Role of water in the physical stability of solid dosage formulations

Research output: Contribution to journalJournal articleResearchpeer-review

Standard

Role of water in the physical stability of solid dosage formulations. / Airaksinen, Sari; Karjalainen, Milja; Shevchenko, Anna; Westermarck, Sari; Leppänen, Ella; Rantanen, Jukka; Yliruusi, Jouko.

In: Journal of Pharmaceutical Sciences, Vol. 94, No. 10, 10.2005, p. 2147-65.

Research output: Contribution to journalJournal articleResearchpeer-review

Harvard

Airaksinen, S, Karjalainen, M, Shevchenko, A, Westermarck, S, Leppänen, E, Rantanen, J & Yliruusi, J 2005, 'Role of water in the physical stability of solid dosage formulations', Journal of Pharmaceutical Sciences, vol. 94, no. 10, pp. 2147-65. https://doi.org/10.1002/jps.20411

APA

Airaksinen, S., Karjalainen, M., Shevchenko, A., Westermarck, S., Leppänen, E., Rantanen, J., & Yliruusi, J. (2005). Role of water in the physical stability of solid dosage formulations. Journal of Pharmaceutical Sciences, 94(10), 2147-65. https://doi.org/10.1002/jps.20411

Vancouver

Airaksinen S, Karjalainen M, Shevchenko A, Westermarck S, Leppänen E, Rantanen J et al. Role of water in the physical stability of solid dosage formulations. Journal of Pharmaceutical Sciences. 2005 Oct;94(10):2147-65. https://doi.org/10.1002/jps.20411

Author

Airaksinen, Sari ; Karjalainen, Milja ; Shevchenko, Anna ; Westermarck, Sari ; Leppänen, Ella ; Rantanen, Jukka ; Yliruusi, Jouko. / Role of water in the physical stability of solid dosage formulations. In: Journal of Pharmaceutical Sciences. 2005 ; Vol. 94, No. 10. pp. 2147-65.

Bibtex

@article{f2762ce416e64f4cb6fba0b9683dfa8f,
title = "Role of water in the physical stability of solid dosage formulations",
abstract = "The interaction of moisture with pharmaceutical solids is highly crucial to an understanding of water-based processes, for example, manufacturing processes or prediction of solid dosage form stability and shelf life. Both the active pharmaceutical ingredient (API) and excipients in the formulation have different moisture sorption properties that can result in unexpected processing-induced phase transitions and they can affect solid-state phase transitions in the final dosage forms. The character of excipient effects on the stability of formulation. Phase transformations in formulations can lead to instability in physicochemical, biopharmaceutical, and processing properties of products. The aim of the present study was to investigate the water sorption properties of different excipients, model the sorption isotherms, examine the phase transitions, and identify differences of excipients in solid dosage form stability using dynamic vapor sorption analysis, near-infrared spectroscopy, and X-ray diffraction methods. The thermal processing was carried out with a variable temperature X-ray powder diffractometer to compare the dehydration behavior of wet excipients and evaluate solid-state properties during heating. These results showed that despite some limitations, moisture sorption isotherms of excipients are useful in predicting solid-state stability, interactions at early stages of formulation development, and effects of moisture on physicochemical properties of the final dosage forms.",
keywords = "Cellulose, Chemistry, Pharmaceutical, Crystallization, Desiccation, Drug Stability, Excipients, Microscopy, Electron, Scanning, Particle Size, Pharmaceutical Preparations, Phase Transition, Spectroscopy, Near-Infrared, Starch, Temperature, Time Factors, Water, X-Ray Diffraction",
author = "Sari Airaksinen and Milja Karjalainen and Anna Shevchenko and Sari Westermarck and Ella Lepp{\"a}nen and Jukka Rantanen and Jouko Yliruusi",
note = "Copyright (c) 2005 Wiley-Liss, Inc. and the American Pharmacists Association",
year = "2005",
month = "10",
doi = "10.1002/jps.20411",
language = "English",
volume = "94",
pages = "2147--65",
journal = "Journal of Pharmaceutical Sciences",
issn = "0022-3549",
publisher = "Elsevier",
number = "10",

}

RIS

TY - JOUR

T1 - Role of water in the physical stability of solid dosage formulations

AU - Airaksinen, Sari

AU - Karjalainen, Milja

AU - Shevchenko, Anna

AU - Westermarck, Sari

AU - Leppänen, Ella

AU - Rantanen, Jukka

AU - Yliruusi, Jouko

N1 - Copyright (c) 2005 Wiley-Liss, Inc. and the American Pharmacists Association

PY - 2005/10

Y1 - 2005/10

N2 - The interaction of moisture with pharmaceutical solids is highly crucial to an understanding of water-based processes, for example, manufacturing processes or prediction of solid dosage form stability and shelf life. Both the active pharmaceutical ingredient (API) and excipients in the formulation have different moisture sorption properties that can result in unexpected processing-induced phase transitions and they can affect solid-state phase transitions in the final dosage forms. The character of excipient effects on the stability of formulation. Phase transformations in formulations can lead to instability in physicochemical, biopharmaceutical, and processing properties of products. The aim of the present study was to investigate the water sorption properties of different excipients, model the sorption isotherms, examine the phase transitions, and identify differences of excipients in solid dosage form stability using dynamic vapor sorption analysis, near-infrared spectroscopy, and X-ray diffraction methods. The thermal processing was carried out with a variable temperature X-ray powder diffractometer to compare the dehydration behavior of wet excipients and evaluate solid-state properties during heating. These results showed that despite some limitations, moisture sorption isotherms of excipients are useful in predicting solid-state stability, interactions at early stages of formulation development, and effects of moisture on physicochemical properties of the final dosage forms.

AB - The interaction of moisture with pharmaceutical solids is highly crucial to an understanding of water-based processes, for example, manufacturing processes or prediction of solid dosage form stability and shelf life. Both the active pharmaceutical ingredient (API) and excipients in the formulation have different moisture sorption properties that can result in unexpected processing-induced phase transitions and they can affect solid-state phase transitions in the final dosage forms. The character of excipient effects on the stability of formulation. Phase transformations in formulations can lead to instability in physicochemical, biopharmaceutical, and processing properties of products. The aim of the present study was to investigate the water sorption properties of different excipients, model the sorption isotherms, examine the phase transitions, and identify differences of excipients in solid dosage form stability using dynamic vapor sorption analysis, near-infrared spectroscopy, and X-ray diffraction methods. The thermal processing was carried out with a variable temperature X-ray powder diffractometer to compare the dehydration behavior of wet excipients and evaluate solid-state properties during heating. These results showed that despite some limitations, moisture sorption isotherms of excipients are useful in predicting solid-state stability, interactions at early stages of formulation development, and effects of moisture on physicochemical properties of the final dosage forms.

KW - Cellulose

KW - Chemistry, Pharmaceutical

KW - Crystallization

KW - Desiccation

KW - Drug Stability

KW - Excipients

KW - Microscopy, Electron, Scanning

KW - Particle Size

KW - Pharmaceutical Preparations

KW - Phase Transition

KW - Spectroscopy, Near-Infrared

KW - Starch

KW - Temperature

KW - Time Factors

KW - Water

KW - X-Ray Diffraction

U2 - 10.1002/jps.20411

DO - 10.1002/jps.20411

M3 - Journal article

C2 - 16136577

VL - 94

SP - 2147

EP - 2165

JO - Journal of Pharmaceutical Sciences

JF - Journal of Pharmaceutical Sciences

SN - 0022-3549

IS - 10

ER -

ID: 140621813