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Pharmaceutical / Nutraceutical Processing Applications: Pharmaceutical Dispensing Applications
Automated dispensing systems are utilized throughout the pharmaceutical industry for the loading of excipients, active pharmaceutical ingredients (API's), and lubricants into Intermediate Bulk Containers (IBC's) and other large vessel devices. In most pharmaceutical plants, separate broaching areas
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Succeeding with Encapsulation Scaleup
as bulk density, moisture content and the porosity of the granules.Preventing dissolution failureDissolution failure typically results from: overlubrication during blending or capsule filling; change in the filling mechanism; changes in plug strength; changes in API particle size. Excess
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Using MEMS to Control Blending at AstraZeneca
is critical in defining the uniformity of dosage units within a batch of tablets, especially in the case of direct compression products. Typically, the API in the compressed blend is analyzed in the finished dosage form for potency and content uniformity. For many existing formulations
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Using MEMS to Control Blending at AstraZeneca
Development , AAPS Pharm Sci Tech 6 (2), pp. E262 E272, 2005. Crocombe R., MEMS Technology Moves Process Spectroscopy into a New Dimension, Spectroscopy Europe, pp. 15 19, July 2004. Parris J., Airiau C., Escott R., Rydzak J. and Crocombe R., Monitoring API Drying Operations with NIR , Spectroscopy 20
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IFPAC 2006 Under the Microscope
and variation in API particle size to dissolution parameters in the finished product. Overall, the types of information she has gleaned from her RCA work and where in the process it can help are: During Process Development: She studied the effect of increasing roller compaction force on tablet matrix
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Succeeding with Encapsulation Scaleup
, specifications should be set for API and even excipient particle size and bulk density.Mixing time and lubricationMixing time and the impact of lubricants should also be considered. It is important to remember that mixing time is usually reduced during scaleup, since larger-volume mixers are much more
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The push toward lifetime lubes
by the International Lubricant Standardization and Approval Committee, and then by the API as Service Classification SL. Oils meeting the new standard (Group II hydrocracked oils for instance) are less volatile which helps cut airborne components. They also have a relatively lower viscosity to improve gas
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Radial Shaft Seals
, providing a slinger action. They add little power loss and can run dry or with grease prepack. However, many ANSI and especially API pumps are migrating to labyrinth or bearing isolators at the thrust and line ends. These sealing devices have non-contacting stator and rotor elements, or lightly loaded