Press Room

Webinar - Thermodynamics applied to amorphous solid dispersion development

Start
Tuesday, February 18, 2020 - 15:00
End
Tuesday, February 18, 2020 - 16:00
Location: online

 

Tuesday, February 18, 2020
3:00 pm GMT   |   10:00 am EST (NA)   |   7:00 am PST (NA)

Registrations to the webinar are subject to approval

 

Speakers

Luis Sousa, PhD - Analytical Chemist

 

Watch On-Demand Webinar

 

Amorphous solid dispersions (ASDs) have been used extensively in the pharmaceutical industry for improving the solubility of poorly water-soluble drugs. Despite their advantages in terms of solubility, amorphous dispersions are not physically stable and tend to phase separate/crystallize with time, thus losing the initial solubility advantage. For that reason, it is essential to investigate the miscibility and the solubility limit of drugs in the polymeric matrixes. Determination of these limits allows defining a safe range of drug loads that can be manufactured and minimize potential stability issues that are inherent to supersaturated ASDs. In this webinar, we will present the most common methods used to determine drug solubility in polymeric matrices, including Hovione’s own thermodynamic approach to solubility determination.

In addition, we will also give an overview of the methodologies used to assess and predict long-term stability of amorphous materials and discuss the thermodynamic and kinetic contributions to drug crystallization in the solid state. In this section we will focus on the evaluation of the kinetics of relaxation and molecular mobility of amorphous materials, as a function of temperature. These are important aspects to be considered in a preliminary evaluation of stability, not only for pure amorphous drugs but also for supersaturated amorphous solid dispersions.

 

Key Learning Objectives:

  • Identify advantages and disadvantages of the different methods used to determine drug-polymer solubility
  • Understand the complexity of phenomena involved in physical stability of amorphous drugs
  • Establish correlations between kinetic and thermodynamic parameters and stability

 

 

Watch On-Demand Webinar

Also in the Press Room

See All

Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at gmp-journal.com  

Article

Continuous Tableting and the Road to Global Adoption

Mar 04, 2024