Faculty Articles

Using USP I and USP IV for discriminating dissolution rates of nano- and microparticle-loaded pharmaceutical strip-films.

Publication Title

AAPS PharmSciTech

Publication Date

12-1-2012

Keywords

basket apparatus, dissolution testing, drug nanoparticles, flow-through cell, griseofulvin, poorly water-soluble drugs, sodium dodecyl sulfate, strip-film dosage form, usp i, usp iv, dissolution rate, nanoparticle formulation, pharmaceutical testing, particle size discrimination, drug delivery system, dissolution medium, regulatory standards, flow rate optimization, glass bead layering, formulation development

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.

DOI

10.1208/s12249-012-9875-3

Volume

13

Issue

4

First Page

1473

Last Page

82

Disciplines

Medical Specialties | Medicine and Health Sciences | Osteopathic Medicine and Osteopathy

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