Phase transformations of erythromycin A dihydrate during pelletisation and drying

Römer, Meike; Heinämäki, Jyrki; Miroshnyk, Inna; Sandler, Niklas; Rantanen, Jukka; Yliruusi, Jouko

doi:10.1016/j.ejpb.2006.12.008

Cited by 18 publications

(13 citation statements)

References 16 publications

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“…However, Raman spectroscopy was able to see the hydration and 572 dehydration phenomena during the process proving the complementarity of Raman and NIR 573 spectroscopy. In another study, at-line NIR spectroscopy was applied to understand the process 574 induced transformations of erythromycin dehydrate during pellet production (Römer et al, 2007). spectroscopy for the in-line monitoring of lyophilization processes.…”

Section: Pelletization 566mentioning

confidence: 99%

Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes

Beer

Burggraeve

Fonteyne

et al. 2011

International Journal of Pharmaceutics

455

213

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Section: Pelletization 566mentioning

confidence: 99%

Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes

Beer

Burggraeve

Fonteyne

et al. 2011

International Journal of Pharmaceutics

455

213

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“…SAXS spectra of the pure API (ibuprofen) and the pellets dried via different techniques. FB fluid bed, D desiccation, L lyophilization undergo a polymorphic transition during drying at elevated temperatures (see, for example, (35)(36)(37)(38)(39)). Thereby, the final pellet properties, such as the drug release behavior, may be changed (38).…”

Section: Discussionmentioning

confidence: 99%

Ibuprofen-Loaded Calcium Stearate Pellets: Drying-Induced Variations in Dosage Form Properties

et al. 2012

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Abstract. Pellets intended for oral dosing are frequently produced via extrusion/spheronization followed by drying. Typically, the last active process step, i.e., drying, is assumed to have little effect on the final dosage form properties (e.g., dissolution characteristics). Thus, there exist only a few studies of this subject. In the present study, calcium stearate/ibuprofen pellets were used as model system to investigate the impact of the drying conditions. Lipophilic calcium stearate matrix pellets containing 20% ibuprofen were prepared via wet extrusion/spheronization. Subsequently, desiccation, fluid-bed drying, and lyophilization were applied for granulation liquid removal. The impact of these drying techniques on the final pellet properties was evaluated. The in vitro dissolution behavior was dramatically altered by the drying techniques that were considered. The investigated pellets showed drug release rates that varied as much as 100%. As no polymorphic transitions occurred during drying, we focused on two possible explanations: (a) a change in the drug distribution within the pellets and (b) a change in pellet micro-structure (porosity, pore size). The ibuprofen distribution proved to be homogeneous regardless of the drying conditions. Pellet porosity and pore sizes, however, were modified by the drying process. Our results clearly demonstrate that a single process step, such as drying, can play a crucial role in achieving desired pellet properties and release profiles.

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“…In comparison to the number of studies reported on the phase transformations during other unit operations (e.g. milling (24), granulation (25) and drying (26)), reported work on the compactionrelated phase transformations is limited so far. In particular, a systematic investigation of the effect of compaction on hydrate forms of pharmaceutical substances is lacking.…”

Section: Introductionmentioning

confidence: 97%

Investigation of Solid Phase Composition on Tablet Surfaces by Grazing Incidence X-ray Diffraction

et al. 2011

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Phase transformations of erythromycin A dihydrate during pelletisation and drying

Cited by 18 publications

References 16 publications

Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes

Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes

Ibuprofen-Loaded Calcium Stearate Pellets: Drying-Induced Variations in Dosage Form Properties

Investigation of Solid Phase Composition on Tablet Surfaces by Grazing Incidence X-ray Diffraction

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