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Vegetable-derived magnesium stearate functionality evaluation by DM(3) approach.
Eur J Pharm Sci. 2016 Jun 30; 89:115-24.EJ

Abstract

This study quantifies the lubricating efficiency of two grades of crystalline vegetable-derived magnesium stearate (MgSt-V) using the DM(3) approach, which utilizes design of experiments (D) and multivariate analysis techniques (M3) to evaluate the effect of a material's (M1) molecular and macroscopic properties and manufacturing factors (M2) on critical product attributes. A 2(3) factorial design (2 continuous variables plus 1 categorical factor) with three center points for each categorical factor was used to evaluate the effect of MgSt-V fraction and blend time on running powder basic flow energy (BFE), tablet mechanical strength (TMS), disintegration time (DT), and running powder lubricant sensitivity ratio (LSR). Molecular characterization of MgSt-V employed moisture sorption-desorption analysis, (13)C nuclear magnetic resonance spectroscopy, thermal analysis, and powder X-ray diffraction. MgSt-V macroscopic analysis included mean particle size, specific surface area, particle morphology, and BFE. Principal component analysis and partial least squares multivariate analysis techniques were used to develop predictive qualitative and quantitative relationships between the molecular and macroscopic properties of MgSt-V grades, design variables, and resulting tablet formulation properties. MgSt-V fraction and blending time and their square effects showed statistical significant effects. Significant variation in the molecular and macroscopic properties of MgSt-V did not have a statistically significant impact on the studied product quality attributes (BFE, TMS, DT, and LSR). In setting excipient release specifications, functional testing may be appropriate in certain cases to assess the effect of statistically significant different molecular and macroscopic properties on product quality attributes.

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Publisher Full Text (DOI)

Authors+Show Affiliations

Haware RV
College of Pharmacy & Health Sciences, Campbell University, Buies Creek, NC 27506, USA.
Dave VS
St. John Fisher College, Wegmans School of Pharmacy, Rochester, NY 14618, USA.
Kakarala B
College of Pharmacy & Health Sciences, Campbell University, Buies Creek, NC 27506, USA.
Delaney S
College of Pharmacy, University of Kentucky, Lexington, KY 40536, USA.
Staton S
Pharmaceutical Education & Research Center (PERC), Campbell University, Buies Creek, NC 27506, USA.
Munson E
College of Pharmacy, University of Kentucky, Lexington, KY 40536, USA.
Gupta MR
College of Pharmacy & Health Sciences, Campbell University, Buies Creek, NC 27506, USA; Pharmaceutical Education & Research Center (PERC), Campbell University, Buies Creek, NC 27506, USA.
Stagner WC
College of Pharmacy & Health Sciences, Campbell University, Buies Creek, NC 27506, USA.

MeSH

Chemistry, PharmaceuticalExcipientsLubricantsLubricationParticle SizePowdersStearic AcidsTabletsVegetablesX-Ray Diffraction

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27108117

Citation

Haware, Rahul V., et al. "Vegetable-derived Magnesium Stearate Functionality Evaluation By DM(3) Approach." European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, vol. 89, 2016, pp. 115-24.
Haware RV, Dave VS, Kakarala B, et al. Vegetable-derived magnesium stearate functionality evaluation by DM(3) approach. Eur J Pharm Sci. 2016;89:115-24.
Haware, R. V., Dave, V. S., Kakarala, B., Delaney, S., Staton, S., Munson, E., Gupta, M. R., & Stagner, W. C. (2016). Vegetable-derived magnesium stearate functionality evaluation by DM(3) approach. European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences, 89, 115-24. https://doi.org/10.1016/j.ejps.2016.04.019
Haware RV, et al. Vegetable-derived Magnesium Stearate Functionality Evaluation By DM(3) Approach. Eur J Pharm Sci. 2016 Jun 30;89:115-24. PubMed PMID: 27108117.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Vegetable-derived magnesium stearate functionality evaluation by DM(3) approach. AU - Haware,Rahul V, AU - Dave,Vivek S, AU - Kakarala,Bhavyasri, AU - Delaney,Sean, AU - Staton,Scott, AU - Munson,Eric, AU - Gupta,Mali Ram, AU - Stagner,William C, Y1 - 2016/04/20/ PY - 2016/01/06/received PY - 2016/04/08/revised PY - 2016/04/17/accepted PY - 2016/4/25/entrez PY - 2016/4/25/pubmed PY - 2017/3/25/medline KW - Basic flow energy KW - Critical material attributes KW - DM(3) approach KW - Excipients KW - Functionality related characteristics KW - Lubricant sensitivity ratio KW - Material science KW - Multivariate analysis KW - Partial least squares regression (PLS) KW - Principal component analysis (PCA) KW - QbD KW - Solid state NMR KW - Thermal analysis SP - 115 EP - 24 JF - European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences JO - Eur J Pharm Sci VL - 89 N2 - This study quantifies the lubricating efficiency of two grades of crystalline vegetable-derived magnesium stearate (MgSt-V) using the DM(3) approach, which utilizes design of experiments (D) and multivariate analysis techniques (M3) to evaluate the effect of a material's (M1) molecular and macroscopic properties and manufacturing factors (M2) on critical product attributes. A 2(3) factorial design (2 continuous variables plus 1 categorical factor) with three center points for each categorical factor was used to evaluate the effect of MgSt-V fraction and blend time on running powder basic flow energy (BFE), tablet mechanical strength (TMS), disintegration time (DT), and running powder lubricant sensitivity ratio (LSR). Molecular characterization of MgSt-V employed moisture sorption-desorption analysis, (13)C nuclear magnetic resonance spectroscopy, thermal analysis, and powder X-ray diffraction. MgSt-V macroscopic analysis included mean particle size, specific surface area, particle morphology, and BFE. Principal component analysis and partial least squares multivariate analysis techniques were used to develop predictive qualitative and quantitative relationships between the molecular and macroscopic properties of MgSt-V grades, design variables, and resulting tablet formulation properties. MgSt-V fraction and blending time and their square effects showed statistical significant effects. Significant variation in the molecular and macroscopic properties of MgSt-V did not have a statistically significant impact on the studied product quality attributes (BFE, TMS, DT, and LSR). In setting excipient release specifications, functional testing may be appropriate in certain cases to assess the effect of statistically significant different molecular and macroscopic properties on product quality attributes. SN - 1879-0720 UR - https://www.unboundmedicine.com/medline/citation/27108117/Vegetable_derived_magnesium_stearate_functionality_evaluation_by_DM_3__approach_ DB - PRIME DP - Unbound Medicine ER -