Continuous manufacturing

Abstract Traditional operation modes, such as running the production processes at constant process settings or within a narrow design space, do not fully exploit the advantages of continuous pharmaceutical manufacturing. Integrating Quality by Control (QbC) algorithms as a standard component of…
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This poster by Glatt Pharmaceutical Services was presented at the PBP World Meeting 2024: Introduction ProCell® Technology is a continuous spouted bed pelletization process which allows the manufacture of pellets with very high active drug loadings (> 95 %) and narrow particle size…
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In this study, a novel floating, controlled-release and core-shell oral tablet of ketamine hydrochloride (HCl) was produced using a dual extrusion by 3D printing method. A mixture of Soluplus® and Eudragit® RS-PO was extruded by a hot-melt extrusion (HME) nozzle at 150–160 °C to fabricate the tablet…
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Solid pharmaceutical formulations with class II active pharmaceutical ingredients (APIs) face dissolution challenges due to limited solubility, affecting in vivo behavior. Robust computational tools, via data mining, offer valuable insights into product performance, complementing traditional methods…
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Abstract Hydroxypropyl methylcellulose (HPMC) is a preferred hydrophilic matrix former for controlled release formulations produced through continuous twin-screw wet granulation. However, a non-homogeneous API distribution over sieve fractions with underdosing in the fines fraction (<150 µm) was…
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Abstract Continuous manufacturing is a novel concept to produce high quality drug products. The manufacture of solid dosage forms starts with the feeding of materials, which is consider a critical step because it could have a high influence on the quality of the final product. Therefore, this unit…
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Abstract This feasibility study evaluates a cleaning process designed to avoid the use of detergents and reduce operator exposure to the active pharmaceutical ingredient (API). The continuous manufacturing equipment was cleaned using excipients to displace ibuprofen residues from the system. The…
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See the new book, edited by Michael A. Repka, Nigel Langley Covers regulatory and manufacturing aspects of 3D printing in drug development Particular focus on hot melt extrusion and extruded filaments suitable for optimizing 3D printing Thorough short text and guide for use on the…
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Hot melt extrusion (HME) is a common unit operation. It is broadly applicable in the pharmaceutical industry and can be implemented in a continuous manufacturing line. However, the conventional way of active pharmaceutical ingredient (API) feeding with a pre-blend consisting of a powdered API and a…
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Abstract Purpose Continuous wet granulation and drying require an adequate process control strategy to ensure the product quality. The most important critical quality attributes of dried granules are the granule size distribution and moisture content. Process analytical technologies (PATs) are…
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