Process optimization of twin-screw melt granulation of fenofibrate using design of experiment (DoE)

Mamidi, Hemanth K.; Palekar, Siddhant; Nukala, Pavan Kumar; Mishra, Saurabh M.; Patki, Manali; Fu, Yige; Supner, Piyush; Chauhan, Gautam; Patel, Ketan

doi:10.1016/j.ijpharm.2020.120101

Cited by 29 publications

(16 citation statements)

References 44 publications

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“…Bagley et al 28 introduced the concept of combined solubility parameter, d v , that was based on the thermodynamic considerations that dispersion forces, d d , and polar forces, d p , show a similar effect, whereas the effect of hydrogen bonding forces, d h , is different. The combined value of the solubility parameter may be calculated using Equation (4).…”

Section: Construction Of Bagley Plotmentioning

confidence: 99%

Application of Thermodynamic Phase Diagrams and Gibbs Free Energy of Mixing for Screening of Polymers for Their Use in Amorphous Solid Dispersion Formulation of a Non-Glass-Forming Drug

Mamidi

Rohera

2021

Journal of Pharmaceutical Sciences

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The objective of the present investigations was to assess the use of thermodynamic phase diagrams and the Gibbs free energy of mixing, DG mix , for the screening of the polymeric carriers by determining the ideal drug-loading for an amorphous solid dispersion formulation and optimum processing temperature for the hot-melt extrusion of a non-glass-forming drug. Mefenamic acid (MFA) was used as a model nonglass-forming drug and four chemically distinct polymers with close values of the solubility parameters, viz. Kollidon® VA64, Soluplus®, Pluronic® F68, and Eudragit® EPO, were used as carriers. The thermodynamic phase diagrams were constructed using the melting point depression data, Flory-Huggins theory, and Gordan-Taylor equation. The Gibbs free energy of mixing was estimated using the values of the drug-polymer interaction parameter, c, and Flory-Huggins theory. The rank order miscibility of MFA in the four polymeric carriers estimated based on the difference in the values of their solubility parameters, Dd, did not correlate well with the thermodynamic phase diagrams and Gibbs free energy plots. The study highlights the limitation of using the solubility parameter method in screening the polymeric carriers for poorly glass-forming drugs and reiterates the applicability of thermodynamic phase diagrams and Gibbs free energy plots in determining the ideal drug-loading and optimum processing temperature for hot-melt extrusion.

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Section: Construction Of Bagley Plotmentioning

confidence: 99%

Application of Thermodynamic Phase Diagrams and Gibbs Free Energy of Mixing for Screening of Polymers for Their Use in Amorphous Solid Dispersion Formulation of a Non-Glass-Forming Drug

Mamidi

Rohera

2021

Journal of Pharmaceutical Sciences

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“…Other solid surfactants with low melting points have been used for melt processing of poorly soluble compounds, including Vitamin E tocopherol polyethylene glycol succinate (TPGS) [ 101 ] and sucrose laurate [ 102 ].…”

Section: Applications Of Twin-screw Melt Granulationmentioning

confidence: 99%

Twin-Screw Melt Granulation for Oral Solid Pharmaceutical Products

2021

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This article highlights the advantages of pharmaceutical continuous melt granulation by twin-screw extrusion. The different melt granulation process options and excipients are described and compared, and a case is made for expanded use of twin-screw melt granulation since it is a flexible and continuous process. Methods for binder selection are profiled with a focus on rheology and physical stability impacts. For twin-screw melt granulation, the mechanism of granulation and process impact on granule properties are described. Pharmaceutical applications of melt granulation ranging from immediate release of soluble and insoluble APIs, taste-masking, and sustained release formulation are reviewed, demonstrating the range of possibilities afforded by twin-screw melt granulation.

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“…The region of the optimal response surface can be represented by contour plots. And, contour plots are representations of the interactions of factors or parameters for a given response and are illustrated in 2D-Contour Plots or 3D-Contour Plots (Mamidi et al, 2021;Denrah and Sarkar, 2019;Politis et al, 2017).…”

Section: Theoretical Backgroundmentioning

confidence: 99%

Thermal treatment process of PET bottles filaments using industrial design of experiments

Cotrim

Machado

Leal

et al. 2021

IJPPM

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PurposeThe purpose of this paper is to present the application of Design of Experiments techniques for the analysis of operating parameters of an industrial oven for the heat treatment process of polyethylene terephthalate (PET) bottle filaments.Design/methodology/approachThe focus is on evaluating new ways of operating the transformation process. The main issue is to raise what are the variables interfering with the performance of the oven. The complete 2k factorial for three factors of control was used to analyze the behavior of these variables and their relationships in the specific response parameter for the process.FindingsThe results presented in this work allow the company to have greater knowledge about the operation of the equipment. The study showed possibilities of 14.8% energy reduction.Research limitations/implicationsThe heat treatment activity was characterized as a critical point in the production process, and techniques with empirical approaches, based on statistical techniques, was an opportunity that the company has to improve the execution of activities without major investments for the quality of the final product. The application of statistical quality techniques showed to be very promising.Originality/valueThe fact that the study was conducted using subjective quality performance makes this work different from others presented in the literature, showing the possibility to apply Design of Experiments using main control factors based on the opinion of experienced personnel involved in the process analyzed.

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Process optimization of twin-screw melt granulation of fenofibrate using design of experiment (DoE)

Cited by 29 publications

References 44 publications

Application of Thermodynamic Phase Diagrams and Gibbs Free Energy of Mixing for Screening of Polymers for Their Use in Amorphous Solid Dispersion Formulation of a Non-Glass-Forming Drug

Application of Thermodynamic Phase Diagrams and Gibbs Free Energy of Mixing for Screening of Polymers for Their Use in Amorphous Solid Dispersion Formulation of a Non-Glass-Forming Drug

Twin-Screw Melt Granulation for Oral Solid Pharmaceutical Products

Thermal treatment process of PET bottles filaments using industrial design of experiments

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