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Lyophilisation

 

Pharmaceutical companies often use lyophilisation (or freeze-drying) to increase the shelf life of the products, such as live virus vaccines, biologics and other injectables. By removing the water from the material and sealing the material in a glass vial, the material can be easily stored, shipped, and later reconstituted to its original form for injection. Another example from the pharmaceutical industry is in tablet or wafer production, the advantage of which is less excipient as well as a rapidly absorbed and easily administered dosage form.

Lyophilisation is also used in manufacturing of raw materials for pharmaceutical products. Active Pharmaceutical Product Ingredients (APIs) are lyophilised to achieve chemical stability under room temperature storage. Bulk freeze-drying of APIs is typically conducted using trays instead of glass vials.

Dry powders of probiotics are often produced by bulk lyophilisation of live microorganisms such as Lactic acid bacteria and Bifidobacteria.

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The importance of disaccharide excipients in biologics

17 February 2021 | By , ,

Many biologic formulations use a variety of high-purity injectable grade disaccharide excipients to ensure functionality and stability of the final product. In this article, Sunil Kumar Nataraj, Bastiaan Dickhoff and Thontesh GC explore the use of these sugars in the stabilisation of biologics and provide recommendations to manufacturers for enhancing…

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Quality control of freeze-dried oral formulations; challenges when developing novel approaches for the delivery of poorly-soluble drugs

22 August 2017 | By ,

A common obstacle encountered in the early stages of drug development is the formulation of poorly water-soluble drugs (PWSDs). One effective approach to improve the dissolution of PWSDs is to render such drugs into their amorphous or disordered form. However, amorphous materials are both physically and chemically unstable, and tend…

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The importance of being small: miniaturisation of freeze drying equipment

18 August 2017 | By ,

Developmental activities for freeze-dried products are dictated by the limited availability and high cost of newly developed active compounds, and by Quality-by-Design requirements. Laboratory-scale freeze dryers used for formulation and process development show an excessive variety of designs and instrumentation concepts, making scale-up activities a challenge. The development of miniaturised…

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PAT Series: Recent achievements in NIR-based on-line monitoring of lyophilisation processes

30 June 2016 | By Adrian Funke - Bayer Pharma AG / Reinhard Gross, Stephan Tosch and Albert Tulke - Bayer Technology GmbH

Process analytical technology (PAT), namely near-infrared (NIR) and Raman spectroscopy, has already been shown to be a useful tool for monitoring, analysing and optimising the complex process of lyophilisation. The latter process is especially challenging in the case of biopharmaceutical formulations due to the instability of active ingredients, leading to…