Looking for a more recent publication or review on Developing early formulations: Practice and perspective. More specifically methods for precipitation potential evaluation for IV and SC administration.
My go to paper has been (1). Li Ping et al. which was published in 2007. I am looking for something newer and my search came up with (2) Williams et al. which was published in 2013.
I am specifically interested in techniques to test in-vitro prior to going in-vivo to make sure the formulation is stable and will not precipitate out of solution for SC or IV administration.
Is Li Ping et al. still the goto paper? I am now checking Williams et al.
From Ping et al., for i.v. formulation - advice to evaluate the formulation in vitro precipitation by using serial dilution method and that for acceptable iv solution formulation, it is important to ensure that drug remain solubilized before and upon injection.
Thank you very much.
(1) Li, Ping, and Luwei Zhao. "Developing early formulations: practice and perspective." International Journal of Pharmaceutics 341.1-2 (2007): 1-19. https://www.sciencedirect.com/science/article/abs/pii/S0378517307004553
(2) Williams, Hywel D., et al. "Strategies to address low drug solubility in discovery and development." Pharmacological reviews 65.1 (2013): 315-499. https://pharmrev.aspetjournals.org/content/65/1/315.short
"Parenteral formulations are mostly aqueous solutions but can also be presented in several dosage forms, depending on the intended route of administration [6]. For example, for IV administration, solutions and microemulsions are the most extensively used, as suspensions can present a risk of capillary blockage by insoluble particles, being more suitable for SC and IM administration [17]. For these preparations some excipients might be needed, such as vehicles, co-solvents, preservatives (particularly in multi-dose preparations), antioxidants, surfactants, chelating agents, inert gases, and complexing agents, to improve or preserve their quality [5]. Thus, there are various categories of parenteral dosage forms such as injections, infusions, concentrates for injection or infusion, powders for injection or IV infusion, gels for injection, and implants [16]." from
Ferreira, Laura, et al. "Cyclodextrin-based delivery systems in parenteral formulations: A critical update review." European Journal of Pharmaceutics and Biopharmaceutics 178 (2022): 35-52.
Article Cyclodextrin-based delivery systems in parenteral formulatio...
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