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Formulation and Development Approaches for Amorphous Solid Dispersion Drug Products - On-demand

This on-demand webinar provides guidance on general strategies for developing a successful amorphous solid dispersion formulation - from formulation intermediates to final dosage forms. The presentation also covers screening, stability and manufacture, including strategies for incorporating amorphous solid dispersions into immediate release tablets. To learn more, view the on-demand webinar.
Authors: Jesus Soto, Aaron Stewart
Publish Date: 03-Sep-2020

Science of Scale for Spray-Dried Intermediates

Speed to market is a critical aspect of developing new pharmaceutical products and scale-up—or scale-down—can play a key part in that process. Significant interest has been focused on the science of scale for spray drying, since this process is the leading technology for formulating drugs with slow dissolution rates or poor solubility, which results in low bioavailability. Lonza has over 20 years of experience in the scale-up and scale-down of spray drying processes. To learn more, read our whitepaper.
Authors: Dr. David Lyon,John Baumann
Publish Date: 01-Sep-2020

Navigating CMC Regulatory Requirements For Accelerated Commercialization

An increasing number of therapies obtain designations with accelerated and priority reviews. The need to streamline the pathway from development to commercialization path for these drug products is of crucial importance. Lonza will share practical Chemistry, Manufacturing, and Controls (CMC) experience on how to navigate regulatory, development, manufacturing and packaging requirements critical for accelerated clinical pathways and commercialization. To learn more, watch our on-demand webinar.
Authors: Dr. Jacqueline Hargis, Jakob Bonde
Publish Date: 25-Aug-2020

Novel High-Drug-Loaded Amorphous Dispersion Tablets of Posaconazole; in vivo and in vitro Assessment

Amorphous solid dispersions (ASDs) can increase the bioavailability of drugs with poor aqueous solubility. However, concentration-sustaining dispersion polymers (CSPs) incorporated in ASDs can result in low drug loading and, therefore, a large dosage-form size or multiple units to meet dose requirements, potentially decreasing patient compliance. To address this challenge, a high-loaded dosage-form (HLDF) architecture for ASDs was developed, in which a drug is first spray-dried with a high glass transition temperature (Tg) dispersion polymer to facilitate high drug loading while maintaining physical stability. This study demonstrates in vivo performance of the HLDF architecture using posaconazole as a model drug.  To learn more, download our publication.
Authors: Deanna M. Mudie*, Aaron M. Stewart, Nishant Biswas, Timothy J. Brodeur, Kimberly B. Shepard, Adam Smith, Michael M. Morgen, John M. Baumann, and David T. Vodak
Publish Date: 24-Aug-2020

Liquid-filled Hard Capsules for Delivery of Highly Potent Compounds

Liquid-filled hard capsules are usually recognized as a technology for bioavailability enhancement of poorly soluble compounds.  They do however also offer some significant advantages when developing and manufacturing some challenging highly potent API (HPAPI) into oral dosage forms.  HPAPI are often highly toxic to the workers employed to manufacture them, the potentially low dose required by the patient presents a challenge to ensure that each drug product contains the correct quantity of API, which can be less than a single particle of the material, as it is supplied to the manufacturer. New molecules are also often highly insoluble or too large for absorption to take place without additional technology being employed.  HPAPI formulated in a liquid provides a means to minimize airborne contamination, reducing the need for engineered containment during the manufacturing process, it can be readily scaled-up in a generic manufacturing process without having to re-invent new containment, provides a mechanism for accurate dosing of low doses and still has the capability to enhance bioavailability for these molecules. To learn more, view our on-demand presentation.
Authors: Alyn McNaughton
Publish Date: 20-Aug-2020

Executive Summary: Specialized Services for Complex Clinical Studies

As an increasing number of new therapeutics move into clinical trials, a new set of challenges must be met to ensure an effective and integrated product supply. This is especially true for many specialty medicines like orphan drugs, where global distribution coordination is critical to reach a sufficient patient population. Specialized clinical supply services for first-in-human therapeutic validation can be required for the effective management of associated tasks including manufacturing, primary and secondary packaging, kitting, and distribution. These services often now include direct-to-patient supply to facilitate rapid clinical trial results. To learn more, read our executive summary.
Authors: David Dreifke, Damian Gant, David Lyon
Publish Date: 18-Aug-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

An Interview with David Lyon - Integrated Offer

Lonza is a contract development and manufacturing organization (CDMO) that provides drug substance and drug product manufacturing services for partner pharma and biotech companies. These services include the entire spectrum from pre-clinical to commercial manufacturing services. While Lonza has capabilities for handling conventional molecules, it specializes in difficult-to-handle molecules, such as antibody-drug conjugates (ADC) or highly-potent active pharmaceutical ingredients (API), and specialty drug product formulations for poorly bioavailable molecules. Importantly, each area that Lonza specializes in is steeped in rigorous scientific based methods.  To learn more, read our article in American Pharmaceutical Review.
Authors: Dr. David Lyon
Publish Date: 10-Aug-2020

Manufacturing Amorphous Solid Dispersions by Spray-drying: Scale-up Approaches

This webinar focuses on manufacturing aspects of amorphous spray-dried dispersions (SDDs) to enable successful scale-up and optimization of the process. An overview of spray drying and typical scale-up challenges are presented, along with a robust process development strategy to ensure critical-to-quality attributes are maintained. Tools and methodologies that enable rapid scale-up that is right the first time from clinical to commercial scale are also highlighted. View the slides to learn more.
Authors: Joel Wood, Kim Shepard
Publish Date: 04-Aug-2020