A Review of Process Validation of Hydrogel Formulation

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Hydrogels are a class of polymeric materials characterized by a hydrophilic structure that enables them to entrap substantial amounts of water in their 3D networks. Eventually, synthetic hydrogels superseded natural ones due to their superior water-absorbing capacity, longer product life, and greater availability of raw materials resources. Variations in the manufacturing process that occur are likely to have a substantial impact on the final product's characteristics. The conclusion drawn from such a comprehensive study of hydrogel in-process shortfalls offers a clearer and more realistic perspective when designing and developing new formulations. The primary goal of this review article is to provide a comprehensive literature review of the technologies used in hydrogel production, including the implications for process design and optimal conditions for preparation and process validation. As per a review of the literature, Hydrogels can adhere to an application surface for lengthy periods before being washed away. This property extends the duration of drug delivery at the application site. Due to their water-washable bases, innovative hydrogels are non-greasy. Therefore, they are superior to conventional hydrogel forms and cause less skin irritation. In addition to this review article, Process validation is an ongoing program, an essential part of GMP, and by aligning process validation operations with the product lifecycle, the pharmaceutical industry ensures that its processes are reliable and consistent over the whole duration of their commercialization.