3) Particle Engineering & DS-DP Co-Processing Archives - Pharma Crystallization Summit

Spherical Cocrystallization of Pharmaceuticals

wpadm — Wed, 07 Sep 2022 00:05:18 +0000

By Prof. Changquan Calvin Sun, Pharmaceutical Materials Science and Engineering Laboratory, University of Minnesota

The development of a quality tablet product requires overcoming deficiencies in pharmaceutical properties of an active pharmaceutical ingredient (API) to meet several performance standards. APIs with poor aqueous solubility present a challenge in tablet development for meeting the desired dissolution performance to assure adequate bioavailability. If it can be adequately controlled for robust manufacturing performance, direct compression is preferred among common manufacturing processes, because of its economy. Cocrystallization is an effective crystal engineering approach for overcoming deficiencies of APIs, e.g., solubility, tabletability, and stability. Spherical crystallization is an established particle engineering technique for improving powder properties to enable direct compression. Spherical cocrystallization holds the potential to simultaneously improve both key pharmaceutical properties and powder properties to enable direction compression of tablets with both robust manufacturability and superior in vivo performance. In this talk, examples of spherical cocrystallization of APIs and their use in developing direct compression tablet formulations will be presented.

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Amorphous or Crystalline? Using Next Generation PAT to Track API Particle Attributes for Enhanced Downstream Processability

wpadm — Mon, 18 Jul 2022 02:26:34 +0000

By Richard Becker, BlazeMetrics

Process Analytical Technology (PAT) has dramatically expanded its capabilities over the last decade. Today’s PAT enables an in-depth understanding of process behavior on both macroscopic and molecular levels, allowing users to accurately track the impact of process variables on system behavior. Whether in a reactor, a continuous flow line, or a filter/dryer, kinetic mechanisms such as nucleation, growth, breakage, agglomeration, and “oiling out” play a major role in downstream drug product manufacturing. Using next generation PAT, these mechanisms are understood in real-time such that they can be related to final crystal morphology, surface, size, and structure, which ultimately drive downstream processability.

In this talk, I will review the enabling improvements to the PAT landscape as they relate to crystal manufacturing and provide examples of how those improvements deepen process understanding, speed process development and in some cases enable new paths to process optimization.

The post Amorphous or Crystalline? Using Next Generation PAT to Track API Particle Attributes for Enhanced Downstream Processability appeared first on Pharma Crystallization Summit.

Particle engineering by spray drying: process dev., scale-up, and technology transfer

wpadm — Mon, 18 Jul 2022 02:14:11 +0000

By Dr. Nima Yazdanpanah, Procegence

Drug substance isolation by crystallization and filtration and spray drying are last stages of the drug substance manufacturing process, where critical quality attributes (CQAs) and powder properties (such as flowability, stability, particle size distribution, and purity) were defined. These unit operations are scale depended and mixing and heat and mass transfer (scale dependent phenomena) could have significant impact on the CQA of product, performance of equipment, and also impact on downstream (drug product) and bioavailability. The manufacturing scale process development, technology transfer, and scale-up are challenging steps at the interface of R&D and manufacturing. The dynamic correlation of critical process parameters (CPPs) and CQAs should be defined for the design space development, control strategy, and CMC. Some notable examples for spray drying would be atomizer selection, flowrate and drying temperature optimization. However, developing the manufacturing scale process by just utilizing lab scale data could be misleading, or running DoE at that large scale is not efficient, especially when small amount of material available or time to the market is short.

At this presentation, some scale-up issues for spray drying will be discussed. Applications of in-silico tools (mathematical simulation) for rapid scale-up and process development and optimization, and challenges and benefits will be demonstrated with case studies.

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Control, is it achievable in amorphous or poorly crystalline peptide isolations?

wpadm — Sat, 16 Jul 2022 03:05:10 +0000

By Dr. Jeremy M. Merritt, Eli Lilly and Co. Abstract: pending

The post Control, is it achievable in amorphous or poorly crystalline peptide isolations? appeared first on Pharma Crystallization Summit.