Articles in this Issue

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  Formulation: Using API Powder in a Bottle or Capsule for Clinical Phase I Studies

  July 12, 2018
  Sometimes simple dosing with API powder in a bottle or capsule for a clinical Phase I study can be acceptable, and it may be quicker to use API powder in either a capsule or a bottle than to develop a formulation. However, use of such an approach is ... read more
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  Directly Compressible ODT Platforms: A Comparison Study

  July 11, 2018
  Orally disintegrating tablets (ODTs are not just another fancy dosage form; they address a very important component of treatment success: compliance. This is especially true for pediatric and geriatric patients. Children and the elderly are not ... read more
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  Mixing and Blending: Using Residence Time Distribution to Understand Continuous Blending

  July 12, 2018
  In recent years, continuous powder mixing has attracted pharmaceutical processing, which has traditionally been a batch-based industry. However, while continuous processing is widely used in bulk solids manufacturing, especially for processing large ... read more
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  Coating: Verifying Film Coater Operating Parameters to Ensure the Quality of Dietary Supplement...

  July 12, 2018
  The final rule of the FDA’s Dietary Supplement GMP Regulation 21 CFR Part 111.30(c) requires dietary supplement manufacturers to “routinely calibrate, inspect, or check the equipment to ensure proper performance.” Additionally, per 21 CFR Part 111.55... read more
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  Tablet Tooling: Maximize the Return on Your Tooling Investment with Proactive Maintenance

  July 12, 2018
  Tablet compression tooling is a significant investment. production costs compared to the cost of a tablet press or fluid-bed dryer, tablet manufacturers typically buy many sets of tooling over a drug product’s life cycle. Excessively worn or ... read more
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  Setting USP–NF Compendial Specifications in a Complex Supply Chain

  July 12, 2018
  With today’s global pharmaceutical supply chain, setting United States Pharmacopeia–National Formulary (USP– NF) compendial specifications for excipients is becoming increasingly complicated. This is due in part to the vast number of ingredients used... read more