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SimpliFiH® Solutions for Accelerated Pharmaceutical Development

With the pharmaceutical industry’s focus on accelerating all aspects of drug discovery and development, it is crucial to reduce the time from initial product concept to first-in-human clinical completion. Numerous factors can slow this process, but challenges can be overcome by aligning with a single, integrated Contract Development and Manufacturing Organization (CDMO) to reduce the time, complexity, risks, and costs associated with engaging multiple partners. To learn more, read our executive summary.
Publish Date: 19-Apr-2021

Solid-Form Screening and Rational Cocrystal Design - On-demand

Solid-form screening and characterization is a crucial part of drug substance development and pre-formulation. Knowledge of the underlying fundamentals of polymorphism, hydrates/solvates, salts, and cocrystals is essential to establish an understanding of a drug substance and its solid-form throughout the drug development lifecycle. In this webcast, experts will discuss many aspects of solid-form screening including in-silico screening, which can save time and speed up the solid-form development process. A case study will review in-silico screening of cocrystals of a pharmacophore using hydrogen bond energies and hydrogen bond propensities. A second case study will examine cocrystallization of nutraceuticals and their versatile use as coformers.  To learn more, view our on-demand webinar.
Publish Date: 04-Mar-2021

Solid-Form Screening and Rational Cocrystal Design - Presentation

Solid-form screening and characterization is a crucial part of drug substance development and pre-formulation. Knowledge of the underlying fundamentals of polymorphism, hydrates/solvates, salts, and cocrystals is essential to establish an understanding of a drug substance and its solid-form throughout the drug development lifecycle. In this webcast, experts will discuss many aspects of solid-form screening including in-silico screening, which can save time and speed up the solid-form development process. A case study will review in-silico screening of cocrystals of a pharmacophore using hydrogen bond energies and hydrogen bond propensities. A second case study will examine cocrystallization of nutraceuticals and their versatile use as coformers.  To learn more, download our webinar slides.
Publish Date: 04-Mar-2021

Lonza Solid Form Services

At Lonza Solid Form Services, we have defined work flows to assess and select solid forms in a cost and time efficient manner that meets the needs of each individual program. To find out more, read our technical brief.
Publish Date: 16-Feb-2021

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: David Lyon
Publish Date: 14-Dec-2020

A Novel Architecture for High Drug-loaded Amorphous Solid Dispersion Tablets; Assessment of in vitro and in vivo Performance, Stability and Manufacturability

Amorphous solid dispersions (ASDs) can increase solubility and dissolution rate of poorly water soluble drugs. However, ASD dosage forms are often large or require multiple units to meet dose requirements due to incorporation of concentration-sustaining polymers (CSPs) in the formulation. 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. The ASD is then granulated with a CSP to extend supersaturation in solution. The HLDF approach differs from traditional ASD architectures in which the dispersion polymer inside the ASD has the dual purpose of maintaining physical stability and extending supersaturation in solution, thereby constraining the formulation and often resulting in low dosage form drug loading. The HLDF platform has the potential to reduce tablet mass by at least 40% while maintaining performance, stability and manufacturability. This presentation describes case studies highlighting the HLDF architecture, including physical stability, in vitro and in vivo performance and manufacturability.
Authors: Deanna Mudie
Publish Date: 28-Oct-2020

Solid Form Screening: A Key Drug Development Step

Solid form selection is critical to a streamlined drug product development program and can ensure that options for drug product and drug substance process are considered early in development, leading to optimized solutions. This executive summary describes (1) Lonza methodology for solid form selection; (2) the importance of solid form selection on drug product and drug substance process selection; and (3) solid form selection case studies.
Authors: Michael Grass
Publish Date: 16-Oct-2020

Lonza Solid Form Screening and its Role in Drug Development - On-demand

Watch our on-demand webinar to learn about the underlying fundamentals of polymorphism, hydrates/solvates, salts, and cocrystals; regulatory requirements; and the importance of solid form screening and characterization in both drug substance and drug product development. To hear more, watch our on-demand webinar.
Authors: Michael Grass
Publish Date: 10-Sep-2020

Solid Form Screening and its Role in Drug Development

In this presentation, learn about the underlying fundamentals of polymorphism, hydrates/solvates, salts, and cocrystals; regulatory requirements; and the importance of solid form screening and characterization in both drug substance and drug product development.  To learn more, download our webinar slides.
Authors: Michael Grass
Publish Date: 10-Sep-2020