Creation and Development of Promethazine (PT) Fast Dissolving Tablet Using Quality by Design Methodology

Abstract

Patients continue to choose the oral route for medicine delivery over other available dosage forms. According to the research, over half of patients will eventually favor oral disintegrating tablets (ODTs) over alternative solid oral dose forms. The oral route is the most favored for administering medication since it has several advantages over other routes. Patients get a variety of pharmacological therapeutic substances used in ODTs to spread their effects throughout the body. Because of the extremely high risk of aspiration and difficulty swallowing, ODTs are recommended for asthma patients. In addition to the restrictions listed above, it is ideal when the patient is on the go or has limited access to water. For the creation of ODTs, several patented and unpatented preparation techniques or technologies are available. Promethazine (PT), a first-generation H1 receptor antagonist, is a medication used to treat motion sickness that is also used as an antihistamine and antiemetic. Due to PT's 2.2-hour half-life and first-pass hepatic degradation, its 88 percent oral bioavailability has been decreased to 27%. As a result, efforts have been undertaken to create tablets that dissolve quickly using the direct compression technique. The tablets were created using the quality by design (QbD) method to successfully transfer technology. Nowadays, risk management for successful QbD has become essential for product approval as the FDA evaluates the execution and effectiveness of the procedure, formulation design as detailed in the application, and QbD.