A high throughput platform for understanding the influence of excipients on physical and chemical stability

Research output: Contribution to journalJournal articleResearchpeer-review

Standard

A high throughput platform for understanding the influence of excipients on physical and chemical stability. / Raijada, Dhara; Cornett, Claus; Rantanen, Jukka; Raijada, Dharaben Kaushikkumar.

In: International Journal of Pharmaceutics, Vol. 453, No. 1, 30.08.2013, p. 285-92.

Research output: Contribution to journalJournal articleResearchpeer-review

Harvard

Raijada, D, Cornett, C, Rantanen, J & Raijada, DK 2013, 'A high throughput platform for understanding the influence of excipients on physical and chemical stability', International Journal of Pharmaceutics, vol. 453, no. 1, pp. 285-92. https://doi.org/10.1016/j.ijpharm.2012.08.025

APA

Raijada, D., Cornett, C., Rantanen, J., & Raijada, D. K. (2013). A high throughput platform for understanding the influence of excipients on physical and chemical stability. International Journal of Pharmaceutics, 453(1), 285-92. https://doi.org/10.1016/j.ijpharm.2012.08.025

Vancouver

Raijada D, Cornett C, Rantanen J, Raijada DK. A high throughput platform for understanding the influence of excipients on physical and chemical stability. International Journal of Pharmaceutics. 2013 Aug 30;453(1):285-92. https://doi.org/10.1016/j.ijpharm.2012.08.025

Author

Raijada, Dhara ; Cornett, Claus ; Rantanen, Jukka ; Raijada, Dharaben Kaushikkumar. / A high throughput platform for understanding the influence of excipients on physical and chemical stability. In: International Journal of Pharmaceutics. 2013 ; Vol. 453, No. 1. pp. 285-92.

Bibtex

@article{f458783ddafd48d79cef695fddbb7123,
title = "A high throughput platform for understanding the influence of excipients on physical and chemical stability",
abstract = "The present study puts forward a miniaturized high-throughput platform to understand influence of excipient selection and processing on the stability of a given drug compound. Four model drugs (sodium naproxen, theophylline, amlodipine besylate and nitrofurantoin) and ten different excipients were selected. Binary physical mixtures of drug and excipient were transferred to a 96-well plate followed by addition of water to simulate aqueous granulation environment. The plate was subjected for XRPD measurements followed by drying and subsequent XRPD and HPLC measurements of the dried samples. Excipients with different water sorbing potential were found to influence distinctly on the phase transformation behaviour of each drug. Moreover, the amount of water addition was also a critical factor affecting phase transformation behaviour. HPLC analysis revealed one of the drug:excipient pairs with a tendency for chemical degradation. The proposed high-throughput platform can be used during early drug development to simulate typical processing induced stress in a small scale and to understand possible phase transformation behaviour and influence of excipients on this.",
keywords = "Chemistry, Pharmaceutical, Drug Stability, Excipients, Naproxen, Nitrofurantoin, Powder Diffraction, Theophylline, Water, X-Ray Diffraction",
author = "Dhara Raijada and Claus Cornett and Jukka Rantanen and Raijada, {Dharaben Kaushikkumar}",
note = "Copyright {\circledC} 2012 Elsevier B.V. All rights reserved.",
year = "2013",
month = "8",
day = "30",
doi = "10.1016/j.ijpharm.2012.08.025",
language = "English",
volume = "453",
pages = "285--92",
journal = "International Journal of Pharmaceutics",
issn = "0378-5173",
publisher = "Elsevier",
number = "1",

}

RIS

TY - JOUR

T1 - A high throughput platform for understanding the influence of excipients on physical and chemical stability

AU - Raijada, Dhara

AU - Cornett, Claus

AU - Rantanen, Jukka

AU - Raijada, Dharaben Kaushikkumar

N1 - Copyright © 2012 Elsevier B.V. All rights reserved.

PY - 2013/8/30

Y1 - 2013/8/30

N2 - The present study puts forward a miniaturized high-throughput platform to understand influence of excipient selection and processing on the stability of a given drug compound. Four model drugs (sodium naproxen, theophylline, amlodipine besylate and nitrofurantoin) and ten different excipients were selected. Binary physical mixtures of drug and excipient were transferred to a 96-well plate followed by addition of water to simulate aqueous granulation environment. The plate was subjected for XRPD measurements followed by drying and subsequent XRPD and HPLC measurements of the dried samples. Excipients with different water sorbing potential were found to influence distinctly on the phase transformation behaviour of each drug. Moreover, the amount of water addition was also a critical factor affecting phase transformation behaviour. HPLC analysis revealed one of the drug:excipient pairs with a tendency for chemical degradation. The proposed high-throughput platform can be used during early drug development to simulate typical processing induced stress in a small scale and to understand possible phase transformation behaviour and influence of excipients on this.

AB - The present study puts forward a miniaturized high-throughput platform to understand influence of excipient selection and processing on the stability of a given drug compound. Four model drugs (sodium naproxen, theophylline, amlodipine besylate and nitrofurantoin) and ten different excipients were selected. Binary physical mixtures of drug and excipient were transferred to a 96-well plate followed by addition of water to simulate aqueous granulation environment. The plate was subjected for XRPD measurements followed by drying and subsequent XRPD and HPLC measurements of the dried samples. Excipients with different water sorbing potential were found to influence distinctly on the phase transformation behaviour of each drug. Moreover, the amount of water addition was also a critical factor affecting phase transformation behaviour. HPLC analysis revealed one of the drug:excipient pairs with a tendency for chemical degradation. The proposed high-throughput platform can be used during early drug development to simulate typical processing induced stress in a small scale and to understand possible phase transformation behaviour and influence of excipients on this.

KW - Chemistry, Pharmaceutical

KW - Drug Stability

KW - Excipients

KW - Naproxen

KW - Nitrofurantoin

KW - Powder Diffraction

KW - Theophylline

KW - Water

KW - X-Ray Diffraction

U2 - 10.1016/j.ijpharm.2012.08.025

DO - 10.1016/j.ijpharm.2012.08.025

M3 - Journal article

VL - 453

SP - 285

EP - 292

JO - International Journal of Pharmaceutics

JF - International Journal of Pharmaceutics

SN - 0378-5173

IS - 1

ER -

ID: 112847783