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

Lucas Sievens-Figueroa, Natasha Pandya, Anagha Bhakay, Golshid Keyvan, Bozena Michniak-Kohn, Ecevit Bilgili, Rajesh N. Davé

Research output: Contribution to journalArticlepeer-review

46 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1473-1482
Number of pages10
JournalAAPS PharmSciTech
Volume13
Issue number4
DOIs
StatePublished - Dec 2012

All Science Journal Classification (ASJC) codes

  • Pharmaceutical Science

Keywords

  • BCS class II
  • dissolution
  • drug nanoparticles
  • flow-through cell
  • pharmaceutical strip-films

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