Filler

Abstract It is necessary to use a scientifically sound process for excipient risk evaluation, selection, and management in order to develop paediatric medicinal products that are both safe and effective. The “Paediatric Excipient Risk Assessment (PERA)” framework, which proposes a comprehensive…
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Die filling is a crucial step in the pharmaceutical tablet manufacturing process. For industrial-scale production using rotary presses, suction filling is typically employed due to its significant efficiency advantages over gravity filling. Despite its widespread use, our understanding of the…
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Producing soft gelatin capsules (softgels) involves meticulous attention to detail and a deep understanding of the materials and processes. In this article, we will delve into the critical aspects of fill material production, exploring techniques to ensure uniformity, the importance of equipment,…
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Softgel capsules are a popular dosage form for pharmaceuticals and supplements, offering benefits like improved bioavailability and ease of swallowing. However, creating effective softgel formulations, especially for suspensions (pastes), involves complex considerations. This article explores these…
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Binder selection is a crucial step in continuous twin-screw wet granulation (TSWG), as the material experiences a much shorter residence time (2–40 s) in the granulator barrel compared to batch-wise granulation processes. Polyvinyl alcohol (PVA) 4-88 was identified as an effective binder during…
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Only few excipients are known to be suitable as pelletization aids. In this study, the potential use of croscarmellose sodium (CCS) as pelletization aid was investigated. Furthermore, the impact of cations on extrusion-spheronization (ES) of CCS was studied and different grades of CCS were tested.…
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Soft Gelatin Capsules (SGCs), commonly known as softgels, have transformed drug delivery since their invention. Despite their 19th-century origins, their widespread adoption only began in the 20th century, thanks to technological advancements by Robert Pauli Scherer. This innovation revolutionized…
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Abstract When tablets are manufactured on a rotary tablet press and the throughput is increased, it leads to changes in powder dynamics during die filling due to formulation characteristics and changing powder flow in the feed frame. This may result, a.o. in increased tablet weight variability,…
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Abstract Roller compaction is gaining importance in the pharmaceutical industry. This study evaluates the impact of ribbon milling conditions on properties of granules and compression mixtures and on drug release from hypromellose-based matrix tablets prepared with two different fillers. In the…
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Abstract Advanced manufacturing technologies such as continuous processing require fast information on the quality of intermediates and products. Process analytical technologies (PAT) to monitor many critical quality attributes (CQAs) have been developed and successfully implemented in…
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