Contract Manufacturing and Packaging September-October 2011 - download pdf or read online

By Jordan Brandes

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The pharmaceutical industry is still dominated by ‘stationary’ batch processes with little, if any, automatic feedback control. This paradigm is predicated on the mindset that uniform products can only be produced by batch processes having a ‘frozen’ manufacturing process [3, 4]. Implementation of hot-melt extrusion (HME) as continuous manufacturing technology for the development of a variety of solid dosage formulation has enormous opportunities to overcome drug related problems. HME has been established as a novel strategy to produce a delivery system with enhanced bioavailability as well as solubility with improved dissolution rate, which is a focus of API research in pharmaceutical drug development.

T. Cole, Journal of Controlled Release, 1995, 36, 342, 250. 25. F. W. Mcginity, Pharmaceutical Development and Technology, 1998, 14, 242. 26. Y. Miyagawa, T. Okabe, Y. Yamaguchi, M. Miyajima and H. Sunada, International Journal of Pharmaceutics, 1996, 138, 215. 27. , J. 1773. 28. A. G. L. W. Mcginity, Drug Development and Industrial Pharmacy, 1999, 25, 625. 29. N. Follonier, E. T. Cole, Drug Development and Industrial Pharmacy, 1994, 20, 1323. 16 Introduction to Hot-Melt Extrusion, Continuous Manufacturing 30.

These measurements together with the use of spectroscopic procedures make it possible to provide multivariate regulatory monitoring for accountability recognition. Additionally, in-line/on-line visible spectroscopy has the potential for monitoring degradation and extrudate colour, if colour matching is important for the product [44]. On-line NIR spectroscopy is used consistently in the industry for understanding blending operations. NIR, mounted on the lid of the blender, can be used to collect several spectra at each revolution.

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Contract Manufacturing and Packaging September-October 2011 by Jordan Brandes

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