Session 1: Smarter Solid State Research by Prediction and Simulation
Locality, Strength, and Hierarchy of Intermolecular Interactions in Crystallization
Self-assembling of molecules in crystallization is collectively driven by intermolecular interactions among the solute and solvent. Better understanding of nucleation mechanism may be perceived in light of the locality, strength, and hierarchy of intermolecular interactions.
Pharmaceutical Crystallization Support by Computational Approaches
Given challenges facing the pharmaceutical industry, an accelerated Drug Development greatly benefits from guidance provided by computational methods.1 This presentation will focus on computational support of the following important tasks related to the pharmaceutical crystallization.
Computation Assisted Solvent Selection in Crystal Form Investigation
Rational selection of solvents plays a critical role in solid form screening and production. On the one hand, a variety of solvents with different properties are chosen in form screening to maximize the screening space of searching for all potential solid forms because some solvents selectively favor the generation of a particular form as a result of crystallization kinetics.
Session 2: Physical Property Based Crystallization Process Development
The Crystallisation Structural Pathway of Para Amino Benzoic acid: From Solvated Molecule through Solute Clustering and Nucleation to the Growth of Facetted Crystals
In solution phase crystallisation processes, understanding and controlling the transition pathway associated with the assembly of molecules from their solvated state, into three-dimensional, ordered crystalline-solids, represents a significant grand challenge for the physical-chemical sciences. Crystallisation can be sub-divided into three-dimensional nucleation and two-dimensional, surface-mediated, crystal growth stages.
Facilitating DS/DP development through integrated solid-state and crystallization development
Crystallization is an important and economic unit operation for the purification of pharmaceutical API. It also serves as the key step to define the required quality attribute of the API (e.g. solid form, particle size distribution) that would impact the subsequent processing (e.g. filtration, drying, milling) and drug product performance (e.g. dissolution, content uniformity). To successfully bring a compound into the market, an integrated approach to link the development of API solid form, isolation and dosage form is essential to ensure the robust delivery of the desired drug product quality, throughout the scale.
A Challenging Path to Controlled Nano-API Crystallization and Isolation
Controlled crystallization of an API in submicron size was enabled based on an accurate solubility profile and a growth inhibition property via semi-continuous processing, to meet special formulation requirements. This process was also challenged by isolation of nano-API crystals to meet the low specification of residual salt content.
Session 3: Particle Engineering and DS-DP Co-Processing
Particle Surface Engineering for Predictive Enhancement of API Properties
Particle surface engineering is a cost-effective, promising route to achieve enhancements in the flowability, bulk density and other properties of a variety of cohesive active pharmaceutical ingredients (APIs). This presentation will discuss predictive enhancements after dry coating based particle surface engineering and discuss models and guidelines for the selection of flow aid type and amount, as well as predicting powder bulk properties from their particle-scale properties such as the particle size and distribution, materials density, surface energy, and surface roughness.
Co-processing: An Effective Particle Engineering Approach for Drug Substances
Dr. Deniz Erdemir, Principal Scientist Bristol Myers Squibb, New Brunswick/New Jersey Abstract coming soon
Drug Particle Engineering Using Microfluidic Emulsion-based Crystallization
This paper will present an overview of recent progress towards single-step fabrication of pharmaceutical drug-excipient microparticles through microfluidic emulsion-based processing. In the pharmaceutical industry, active pharmaceutical ingredients typically undergo a series of secondary manufacturing operations, such as crystallization and formulation with additives and excipients, to obtain drug products of varying types, such as orally ingestible tablets or injectables.
Session 4: Partnering for Addressing Challenges of Today & the Future
Partnering for Addressing API Crystallization Engineering Challenges of Today and the Future
In light of the balancing act among quality, speed, and cost, collaborative partnering between pharmaceutical companies and contract research/manufacturing organizations is becoming increasingly important in meeting our goals of delivering high quality APIs and drug products to patients. This talk will summarize the challenges the pharmaceutical industry is facing today and will continue to face in the future in the area of API crystallization engineering and manufacturing.
Integrative Approaches to Addressing Canonical Problems in Pharmaceutical Crystallization
Problems associated with polymorphic instability and increasingly insoluble drug candidates represent white space to innovate novel forms and processing methods with better properties in the drug product. But the journey from identifying new solid forms to creating engineered particles with optimal formulation properties has often been too inefficient to realize this goal.
Addressing Bottleneck Problems in Crystallization R&D for New Drug Development
Diverse crystallization challenges encountered by CfPC (Center for Pharma Crystallization) and our clients will be analyzed systematically to provide insights into main bottleneck problems in today’s drug development programs.