Quality by Design (QbD)

Abstract Pharmaceutical continuous manufacturing provides the appropriate tools (e.g. the understanding of process dynamics and appropriate and adaptable control strategy) in order to deal with Quality-by-Design expectations and even to the future smart manufacturing described by…
Read More...

Traditional otic drug delivery methods lack controlled release capabilities, making reverse gelatination gels a promising alternative. Reverse gelatination gels are colloidal systems that transition from a sol to a gel phase at the target site, providing controlled drug release over an extended…
Read More...

Background: The ever-growing emergence of antibiotic resistance associated with tuberculosis (TB) has become a global challenge. In 2012, USFDA has given expedited approval to bedaquiline (BDQ), as a new treatment for drug-resistant TB in adults when no other viable options are available. BDQ is a…
Read More...

Rosacea is a multifactorial chronic inflammatory dermatosis characterized by flushing, nontransient erythema, papules and pustules, telangiectasia, and phymatous alterations accompanied by itching, burning, or stinging, the pathophysiology of which is not yet fully understood. Conventional topical…
Read More...

Developing amorphous solid dispersions with good flow properties is always challenging for formulation scientists to convert into tablets. Hence, the present study investigates the impact of the combination of melt-dispersion and surface-adsorption methods to prepare melt-dispersion granules with…
Read More...

Evolving therapeutic landscape through combinatorial chemistry and high throughput screening have resulted in an increased number of poorly soluble drugs. Drug delivery strategies quickly adapted to convert these drugs into successful therapies. Amorphous solid dispersion (ASD) technology is widely…
Read More...

For more than five decades, pharmaceutical manufacturers have been relying heavily on batch manufacturing that is a sequential, multistep, laborious, and time-consuming process. However, late advances in manufacturing technologies have prompted manufacturers to consider continuous manufacturing (CM)…
Read More...

Abstract Lactose is one of the most widespread excipients used in the pharmaceutical industry. Because of its water solubility and acceptable flowability, lactose is generally added into tablet formulation to improve wettability and undesirable flowability. Based on quality by design, a better…
Read More...

1. What is the design space? The design space (DS) is a multidimensional combination and interaction of input variables (e.g., properties of raw materials) and process parameters that have been proven to ensure the quality of drug products. Operation within the DS is not considered a change,…
Read More...

With the emergence of quality by design (QbD), it becomes imperative to gain understanding of the impact of batch-to-batch variability of raw materials on the performance of processes. Feeding is the first unit of operation in a continuous manufacturing line and is critical for the final product…
Read More...