Pharmaceutical Engineering & Drug Delivery

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...

An asymmetric membrane (AM) tablet was developed for a soluble model compound to study the in vitro drug release mechanisms in challenge conditions, including osmotic gradients, concentration gradients, and under potential coating failure modes. Porous, semipermable membrane integrity may be...

Multiple proposals are found in literature to analyze the impact of raw materials onto product using data analysis. From the methods proposed, the L-PLS is the only method that not only considers the ratio in which ingredients are mixed, but also the physical properties of the lots of raw material...

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...

The Office of Generic Drugs ensures the therapeutic equivalence and quality of generic drug products. This is based principally upon a regulatory paradigm that requires pharmaceutically equivalent drug products containing the same active ingredient, dosage form, and strength (among other things),...

The challenge of transferring a process monitoring model across different scales is a different problem than the one addressed in previous studies that have focused on transferring operating procedures looking to produce the same grade of product [1, 2, 3, 4]. In the development of a new...

There has been an increase in science and risk-based approaches under the Quality by Design paradigm in new drug submissions to the FDA. There are particular challenges for generic drug manufacturers with respect to using QbD approaches, especially with more complex dosage forms, such as modified...

Xylitol is a five-carbon sugar alcohol and has been used as a sugar substitute in the food industry because of its low caloric and anti-carcinogenic characteristics. In addition, xylitol is a building block for a variety of commodity chemicals. Biological routes for producing xylitol from...

Metabolic engineering has evolved to the point of fulfilling the dream of having our industrial chemicals produced renewably. Carboxylic acids (e.g., short chain fatty acids (SCFAs) such as octanoic acid (C8)) are one such chemical intermediate that can be produced with Escherichia coli engineered...

QbD is a systematic approach to pharmaceutical development and product lifecyclemanagement. QbD provides new opportunities and modern tools to utilize in analytical research and development. ICH guidelines and implementation strategies focused mainly on formulation and manufacturing design and...