A combined mathematical model linking the formation of amorphous solid dispersions with hot-melt-extrusion process parameters

[Display omitted] Hot-melt extrusion allows for the continuous production of amorphous solid dispersions, which are used to enhance bioavailability of poorly soluble drugs in pharmaceutical drug delivery. To facilitate formulation and extrusion process development, we propose a mathematical model de...

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Published inEuropean journal of pharmaceutics and biopharmaceutics Vol. 132; pp. 127 - 145
Main Authors Schittny, A., Ogawa, H., Huwyler, J., Puchkov, M.
Format Journal Article
LanguageEnglish
Published Netherlands Elsevier B.V 01.11.2018
Subjects
Amorphous solid dispersion
Bioavailability
Chemistry, Pharmaceutical - methods
Drug Compounding - methods
Drug Delivery Systems
Drug Development - methods
Formulation development
Hot Temperature
Hot-melt extrusion
Models, Theoretical
Pharmaceutical Preparations - administration & dosage
Pharmaceutical Preparations - chemistry
Polymers - chemistry
Poorly water-soluble drugs
Process modeling
Solubility
Hot-melt extrusion
Formulation development
Amorphous solid dispersion
Poorly water-soluble drugs
Process modeling
Bioavailability
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Abstract [Display omitted] Hot-melt extrusion allows for the continuous production of amorphous solid dispersions, which are used to enhance bioavailability of poorly soluble drugs in pharmaceutical drug delivery. To facilitate formulation and extrusion process development, we propose a mathematical model describing the formation of amorphous solid dispersions in the context of this process. The model is based on the calculation of two key process values: (1) time to dissolution of solid drug particles in molten polymer during extrusion and (2) mean residence of material in the extruder. We suggest that their linking allows for rational process design. Experimental data support the validity of our model for both key process values as well as the overall process. This modeling approach allows for fast and cost-effective formulation and extrusion process development as well as feasibility estimations in early stages of drug development.
AbstractList [Display omitted] Hot-melt extrusion allows for the continuous production of amorphous solid dispersions, which are used to enhance bioavailability of poorly soluble drugs in pharmaceutical drug delivery. To facilitate formulation and extrusion process development, we propose a mathematical model describing the formation of amorphous solid dispersions in the context of this process. The model is based on the calculation of two key process values: (1) time to dissolution of solid drug particles in molten polymer during extrusion and (2) mean residence of material in the extruder. We suggest that their linking allows for rational process design. Experimental data support the validity of our model for both key process values as well as the overall process. This modeling approach allows for fast and cost-effective formulation and extrusion process development as well as feasibility estimations in early stages of drug development.
Hot-melt extrusion allows for the continuous production of amorphous solid dispersions, which are used to enhance bioavailability of poorly soluble drugs in pharmaceutical drug delivery. To facilitate formulation and extrusion process development, we propose a mathematical model describing the formation of amorphous solid dispersions in the context of this process. The model is based on the calculation of two key process values: (1) time to dissolution of solid drug particles in molten polymer during extrusion and (2) mean residence of material in the extruder. We suggest that their linking allows for rational process design. Experimental data support the validity of our model for both key process values as well as the overall process. This modeling approach allows for fast and cost-effective formulation and extrusion process development as well as feasibility estimations in early stages of drug development.
Author Schittny, A.
Ogawa, H.
Huwyler, J.
Puchkov, M.
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Keywords Hot-melt extrusion
Formulation development
Amorphous solid dispersion
Poorly water-soluble drugs
Process modeling
Bioavailability
Language English
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Snippet [Display omitted] Hot-melt extrusion allows for the continuous production of amorphous solid dispersions, which are used to enhance bioavailability of poorly...
Hot-melt extrusion allows for the continuous production of amorphous solid dispersions, which are used to enhance bioavailability of poorly soluble drugs in...
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SubjectTerms Amorphous solid dispersion
Bioavailability
Chemistry, Pharmaceutical - methods
Drug Compounding - methods
Drug Delivery Systems
Drug Development - methods
Formulation development
Hot Temperature
Hot-melt extrusion
Models, Theoretical
Pharmaceutical Preparations - administration & dosage
Pharmaceutical Preparations - chemistry
Polymers - chemistry
Poorly water-soluble drugs
Process modeling
Solubility
Title A combined mathematical model linking the formation of amorphous solid dispersions with hot-melt-extrusion process parameters
URI https://dx.doi.org/10.1016/j.ejpb.2018.09.011
https://www.ncbi.nlm.nih.gov/pubmed/30240820
https://search.proquest.com/docview/2111143719
Volume 132
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