Pharmaceutical solids processing

VII. WATER SORPTION BY PHARMACEUTICAL SOLIDS SUBJECTED TO PROCESSING... 

The first demonstration of solid state fluorescence of API dates back to 1961, while its in-line use for final drug product manufacturing was not demonstrated until recently." While in its infancy as a process analytical technology for real-time monitoring and product parametric real-time release, the applications identified and in some instances demonstrated include (i) blend endpoint API content nniformity detection " (ii) segregation monitoring or API content at various process critical control points and (iii) at-line tablet content uniformity determination. The fundamentals of solid-state luminescence spectroscopy for pharmaceutical solids has been covered by Brittain."... 

Y. Roggo, N. lent, A. Edmond, P. Chains aud M. Ukuschueider, Characteriziug process effects ou pharmaceutical solid forms using near-infrared spectroscopy and infrared imaging, Eur. J. Pharm. Biopharm. 61 100-110 (2005). 

Price R, Young PM. 2005. On the physical transformations of processed pharmaceutical solids. Micron 36 519-524. 

Cocrystals are becoming increasingly important as a means of controlling the properties of pharmaceutical solids by designing multiple component molecular networks that introduce the desired functionality. Because cocrystal design is based on supramolecular synthesis, it provides a powerful approach for the proactive discovery of novel pharmaceutical solid phases. Application of the fundamental concepts presented here on cocrystallization processes is essential for the pharmaceutical scientist to anticipate the formation of cocrystals during pharmaceutical processes and storage, as well as to develop reliable methods for cocrystal discovery and production. 

No attempt will be made to provide a comprehensive summary of the numerous studies that have been conducted and which show how water influences the processing and stability of pharmaceutical solids and dosage forms. For more information, the reader is referred to some classical texts,recent general articles on the subject,and those with specific emphasis on the role of water on stability or compaction properties. ... 

In the pharmaceutical solid dosage form development process, compaction simulators can be used throughout the life of a compound. Royce and coworkers categorized the lifecycle of a compound into three phases (1). 

Dalton, C. R. and Hancock, B. C. Processing and storage effects on water vapor sorption by some model pharmaceutical solid dosage formulations. Int. ]. Pharm. 156 143—151, 1997. 

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