Fractional factorial designs for optimizing experimental conditions for Hiestand's Indices of Tableting Performance

Venkatesh, Gopi; Coleman, Jo Ann N.; Wrzosek, Tom J.; Duddu, Sarma P.; Palepu, Nagesh R.; Bandyopadhyay, Rebanta; Grant, David J.W.

doi:10.1016/s0032-5910(98)00007-2

Cited by 12 publications

(5 citation statements)

References 6 publications

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“…Statistical approaches using factorial designs have been employed to identify experimental conditions that can differentiate materials based on the tableting indices. These have included indenter specifications, compact size, and storage time, but the type of material (deformation behavior) has been the primary determinant of differentiation . The application of DTI to characterize powder compaction behavior by various methods has shown mixed results.…”

Section: Introductionmentioning

confidence: 99%

“…These have included indenter specifications, compact size, and storage time, but the type of material (deformation behavior) has been the primary determinant of differentiation. 14 The application of DTI to characterize powder compaction behavior by various methods has shown mixed results. The indices have been compared with that of Luenberger's percolation theory using different excipients with brittle or plastic characteristics.…”

Section: Introductionmentioning

confidence: 99%

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The Impact of Hot Melt Extrusion and Spray Drying on Mechanical Properties and Tableting Indices of Materials Used in Pharmaceutical Development

Iyer

Hegde

Zhang

et al. 2013

Journal of Pharmaceutical Sciences

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The impact of melt extrusion (HME) and spray drying (SD) on mechanical properties of hypromellose acetate succinate (HPMCAS), copovidone, and their formulated blends was studied and compared with that of reference excipients. Tensile strength (TS), compression pressure (CP), elastic modulus (E), and dynamic hardness (Hd ) were determined along with Hiestand indices using compacts prepared at a solid fraction of ∼0.85. HPMCAS and copovidone exhibited lower Hd , lower CP, and lower E than the reference excipients and moderate TS. HPMCAS was found to be highly brittle based on brittle fracture index values. The CP was 24% and 61% higher for HPMCAS after SD and HME, respectively, than for unprocessed material along with a higher Hd . Furthermore, the TS of HPMCAS and copovidone decreased upon HME. Upon blending melt-extruded HPMCAS with plastic materials such as microcrystalline cellulose, the TS increased. These results suggest that SD and HME could impact reworkability by reducing deformation of materials and in case of HME, likely by increasing density due to heating and shear stress in a screw extruder. A somewhat similar effect was observed for the dynamic binding index (BId ) of the excipients and formulated blends. Such data can be used to quantitate the impact of processing on mechanical properties of materials during tablet formulation development.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The Impact of Hot Melt Extrusion and Spray Drying on Mechanical Properties and Tableting Indices of Materials Used in Pharmaceutical Development

Iyer

Hegde

Zhang

et al. 2013

Journal of Pharmaceutical Sciences

View full text Add to dashboard Cite

show abstract

“…The center points were added to the design to investigate the reproducibility, random error of the experiments, [19] and nonlinearity and to provide additional degrees of freedom (df) for the estimation of error variance. [20] A 2 n factorial design is the simplest type of factorial design as it uses two levels and thereby reduces the number of required experimental conditions. In a 2-level n-factor system, training data have to be selected so that they lie at each of the corners of n dimensional space.…”

Section: Design Of Experiments (Doe)mentioning

confidence: 99%

Microstructural and Statistical Study of Semisolid Casting of 6061 Alloy Using a Miniature Cooling Slope

Hajihashemi

Niroumand

Shamanian

2014

Metall Mater Trans B

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Preparation of metallic semisolid slurries using the cooling slope method is increasingly becoming popular because of the simplicity of design and control of the process. Microstructural features of the resultant semisolid castings such as size and sphericity of the primary particles are affected by several processing parameters such as pouring rate, cooling slope surface angle and length as well as the melt superheat. In this work, a miniature cooling slope for semisolid casting of small parts was built and attempts were made to develop an empirical relationship showing the correlation between the sphericity of the microstructure of semisolid cast 6061-aluminum alloy and the processing variables. The relationships were developed by a two-level factorial method. The results showed that the interaction of cooling slope length and pouring rate factors had the most effect on the sphericity of the final semisolid cast microstructure.

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“…With the aid of ANOVA a formulation with a fast dissolution time was found and tested. Venkatesh et al [33] implemented three fractional factorial designs. The objective was to identify experimental conditions that maximize the differentiation between materials in terms of their characteristics determined by Hiestand's indices of tableting performance.…”

Section: Multivariate Designmentioning

confidence: 99%

Multivariate methods in pharmaceutical applications

Gabrielsson

Lindberg

Lundstedt

2002

Journal of Chemometrics

182

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This review covers material published within the field of pharmacy in the last five years. Articles concerning experimental design, optimization and applications of multivariate techniques have been published, from factorial designs to multivariate data analysis, and the combination of the two in multivariate design. The number of publications on this topic testifies to the good results obtained in the studies. Much of the published material highlights the usefulness of experimental design, with many articles dealing with optimization, where much effort is spent on getting useful results. Examples of multivariate data analysis are comparatively few, but these methods are gaining in use. The employment of multivariate techniques in different applications has been reviewed. The examples in this review represent just a few of the possible applications with different aims within pharmaceutical applications. A number of companies are using experimental design as a standard tool in preformulation and in combination with response surface modeling. The properties of e.g. a tablet can be optimized to fulfill a well-specified aim such as a specific release profile, hardness, disintegration time etc. However, none of the companies apply multivariate methods in all steps of the drug development process. As this is still very much a growing field, it is only a question of time before experimental design, optimization and multivariate data analysis are implemented throughout the entire formulation process, from performulation to multivariate process control.

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Fractional factorial designs for optimizing experimental conditions for Hiestand's Indices of Tableting Performance

Cited by 12 publications

References 6 publications

The Impact of Hot Melt Extrusion and Spray Drying on Mechanical Properties and Tableting Indices of Materials Used in Pharmaceutical Development

The Impact of Hot Melt Extrusion and Spray Drying on Mechanical Properties and Tableting Indices of Materials Used in Pharmaceutical Development

Microstructural and Statistical Study of Semisolid Casting of 6061 Alloy Using a Miniature Cooling Slope

Multivariate methods in pharmaceutical applications

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