Measurement of agitation force in dissolution test and mechanical destructive force in disintegration test

Kamba, Masaharu; Seta, Yasuo; Takeda, Nao; Hamaura, Takeshi; Kusai, Akira; Nakane, Hisanori; Nishimura, Kenji

doi:10.1016/s0378-5173(02)00535-5

Cited by 47 publications

(30 citation statements)

References 11 publications

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“…The dissolution rates for the central and 5-mm-off positions were significantly different, with the latter being significantly higher than the former (Table 3). The results are consistent with previous reports (9,(18)(19)(20), since the rate of dissolution increased significantly when the shaft was offset 2-10 mm from the central axis of the vessel. The increase in dissolution rate could be explained by the difference in agitation force at the position used.…”

Section: Discussionsupporting

confidence: 93%

“…Dissolution testing is a useful tool for the quality control of oral products, and it provides important information concerning bioequivalence. However, there are several sources of variability in dissolution testing such as temperature, pH (4,5), and aeration (6) of the test medium; rotation and agitation of the paddle shaft (4,7,8); sample position (4,9); sample storage conditions (6); and analytical methods (10), which potentially affect decision errors of quality evaluation. Qualification of the test apparatus and procedures is required.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Effect of Paddle-Shaft Position on the Dissolution Rate of Sodium Diclofenac Tablets and the Equivalence Assessment of a Generic Product

Fujimoto¹,

Mihara²,

Jorgenson³

et al. 2009

Dissolution Technol.

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Dissolution testing is useful for controlling the quality of oral products and rejecting bioinequivalent products. However, several sources of variability in dissolution tests can affect evaluations of quality. The purpose of this study was to investigate the effects of paddle-shaft position on the dissolution rates of a brand-name (BR) and four genericequivalent (GE), rapid-release tablets of sodium diclofenac. The paddle was shifted 5 mm from the center of the vessel, and the dissolution profiles were compared with that obtained at the central position. Although the GEs had a wide range of variability and significantly different dissolution profiles, they were estimated to be equivalent to the BR when the paddle was set at the center of the vessel. The 5-mm-shifted position significantly increased the dissolution rates of all products with the result that some GEs did not meet the criteria for equivalence.In conclusion, paddle position is potentially a cause of error in GE equivalence assessments. The paddle should be accurately positioned at the center of the vessel in dissolution tests for the equivalence assessment of GEs.

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Section: Discussionsupporting

confidence: 93%

Section: Introductionmentioning

confidence: 99%

Effect of Paddle-Shaft Position on the Dissolution Rate of Sodium Diclofenac Tablets and the Equivalence Assessment of a Generic Product

Fujimoto¹,

Mihara²,

Jorgenson³

et al. 2009

Dissolution Technol.

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show abstract

“…This is somewhat surprising since Kamba et al . showed that the use of disks adds destructive forces to the disintegration test (13). A third product (glucosamine tablets) only showed a partial impact of the beaker size and the equipment used on the disintegration time when no disks were used.…”

Section: Resultsmentioning

confidence: 99%

Investigation of the Performance of the Disintegration Test for Dietary Supplements

Almukainzi

Salehi

Bou‐Chacra

et al. 2010

AAPS J

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Abstract. The aim of this study was to investigate how beaker size, basket assembly, use of disk, and immersion medium impact the disintegration time of dietary supplements. The disintegration times were determined for five tablet and two capsule products. A two-station disintegration tester was used with Apparatus A or Apparatus B as described in the United States Pharmacopeia (USP) chapters, <701> and <2040>. Two beakers complying with the harmonized specifications were used, one with a volume of 1,000 mL and one with a 1,500-mL volume. The disintegration data were analyzed using ANOVA for the following factors: beaker size, equipment (App A and B) and condition (with/without disk). Two tablet products were not sensitive to any changes in the test conditions or equipment configurations. One product was only partially sensitive to the test conditions. The other products showed impact on the disintegration time for all test conditions. The results revealed that these tablet products might pass or fail current USP disintegration requirements depending on the equipment configuration. Similar results were obtained for the two investigated capsule formulations. One product might fail current USP disintegration requirements if the large beaker was used, but might pass the disintegration requirements when the small beaker was used. Hydroxy propyl methyl cellulose capsules were mostly influenced if sodium instead of a potassium buffer was used as the immersion medium. The results demonstrate that the current harmonized ICH specifications for the disintegration test are insufficient to make the disintegration test into reliable test for dietary supplements.

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“…Kamba et al 11 have recently determined, using a fluid resistance sensor, that there is a considerable change in agitation force intensity toward the base of the dissolution vessel. Alterations in hydrodynamics in the United States Pharmacopeia (USP) paddle dissolution apparatus may significantly affect drug dissolution, and the dissolution rates may change depending on the location of the dissolving substance in the dissolution vessel.…”

Section: Introductionmentioning

confidence: 99%

Computational fluid dynamics modeling of the paddle dissolution apparatus: Agitation rate, mixing patterns, and fluid velocities

et al. 2004

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The purpose of this research was to further investigate the hydrodynamics of the United States Pharmacopeia (USP) paddle dissolution apparatus using a previously generated computational fluid dynamics (CFD) model. The influence of paddle rotational speed on the hydrodynamics in the dissolution vessel was simulated. The maximum velocity magnitude for axial and tangential velocities at different locations in the vessel was found to increase linearly with the paddle rotational speed. Path-lines of fluid mixing, which were examined from a central region at the base of the vessel, did not reveal a region of poor mixing between the upper cylindrical and lower hemispherical volumes, as previously speculated. Considerable differences in the resulting flow patterns were observed for paddle rotational speeds between 25 and 150 rpm. The approximate time required to achieve complete mixing varied between 2 to 5 seconds at 150 rpm and 40 to 60 seconds at 25 rpm, although complete mixing was achievable for each speed examined. An analysis of CFDgenerated velocities above the top surface of a cylindrical compact positioned at the base of the vessel, below the center of the rotating paddle, revealed that the fluid in this region was undergoing solid body rotation. An examination of the velocity boundary layers adjacent to the curved surface of the compact revealed large peaks in the shear rates for a region within ~3 mm from the base of the compact, consistent with a 'grooving' effect, which had been previously seen on the surface of compacts following dissolution, associated with a higher dissolution rate in this region.

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Measurement of agitation force in dissolution test and mechanical destructive force in disintegration test

Cited by 47 publications

References 11 publications

Effect of Paddle-Shaft Position on the Dissolution Rate of Sodium Diclofenac Tablets and the Equivalence Assessment of a Generic Product

Effect of Paddle-Shaft Position on the Dissolution Rate of Sodium Diclofenac Tablets and the Equivalence Assessment of a Generic Product

Investigation of the Performance of the Disintegration Test for Dietary Supplements

Computational fluid dynamics modeling of the paddle dissolution apparatus: Agitation rate, mixing patterns, and fluid velocities

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