In vitro release testing method development for ophthalmic ointments
Publication date: 30 June 2017 Source:International Journal of Pharmaceutics, Volume 526, Issues 1–2 Author(s): Quanying Bao, Jie Shen, Rajan Jog, Carmen Zhang, Bryan Newman, Yan Wang, Stephanie Choi, Diane J. Burgess It is essential as well as challenging to develop a reliable in vitro release testing method for determining whether differences in release profiles exist between qualitatively and quantitatively equivalent ophthalmic ointment formulations. There is a lack of regulatory guidance on in vitro release testing methods for ophthalmic formulations. Three different in vitro release testing methods 1) USP apparatus 4 with semisolid adapters; 2) USP apparatus 2 with enhancer cells; and 3) Franz diffusion cells were investigated. Qualitatively and quantitatively equivalent ointments were prepared via hot melting and simple mixing methods using four different sources of excipients (i.e. white petrolatum). The ointment formulations were characterized for content uniformity, particle size, and rheological parameters. All the formulations showed adequate content uniformity and similar particle size. The ointments prepared via the hot melting processes showed higher rheological parameters, as did the ointments prepared using ‘white’ petrolatum that exhibited a yellowish color. The three in vitro release testing methods were compared and evaluated for reproducibility, discriminatory capability, and correlation with the rheological parameters. Compared with th...
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J. Mater. Chem. A, 2018, Accepted Manuscript DOI: 10.1039/C8TA02629G, PaperYongji Guan, Qunfeng Shao, Wenqiong Chen, Jiao Zhang, Xiaoping Zhang, Youquan Deng Inspired by the interesting phenomenon that biological systems have the inherent skill to generate considerable bioelectricity when the salt content in fluids flows over the highly selective ion channels on... The content of this RSS Feed (c) The Royal Society of Chemistry
20 –22 June 2018, Naples, Italy
21 –22 June 2018, London, United Kingdom