Time Dependence of Elastic Recovery for Characterization of Tableting Materials

Picker, Katharina M.

doi:10.1081/pdt-100000014

Cited by 60 publications

(30 citation statements)

References 19 publications

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“…11). Radial dimension changes were negligible compared to the axial changes, as expected since pressure is applied in axial direction during compression (Haware et al, 2010;Picker, 2001).…”

Section: Tablet Axial Recovery Over Timesupporting

confidence: 61%

In-line monitoring of compaction properties on a rotary tablet press during tablet manufacturing of hot-melt extruded amorphous solid dispersions

Grymonpré

Verstraete

Bockstal

et al. 2017

International Journal of Pharmaceutics

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As the number of applications for polymers in pharmaceutical development is increasing, there is need for fundamental understanding on how such compounds behave during tableting. This research is focussed on the tableting behaviour of amorphous polymers, their solid dispersions and the impact of hot-melt extrusion on the compaction properties of these materials. Soluplus, Kollidon VA 64 and Eudragit EPO were selected as amorphous polymers since these are widely studied carriers for solid dispersions, while Celecoxib was chosen as BCS class II model drug. Neat polymers and physical mixtures (up to 35% drug load) were processed by hot-melt extrusion (HME), milled and sieved to obtain powders with comparable particle sizes as the neat polymer. A novel approach was used for in-line analysis of the compaction properties on a rotary tablet press (Modul P, GEA) using complementary sensors and software (CDAAS, GEA). By combining 'in-die' and 'out-of-die' techniques, it was possible to investigate in a comprehensive way the impact of HME on the tableting behaviour of amorphous polymers and their formulations. The formation of stable glassy solutions altered the formulations towards more fragmentary behaviour under compression which was beneficial for the tabletability.Principal component analysis (PCA) was applied to summarize the behaviour during compaction of the formulations, enabling the selection of Soluplus and Kollidon VA 64 as the most favourable polymers for compaction of glassy solutions.

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“…11). Radial dimension changes were negligible compared to the axial changes, as expected since pressure is applied in axial direction during compression (Haware et al, 2010;Picker, 2001).…”

Section: Tablet Axial Recovery Over Timesupporting

confidence: 61%

In-line monitoring of compaction properties on a rotary tablet press during tablet manufacturing of hot-melt extruded amorphous solid dispersions

Grymonpré

Verstraete

Bockstal

et al. 2017

International Journal of Pharmaceutics

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“…Since elastic recovery is typically most pronounced in the axial than radial directions (20), the above observations could be partially attributed to the variation in tablet core thickness being more evident at the tablet face. This was further substantiated by the greater standard deviation of tablet core thickness when compared to tablet core length or breadth prior to coating (Table IV).…”

Section: Screeningmentioning

confidence: 91%

Optimization of Process Parameters for a Quasi-Continuous Tablet Coating System Using Design of Experiments

2010

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Abstract. The aim of this study was to identify and optimize the critical process parameters of the newly developed Supercell quasi-continuous coater for optimal tablet coat quality. Design of experiments, aided by multivariate analysis techniques, was used to quantify the effects of various coating process conditions and their interactions on the quality of film-coated tablets. The process parameters varied included batch size, inlet temperature, atomizing pressure, plenum pressure, spray rate and coating level. An initial screening stage was carried out using a 2 6−1(IV) fractional factorial design. Following these preliminary experiments, optimization study was carried out using the Box-Behnken design. Main response variables measured included drug-loading efficiency, coat thickness variation, and the extent of tablet damage. Apparent optimum conditions were determined by using response surface plots. The process parameters exerted various effects on the different response variables. Hence, trade-offs between individual optima were necessary to obtain the best compromised set of conditions. The adequacy of the optimized process conditions in meeting the combined goals for all responses was indicated by the composite desirability value. By using response surface methodology and optimization, coating conditions which produced coated tablets of high drug-loading efficiency, low incidences of tablet damage and low coat thickness variation were defined. Optimal conditions were found to vary over a large spectrum when different responses were considered. Changes in processing parameters across the design space did not result in drastic changes to coat quality, thereby demonstrating robustness in the Supercell coating process.

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“…High-pressure zones within the compact were expected to show more expansion than low-pressure zones. Therefore, it is generally well accepted that the radial recovery is less extensive than axial recovery due to the axial nature of compaction (10,24). Consequently, most studies had focused on evaluating changes in tablet height post-compaction.…”

Section: Tablet Dimensional Changes Post-compactionmentioning

confidence: 99%

“…Typical analytical methods to measure tablet dimensional changes utilize the micrometer screw gauge (10,21), thermomechanical analysis (10), or linear voltage displacement transducer (8,22). An ideal analytical technique to measure gradual tablet recovery by dimensional measurements should be contactless, continuous, and convenient.…”

Section: Tablet Dimensional Changes Post-compactionmentioning

confidence: 99%

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A Study on In-Line Tablet Coating—the Influence of Compaction and Coating on Tablet Dimensional Changes

et al. 2012

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Abstract. Prior to coating, tablets are usually stored for a definite period to enable complete strain recovery and prevent subsequent volumetric expansion-related coating defects. In-line coating is defined as the coating of tablets immediately after compaction. In-line coating will be expected to improve manufacturing efficiencies. In this study, the possibility of in-line coating was studied by evaluating the influence of compaction and coating on tablet dimensional changes. The use of tapered dies for compaction was also evaluated. Two types of tablet coaters which presented different coating environments, namely the Supercell™ coater and pan coater, were employed for coating. The extent of tablet dimensional changes was studied in real time using optical laser sensors in a controlled environment. After compaction, tablet dimensional changes were found to be anisotropic. In contrast, coating resulted in isotropic volume expansion in both the axial and radial directions. Pan coating resulted in significantly greater tablet dimensional changes compared to Supercell™ coating. There was no significant difference in dimensional changes of tablets coated in line or after complete viscoelastic strain recovery for Supercell™ coating. However, significantly different dimensional changes were observed for pan coating. The use of tapered dies during compaction was found to result in more rapid viscoelastic strain recovery and also significantly reduced tablet dimensional changes when tablets were immediately coated after compaction using the pan coater. In conclusion, the Supercell™ coater appeared to be more suitable for in-line tablet coating, while tapered dies were beneficial in reducing tablet dimensional changes when the pan coater was employed for in-line coating.

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Time Dependence of Elastic Recovery for Characterization of Tableting Materials

Cited by 60 publications

References 19 publications

In-line monitoring of compaction properties on a rotary tablet press during tablet manufacturing of hot-melt extruded amorphous solid dispersions

In-line monitoring of compaction properties on a rotary tablet press during tablet manufacturing of hot-melt extruded amorphous solid dispersions

Optimization of Process Parameters for a Quasi-Continuous Tablet Coating System Using Design of Experiments

A Study on In-Line Tablet Coating—the Influence of Compaction and Coating on Tablet Dimensional Changes

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