Formulation, Development and Evaluation of Intravenous Injection Containing Corticosteroid

Abstract

Corticosteroids are potent anti-inflammatory agents widely used in the treatment of various medical conditions. The formulation of an intravenous injection presents unique challenges in terms of stability, compatibility, and efficacy. The development process involves selecting appropriate excipients, optimizing the formulation to ensure solubility and stability, and determining the most suitable delivery system for efficient drug release. Evaluation of the intravenous injection includes assessing its physicochemical properties, compatibility with commonly used infusion solutions, and in vitro/in vivo performance. The Quality Target Product Profile (QTPP) was established to define the desired quality attributes of the intravenous injection, including the route of administration, dosage form, drug substance, and target product quality characteristics. Critical Quality Attributes (CQAs) were then identified, such as appearance, pH, osmolarity, sterility, and drug content, to ensure the product meets the specified quality requirements. The results of this study provide valuable insights into the design and optimization of intravenous corticosteroid formulations, with the potential to enhance therapeutic outcomes and patient safety. This research contributes to the advancement of pharmaceutical science and the development of effective intravenous drug delivery systems.