New and Extended Applications for USP Drug Release Apparatus 3.

Borst, Ian; Ugwu, Sydney O.; Beckett, A. H.

doi:10.14227/dt040197p11

Cited by 29 publications

(31 citation statements)

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“…This information is of great use to the formulator. USP Apparatus 3 also has an important application in the assessment of gastro-resistant formulations, considering the possibility of change in the dissolution FIGURE 2 -Schematic representation of apparatus 3 and its six lines of vessels, each containing a dissolution medium with a different pH value, by way of example, simulating the passage of the product through the gastrointestinal (GI) tract (Borst, Ugwu, Beckett, 1997). medium during the assay. The dissolution profiles of a hypothetical gastro-resistant formulation in USP apparatuses 1 and 3 can be found in Figures 5 and 6, respectively.…”

Section: Applications For Modified-release Solid Oral Dosage Formsmentioning

confidence: 99%

“…It is particularly critical in the case of dosage forms that are subject to erosion, such as hydrophilic matrices (Kavanagh, Corrigan, 2004;Missaghi, Fassihi, 2005;Asare-Addo et al, 2010). Although it may be difficult to select the agitation intensity that best mimics in vivo conditions, it is common to use 5-15 dips per minute (dpm) to simulate the fasted state and 30-40 dpm for the fed state, thus representing the greater turbulence within the stomach (Borst, Ugwu, Beckett, 1997). Furthermore, inert spheres of varying densities may be added in order to simulate interaction with solid food particles in movement (Missaghi, Fassihi, 2005).…”

Section: Simulation Of Fasted and Fed Statesmentioning

confidence: 99%

“…With the purpose of addressing this issue, a group of researchers from the University of London, headed by Professor A.H. Beckett, developed the reciprocating cylinder method (Borst, Ugwu, Beckett, 1997;Yu, Wang, Hussain, 2002).…”

Section: Introductionmentioning

confidence: 99%

“…However, the method was extremely labor-intensive and there were limitations with regards to automatization of the system (Borst, Ugwu, Beckett, 1997;Jorgensen, Bhagwat, 1998).…”

Section: Introductionmentioning

confidence: 99%

“…This proposal was incorporated into the U.S. Pharmacopeia in 1991 (Yu, Wang, Hussain, 2002) as USP apparatus 3, making it an alternative to USP apparatuses 1 and 2 for the assessment of dissolution characteristics of products that consist of solid oral modified-release dosage forms (Borst, Ugwu, Beckett, 1997;Krämer, Grady, Gajendran, 2005;Wang, Fotaki, Mao, 2009).…”

Section: Introductionmentioning

confidence: 99%

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Applications of USP apparatus 3 in assessing the in vitro release of solid oral dosage forms

Pezzini

Issa

Duque

et al. 2015

Braz. J. Pharm. Sci.

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USP Apparatus 3 (reciprocating cylinder) is a very versatile device for the in vitro assessment of release characteristics of solid oral dosage forms, because it enables the product to be subjected to different dissolution media and agitation speeds in a single run. In this paper, a brief history and a description of this system are presented, along with its applications in the development of immediate and modified release products and in the simulation of fasted and fed states using biorelevant media. Furthermore, a comparison is made with the basket and paddle apparatus, especially highlighting the superior hydrodynamics of USP apparatus 3, since the results are not sensitive to factors such as the presence of sample collection probes or air bubbles in the dissolution medium.Uniterms: Solid dosage forms/in vitro release. Solid dosage forms/dissolution. Apparatus 3/use/evaluation of solid dosage forms. Reciprocating cylinders.USP aparato 3 (cilindros recíprocos) é um equipamento bastante versátil para a avaliação das características de liberação in vitro de formas farmacêuticas sólidas orais, pois permite que o produto seja submetido a diferentes meios de dissolução e condições de agitação, em um único ensaio. Neste trabalho, são apresentados um breve histórico e a descrição desse sistema, suas aplicações no desenvolvimento de produtos de liberação imediata e modificada, assim como sua utilização na simulação dos estados não alimentado e alimentado com o emprego de meios biorrelevantes. Além disso, uma comparação é estabelecida com o cesto e a pá, com destaque para a hidrodinâmica superior do USP aparato 3, que faz com que os resultados não sejam influenciados por fatores como o uso de sondas de coleta de amostras ou presença de bolhas de ar no meio de dissolução.Unitermos: Formas farmacêuticas sólidas/liberação in vitro. Formas farmacêuticas sólidas/dissolução. USP Aparato 3/uso/avaliação de formas farmacêuticas sólidas. Cilindros recíprocos.

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Section: Applications For Modified-release Solid Oral Dosage Formsmentioning

confidence: 99%

Section: Simulation Of Fasted and Fed Statesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“…However, the method was extremely labor-intensive and there were limitations with regards to automatization of the system (Borst, Ugwu, Beckett, 1997;Jorgensen, Bhagwat, 1998).…”

Section: Introductionmentioning

confidence: 99%