Pharmaceutical Technology September 2017

September 2017 | Volume 2017 Supplement, Issue 4
Pharmaceutical Technology 2017 Issue APIs, Excipients, and Manufacturing Supplement
Pulmonary drug delivery is becoming increasingly used. When developing pulmonary drugs, pharmaceutical chemists must consider drug absorption, control of particle size, suitable toxicology models, and patient compliance. The author reviews the issues specific to developing drugs designed for pulmonary delivery and considers how—with the right knowledge and expertise—these challenges can be overcome.
Informatics software can be used to address the challenges of quality by design, such as managing impurity data when developing an impurity control strategy.
Functionalized calcium carbonate provides high porosity, which enables fast disintegration, and excellent compactibility that results in harder tablets at low compression forces.
Innovative new technologies released over the past several months seek to enhance bio/pharmaceutical development and manufacturing. 
Implementing quality by design in product design and formulation and manufacturing workflows can help improve efficiency and shorten development times.
While cold-form, foil-foil (aluminumaluminum) blister packaging is considered the most moisture-protective packaging available, in fact, plastic containers such as bottles and tubes, when combined with desiccants, such as silica gel canisters and packets, will often provide lower internal relative humidity for long time periods.
Regulatory outsourcing can result in improved compliance, greater transparency, higher productivity, increased cost-effectiveness, and desired strategic outcomes.
The industry needs a single standard cleaning limit at 25 mg/m2.
QbD principles and strategic thinking can reduce the time required to optimize formulation. 
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