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

Citation data:

AAPS PharmSciTech, ISSN: 1530-9932, Vol: 13, Issue: 4, Page: 1473-82

Publication Year:
2012
Usage 25
Abstract Views 20
Link-outs 5
Captures 38
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Citations 25
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Repository URL:
https://nsuworks.nova.edu/hpd_com_faculty_articles/1448
PMID:
23090112
DOI:
10.1208/s12249-012-9875-3
PMCID:
PMC3513447
Author(s):
Sievens-Figueroa, Lucas; Pandya, Natasha; Bhakay, Anagha; Keyvan, Golshid; Michniak-Kohn, Bozena; Bilgili, Ecevit; Davé, Rajesh N
Publisher(s):
American Association of Pharmaceutical Scientists (AAPS); NSUWorks
Tags:
Pharmacology, Toxicology and Pharmaceutics; Medical Specialties; Medicine and Health Sciences; Osteopathic Medicine and Osteopathy
article description
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.