USP apparatus 4 method for in vitro release testing of protein loaded microspheres

Rawat, Archana; Burgess, Diane J.

doi:10.1016/j.ijpharm.2011.02.057

Cited by 31 publications

(11 citation statements)

References 32 publications

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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).…”

Section: Introductionmentioning

confidence: 99%

“…Although the use of the USP 1, USP 2 and USP 4 for conventional solid dosage forms have been presented before (19)(20)(21)(22)(23)(24)(25)(26), there is usually a lack of standard regulatory tests for new solid dosage forms, which represents a major obstacle in their development (31). One of these new solid dosage forms, pharmaceutical strip-film products, has received much attention because of several advantages including rapid disintegration and dissolution in the oral cavity and increased bioavailability (32)(33)(34)(35).…”

Section: Introductionmentioning

confidence: 99%

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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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Section: Introductionmentioning

confidence: 99%

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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“…Choosing the right apparatus has proven to be pivotal since literature has reported signifi cant variations in release profi les between different apparatus [48][49][50] . Figure 23.6 shows an example where two different fl ow-through apparatus were used for the same formulation and the resultant in vitro release profi les were very different.…”

Section: Methodsmentioning

confidence: 99%

“…Sample and separate is the most popular method for particulate parenteral products, mainly due to its simplicity and practicability [50][51][52][53][54][55][56][57][58][59][60][61][62] . In general, micro-or nanoparticles are suspended in a certain amount of release media and the system is subjected to agitation.…”

Section: Sample and Separatementioning

confidence: 99%

“…Continuous fl ow release methods have been used in in vitro release testing in order to assist in simulating in vivo conditions [48][49][50][70][71][72][73][74][75][76][77] . A continuous fl ow apparatus consists of a fl ow-through cell that holds the sample, a fi lter at the top of the fl ow-through cell to prevent particulates from passing out of the sample cell, a pump that drives the dissolution media through the fl ow-through cell, a water bath that maintains the media at a desired temperature and a media reservoir [ 75 ] .…”

Section: Continuous Flowmentioning

confidence: 99%

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In Vitro Drug Release Testing and In Vivo/In Vitro Correlation for Long Acting Implants and Injections

Kastellorizios

Burgess

2011

Long Acting Injections and Implants

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An advantage of long acting implants and injections is their ability to maintain a relatively constant drug concentration at the site of interest. In vitro drug release testing, particularly where an in vivo / in vitro relationship has been established, can help in ensuring in vivo performance. There are various in vitro release testing methods, which are chosen, based on availability, dosage form specifi cations and drug properties. These are categorized into three groups: sample and separate, fl ow-through and dialysis. Although there are currently no standard methods for in vitro release testing of controlled release parenterals, standard dissolution apparatus specifi ed by the United States Pharmacopeia have been adapted in some cases and the development of compendial monographs is anticipated. An in vivo / in vitro correlation can predict the bioavailability characteristics of a product based on release in vitro .

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Recent research and development of PLGA/PLA microspheres/nanoparticles: A review in scientific and industrial aspects

et al. 2018

Front. Chem. Sci. Eng.

111

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USP apparatus 4 method for in vitro release testing of protein loaded microspheres

Cited by 31 publications

References 32 publications

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

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

In Vitro Drug Release Testing and In Vivo/In Vitro Correlation for Long Acting Implants and Injections

Recent research and development of PLGA/PLA microspheres/nanoparticles: A review in scientific and industrial aspects

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