Pharmaceutical Engineering & Drug Delivery

The aim of Process Analytical Technology (PAT) is to gain deeper insight in pharmaceutical manufacturing processes, replacing empirical approaches by knowledge-based procedures. A detailed understanding of the key parameters of a process and their impact on the product quality allows companies to “...

Solid dosage forms, such as tablets and capsules, have been predominately manufactured through batch processes in pharmaceutical industry for years. The development of continuous manufacturing processes is of high interest to the pharmaceutical industry to reduce the huge costs associated with...

Added by Shekhar Viswanath on behalf on John Peterson

This talk will focus on the use of advanced multivariate latent variable models to aid the accelerated development of the product and the process, as well as the incorporation of these models into a process improvement cycle at the manufacturing scale.

The melt-spray-congeal (MSC) process is a rotary atomization technique for the production of a multiparticulate pharmaceutical dosage form. The final drug product consists of a wax matrix microsphere with the active pharmaceutical ingredient (API) dispersed throughout. The drug is released from the...

The presentation will be focus on the approach for systematic development of oral suspensions. Suspension is a complex dosage form in which coarse dispersion in which insoluble solid particles (internal phase) is dispersed uniformly throughout the suspending medium (external phase). Strategies for...

In the pharmaceutical industry, dissolution testing is a critical step in quality control and a standard method for assessing batch-to-batch consistency of solid oral drug delivery systems, such as tablets. One of the most widely used dissolution test devices is the UPS Apparatus II (paddle). Even...

Quality by design is an essential part of the modern approach to pharmaceutical quality. But there is uncertainty in the generic drug industry about how the core concepts in ICH Q8(R1) will apply to development of generic drugs. FDA's Office of Generic Drugs has been revising its approaches to...

This presentation will cover how qualitative models can be used to capture and demonstrate process understanding and improve communication between disciplines, across geographical locations, languages and cultures both within, and between, organisations and regulators within a QbD framework. The...

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