A collaborative in vitro dissolution study: comparing the flow-through method with the USP paddle method using USP prednisone calibrator tablets

Wennergren, Bo; Lindberg, Jan Erik; Nicklasson, Martin; Nilsson, Gunilla Åkesson; Nyberg, Gunilla; Ahlgren, Rolf; Persson, Christiane; Palm, Bo

doi:10.1016/0378-5173(89)90358-x

Cited by 24 publications

(15 citation statements)

References 2 publications

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“…Differences observed between results produced by these two methods are largely due to differences in the hydrodynamic conditions which exist around the sample. The paddle apparatus generates shear forces around samples via agitation of the bulk medium, while for the flow-through apparatus, shear is provided by the pulsatile flow over the particles (5).…”

Section: Comparison Of Closed-loop Flow-through Methods With Paddle Mmentioning

confidence: 99%

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In Vitro Dissolution Testing with Flow-Through Method: A Technical Note

Gao

2009

AAPS PharmSciTech

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Section: Comparison Of Closed-loop Flow-through Methods With Paddle Mmentioning

confidence: 99%

“…A flowthrough method using the official USP 4 apparatus operated in open-loop mode is capable of maintaining a continuous flow of fresh dissolution medium, thus, maintaining infinite sink conditions (3)(4)(5)(6). This operational mode provides an environment potentially closer to that of the digestive tract.…”

Section: Introductionmentioning

confidence: 99%

In Vitro Dissolution Testing with Flow-Through Method: A Technical Note

Gao

2009

AAPS PharmSciTech

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“…The flow-through cell dissolution apparatus has been successfully used to study dissolution of different solid dosage forms including tablets, capsules, powders, suppositories, dispersed systems, implants, and microspheres (19)(20)(21)(22)(23)(24)(25)(26). This dissolution technique has been proven to be reproducible and robust, which is an important characteristic for dissolution testing (27)(28)(29). The increased sensitivity of the flow-through cell dissolution method related to particle size of a poorly soluble drug powder has also been reported recently (30,31).…”

Section: Introductionmentioning

confidence: 99%

Using USP I and USP IV for Discriminating Dissolution Rates of Nano- and Microparticle-Loaded Pharmaceutical Strip-Films

et al. 2012

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Abstract. Recent interest in the development of drug particle-laden strip-films suggests the need for establishing standard regulatory tests for their dissolution. In this work, we consider the dissolution testing of griseofulvin (GF) particles, a poorly water-soluble compound, incorporated into a strip-film dosage form. The basket apparatus (USP I) and the flow-through cell dissolution apparatus (USP IV) were employed using 0.54% sodium dodecyl sulfate as the dissolution medium as per USP standard. Different rotational speeds and dissolution volumes were tested for the basket method while different cell patterns/ strip-film position and dissolution media flow rate were tested using the flow-through cell dissolution method. The USP I was not able to discriminate dissolution of GF particles with respect to particle size. On the other hand, in the USP IV, GF nanoparticles incorporated in strip-films exhibited enhancement in dissolution rates and dissolution extent compared with GF microparticles incorporated in strip-films. Within the range of patterns and flow rates used, the optimal discrimination behavior was obtained when the strip-film was layered between glass beads and a flow rate of 16 ml/min was used. These results demonstrate the superior discriminatory power of the USP IV and suggest that it could be employed as a testing device in the development of strip-films containing drug nanoparticles.

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“…When flow rates of 2 and 4 ml/min were utilised, it was visually noticed that very slow disintegration took place and limited or no drug release was detected following 1 h. This could be due to the weak disintegrating effect of flow-through cell in comparison to paddle-based dissolution tests (27). In flow-through systems, these agitation forces are mainly generated from the pulses of the peristaltic pump and they are likely to be minimal when a Fig.…”

Section: Resultsmentioning

confidence: 99%

Instrumentation of Flow-Through USP IV Dissolution Apparatus to Assess Poorly Soluble Basic Drug Products: a Technical Note

et al. 2015

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Abstract. Supersaturation and precipitation are common limitations encountered especially with poorly soluble basic drugs. The aims of this work were to explore the pattern of dissolution and precipitation of poorly soluble basic drugs using a United States Pharmacopoeia (USP) IV dissolution apparatus and to compare it to the widely used USP II dissolution apparatus. In order to investigate the influence of gastric emptying time on bioavailability, tables of two model drugs (dipyridamole 100 mg and cinnarizine 15 mg) were investigated and pH change from 1.2 to 6.8 were achieved after 10, 20 or 30 min using USP II or USP IV dissolution apparatuses. Using USP II, dipyridamole and cinnarizine concentrations dropped instantly as a result of drug precipitation with drug crystals evident in the dissolution vessel. At pH change times of 10, 20 and 30 min, the total amount of dissolved drug was dependent on pH change time. Using USP IV, at a flow rate of 8 ml/min, it was possible to have comparable release to agitation at 50 rpm using USP II suggesting that comparable hydrodynamic forces are possible. No drop in drug percentage occurs as the dissolved fraction was readily emptied from the flow cell, preventing drug accumulation in the dissolution medium. However, a negligible percentage of drug release took place following pH change. In conclusion, the use of the flow-through cell dissolution provided laminar flow, use of realistic fluid volumes and avoided precipitation of dissolved drug fraction in the gastric phase as it is discharged before pH change.

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A collaborative in vitro dissolution study: comparing the flow-through method with the USP paddle method using USP prednisone calibrator tablets

Cited by 24 publications

References 2 publications

In Vitro Dissolution Testing with Flow-Through Method: A Technical Note

In Vitro Dissolution Testing with Flow-Through Method: A Technical Note

Using USP I and USP IV for Discriminating Dissolution Rates of Nano- and Microparticle-Loaded Pharmaceutical Strip-Films

Instrumentation of Flow-Through USP IV Dissolution Apparatus to Assess Poorly Soluble Basic Drug Products: a Technical Note

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