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End Point Determination and Scale-up of Fluid Bed Coating Through the Use of Process Analytical Tools

In this presentation, experts will demonstrate a systematic approach to development, implementing quality-by-design principles to link critical process parameters to the spray-layered dispersion potency for a fluid bed coating process.
Authors: Daniel Kuntz, Erin Hyde
Publish Date: 11-Nov-2020

Methanol-assisted Secondary Drying to Accelerate Residual Solvent Removal in Spray-dried Polymers

Drug candidates with low aqueous solubility require bioavailability enhancement techniques to enable oral delivery. Spray drying has been used to manufacture amorphous solid dispersions with enhanced oral bioavailability, resulting in over a dozen commercial products and many more in clinical trials. After spray drying is used to convert a liquid feed to a solid powder, residual solvent remains in the product, which must be removed to meet ICH safety specifications. The process of residual solvent removal is called secondary drying. Typical secondary drying techniques, such as drying in the presence of water vapor or vacuum drying often suffice. Some spray-dried materials are more challenging, requiring 24 hours or longer to secondary dry at typical conditions. This work introduces methanol-assisted secondary drying, a technique which can be used to accelerate residual solvent removal from spray-dried products.
Authors: Dr. Kimberly Shepard
Publish Date: 05-Nov-2020

Encapsulating Low Viscosity Products Using Liquid Filling and Banding Technology

Coni-Snap® capsule shells have been used routinely for banding liquid filled capsules. Due to the venting system, very low viscosity materials are likely to leak from the capsules following filling and preceding banding. This can cause poor band adherence and affect processing time and product yield. In order to overcome this, thixotropic agents are added to formulations to reduce leaking, which may lead to dissolution and potential bioavailability changes. Licaps® capsule shells have been designed for liquid encapsulation micro spray sealing (LEMS®) sealing applications. The newly designed Licaps® capsules dual ring system is designed to provide a double barrier between the capsule contents and seal zone. Based on the locking ring system, it was therefore anticipated that the new design capsule may also be beneficial in capsule banding. To learn more, download our poster.
Authors: Dr. Jenifer Mains
Publish Date: 05-Nov-2020

Case Study: Application of Colorista® Capsules for Rapid Product Development with Proof of Concept Data

The objective of this study was to design the most suitable solid oral delivery system with an acceptable shelf life at room temperature or at refrigerated conditions. This study was initiated with an extensive excipient compatibility study using pharmaceutical excipients and stabilizers, followed by a blend stability study, a manufacturing process and dosage form selection study, and an accelerated stability study using the final formulation in Colorista® capsules. To learn more, download our poster.
Authors: Namrata Vora
Publish Date: 05-Nov-2020

Modeling the Impact of Amorphous Drug-Polymer Colloids on the Absorption of Poorly Water Soluble Drugs

Formulation of amorphous solid dispersions, as means to improve absorption for poorly water soluble drugs, has proven to be a reliable and effective approach. In assessing how these formulations perform in vivo, it has been observed that they can dissolve into multiple species in biorelevant media. These species can be supersaturated free drug, drug partitioned into bile salt micelles and amorphous drug-polymer colloids, as well as precipitated amorphous or crystalline drug. Here, the impact of amorphous drug-polymer colloids on the absorption of several water insoluble drugs is modeled based on a modified permeability equation that takes these nano-sized colloids into account. The model simulations are compared to three literature in vivo studies, as well as the simulation for those using the standard permeability calculation. To learn more, download our poster.
Authors: Aaron Stewart
Publish Date: 05-Nov-2020

A Hierarchical Mass Transfer Model for Drug Particle Dissolution

Dissolution tends to be the rate-limiting step in oral delivery of poorly soluble, highly permeable solid dosage forms. Drug properties that can be rate-controlling in the dissolution process are intrinsic solubility, pKa, particle size and polydispersity, particle shape, and acid/base character. In addition to drug properties, physiological parameters such as the buffer type and concentration, bulk pH, fluid volume, and hydrodynamic conditions play a role in drug dissolution both under in vivo and in vitro conditions. Understanding the critical factors in drug dissolution under in vitro and in vivo conditions facilitates the development of in vitro predictive dissolution methodologies that can simulate the in vivo drug dissolution. To learn more, download our poster.
Authors: Dr. Deanna Mudie
Publish Date: 05-Nov-2020

Rapid Fire Presentation: Measuring Lipolytic Activity in Biologics Drug Substance and Drug Product

Polysorbate degradation is discussed being oxidatively and hydrolytically, via lipolytic activity of enzymes (Lipases) in HCP. We developed an analytical assay to detect and measure lipolytic activity in biopharmaceutical partly purified DS, drug substance (DS) and drug product (DP). The assay was optimized by variation of key parameters. The assay can support the optimization of the downstream purification process in order to remove HCPs with lipolytic activity. Furthermore it can be used to measure lipolytic activity in DS / DP samples and support root cause investigations related to polysorbate degradation. To learn more, download our rapid-fire presentation.
Authors: Andreas Zerr
Publish Date: 03-Nov-2020

Rapid Fire Presentation: in vivo Protein Stability - What Happens After Administration?

Knowledge of the stability of therapeutic proteins in vivo, or after administration to patients, is limited. This talk explains the relevance of in vitro studies to assess the stability of therapeutic proteins under simulating physiologic conditions. in vivo degradation of a therapeutic protein may alter treatment efficacy and/or patient safety. Moreover, in vitro studies can support the selection of better molecules in early stages of pharmaceutical development. In our study, we compared the physical stability of 8 different monoclonal antibodies (mAbs) in phosphate-buffered saline (PBS) and human serum. mAbs were characterized with respect to fragmentation, aggregation, and proteinaceous particle formation. To learn more, download our rapid fire presentation. 
Authors: Joachim Schuster
Publish Date: 02-Nov-2020

Rapid Fire Presentation: Polysorbate in Biologics – Understanding Degradation by Applying Proper Analytics

Polysorbates are excipients in biopharmaceutical formulations that protect the therapeutic proteins from interfacial stress. The biopharmaceutical industry currently phases a problem due to observed degradation - oxidatively and hydrolytically - of polysorbate in drug product formulations, leading to increased formation of sub-visible and visible particles and to a potential loss of protecting propensity of the surfactant. Interestingly, mitigation of the effects observed in drug product often can be provided already during drug substance manufacturing and compounding. However, a proper analytical toolbox is necessary to spot polysorbate degradation at an early stage and to differentiate the degradation mechanisms. In this work, we present an optimized analytical toolbox to control polysorbate quantity and quality. Additionally we present analytical strategies to be applied for root cause investigations once polysorbate degradation is observed. To learn more, download our presentation.
Authors: Dr. Michael Jahn
Publish Date: 02-Nov-2020

Rapid Fire Presentation: Processing Low Viscosity Products Using Liquid Filling and Banding Technology

Alongside the ability to formulate and deliver challenging poorly aqueous soluble APIs, liquid-filled capsule-based systems have a number of advantages. Lipid-based formulations can be formulated and manufactured in soft gel capsules or hard capsule shells. When developing a liquid-filled hard capsule, capsule selection is fundamental and needs to be assessed early on in the process, with a view to scale up to be performed. When enhancing bioavailability with lipid-based systems, a number of oils and surfactants are employed and often these materials are of low viscosity. This rapid fire presentation focuses on the processing of such oils and scale up considerations.
Authors: Dr. Jenifer Mains
Publish Date: 29-Oct-2020