Granulation

Recently, the pharmaceutical industry has undergone changes in the production of solid oral dosages from traditional inefficient and expensive batch production to continuous manufacturing. The latest advancements include increased use of continuous twin-screw wet granulation and application of…
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In twin screw melt granulation, granules are produced by passing mixtures of drug substances and polymeric binders through twin screw extruder such that temperatures are maintained below melting point of drugs but above glass transition of polymers used, whereby the polymers coat surfaces of drug…
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This chapter discusses different excipients traditionally used in granulation applications and the emerging high-functionality co-processed excipients that can improve granulation processing. Successful manufacturing of tablets or capsules requires formulators to consider several factors. These…
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Continuous twin screw wet granulation is one of the key continuous manufacturing technologies that have gained significant interest in the pharmaceutical industry as well as in academia over the last ten years. Given its considerable advantages compared to wet granulation techniques operated in…
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Binders or “granulating agents” are a critical formulation component in tablets made by direct compression, as well as dry, wet, and melt granulation, ensuring appropriate plasticity, compactibility, and binding ability. In wet granulation, surface wetting ability to allow adhesion and cohesion…
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Characterization of drug substances and excipients is a very important step at the preformulation phase of product development. Although testing will involve additional time and cost, failure to carry out the appropriate characterization tests can be even more costly to the manufacturers if the…
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This study aimed to compare the manufacturability and granule and tablet properties of green fluidized bed granulation (GFBG) and of direct compression (DC). Acetaminophen was used as a low compactabil- ity model drug. The process time of GFBG to produce final mixtures was comparable to that of DC,…
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Comprehensive understanding of an integrated continuous pharmaceutical technology was achieved in this study by a combining design of experiments and mechanistic modeling-based simulations. The powder to granule line consisted of twin-screw wet granulation, vibrational fluid-bed drying and milling.…
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Despite significant advances in the research domain of continuous twin screw granulation, limited information is currently available on the impact of raw material properties, especially considering batch-to-batch variability. The importance of raw material variability and subsequent mitigation of…
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The U.S. Food and Drug Administration (FDA) emphasizes drug product development by Quality by Design (QbD). Critical material attributes (CMAs) are a QbD element that has an impact on pharmaceutical operations and product quality. Pharmaceutical drugs often crystallize as needle-shaped (a CMA)…
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