Pharmaceutical Engineering & Drug Delivery

Inhalation Powders have become an important dosage form in developing products for delivery to the lungs. Since the approval of the first DPI in the US in the late 1990’s there has been a rapid surge in the number of drug development programs involving Dry Powder Inhalers. The draft MDI/DPI...

The development of fundamental models for fed-batch pharmaceutical processes range from very challenging to almost impossible as not all the inner workings of the process are quantitatively known. Thus, the accurate calculation of the Design Space in which the process will be operated is a...

Quality by Design principles are well established in the pharmaceutical industry. It is becoming common place to develop the design space for a drug product and include it in the regulatory filing. There are a broad range of methods to establish design space, some of which are focused on individual...

The Food and Drug Administration requires from pharmaceutical companies the development of extensive knowledge databases regarding the control of the manufacturing process of a drug product. Through development and validation, drug manufacturers discover their process boundaries and identify a...

Tablet coating is an important processing step in the pharmaceutical industry in which tablets are coated with an aqueous or organic film coating for both aesthetic and functional reasons. Mathematical models of tablet film coating are important in pharmaceutical development as they aid in design...

Summary Developing products comprising un-bound fine cohesive powders throws up significant challenges. Dry powder inhalers present a prime example. Why? Because the behaviour of fine cohesive particle behaviour is notoriously complex, and notably more so than any single phase solid, liquid or...

In the Quality by Design (QbD) framework, there is a significant emphasis on the robust characterization of manufacturing processes and prospectively identifying the engineering design space that ensures product quality. Although the QbD approach is expected to bring about significant long-term...

In accordance with ICH Q8/9/10 and the FDA QbD initiative, companies are adding more and more PAT equipment, installing more sophisticated control systems, and moving to real-time release. Throughout this process, many questions have come to light. How is PAT justified for controlling quality...

Modified release dosage forms (MRDFs) can be designed and manufactured in various shapes and structures using different materials. Depending on the design, formulation and properties of drug and excipients (e.g. polymers), drug release from MRDFs can undergo varying mechanisms. In addition, the...

In the development of wet granulated drug products, two primary sources of variance (disturbance) include the operational scale of the high shear wet granulation (HSWG) process and Active Pharmaceutical Ingredient (API) lot-to-lot variability, particularly for formulations containing a high drug...