The issue of controlling genotoxic impurities in novel active pharmaceutical ingredients
(APIs) is a significant challenge. Much of the current regulatory concern, has been focused …

Revised to reflect modern pharmaceutical compacting techniques, this Second Edition
explores compaction of powder constituents (both active ingredient and excipients) and …

The pharmaceutical formulation process is a highly specialized task requiring specific
domain knowledge and often years of experience. Knowledge-based systems, expert …

Developing pharmaceutical product formulation in a timely manner and ensuring quality is a
complex process that requires a systematic, science-based approach. Information from …

The purpose of this article was to build an expert system for the development and
formulation of push–pull osmotic pump tablets (PPOP). Hundreds of PPOP formulations …

It is axiomatic that the physicochemical properties of candidate drugs can influence their
subsequent development. The results of characterization studies carried out will influence …

Preformulation studies are the physical, chemical, and biological studies needed to
characterize a drug substance for enabling the proper design of a drug product, whereas the …

The major objective of product optimization is to ensure that the product selected for further
development (the intended commercial product) is fully optimized and complies with the …

A lot of mathematical and statistical calculations are involved in optimization of
pharmaceutical formulations. Computations involving correlating variables with responses …

Before a new drug can be released on the market, it must be formulated to produce a quality
product that is acceptable to both regulatory bodies and patients and can be manufactured …