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Physical attributes of tablets and ink printing
Q: Do the physical attributes of tablets impact the quality of their ink-printed logos?
As drug-development technology advances, solid oral dosage forms (SODFs) become available in an increasingly wide variety of shapes, sizes, colors, and material compositions. Given the various options for tablet coatings to enhance the look, feel, and taste of drug products, the possibilities seem endless.
This vast array of physical variations exists for several reasons, from specific drug-delivery mechanisms to marketing and general appeal. The inherent need to label and otherwise mark SODFs requires marking machine vendors to develop technology that can adapt to these variations.
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Successful submission of drug master files
Q: What are the criteria for successful submission and review of a drug master file for an active pharmaceutical ingredient?
Under the Generic Drug User Fees Act (GDUFA), the FDA applies a holistic, life-cycle approach to the evaluation of active pharmaceutical ingredients (APIs), featuring innovation, transparency, engagement of stake holders, communication, and collaboration. While the GDUFA program's goals include communication and collaboration with the generic drug industry, those goals are achievable only through successful submissions and the engagement of industry and FDA scientific assessors.
In Tablets & Capsules magazine
Troubleshooting capsule filling operations
This article describes common problems encountered during capsule filling and provides troubleshooting tips for solving them.
Two-piece hard-shell capsules are an attractive and versatile solid oral dosage delivery system that can be used with powder, granule, minitablet, liquid, and semi-solid formulations. Modern hard capsules are designed to work with fully automated capsule filling machines at fill rates of 200,000 or more capsules per hour. Achieving maximum speed, efficiency, and throughput during capsule filling requires care and planning, from the receipt of the empty capsules to final packaging.
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Events and continuing education
July 26, 2021
T&C Solid Dosage Sourcebook