Emerging Trends in Formulation Development
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Pharma Tech Outlook: Pharma Tech Magazine

Emerging Trends in Formulation Development

Pharma Tech Outlook | Monday, November 21, 2022

The rapidly evolving trends, particularly continuous manufacturing and moving from powder to tablet, bring new changes to the pharmaceutical industry and provide exciting opportunities for future treatments.

FREMONT, CA: In recent years, the pharmaceutical industry's drug discovery and development pace has accelerated, including the shortening of development timelines, and the introduction of new treatments has outpaced the number of approvals. This indicates the ability of the industry to respond quickly to immediate needs with RNA-based vaccines and therapies triggered by the pandemic environment. At the same time, new treatment approaches and active substances often pose new challenges, resulting in a need for new formulation approaches and technologies to meet this demand.

A general trend observed for advanced manufacturing technologies across the pharmaceutical sector, with a high focus on connected and more efficient processes such as continuous manufacturing, new technologies suitable for individualised and on-demand medicine, and an enticing effort to offer solutions for challenging compounds in the pipeline.

Digitalisation, challenging compounds, and a fast pace of development have led to a trend for modelling, predictive approaches, and digital collaboration in the pharmaceutical sector. Additionally, the increasing number of biomolecules in the pipeline has additional and specific challenges like protein purification and stability. These fast-evolving trends and developments have the potential to change the pharmaceutical landscape and offer exciting opportunities for future treatments.

Moving from Powder to Tablet

Tablets are the most popular dosage forms. Besides advantages in handling, shipping, and storage, optimal patient compliance and easy self-administration make them attractive. Today, most tablets are manufactured in a complex, multistep process called batch manufacturing. Every step, such as blending, tabletting, and coating, is performed as a stand-alone process with subsequent quality inspection and potential storage or shipping steps.

This lack of flexibility and agility poses a potential risk to the healthcare system. Therefore, a paradigm shift is seen from traditional batch manufacturing to continuous manufacturing (CM) of the drug product, supported by authorities. The process refers to starting materials, including APIs and excipients, that are continuously fed to the solid dosage manufacturing line. However, the finished product is taken out of the system with online and real-time quality monitoring.

In terms of continuous manufacturing equipment, the simplest set-up includes loss-in-weight feeders dedicated to excipients and APIs, a blender to mix the raw materials, a possible blender for the lubricant, and the rotary tablet press. This includes additional dry or wet granulation units and a coaster. Disturbances can easily occur if the material accumulates, flows poorly, or shows triboelectric tendencies in feeding.

Low-dose API formulations lead to challenges in blending homogeneity during blending. Therefore, the right excipient application will play a primary role in ensuring a smooth and efficient process. Understanding the critical material attributes (CMA) and critical process parameters, targeting CQAs, and implementing a control strategy to ensure a robust process and deliver an environment for continual improvement is part of the quality by design (QdB) approach directly implemented when deciding on a continuous manufacturing setup. Thus, the continuous manufacturing approach paves the way for straightforward tablet manufacturing and highlights various advantages.

 

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