Automation in Dissolution Testing

Hanson, William A.; Paul, Albertha

doi:10.1201/b14198-5

Cited by 23 publications

(24 citation statements)

References 3 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: 83%

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: 83%

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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“…В то же время, разработка биорелевантных методик испытания "Растворение" для таких ЛВ может вызвать ряд трудностей, связанных с их низкой растворимостью. Применение проточной методики, подразумевающей использование больших объемов сред растворения, не всегда обеспечивает хорошую воспроизводимость результатов испытания и требует использования дорогостоящего оборудования [14]. Проведённые J. Dressman исследования наглядно показали преимущество использования биорелевантных сред для малорастворимых, липофильных ЛВ.…”

Section: биофармацевтическая классификационная системаunclassified

The dissolution test in biorelevant media as a prognostic tool for modeling of drug behavior in vivo

Savchenko

et al. 2011

BIOMED KHIM

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Рассмотрен современный способ моделирования поведения лекарственных средств (ЛС) в условиях in vivo -испытанию "Растворение" в биорелевантных средах, имитирующих состав физиологических жидкостей желудочно-кишечного тракта: кишечный сок натощак (FeSSIF) и кишечный сок после еды (FaSSIF). Приведен состав и методики приготовления данных сред растворения. Показано преимущество использования биорелевантных сред растворения в качестве прогностического инструмента высвобождения лекарственных веществ (ЛВ) из ЛС различных классов биофармацевтической классификационной системы (БКС) в данных средах.Ключевые слова: тест "Растворение", биорелевантные среды, биофармацевтическая классификационная система (БКС), FeSSIF, FaSSIF, биовейвер, абсорбция.ВВЕДЕНИЕ. Одной их важнейших задач биомедицины и биофармации является понимание процесса доставки лекарственного вещества (ЛВ) до органов или клеток-мишеней. Одним из ключевых этапов данного процесса является поведение лекарственной формы (ЛФ) в желудочно-кишечном тракте (ЖКТ). При этом ЛВ проходит через следующие стадии: высвобождение ЛВ из ЛФ, растворение ЛВ в биологических жидкостях ЖКТ и его всасывание через стенку кишечника. Поскольку изучение данных процессов в условиях in vivo или in situ является трудоемким и дорогостоящим, одной из основных задач в этом направлении является возможность достоверно смоделировать данные процессы в условиях in vitro.

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“…Hence, some issues have to be addressed before starting the measurement. Air bubbles affect parameters such as the pH after altering the medium, the medium flow, or the wetting and dissolution of test substances (25,32). For media degassing, techniques such as vacuum filtration, heat, ultrasound, membrane filtration, and sparging with inert gases are available (33,34).…”

mentioning

confidence: 99%

“…Because production of these media is time consuming and expensive, they are less suitable for FTC applications in the open system (e.g., quality control) (17,23,24). Alternatively, surfactants such as polyoxyethylene sorbitol oleate (Tween ® 80, a nonionic surfactant), cetyl trimethyl ammonium bromide (CTAB, a cationic surfactant), or sodium dodecyl sulfate (SDS, an anionic surfactant) can be added (25)(26)(27)(28). When SDS is used, the composition of SIF has to be modified because of the incompatibility of SDS and potassium ions (29).…”

mentioning

confidence: 99%

Flow-Through Cell Method and IVIVR for Poorly Soluble Drugs

Wähling¹,

Schröter²,

Hanefeld³

2011

Dissolution Technol.

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The percentage of poorly soluble compounds in drug discovery and development increases steadily. A variety of possibilities exists for increasing solubility and bioavailability; among them is the formation of salts. For the characterization of poorly soluble active pharmaceutical ingredients (API), it is necessary to develop appropriate analytical methods to determine relevant physicochemical properties. One important physicochemical parameter is the dissolution rate. As the flow-through cell (FTC) offers various advantages, such as operating with pH gradients and in sink conditions or applying unlimited amount of media, the FTC is particularly suitable for poorly soluble compounds. When developing an FTC method it is important to consider the physiological circumstances. By choosing the appropriate conditions for media, volume, flow rate, and so forth, it is possible to predict in vivo behavior. The focus of this work was to develop a small-scale FTC method for poorly soluble compounds designed for determining dissolution kinetics in the early development phase, where only limited amount of drug is available. The predictive power of the presented system could be demonstrated by an in vitro-in vivo relationship (IVIVR) study.

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Automation in Dissolution Testing

Cited by 23 publications

References 3 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

The dissolution test in biorelevant media as a prognostic tool for modeling of drug behavior in vivo

Flow-Through Cell Method and IVIVR for Poorly Soluble Drugs

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