Deficiencies in Traditional Oral Dosage Forms and the Emergence of Controlled-Release Powder Manufacturing

Abstract

The importance of providing safe and effective delayed- and extended-release oral formulations that can replace products requiring multiple administrations has been continually cited as an area in need of improvement for pharmaceutical companies. Such controlled release challenges become especially critical when they must be adapted for paediatrics, those suffering from dysphagia, or patients with specific dosage administration limitations. More often than not, lack of palatability and taste-masking compound this formulation challenge. Many particulate approaches show promise, but can be fraught with broad particle size distributions, initial drug burst, poor drug entrapment efficiency, low drug loading, and limited scalability. Here, we summarize the key factors that drive formulation development of format-flexible controlled-release oral powders, and the manufacturing aspects involved with some of the foremost marketed products, including next-generation single-step layered powder manufacturing (below).