Loss-in-Weight Feeding Trials Case Study: Pharmaceutical Formulation
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Abstract
This article presents a case study of a continuous feeding strategy for five pharmaceutical components (active pharmaceutical ingredient (API), Prosolv HD90, crospovidone, magnesium stearate, and colloidal silicon dioxide), for the purpose of developing a direct compression continuous manufacturing system. Feeding options for each of these five powders were examined. Prosolv HD90 and crospovidone easily resulted in optimal feeding conditions, whereas the remaining powders in the formulation presented some challenges. The API displayed flow issues, leading to clogging of the screen with small openings. Magnesium stearate exhibited shear sensitivity; increasing shear of the powder due to hopper agitation resulted in drifting feeding performance. Colloidal silicon dioxide exhibited electrostatic issues that render most tooling options unsuitable for steady operation. All of these difficulties were resolved using the methods described in this article.
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Affiliations
- Rutgers State University
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Classification Areas
- API
- Oral Solid Dose
- Process Control