HomePublications

A multi-technique characterization of the stability of surfactant containing solid dispersion based buccal patches prepared by hot melt injection moulding

Research output: Contribution to journalArticle

Standard

Harvard

APA

Vancouver

Author

Bibtex- Download

@article{707f5baa3b8f4b12a54012598ff8983b,
title = "A multi-technique characterization of the stability of surfactant containing solid dispersion based buccal patches prepared by hot melt injection moulding",
abstract = "This study investigates the stability of typically complex multi-component hydrophilic solid dispersions that could be used in a clinical application. Felodipine solid dispersions in two types of blends consisting of PEG, PEO and Tween 80 or Vit E TPGS were prepared by hot melt-injection moulding (HMIM) across a range of drug loadings and subjected to a range of storage conditions. Microscopy, thermal analysis, spectroscopy and powder X-ray diffraction were used to characterize the systems. The semi-solid surfactant TPGS showed a better solubilizing effect on the drug than the liquid surfactant Tween 80 in the fresh state and offered some degree of protection over the chemical degradation of PEG/PEO. Better storage stability was observed for the systems with low drug loading. Crystallization of a new metastable polymorphic form of felodipine in the patches with drug loadings at and above the saturation point was observed. Quantitative comparison of the data sets was achieved by a normalisation process and calculation of statistical variance. TPGS containing patches were more sensitive to the aging process than Tween containing patches. For both surfactants, such instability is more responsive to the storage temperature than humidity. This study established a methodology for probing the complex stabilities of multi-component dispersions.",
keywords = "Hot melt extrusion, injection moulding, surfactants, solid dispersions, physical stability, polymorph",
author = "Muqdad Alhijjaj and Peter Belton and Sheng Qi",
year = "2017",
month = "8",
day = "7",
doi = "10.1016/j.ijpharm.2017.06.048",
language = "English",
volume = "528",
pages = "547–562",
journal = "International Journal of Pharmaceutics",
issn = "0378-5173",
publisher = "Elsevier",
number = "1-2",

}

RIS (suitable for import to EndNote) - Download

TY - JOUR

T1 - A multi-technique characterization of the stability of surfactant containing solid dispersion based buccal patches prepared by hot melt injection moulding

AU - Alhijjaj, Muqdad

AU - Belton, Peter

AU - Qi, Sheng

PY - 2017/8/7

Y1 - 2017/8/7

N2 - This study investigates the stability of typically complex multi-component hydrophilic solid dispersions that could be used in a clinical application. Felodipine solid dispersions in two types of blends consisting of PEG, PEO and Tween 80 or Vit E TPGS were prepared by hot melt-injection moulding (HMIM) across a range of drug loadings and subjected to a range of storage conditions. Microscopy, thermal analysis, spectroscopy and powder X-ray diffraction were used to characterize the systems. The semi-solid surfactant TPGS showed a better solubilizing effect on the drug than the liquid surfactant Tween 80 in the fresh state and offered some degree of protection over the chemical degradation of PEG/PEO. Better storage stability was observed for the systems with low drug loading. Crystallization of a new metastable polymorphic form of felodipine in the patches with drug loadings at and above the saturation point was observed. Quantitative comparison of the data sets was achieved by a normalisation process and calculation of statistical variance. TPGS containing patches were more sensitive to the aging process than Tween containing patches. For both surfactants, such instability is more responsive to the storage temperature than humidity. This study established a methodology for probing the complex stabilities of multi-component dispersions.

AB - This study investigates the stability of typically complex multi-component hydrophilic solid dispersions that could be used in a clinical application. Felodipine solid dispersions in two types of blends consisting of PEG, PEO and Tween 80 or Vit E TPGS were prepared by hot melt-injection moulding (HMIM) across a range of drug loadings and subjected to a range of storage conditions. Microscopy, thermal analysis, spectroscopy and powder X-ray diffraction were used to characterize the systems. The semi-solid surfactant TPGS showed a better solubilizing effect on the drug than the liquid surfactant Tween 80 in the fresh state and offered some degree of protection over the chemical degradation of PEG/PEO. Better storage stability was observed for the systems with low drug loading. Crystallization of a new metastable polymorphic form of felodipine in the patches with drug loadings at and above the saturation point was observed. Quantitative comparison of the data sets was achieved by a normalisation process and calculation of statistical variance. TPGS containing patches were more sensitive to the aging process than Tween containing patches. For both surfactants, such instability is more responsive to the storage temperature than humidity. This study established a methodology for probing the complex stabilities of multi-component dispersions.

KW - Hot melt extrusion

KW - injection moulding

KW - surfactants

KW - solid dispersions

KW - physical stability

KW - polymorph

U2 - 10.1016/j.ijpharm.2017.06.048

DO - 10.1016/j.ijpharm.2017.06.048

M3 - Article

VL - 528

SP - 547

EP - 562

JO - International Journal of Pharmaceutics

JF - International Journal of Pharmaceutics

SN - 0378-5173

IS - 1-2

ER -

ID: 112962876