APIs and Excipients

The author provides a direction for identifying genotoxic impurities early in the drug development process, regulating genotoxic impurities at acceptable levels in the API or drug product, and avoiding negative product regulation late in the development and/or marketing process, including expensive recalls.

Technological advancements can address the formulation and dissolution challenges of HPMC polymers.

In this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.

EMA plans to issue new guidance, as US and European regulators respond to reports of nitrosamine contamination in H2 blockers, including Zantac, that contain rantidine.

Regulatory bodies are taking a more stringent approach to excipient quality, but unlike guidance on GMP for APIs, those for excipients offer a framework only, meaning the onus lies with the manufacturer or supplier.

Innovation in manufacturing technologies must occur to ensure the availability of gene therapies and cell therapies.

While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.

A design strategy can ensure conflicting properties are managed appropriately for multi-API controlled-release formulations.

Rapid change towards industry developing and manufacturing niche APIs is leading to smaller-scale facilities that offer higher containment and flexibility.

Pharmaceutical Technology spoke with Anil Kane, executive director, global science and technology, pharmaceutical development services, at Thermo Fisher Scientific about the industry’s need for more capacity in the manufacture of highly potent APIs.

Does the pharmaceutical industry have adequate access to contained equipment, facilities, and infrastructure for the manufacture of highly potent APIs?

Nanotechnology is enabling enhanced bioavailability, improved stability, and targeted delivery of challenging APIs.

Excipients and new processing techniques can make a real difference in the development of highly potent therapies.

Automated candle and pressure-plate filtration equipment for removing catalyst residues from API slurries are operated in a closed system.

Confidence in the quality systems and scientific competence of the API manufacturing team is essential.

Understanding the API, delivery mechanism, and excipient functionality is essential to solving drug solubility challenges.

In a deal worth $530 million, the companies will develop and commercialize an anti-epileptic drug candidate in Europe.

New platform technologies, advanced modeling tools, and addressing patient needs are important developments.

Orphan and cancer drugs continue to lead, but treatments for many common diseases were also approved in 2018.

Antibody-based drugs offer new mechanisms of action and greater specificity.

Demand for highly potent APIs continues to rise.

Integration of new modeling and analytical tools with flow chemistry are notable trends.

Existing software tools cannot take into account the complexity of disease.

Low-temperature chemistry enables performance of more challenging and selective chemistry.

With the right excipients, formulators can control when, where, and how an API is released.

From separation systems to reactor technology, new tools are increasing the feasibility of continuous API production.

Bioprocess understanding, the right equipment, and automation help, but multifunctional teamwork is the key to API production success.

CMOs/CDMOs that are easy to work with, have demonstrated performance track records, and plan for the future are preferred.

Highly complex APIs developed to treat rare and orphan diseases present big technical questions for contract developers.

Regulations and industry guidelines focus on ensuring excipient safety by specifying risk assessments and shared responsibility.