The Effects of Buffer Molarity, Agitation Rate, and Mesh Size on Verapamil Release from Modified-Release Mini-Tablets Using USP Apparatus 3

Khamanga, Sandile M.; Walker, Roderick B.

doi:10.14227/dt140207p19

Cited by 10 publications

(5 citation statements)

References 13 publications

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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%

“…Traditionally, hydrogel-drug delivery system samples are immersed in a releasing medium, partly mimicking physiological conditions in terms of pH (saline buffer) with control over temperature and CO 2 concentration (using incubators) [8,19,61,68]. Agitation, ionic strength, enzymatic presence/absence are other parameters that are often controlled in the final release system [12,35,37,113]. At every time point, supernatant samples are collected for drug concentration analysis.…”

Section: Release Assays and Interpretation Of Release Kineticsmentioning

confidence: 99%

“…In addition, the ionic drug verapamil is more soluble at higher drug molarities. Both events, therefore, led to a faster release at higher drug molarities [113]. Other studies have reported the usage of simulated gastric fluid (SGF) and simulated intestinal fluid (SIF) since the focus of the drug delivery systems in question was to release drugs via the oral route [60,67].…”

Section: Composition Of the Release Mediamentioning

confidence: 99%

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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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Section: Agitationmentioning

confidence: 99%

Section: Release Assays and Interpretation Of Release Kineticsmentioning

confidence: 99%

Section: Composition Of the Release Mediamentioning

confidence: 99%

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

et al. 2020

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“…Initially, in Method M1, the influence of the immersion rate of 5, 15, 30, 40 and 50 dpm were evaluated, as previously indicated by Borst et al 22) The comparison was conducted in a series of media at defined times; HCl (pH 1.2) -1 h, ABS (pH 4.5) -2 h, PBS (pH 5.8) -1 h, PBS (pH 6.8) -5 h, PBS (pH 7.2) -1 h, which are based on the physiological transit time and the specific pH in each portion of the GIT. 11,23) The percentage of MTF dissolved during 10 h by Method M1 was greater than 85% for 30, 40 and 50 dpm immersion rates with the dissolved amount of drug proportional to the increase in the immersion rate, as shown in Fig. 2A.…”

Section: Development Of a Dissolution Methods With Uspmentioning

confidence: 83%

Development of USP Apparatus 3 Dissolution Method with IVIVC for Extended Release Tablets of Metformin Hydrochloride and Development of a Generic Formulation

et al. 2019

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Metformin is a euglycemic drug for the treatment of type 2 diabetes mellitus. To date, there are 13 dissolution methodologies described in the U.S. Pharmacopoeia (USP) to evaluate the release profile of metformin from extended-release tablets utilizing either a USP apparatus 1 (basket) or 2 (paddle). In the absence of a protocol for a USP apparatus 3 (reciprocating cylinder), the goal of this work was to develop an in vitro dissolution method for metformin extended-release tablets based on an in vivo-in vitro correlation (IVIVC). Following a systematic evaluation, a final dissolution method, M4, was defined. It applied 30 dips per minute (dpm) over a total period of 10 h into a series of solutions that included 2 h in HCl media (pH 1.2), 1 h in an acetate buffer solution (pH 4.5), 1 h in phosphate buffer solution (PBS) (pH 5.8) and 6 h in PBS (pH 6.8). This method showed a significant IVIVC with a calculated R 2 > 0.98 (point-to-point correlation, Level A) and it was successfully used as a tool to assist in the development of generic extended release formulations for metformin consisting of a lipophilic matrix system.

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“…In vitro drug-release studies were performed using USP Apparatus 3 (VanKel Industries, New Jersey, USA) as described (10) to determine the effect of continuous pH change over time on drug-release characteristics. A model VK 750D digitally controlled water circulation/heater (VanKel Industries, New Jersey, USA) was used to maintain the temperature of the dissolution media of different buffers of different pH values (180 mL per vessel) at 37 ± 0.5 °C.…”

Section: In Vitro Dissolution Studiesmentioning

confidence: 99%

Drug Transport Mechanisms from Carbopol/Eudragit Verapamil Sustained-Release Tablets

Khamanga¹,

Walker

2011

Dissolution Technol.

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The objectives of this study were to compare dissolution profiles of a verapamil (VRP) formulation manufactured inhouse and Isoptin SR using USP Apparatus 2 and 3 and to elucidate drug release kinetics of these dosage forms. Eudragit NE 30D (ethyl acrylate-methyl methacrylate copolymer in a 2:1 ratio) aqueous dispersion was used as a granulating binder for the manufacture of VRP mini-matrix sustained-release tablets. The wet granulation process was performed to prepare free-flowing granules that were blended with Carbopol. The tablets were manufactured using a single-punch press by compression of the granules with magnesium stearate as a lubricant. Drug release was determined in phosphate buffer solution using USP Apparatus 2 and 3. Dissolution data were fitted to zero-and first-order models; in addition, the kinetic data were determined by evaluation of Higuchi release kinetics. The mechanism of drug release was established using the Korsmeyer-Peppas model. In general, all tablets showed high mechanical resistance with less than 1% friability. There was no significant difference between the dissolution profiles of the formulation manufactured in-house and the commercially available product. The release mechanism of the formulated and marketed products was controlled by anomalous non-Fickian diffusion. VRP release was prolonged for 12 h indicating the usefulness of the formulation as a twice-daily dosage form. The mechanism of drug release for the dosage forms was unaffected by the choice of apparatus.

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The Effects of Buffer Molarity, Agitation Rate, and Mesh Size on Verapamil Release from Modified-Release Mini-Tablets Using USP Apparatus 3

Cited by 10 publications

References 13 publications

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

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

Development of USP Apparatus 3 Dissolution Method with IVIVC for Extended Release Tablets of Metformin Hydrochloride and Development of a Generic Formulation

Drug Transport Mechanisms from Carbopol/Eudragit Verapamil Sustained-Release Tablets

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