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in vivo-predictive in vitro Methods for Characterizing Amorphous Solid Dispersions

A significant fraction of pharma and biotech pipelines are comprised of poorly soluble and, hence, poorly bioavailable compounds. Amorphous solid dispersions (ASDs) are a proven technology that have been commercialized in over twenty products. Key to progressing ASDs is the use of rapid, bulk-sparing methods to characterize ASD performance and identify commercially relevant formulations early, and avoid re-formulation later in the project lifecycle. This talk focuses on identification of methods for predicting ASD performance and case studies for poorly soluble molecules. To learn more, watch our on-demand presentation.
Authors: Dr. David Lyon
Publish Date: 14-Dec-2020

5-Azacytidine Inhaled Dry Powder Formulation Profoundly Improves Pharmacokinetics and Efficacy for Lung Cancer Therapy

This on-demand presentation covers manufactured respirable 5AZA powder using a modified spray drying process. Pharmacokinetics of inhaled dry powder and aqueous formulations of 5AZA is compared to an injected formulation. Efficacy studies and effect of therapy on the epigenome were conducted in an orthotopic rat lung cancer model for inhaled formulations. These findings could lead to widespread use of this drug as the first inhaled dry powder therapeutic for treating local and metastatic lung cancer, for adjuvant therapy, and in combination with immunotherapy to improve patient survival.  To learn more, watch our presentation.
Authors: Dr. David Lyon
Publish Date: 10-Dec-2020

Podcast: Innovations in HPAPI and Antibody-Drug Conjugates Drug Development

Antibody-drug conjugates (ADCs), which use antibodies to send cancer-killing molecules directly where they are needed, are one area of focus for oncology researchers. ADCs combine the potency of small molecules (highly potent APIs, or HPAPI) with the selectivity of cancer-specific antibodies.  To learn more, watch our podcast.
Authors: Dr. Maurits Janssen
Publish Date: 22-Nov-2020

APIs and Toxins/Linkers for ADCs: A Vision on Highly Potent Development, Scale-up and Manufacturing

Drug development based on potent compounds can be quite challenging. Complications with the interface between operations in drug substance and drug product handling can result in increased program complexity and cost. This also applies when the potent compound is used as toxin/linker for application in ADCs.  In this presentation, we will elaborate on best practices and requirements that facilitate accelerated timelines to clinic & market: (1) Development, rapid scaling and commercial production of HPAPI drug substance, (2) Integrated containment for particle engineering and drug products, and (3) Impact of supporting integrated service-offerings on expansion strategies.
Authors: Dr. Maurits Janssen
Publish Date: 20-Nov-2020

Applying Visual Techniques to the Product Design of Lipid Multiparticulates

Lipid multiparticulates (LMPs) are versatile drug delivery systems that offer flexibility in both drug release and final dosage form. The wide variety of available matrices and formulation approaches make LMPs amenable to a broad range of targeted release kinetics and delivery strategies. The solvent-free melt-spray-congeal process results in LMPs with controlled and narrow particle size distributions. For the final dosage form, LMPs can be given as sachets, incorporated into capsules and tablets, or used as injectables.  This webinar discusses the process for formulation selection and LMP manufacturing through the lens of visual techniques to study critical-to-quality attributes.
Authors: Amanda Pluntze, Cody Prather
Publish Date: 20-Nov-2020

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

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

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

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

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