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Technical Considerations for Capsule-Based Inhalation Product Development

This webinar explores the technical issues that must be explored for successful development of effective capsule-based products. Key design considerations are discussed, including formulation attributes; technology selection (e.g., spray-drying, micronization); and capsule and device considerations. To learn more, please view our webinar.
Authors: Dr. Herbert Chiou, Dr. Salvatore Mercuri
Publish Date: 07-Apr-2020

Oral Peptide Delivery Utilizing Specialized Encapsulation Technologies

This webinar covers the physicochemical requirements for peptides and biological oral delivery barriers. Both aspects are crucial to reduce risk in pharmaceutical development and increase the success rate of first-in-human trials using innovative approaches. The physicochemical attributes of peptides for oral administration will be explained, as will performance criteria for peptide formulation and biological hurdles to overcome low oral bioavailability of formulated peptides. To learn more, please view our webinar.
Authors: Dr. Hassan Benameur
Publish Date: 01-Apr-2020

Formulation Selection and in vitro Screening for Oral Bioavailability Enhancement

Oral administration of small molecules is an ongoing challenge because most new drug candidates have poor aqueous solubility. The choice of the best delivery technology for such compounds, as well as the means to evaluate the effectiveness of that technology choice, is crucial. This webinar describes use of a proven model-based technology-selection method for low-solubility molecules and in vitro evaluation strategies for three challenging classes of compounds, including one with high-dose requirements. To learn more, please view our recorded presentation.
Authors: Dr. Michael Grass
Publish Date: 17-Mar-2020

Improving Bioavailability & Solubility: Understand Your Molecule

Dr. David Lyon, Senior Fellow at Lonza, joins industry experts in this special feature on improving the bioavailability and solubility of drugs in pharmaceutical pipelines. He provides information on amorphous solid dispersions (ASDs) and lipid-based formulations (LBFs) and guides for technology selection based on molecular properties. To learn more, please read our article.
Authors: Dr. David Lyon
Publish Date: 01-Mar-2020

in vitro Test Methodologies for Characterizing Bioavailability Enhancing Formulations

Given the large number of low-solubility compounds in development, improved methods are needed to evaluate the effectiveness of bioavailability-enhancement approaches. This webinar covers the evaluation of in vitro methods for characterizing bioavailability-enhancing formulations, criteria for selecting the optimal in vitro methods based on compound properties and dose, and case studies for multiple low-solubility compounds. To learn more, please view our presentation.
Authors: Dr. Aaron Stewart
Publish Date: 27-Feb-2020

in vitro Test Methodologies for Characterizing Bioavailability Enhancing Formulations

Given the large number of low-solubility compounds in development, improved methods are needed to evaluate the effectiveness of bioavailability-enhancement approaches. This webinar covers the evaluation of in vitro methods for characterizing bioavailability-enhancing formulations, criteria for selecting the optimal in vitro methods based on compound properties and dose, and case studies for multiple low-solubility compounds. To learn more, please view our webinar.
Authors: Dr. Aaron Stewart
Publish Date: 27-Feb-2020

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

Epigenetic therapy through demethylation of 5-methylcytosine has been largely ineffective in treating lung cancer, likely due to poor tissue distribution with oral or subcutaneous delivery of drugs such as 5-azacytidine (5AZA). This publication describes the development of an inhalable, stable dry-powder formulation of 5AZA. This work 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, when combined with immunotherapy, for improving patient survival. To learn more, please read our publication.
Authors: Dr. David Vodak, Lovelace Respiratory Research Institute (LRRI)
Publish Date: 27-Feb-2020

Impact of Process Parameters on Particle Morphology and Filament Formation in Spray-Dried Eudragit L100 Polymer

In preparing amorphous solid dispersions (ASDs) to increase bioavailability, Eudragit L100 has proven a useful excipient, due to its favorable impact on ASD physical stability and dissolution performance. However, when Eudragit L100 is spray-dried, high-aspect-ratio filaments can form, which negatively impact downstream ASD performance and dosage form manufacturability. This paper describes a study of how such filaments form and a particle-design space that identifies key processing parameters that can be used to mitigate the risk of filament formation. To learn more, please read our publication.
Authors: Dr. Kimberly Shepard, Molly Adam, Dr. Michael Morgen, Dr. Deanna Mudie, Daniel Regan, John Baumann, Dr. David Vodak
Publish Date: 15-Feb-2020

Setting a New Gold Standard in ADC Production

Antibody drug conjugates (ADCs) have shown great promise in oncology but many pharma companies have been hamstrung by the challenges of ADC manufacturing. This article describes Lonza's combination of all three necessary manufacturing processes--monoclonal antibody (mAb) production, cytotoxic production, and bioconjugation--under a single quality system at its plant in Visp, Switzerland. To learn more, please read the article.
Authors: Meagan Parrish, Dr. Maurits Janssen
Publish Date: 12-Feb-2020

The Lonza Powder-In-Capsule Microdosing Approach

Precision powder microdosing systems--including API-in-capsule or -bottle approaches--can help biopharmaceutical companies increase speed to clinic, quickly assess new candidate compounds, and limit costs during the formulation and dosage-form development. This article describes Lonza's Xcelodose® systems, which have become an industry standard for rapid and accurate microdosing. A case study is presented. To learn more, please read our article.
Authors: Jeff Williamson, Ben Sahacic
Publish Date: 12-Feb-2020