Formulation Development and Evaluation of Highly Oxidative Degradative Drug Molecule Injectable Dosage form by Lyophilisation Techniques

Abstract

Adrenaline (ADR) It is lifesaving and is the only first-line drug for the treatment of anaphylaxis. Adrenaline (ADR) is the endogenous catecholamine with potent alpha- and beta-adrenergic stimulating properties. Alpha-adrenergic action increases systemic and pulmonary vascular resistance, increasing both systolic and diastolic blood pressure. Adrenaline is released in the bloodstream, which increases heartbeat, muscle strength, blood pressure, and glucose metabolism. Oxidation degradation of the medicinal product is the main route of degradation. Affects chemical and physical changes in drugs during the formulation development process. Physicochemical changes in the product can affect both the safety and efficacy of the drug product. Main product development strategy to develop, a stable, freeze-dried product of epinephrine for injection. The stability of adrenaline injection is of paramount objective as it is classified as a catechol compound that is sensitive to oxidation to o-quinone and therefore can react further to form highly colored compounds. Adrenergic drugs further react to form adrenochrome, a highly colored indole derivative. The rate of this reaction increased with pH, temperature and presence of the metal ions. Aqueous solutions of adrenergic agonists decompose rapidly when exposed to air, light, or heat, turning pink due to oxidation to adrenochrome and brown due to melanin formation. Due to its strong oxidizing properties and easy decomposition in aqueous solutions. To achieve this, the aqueous solutions of adrenergic agonists decompose rapidly when exposed to air, light, or heat, turning pink due to oxidation to adrenochrome and brown due to melanin formation. Due to its strong oxidizing properties and easy decomposition in aqueous solutions.