Formulation

CDMOs have established strategies for handling new chemical entities with unknown biological activity.

Applying the right formulation strategies early in the drug development process can help avoid costly late-stage failures.

EMA and FDA guidance encourages design of drug products to improve patient compliance.

Considerations in selecting a dosage form for drug delivery to the lungs.

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.

Implementing quality by design in product design and formulation and manufacturing workflows can help improve efficiency and shorten development times.

QbD principles and strategic thinking can reduce the time required to optimize formulation. 

The generic pharmaceuticals firm has sold its Baddi, India formulations manufacturing facility following a recent fire at its joint-venture plant in Algeria.

Lonza further expands its micronization services with the acquisition of Swiss contract manufacturer, Micro-Macinazione, following its previous $5.5-billion acquisition of dosage form provider, Capsugel.

Safe and effective drug targeting with ADCs requires careful selection of drug, antibody, and linker. 

Safe and effective drug targeting with ADCs requires careful selection of drug, antibody, and linker.

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.

Pfizer’s new format of ibuprofen (AdvilR Liqui-GelsR Minis) uses Catalent’s softgel technology to deliver the formulation in a more concentrated fill, resulting in smaller capsules.

After FDA found a “significant shift in the route of abuse,” Endo voluntarily removes OPANA ER from the market.

Poly(lactide-glycolide) has been used for drug-delivery applications because of its beneficial physicochemical properties, long safety record, and reliable commercial supply.

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

New ADC therapies must overcome manufacturing challenges to reach market.

The more pharma science and technology change, the more business and policy concerns stay the same.

Drug costs, biosimilars, and cloud-based technologies will shape the pharmaceutical industry in the years to come.

Pharma’s test of continuous manufacturing is starting with oral solid-dosage forms.

The United Kingdom’s Center for Process Innovation (CPI) is investing in a new project, Microstar, which seeks to reduce risk for formulators through the development of accelerated screening methods for predictive design.

Industry experts discuss best practices for dissolution testing of poorly soluble, immediate-release, and controlled-release formulations and the different analytical approaches used.

Modern air jet milling can be used to investigate the feasibility of micronization as a solubilization approach in formulation development.

Efficient synthesis of complex cannabinoids is possible while avoiding marijuana cultivation.

Prefilled dual-chamber cartridges offer several advantages. Several steps should be taken to determine if a dual-chamber system is viable for a lyophilized injectable drug product.

Transdermal and inhaled/nasal delivery provide alternative routes of administration for macromolecules.

In implementing quality by design for drug formulation, it is crucial to identify the critical properties of excipients and understand how their variation affects the final drug product.

Carglumic acid is used in the management of rare, life-threatening inborn metabolic disorders affecting the urea cycle.

Design of experiment plays a crucial role in the optimization process of formulation development.

Interpretation of calorimetric data is tricky. The author suggests 10 questions that should be asked of any calorimetric method, along with the rationales behind them.