20. August 2018
Material properties are known to have a significant impact on pharmaceutical manufacturing performance, particularly for solid product processes. Evaluating the performance of a specific material, for example an active pharmaceutical ingredient or excipient, is critical during development stages in order to determine the impact of material properties on the process. However, materials may be scarce during the early stages of process development due to high cost, unavailability, import...

20. August 2018
Based on characterization of a wide range of fillers and APIs, thirty divergent blends were composed and subsequently compressed on a rotary tablet press, varying paddle speed and turret speed. The tablet weight variability was determined of 20 grab samples consisting of each 20 tablets. Additionally, the bulk residence time, ejection force, pre-compression displacement, main compression force, die fill fraction and feed frame fill fraction were determined during each run. Multivariate data...

19. August 2018
The staff of the FDA’s Center for Drug Evaluation and Research (CDER) always tries to utilize cutting-edge science and up-to-date process management, befitting our stature as the global “gold standard” in drug regulation. Maintaining that standard requires us to keep up with evolving technology and the latest scientific, medical and regulatory advances. Current factors impacting drug development include the genomic revolution, the rise of targeted therapy, the availability of digital...

18. August 2018
In contrast to classic single-unit dosage forms such as tablets, the dosage of the drug substance in multi-particulate systems is divided on a plurality of subunits – typically consisting of thousands of spherical pellet particles with a diameter of between 100 and 2,000 μm. This means that non-disintegrating, monolithic single-unit forms retain their structure in the digestive tract, whereas the multi-particular preparations consist of numerous sub-units which disperse after administration....

18. August 2018
Older adults with multimorbidity, polypharmacy, and complex health needs are the major consumer of health care. Ensuring that medicines are used safely, effectively, and delivered efficiently in this population is challenging. In this context, the approach to medicines delivery should seek to overcome some of the difficulties of delivering medicines to older people, and ensure each medication is delivered by the optimal and most convenient route for the patient in question. However, this poses...

18. August 2018
The development of oral dosage forms for poorly water-soluble active pharmaceutical ingredients (APIs) is a persistent challenge. A range of methods has been explored to address this issue, and amorphous solid dispersions (ASDs) have received increasing attention. ASDs are typically prepared by starting with a liquid precursor (a solution or melt) and applying energy for solidification. Many techniques can be used, with the emergence of electrospinning as a potent option in recent years. This...

17. August 2018
In current study a holistic material characterization approach was proposed and an extensive raw material property database was developed including a wide variety of APIs and excipients with different functionalities. In total 55 different materials were characterized and described by over 100 raw material descriptors related to particle size and shape distribution, specific surface area, bulk, tapped and true density, compressibility, electrostatic charge, moisture content, hygroscopicity,...

17. August 2018
In continuous manufacturing of solid dosage forms, continued assurance of process performance and product quality is based on accurate and consistent flow of solid materials. Acknowledging the multidimensionality of material flow properties is often the first step to explore the material knowledge space.

17. August 2018
This webinar explores how the choice of excipients can improve API stability in a solid dosage drug formulation. Abstract Many factors in a drug formulation can have a negative effect on the stability of the API, which can result in a reduced shelf life, less effective medicinal effect on the patient, or in the worst cases, harm to a patient. API stability can be negatively affected by various factors, including excipients. This webinar explores how the choice of excipients can improve API...

17. August 2018
At the BASF Solubilization Symposium Dr. Frank Romanski speaks about poorly water-soluble drugs, solubilization techniques, lipid complexity and the need for surfactants.

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