Nifedipine Oral Disintegration Tablet: Design, Optimization, Invivo-pharmacokinetic and Stability Studies (original) (raw)
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Formulation and Evaluation of Fast Disintegrating Tables of Nifedipine by QbD Approach
2015
Fast dissolving tablet format is designed to allow administration of an oral solid dose form in the absence of water or fluid intake. Such tablets readily dissolve or disintegrate in the saliva. Nifedipine is a calcium channel blocker which is used as an antianginal and antihypertensive drug. The aim of this study was to improve the solubility of Nifedipine by solid dispersion technique and increasing its disintegration time by formulation of fast dissolving tablets by Direct Compression method using QbD approach, and various ratios of Cross povidone and Cross Carmellose Sodium as superdisintegrants. The solid dispersions of Nifedipine were formulated with five different polymers as Polyvinylpyrrolidone K 30(PVP k30), Polyethyleneglycol (PEG) 4000, Polyethyleneglycol (PEG) 6000, Urea and Mannitol. The solid dispersions were prepared in five different ratios by solvent evaporation method. The solid dispersion giving the maximum solubility was formulated into fast dissolving tablets u...
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...
Tablet among the all dosage form is the common one and in the Pharmacy it is the mother of Pharmacy. Generally tablet are accepted in all category of patient. In children Dispersible form and in female for virginal infection virginal form are the preferred. The most common preferred route is oral rout of administration. In ancient Ayurveda, Unani, Greek, Egyptian remedies drug in the form of Churna, Bhasma, Gutika, Araka, are administered though oral rout. Pills which are coated by natural resinous material are administered in the form of tablet through oral rout. Today oro-dispersible tablet from novel drug delivery system gain importance from patient. Which is administer to the patient to control the various immediate action viz. attack of angina or hypertension in cardiac problems. Orodispersible tablet gets dispersed in oral cavity in absence of water and release fast drug which result fast pharmacological action. In the market drug from Analgesic, Antipyretic, Antihypertensive and many more are available in the form of the orodispersible tablet. Various manufacture are formulated this formulation by various method. The most importance thing in this formulation are masking of taste of drugs. Generally oro-dispersible tablet are prepared by direct compression method. Dry granulation, wet granulation, Spry drying is the various methods for preparation of oro-dispersible tablet. Oro-dispersible tablet generally contains filler, glidant, anti-adherent super disintegrate, Flavoring agent sweetener and resins. Evaluation parameter includes hardness, friability, wetting time, moisture uptake, disintegration test, and dissolution test. Wetting time, Disintegration time, and Dissolution test is directly proportional to the hydrophobic ingredient added for lubrication, anti-adherent, Glidant action. These hydrophobic ingredient are Magnesium Stearate. To oppose the action of magnesium stearate, hydrophilic additives are incorporated viz Sodium lauryl sulphate. From Marketing point of view special Marketing Executive team required to promote the new technique , new formulation with demonstration to the Cardiac Surgeon, Pediatrics, Orthopedics, Gynecologists, Ophthalmologists, Urologist. After demonstration that how to use the Orodispersible tablet these marketing team personally serve to the new admitted patients.
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.
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.
Formulation and Evaluation of Nifedipine Sustained Release Tablets by Using Different Polymers
Journal of Biomedical and Pharmaceutical Research, 2019
Oral drug delivery has been known for many years because the most generally utilized route of administration among all the routes that are explored for the general delivery of medication via various pharmaceutical products of different dosage forms. The reason that the oral route achieved such quality could also be partly attributed to its simple administration moreover because the ancient belief that by oral administration the drug is well absorbed because the food stuffs that area unit eaten daily. In fact the event of a pharmaceutical product for oral delivery, no matter its physical kind involves variable extents of optimization of dose kind characteristics at intervals the inherent constraints of GI physiology. The rationale for development of a extended release formulation of a drug is to enhance its therapeutic benefits, minimizing its side effects while improving the management of the diseased condition. The aim of the present investigation is to formulate and evaluate mat...
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.