Pharmaceutical Technology-09-01-2018

This article examines IVBE testing requirements for topical creams and explores some of the analytical techniques necessary.

The human skin protects the body from physical, mechanical, and chemical insults while preventing endogenous water loss. This function is predominantly achieved by a thin (10–30 µm) cornified outermost layer-the stratum corneum (SC)-generated through terminal differentiation of the basal epidermal keratinocytes. The stratum corneum protects the human body, but also severely limits drug delivery into and across the skin.

Thixotropic gels, thermosoftened systems, and self-emulsifying systems have expanded the range of potential excipients for liquid-filled hard capsules (LFHC).

API-in-capsule approaches enable pharmaceutical companies to quickly assess new drug candidates with reduced API consumption and to increase speed to clinic.

Immobilizing the antibodies on a solid-phase support, such as a resin, and carrying out the conjugation of the payload-linker while the antibodies are bound to that support will prevent aggregation at its source.

Commonly referred to as the future of advanced pharmaceutical manufacturing, continuous manufacturing has gained major traction in the past 10 years to enable significant improvements in efficiency, safety, cost, and speed to market.

Automated robotic arms manipulate nested trays and containers inside closed aseptic filling systems.

Increasingly stringent audit requirements will make third-party accredited GMP audits critical for pharmaceutical excipients and raw materials.

Sample preparation-specifically, API extraction and dilution-can introduce errors. Use of best practices and automation can reduce variability.

Click the title above to open the Pharmaceutical Technology 2018 APIs, Excipients, and Manufacturing Supplement in an interactive PDF format.