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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

Particle Engineering For Inhalation Drug Delivery

Inhalation-based drug products play a critical role in addressing the rising incidence of respiratory diseases around the globe.  Particle engineered-based formulations are key in designing and developing effective dry powder inhaler (DPI)-based drugs.  This article discusses key parameters for choosing the right particle engineering approach to meet DPI target product profiles.
Authors: Matthew Ferguson
Publish Date: 15-Oct-2020

Engineering Approaches to Respiratory Drug Delivery: Mannitol Case Study

Spray drying and jet milling are commercially viable engineering processes for the development of respirable drug products. This summary presents a case study that explores the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol. To learn more, please read our executive summary.
Authors: Cameron Kadleck, Matthew Ferguson, Jimmy Beaty
Publish Date: 08-Oct-2020

Particle Engineering For Respiratory Drug Delivery

Pulmonary illness rates are increasing and respiratory diseases. A critical quality attribute of inhalable powders is that they are in the 1-5 micron size range for optimum deposition in the lung.  This executive summary contains (1) discussion of particle engineering approaches for inhaled compounds; (2) comparison of ‘bottom-up’ approaches—micronization—vs. ‘top-down’ approaches such as spray drying; and (3) a case study of inhalable mannitol powders produced by micronization and spray drying. To learn more, read our executive summary.
Authors: Dr. Matthew Ferguson
Publish Date: 17-Aug-2020

Particle Engineering for Dry Powder Inhalers

As respiratory diseases continue to be a leading cause of death and disabilities across the globe, inhalation drug products can play a role in treatments. Particle engineering innovations can help keep these medicines affordable and patient-centric. In Inhalation Magazine, Cameron Kadleck, Joseph Churchman and Herbert Chiou write how choosing the right technology for particle engineering positions the development process for an accelerated timeline and helps life-saving therapies reach patients faster. Understanding API properties, target drug profiles and potential risks all play a role in choosing the right particle engineering technology, such as spray drying or micronization.  To learn more, read our article.
Authors: Cameron Kadleck, Joseph Churchman and Herbert Chiou
Publish Date: 14-Aug-2020

Engineering Approaches to Respiratory Drug Delivery

Spray drying and jet milling are commercially viable engineering processes for the development of respirable drug products.  This case study explores the material and performance properties of mannitol, spray-dried and jet-milled, for respiratory delivery.  The head to head comparison reveals opportunities and risks for designing a product based on each approach.  Key learning objectives include: (1) understanding the pros and cons of spray drying vs. jet milling; (2) learning how to conduct a risk assessment to inform engineering technology selection; and (3) exploring how particle morphology influences aerodynamic performance.  To learn more, please view our on-demand webinar.
Authors: Cameron Kadleck, Jimmy Beaty
Publish Date: 30-Jul-2020

Lonza Small Molecule Capabilities: Drug Substance to Drug Product, Parenteral to Oral

Lonza Pharma and Biotech is a multi-national contract development & manufacturing organization (CDMO) that specializes in difficult-to-manufacture drug substance, drug product intermediates and drug product. In this introductory 30-minute interactive discussion, David Lyon, Sr. Fellow, Research, will highlight Lonza’s capabilities across the spectrum of drug development inclusive of parenteral, inhaled, and oral drug delivery. This introductory discussion will lead the way to future discussions taking deep dives into the highlighted areas.
Authors: Dr. David Lyon
Publish Date: 23-Jul-2020

DPI Formulation Development and Manufacturing

The respiratory system provides an attractive drug-absorption target to treat local and systemic diseases and is increasingly used to deliver small molecules and biotherapeutics. As described in this technical brief, Lonza has extensive experience in formulation development and manufacturing of respiratory drug-delivery products from proof of concept (POC) to manufacturing of dry-powder inhalation (DPI) formulations. Capabilities include optimized particle engineering, precision micro-dosing, rapid screening, clinically relevant testing, and Good Manufacturing Practice (GMP) production. To learn more, please read our technical brief.
Publish Date: 01-May-2020

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

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