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...
Abstract “I have noticed in operations of this kind, which I have seen performed by others upon the living, and in a number of excisions, which I have myself performed on the dead body, that most of the difficulty in the separation of the tumor has occurred in the region of these ligaments…. This difficulty, I believe, to be a very frequent source of that accident, which so commonly occurs in removal of goiter, I mean division of the recurrent laryngeal nerve.” Sir James Berry (1887)
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Paula G. Slater, Sebastian E. Gutierrez-Maldonado, Katia Gysling, Carlos F. Lagos
Abstract AimsTo identify gestational diabetes mellitus exposure‐associated DNA methylation changes and assess whether such changes are also associated with adiposity‐related outcomes. MethodsWe performed an epigenome‐wide association analysis, using Illumina 450k methylation arrays, on whole blood collected, on average, at 10.5 years of age from 81 gestational diabetes‐exposed and 81 unexposed offspring enrolled in the EPOCH (Exploring Perinatal Outcomes in Children) study, and on the cord blood of 31 gestational diabetes‐exposed and 64 unexposed offspring enrolled in our own ‘Healthy Start’ cohort. V...
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Authors: PMID: 29457548 [PubMed - in process]
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