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Granulation
The effect of screw configuration and formulation variables on liquid requirements and granule…
The effect of two screw configurations with varying stagger angle was evaluated on the liquid amount required to produce good quality granules for a highly (mannitol-based) and a poorly (DCP-based) soluble formulation containing different binders. It is generally known that the use of a higher…
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Streamlining the development of an industrial dry granulation process for an immediate release…
In industrial practice, the development of pharmaceutical dry granulation processes typically involves time- and resource-intensive multivariate experiments. These experiments are used to identify the set of operating conditions, their allowed ranges and chosen setpoints where the desired product…
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Prediction of quality attributes (mechanical strength, disintegration behavior and drug release) of…
High shear wet granulation is commonly applied technique for commercial manufacturing of tablets. Granulation process for tablets manufacturing is generally optimized by hit and trial which involves preparation of granules under different processing parameters, compression of granules and evaluation…
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Application of Dry Granulation to Facilitate Raw Material Handling
Pharmaceutical and biopharmaceutical manufacturing relies on the timely and seamless orchestration of many steps to meet aggressive timelines and ensure operational efficiency. A fundamental element of the processing workflow that can impact schedules is the use of multi-ton quantities of bulk raw…
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High shear wet granulation: Improved understanding of the effects of process variables on granule…
High shear wet granulation (HSWG), as a widely used granulation technology, has been studied extensively. However, for the HSWG of formulations containing hydrophobic components, the influence of process variables on the properties of granules and tablets has not been reported. In the present study,…
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A Hybrid Model to Predict Formulation Dependent Granule Growth in a Bi-Component Wet Granulation…
In this study, a hybrid modeling framework was developed for predicting size distribution and content uniformity of granules in a bi-component wet granulation system with components of differing hydrophobicities. Two bi-component formulations, (1) ibuprofen-USP and micro-crystalline cellulose and…
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Solving Compactability Issues for the Preparation of ODTs
Introduction
Formulators often face compactability issues for the preparation of orally disintegrating tablets (ODTs) where active pharmaceutical ingredients (APIs) are poorly compressible or formed in a coated pellet. HiSORAD™, one of the best-in-class co-processed excipient for ODT, may work as…
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A review on key aspects of wet granulation process for continuous pharmaceutical manufacturing of…
Wet granulation process is a major unit operation in production of pharmaceuticals as solid dosage oral formulation. Indeed, granulation is used to improve the formulation properties such as flowability, compressibility, and so on for pharmaceutical manufacturing. Different types of granulations can…
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Control Strategy for Process Development of High-Shear Wet Granulation and Roller Compaction to…
In this study, we developed a control strategy for a drug product prepared by high-shear wet granulation and roller compaction using integrated quality by design (QbD). During the first and second stages, we optimized the process parameters through the design of experiments and identified the…
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A linear scale-up approach to fluid bed granulation
Fluid bed granulation (FBG) is used extensively in the pharmaceutical industry and it is known to be a complex process, because the final product quality of the FBG process is determined by a complex interplay between the process parameters, fluid dynamics, and material properties. Due to this…
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