Simulated Biological Fluids with Possible Application in Dissolution Testing

Abstract

This literature review is a compilation of the composition and, in most cases, the preparation instructions for simulated biological fluids that may be used as dissolution media in the evaluation of dissolution profiles and amount of drug released from pharmaceutical dosage forms.The use of simulated biological fluids can give a better understanding of the release mechanisms and possible in vivo behavior of a product and enhance the predictive capability of the dissolution testing.A summary of the major characteristics of the most used routes of administration that may affect dissolution and absorption of drug substances is presented.The routes and simulated biological fluids covered by this review are:• Parenteral: simulated body fluid and simulated synovial fluid.• Oral: fasted-state simulated gastric fluid, fed-state simulated gastric fluid, fasted-state simulated intestinal fluid, fed-state simulated intestinal fluid, simulated colonic fluid, fasted-state simulated colonic fluid, and fed-state simulated colonic fluid.• Buccal and sublingual: simulated saliva.• Pulmonary: simulated lung fluid.• Vaginal: simulated vaginal fluid and simulated semen.• Ophthalmic: simulated tears.Simulated sweat is also included.Some examples of how these simulated biological fluids are used to evaluate dosage forms are included in each route of administration.