Manufacturing, Solid and Semi-Solid Dosage Drugs

This article presents considerations for preventing hazards associated with dust in pharmaceutical production, particularly as relates to the United Kingdom's Control of Substances Hazardous to Health (COSHH) Regulations.

Tableting instruments (i.e., compaction simulators) that simulate high-speed presses can be used in a quality-by-design (QbD) approach to perform in-depth material characterization and direct scale-up.

FDA approves Vertex's cystic fibrosis drug, Symdeko (tezacaftor/ivacaftor and ivacaftor), which is made using a continuous manufacturing process.

A systematic framework and software are needed to implement material traceability in continuous pharmaceutical tablet manufacturing.

New technologies, such as NIR and Raman, enable online measurements of blending and content uniformity in the production of solid dosage forms.

Colorcon's Opadry SGR, Rapid Sugar Film Coating System, is an aqueous, high-gloss sugar film coating system for pharmaceutical products.

Industry lessons from a fast-track technology transfer of a soft-gelatin capsule (softgel) are multifold. This case study reviews the success factors for effective execution of the technology transfer, which include: strong relationship between the customer, the contract development and manufacturing organization, and other partners based on deep knowledge in the technology; established and proven quality-by-design processes; risk mitigation management; project leadership; flawless execution; and mutual trust.

The company completed its oral solid dose production facility in Suzhou, China.

In Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets.

Fette Compacting and Glatt have joined forces to develop integrated solutions for the continuous manufacturing of oral solid-dosage drug forms.

As part of Recipharm’s ongoing initiative to improve profitability and competitiveness, a decision has been made to end operations in Stockholm and Höganäs.

Experts from Colorcon share insights on how manufacturers can play a role in minimizing the risk of medication errors by ensuring that the medicines they develop are well differentiated, especially between dosages of the same product.

The shift toward continuous manufacturing among European pharmaceutical manufacturers has not been accompanied by a similar strong increase in the use of automation and sensor-based on-line monitoring.

In Part I of this article series, the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies is investigated, and an improved approach is suggested.

Eli Lilly was awarded the 2017 FOYA Overall Winner for its continuous direct compression manufacturing installation projects.

The company has passed inspection by the UK Medicines and Healthcare products Regulatory Agency, and is now licensed to develop, manufacture, and pack non-potent and potent solid oral drug products at its site in Loughborough, England.

The partnership and the formation of the institute intend to bring together industry, academia, and regulators to tackle challenges and provide solutions for continuous manufacturing.

Clariant’s Tri-Sorb Desiccant Tablets are designed for USP moisture testing of blister packs.

Support from FDA, a best practice guide, collaborative research, and new facilities signify progress in solid-dosage continuous manufacturing.

The Portable, Continuous, Miniature, and Modular (PCMM) collaboration is alive and well, and the second generation of its modular continuous manufacturing equipment is now available.

Recro Gainsville expands its tableting capacity with the addition of a tablet press and film coater.

Oral solid-dosage and parenteral drug manufacturing equipment and systems have made great strides in safety and efficiency.

Anil Kane, executive director, Global Head of Technical & Scientific Affairs at Patheon, shared his perspective of changes to solid-dosage pharmaceutical manufacturing.

Tablet coating from DISONA can handle batch sizes up to 3 kg.

Materials and equipment innovations have advanced tablet coating from sugar to copolymers and simplified pharma production.