Impact of Vibration and Agitation Speed on Dissolution of USP Prednisone Tablets RS and Various IR Tablet Formulations

Seeger, Nicole; Lange, S.; Klein, Sandra

doi:10.1208/s12249-015-0356-3

Cited by 9 publications

(10 citation statements)

References 14 publications

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“…Coning was not observed within the range of 50-100 rpm, irrespective of whether sinkers were used. As expected, increasing the rpm resulted in a faster dissolution rate (24). At 50 rpm, about 95% of the drug dissolved within 30 minutes, whereas the same amount of ketoprofen dissolved after 20 minutes at 75 rpm and in just 10 minutes at 100 rpm.…”

Section: Ketoprofen Capsulessupporting

confidence: 73%

Investigation of Dissolution Performance of Hard Gelatin Capsule Products Using Various Sinkers

Mansuroglu¹,

Dressman²

2020

Dissolution Technol.

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Dissolution testing is a commonly used tool for the quality control of various dosage forms. For this purpose, consistent test conditions are necessary to obtain reproducible test results. Typical issues that can affect the dissolution performance of tested capsule formulations are floating and coning. Recently, the International Conference on Harmonisation (ICH) guideline recommended the use of sinkers to prevent coning, although no accompanying data to support the recommendation has been published in the open literature to date. Therefore, we initiated studies designed to address the following key questions. A) Do all sinkers prevent flotation of the dosage form? B) Does using sinkers consistently increase the dissolution rate? C) Do sinkers consistently decrease coning? Three commercially available hard capsule drug products were studied: acetaminophen, fluconazole, and ketoprofen. Dissolution was performed without a sinker and with four commercially available sinkers (CLIPS, CAPLOTH, CAPWAST, and JP). Analysis of the results revealed that, although three of the four sinkers were able to adequately address flotation problems, in many cases their use led to artifactual increases or decreases in the dissolution of the capsules. Further, sinkers do not seem to be generally useful for addressing coning issues. Instead, an increase in the stirring speed or use of peak vessels should be considered.

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Section: Ketoprofen Capsulessupporting

confidence: 73%

Investigation of Dissolution Performance of Hard Gelatin Capsule Products Using Various Sinkers

Mansuroglu¹,

Dressman²

2020

Dissolution Technol.

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“…The authors stipulated that higher agitation speeds led to quicker drug release, although no statistical analysis was used and error bars were not presented, questioning whether any significance was achieved within this agitation range and this system [35]. The effect of agitation was, however, also demonstrated in other studies, enforcing the concerns about the critical role of this parameter, although not sufficiently studied yet in hydrogel systems [113,[115][116][117]. Table 4 provides the parameters that have been used for the limited in vitro release studies from various hydrogel drug delivery systems.…”

Section: Agitationmentioning

confidence: 99%

Hydrogels as Drug Delivery Systems: A Review of Current Characterization and Evaluation Techniques

et al. 2020

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Owing to their tunable properties, controllable degradation, and ability to protect labile drugs, hydrogels are increasingly investigated as local drug delivery systems. However, a lack of standardized methodologies used to characterize and evaluate drug release poses significant difficulties when comparing findings from different investigations, preventing an accurate assessment of systems. Here, we review the commonly used analytical techniques for drug detection and quantification from hydrogel delivery systems. The experimental conditions of drug release in saline solutions and their impact are discussed, along with the main mathematical and statistical approaches to characterize drug release profiles. We also review methods to determine drug diffusion coefficients and in vitro and in vivo models used to assess drug release and efficacy with the goal to provide guidelines and harmonized practices when investigating novel hydrogel drug delivery systems.

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“…The dissolution process of disintegrating tablets can be best expressed by paddle apparatus, as it has inherent advantages over a rotating basket apparatus (24). Hence, all dissolution tests of lercanidipine HCl tablets (disintegrating tablets) were performed with a paddletype apparatus.…”

Section: Dissolution Test Optimizationmentioning

confidence: 99%

Dissolution Method Development and Validation for Lercanidipine Hydrochloride Tablets

Shaikh¹,

Patel²,

Patel³

et al. 2018

Dissolution Technol.

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Lercanidipine hydrochloride (HCl) is L-type calcium channel blocker widely used in the management of hypertension. According to the BCS classification system, it is classified under BCS class II drugs, showing low solubility and high permeability. The dissolution profile and thus the in vivo performance of this class of drugs widely depend on their solubility and hence their behaviour in dissolution medium. Lercanidipine HCl is not official in any pharmacopeia, so no official dissolution method is available. The present work is mainly focussed on development and validation of a dissolution test that can be used as a quality control test for lercanidipine HCl tablets and formulations. Saturation solubility and sink conditions that can be achieved in different media suggested that 0.1 N HCl, acetate buffer pH 4.5, and phosphate buffer pH 6.8 can be used as a dissolution medium. Dissolution tests of lercanidipine HCl tablets were carried out in these different media at different rotation speeds using a USP type II (paddle) apparatus. The most suitable dissolution conditions were 0.1 N HCl pH 1.2 (900 mL at 37 ± 0.5 °C) as a dissolution medium and a paddle apparatus at 100 rpm for 60 min. The analysis of released lercanidipine HCl was done by ultraviolet spectrophotometry. The developed method was validated according to ICH guidelines. This method showed linearity with an r 2 value of 0.999 within the concentration range of 2-20 µg/mL. The method was found to be accurate with recoveries ranging from 98.50% to 103.72%. The interday and intraday precision was below RSD 2%. The developed method can effectively be used for quality control evaluation of lercanidipine HCl tablets.

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Impact of Vibration and Agitation Speed on Dissolution of USP Prednisone Tablets RS and Various IR Tablet Formulations

Cited by 9 publications

References 14 publications

Investigation of Dissolution Performance of Hard Gelatin Capsule Products Using Various Sinkers

Investigation of Dissolution Performance of Hard Gelatin Capsule Products Using Various Sinkers

Hydrogels as Drug Delivery Systems: A Review of Current Characterization and Evaluation Techniques

Dissolution Method Development and Validation for Lercanidipine Hydrochloride Tablets

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