Comparison of dissolution profiles obtained from nifedipine extended release once a day products using different dissolution test apparatuses

Garbacz, Grzegorz; Golke, Berit; Wedemeyer, Ralph-Steven; Axell, Marie; Söderlind, Erik; Abrahamsson, Bertil; Weitschies, Werner

doi:10.1016/j.ejps.2009.06.010

Cited by 61 publications

(36 citation statements)

References 34 publications

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“…Although stirring rate is an important factor in dissolution testing, it is suggested that investigations related to mixing and agitation rates encountered in vivo also be conducted. [90][91][92][93][94][95][96] …”

Section: In Vitro Factorsmentioning

confidence: 99%

“…Furthermore, churning and agitation will differ based on the fed and fasted states; therefore, a closer inspection of the dissolution apparatus speeds and a better assessment of the agitation on dissolution also needs to be considered. [91][92][93][94][95][96] The presence of food will change the pH in the stomach; however, the changes are not uniform throughout the three distinct regions of the stomach (fundus, body, and antrum). 101,102 It was revealed that the gastric body and fundal pHs raised to a pH 4.5 in a time-dependent manner postfeeding, 101 whereas the antral pH remained at 2 throughout the time that food was present.…”

Section: In Vivo Factorsmentioning

confidence: 99%

See 1 more Smart Citation

Assessing the performance of amorphous solid dispersions

Newman¹,

Knipp

Zografi

2012

Journal of Pharmaceutical Sciences

337

235

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Section: In Vitro Factorsmentioning

confidence: 99%

Section: In Vivo Factorsmentioning

confidence: 99%

Assessing the performance of amorphous solid dispersions

Newman¹,

Knipp

Zografi

2012

Journal of Pharmaceutical Sciences

337

235

View full text Add to dashboard Cite

“…Formulation properties including the nature and amount of polymer, type and amount of excipients, hydration and tablet compression properties also affect the release profiles of solid dosage forms (Bravo et al, 2002). The dissolution of SR nifedipine tablet preparations are also affected by dissolution test conditions (Garbacz et al, 2009). Tables 5 and 6 show the difference and similarity factors for 30 mg and 20 mg strength nifedipine SR tablets, respectively.…”

Section: Resultsmentioning

confidence: 99%

Comparative in vitro dissolution of commercially available sustained release nifedipine tablet brands in the Kumasi Metropolis, Ghana

Osei-Asare¹,

Kipo²,

Ofori-Kwakye³

et al. 2015

J App Pharm Sci

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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.

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“…This dynamic process provides a better representation of the transit of the drug formulation through the GI tract, which more closely captures the kinetic aspects of the actual in vivo drug release process. Garbacz et al have also showed diclofenac and nifedipine drug dissolution profiles to be predicted using a dissolution apparatus that mimics in vivo physical stresses [146,147]. Kostewicz et al [148] also developed a two-compartmental apparatus using a peristaltic pump using fasted and fed state-simulated media.…”

Section: Dissolution Apparatusesmentioning

confidence: 99%

Drug release from matrix tablets: physiological parameters and the effect of food

Nokhodchi

Asare-Addo

2014

Expert Opinion on Drug Delivery

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Introduction: As dissolution plays an important and vital role in the drug-delivery process of oral solid dosage forms, it is, therefore, essential to critically evaluate the parameters that can affect this process. Areas covered:The consumption of food as well as the physiological environment and properties of the gastrointestinal tract, such as its volume and composition of fluid, the fluid hydrodynamics, properties of the intestinal membrane, drug dose and solubility, pK a , diffusion coefficient, permeability and particle size, all affect drug dissolution and absorption rate. There are several dissolution approaches that have been developed to address the conditions as experienced in the in vivo environment, as the traditional dissolution being a quality control method is not biorelevant and as such do not always produce meaningful data. This review also describes the development of a systematic way that differentiates between robust and non-robust formulations by varying the effects of agitation and ionic strength through the use of the automated United States Pharmacopeia type III Bio-Dis apparatus. Expert opinion:With the improved understanding of the physiological parameters that can affect the oral bioperformance of dosage forms, strides have, therefore, been made in making dissolution testing methods more bio-logically based with the view of obtaining more in vitro--in vivo correlations.Keywords: agitation rate, biodissolution, drug release, effect of food, hydrophilic matrices, ionic strength Highlights -Understanding all the physiological parameters can serve as a basis for designing dissolution testing methods and systems that can more fully represent the gastrointestinal (GI) tract in humans and allow more in vitro-in vivo (IVIVC) correlations to be obtained thereby improving the oral bioperformance of dosage forms.-Simulation of GI conditions is essential to adequately predict the in vivo behaviour of drug formulations.-The choice of appropriate media for in vitro tests is crucial to their ability to correctly forecast the food effect in pharmacokinetic studies.-Several methods of dissolution testing have been conducted and are still ongoing that seek to further understand and develop media and dissolution methods to better represent the in vivo conditions and to aid in the better prediction of in vivo drug release.-Systematic change of agitation method and ionic strength evaluation may be used as additional tools in allowing for the identification of potential fed and fasted effects on drug release from hydrophilic matrices in the drive for developing dissolution methodologies that are more relevant in helping to achieve more IVIVC.

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Comparison of dissolution profiles obtained from nifedipine extended release once a day products using different dissolution test apparatuses

Cited by 61 publications

References 34 publications

Assessing the performance of amorphous solid dispersions

Assessing the performance of amorphous solid dispersions

Comparative in vitro dissolution of commercially available sustained release nifedipine tablet brands in the Kumasi Metropolis, Ghana

Drug release from matrix tablets: physiological parameters and the effect of food

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