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Article / Jun 21, 2022

Drug Solutions Podcast: The Evolving Landscape of Oral Solid Dosage Forms, 21 June 2022

In this episode of the Drug Solutions Podcast, Feliza Mirasol, science editor, discusses the changing parameters for oral solid dosage forms as driven by APIs and new chemical entities with Deepak Thassu, vice-president R&D and Regulatory Submission, LGM Pharma, and Marco Gil, senior vice-president of Sales & Marketing, Hovione.


Drug Product Solutions Podcast thumbnail | Hovione


Oral solid dosage forms are a dynamic, ever-changing landscape, driven primarily by more highly potent new chemical entities (NCEs) that require particularly specific formulations. In this Drug Solutions Podcast episode, Deepak Thassu, vice-president R&D and Regulatory Submission, LGM Pharma, and Marco Gil, senior vice-president of Sales & Marketing, Hovione, discuss how, in addition to NCEs, older, more established APIs are finding renewed life because these APIs are continually enhanced to have higher potency at lower doses, changing the way their formulation is handled. Looking toward the future, the bio/pharma industry is also tackling the issue of converting large-molecule (biologic) drugs into orally administered dosage, rather than parenteral administration, for increased patient compliance. Among the issues discussed are:

  • The latest developments in oral solid dosage technology and methodologies
  • What remains the biggest challenges in formulating APIs for oral solid dosage administration
  • How the industry is tackling the issue of enhancing bioavailability through better oral solid dosage formulations/technologies, etc.
  • Some “best-practice” approaches to formulating oral solid dosage products


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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  


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