Vibration Measurements on Dissolution Systems and Effects on Dissolution of Prednisone Tablets RS

Vangani, Saroj; Flick, Tawnya G.; Tamayo, Germinia; Chiu, Rick W.; Cauchon, Nina S.

doi:10.14227/dt140107p6

Cited by 10 publications

(8 citation statements)

References 3 publications

(1 reference statement)

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“…However, it is still not clear whether a simple experiment with formerly two and nowadays just one immediate release (IR) tablet formulation type(s) is appropriate to decide on the applicability of a dissolution test system in QC and/or formulation development. In addition to this, in the recent past, more and more questions were arising on how to address the effects of vibration on dissolution test results [3][4][5][6][7]. Vibration can result in the addition of energy to a system, e.g., a dissolution bath and can thus potentially alter the results of an experiment.…”

Section: Introductionmentioning

confidence: 99%

“…Vibration can result in the addition of energy to a system, e.g., a dissolution bath and can thus potentially alter the results of an experiment. In the USP therefore, the statement BNo part of the assembly, including the environment in which the assembly is placed, contributes significant motion, agitation, or vibration beyond that due to the smoothly rotating stirring element^ [5] can be found, but from this simple statement, it is not clear, what are critical vibration levels and how to assess them in calibration of the equipment and in routine dissolution testing.…”

Section: Introductionmentioning

confidence: 99%

“…Due to the inability to properly measure vibration levels at the most relevant point of a dissolution apparatus which would be inside a dissolution vessel during operation, in recent studies, accelerometers/vibration meters were used to measure environmental and induced vibration at various locations of a dissolution instrument in the course of dissolution experiments with USP Prednisone Tablets RS [4,5,[10][11][12]. In all of the cited studies, it became obvious that one of the biggest challenges is to determine the right location for recording vibration levels that are relevant to the dissolution process in the vessel.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

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

2015

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Abstract. Dissolution testing is an in vitro procedure which is widely used in quality control (QC) of solid oral dosage forms and, given that real biorelevant test conditions are applied, can also be used as a predictive tool for the in vivo performance of such formulations. However, if a dissolution method is intended to be used for such purposes, it has to deliver results that are only determined by the quality of the test product, but not by other variables. In the recent past, more and more questions were arising on how to address the effects of vibration on dissolution test results. The present study was performed to screen for the correlation of prednisone dissolution of USP Prednisone Tablets RS with vibration caused by a commercially available vibration source as well as to investigate how drug release from a range of immediate release formulations containing class 1-4 drugs of the biopharmaceutical classification scheme is affected by vibration when performing dissolution experiments at different agitation rates. Results of the present study show that the dissolution process of oral drug formulations can be affected by vibration. However, it also becomes clear that the degree of which a certain level of vibration impacts dissolution is strongly dependent on several factors such as drug properties, formulation parameters, and the design of the dissolution method. To ensure the establishment of robust and predictive dissolution test methods, the impact of variation should thus be considered in method design and validation.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

2015

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“…The effect of vibration on instruments from various suppliers has also been investigated and is documented in existing literature (3). The method of vibration analysis and investigation was also reviewed by this independent body, and the results make quite interesting reading.…”

Section: Modern Dissolution Testers and Vibrationmentioning

confidence: 99%

Technical Note: Why Is Vibration an Issue for Dissolution Testing?

Burmicz¹

2008

Dissolution Technol.

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“…The variables in both of these apparatus are vessels, shaft dimensions, shaft wobble, rotation speed, shaft height from the bottom of the vessel, vessel centering and tilt, temperature, leveling of the dissolution apparatus at its base, vibration, and so forth. Many literature articles describe methods to control these variables (4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23). However, none of these address control of basket variability (refer to USP <711>).…”

Section: Introductionmentioning

confidence: 99%