A key principle of developing a new medicine is that quality should be built in, with a thorough understanding of the product and the manufacturing process supported by appropriate process controls. Quality by design principles that have…

Tablets can be manufactured using a rotary tablet press, which consists of a feed frame followed by the compression and compaction of the powder and subsequent ejection of the tablets. From Quality by Design (QbD) perspectives the feed…

Recombinant proteins are large and complex molecules, whose therapeutic activity highly depends on their structure. Formulation of biopharmaceuticals aims at stabilizing protein conformation, promoting its efficacy, and preventing safety…

The developments in pharmaceutical excipient science and technology since 1995 have been reviewed. The field of excipients science and technology has changed and continues to change. Some good progress has been made in such areas as…

Curcumin is a natural product with chemopreventive and other properties that are potentially useful in treating skin diseases, including psoriasis and melanoma. However, because of the excellent barrier function of the stratum corneum…

The study focused on the fluid-bed granulation process of a product with two active pharmaceutical ingredients, intended for coated tablets preparation and further transfer to industrial scale. The work aimed to prove that an accurate…

The pharmaceutical development of amorphous solid dispersions (ASDs) by hot-melt extrusion (HME) is briefly reviewed. A systematic step-by-step approach is presented, where thermodynamics, polymer screening, multivariate statistics and…

Microcrystalline Cellulose (MCC) has been used as a pharmaceutical excipient for many years, due to its abundance, ease of production and resistance to degradation.  As with any excipient, however, variability between batches of supplied…

Wet granulation is one of the most important unit operations in the production of pharmaceutical dosage forms. This chapter describes various wet granulation methodologies, with major focus on high-shear wet granulation (HSWG) and…

Quality by design (QbD) is a scientific and risk-based approach applicable throughout the product development process. The QbD principles are outlined in the ICH guidelines (Q8, Q9, and Q10) and are aimed at establishing a systematic…