifedipine ODT shows better bioavailability and faster duration of the...
Dissolution Technologies, 2009
INTRODUCTION N ifedipine is a calcium-channel blocking agent that is widely used in the treatment of angina pectoris and systemic hypertension (1). The pharmacokinetics and pharmacodynamics of nifedipine have been investigated in numerous studies (2-4). Clinical experiences gained with oral nifedipine formulations with immediate-release (IR) characteristics clearly show that a steep rise in the drug plasma concentration results in an increase in heart rate and drug-specific side effects (5-7). Therefore, it has been generally accepted that extended-release (ER) formulations are most efficient for routine hypertension therapy with nifedipine. The ER dosage forms should primarily reduce the occurrence of steep rises in plasma concentration of the drug. Another important therapeutic goal that can be achieved with ER formulations is the improvement of chronic therapy compliance by prolongation of the dosing intervals.
Dhaka University Journal of Pharmaceutical Sciences, 2015
Fast disintegrating tablets of nifedipine prepared by superdisintegrant addition and sublimation methods were evaluated. Twelve batches of tablets were formulated by direct compression using varying concentrations of crospovidone and croscarmellose sodium. Camphor was incorporated into six of the batches. Their granules were evaluated for pre-compression and post-compression parameters. FTIR analysis of the drug and excipients was also carried out. Results obtained showed that their granules were free flowing with angle of repose < 26° and Carr's index < 19 %. The tablets gave hardness of 3.67-5.99 kgf, friability of < 1 %, wetting and disintegration times of < 101 and < 91 secs, respectively. Dissolution profiles showed all the tablets released over 92 % of their drug within 30 mins. FTIR analysis demonstrated no interactions between nifedipine and excipients. The sublimation method in combination with superdisintegrant addition method of formulation yielded fast disintegrating tablets of superior quality than the superdisintegrant addition method alone.