title: Using USP I and USP IV for discriminating dissolution rates of nano- and microparticle-loaded pharmaceutical strip-films.
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.
authors.affiliation: Department of Chemical, Biochemical, and Pharmaceutical Engineering, New Jersey Institute of Technology, Newark, New Jersey, USA.
authors.forename: Lucas
authors.initials: L
authors.lastname: Sievens-Figueroa
authors.forename: Natasha
authors.initials: N
authors.lastname: Pandya
authors.forename: Anagha
authors.initials: A
authors.lastname: Bhakay
authors.forename: Golshid
authors.initials: G
authors.lastname: Keyvan
authors.forename: Bozena
authors.initials: B
authors.lastname: Michniak-Kohn
authors.forename: Ecevit
authors.initials: E
authors.lastname: Bilgili
authors.forename: Rajesh N
authors.initials: RN
authors.lastname: Davé
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004304:Dosage Forms; D006118:Griseofulvin / Q000737:chemistry*; D008567:Membranes, Artificial; D053758:Nanoparticles / Q000737:chemistry*; D010316:Particle Size; D012967:Sodium Dodecyl Sulfate / Q000737:chemistry; D012995:Solubility; D014867:Water
chemical_list: D004304:Dosage Forms; D008567:Membranes, Artificial; D014867:Water; D006118:Griseofulvin; D012967:Sodium Dodecyl Sulfate