SUPAC Guidance on Qualitative Changes The USFDA SUPAC (Scale-Up and Post-Approval Changes) guidance categorizes formulation changes based on their impact on product performance. A qualitative change refers to the replacement or removal of an excipient, classified as a Level 3 change, which is considered major and requires regulatory approval. Key Regulatory Requirements for Level 3…
A BE study may or may not be required, depending on several factors. Here’s a structured approach to determine whether regulatory agencies like the FDA or EMA would require a BE study for this type of qualitative formulation change: Regulatory Perspective on Excipients in Bioequivalence Regulatory agencies consider excipients when evaluating bioequivalence, especially when they…
Today, let’s dive into the intricate world of overcoming solubility challenges in drug formulation. Join me as we explore the hurdles posed by poor solubility and the ingenious strategies formulated by scientists to tackle this pervasive issue. Solubility Challenges Formulation Strategies Nanosuspensions: Solid Dispersions: Cyclodextrin Complexation: Overcoming solubility challenges is pivotal in developing effective therapies….
What is a Discriminatory Medium? A discriminatory medium in biopharmaceutical studies is a dissolution medium that can effectively differentiate between formulations based on their in vitro drug release characteristics. It is designed to highlight differences in formulation, process variables, or drug substance properties that may impact in vivo performance. Why is a Discriminatory Medium Important?…
In formulation development, diluents (or fillers) are often seen as passive ingredients, just there to add bulk, improve compressibility, or adjust dose uniformity. But what if I told you they play critical hidden roles that can make or break a formulation? Here’s a look at some surprising functionalities beyond their textbook definitions: Lactose isn’t just…
The formulation of biologics presents unique challenges due to their structural complexity and sensitivity to environmental conditions. This review explores critical aspects of biologic formulation, including stability considerations, excipient selection, and delivery systems. Additionally, biopharmaceutical factors such as absorption, distribution, metabolism, and excretion (ADME) of biologics are discussed. Recent advancements in formulation strategies, including novel…
