Evaluation of the solid state form of tadalafil in sub-micron thin films using nanomechanical infrared spectroscopy

Fatemeh Samaeifar; Andrea Casci Ceccacci; Sanjukta Bose Goswami; Line Hagner Nielsen; Ahmad Afifi; Kinga Zór; Anja Boisen

doi:10.1016/j.ijpharm.2019.05.010

Evaluation of the solid state form of tadalafil in sub-micron thin films using nanomechanical infrared spectroscopy

Int J Pharm. 2019 Jun 30:565:227-232. doi: 10.1016/j.ijpharm.2019.05.010. Epub 2019 May 9.

Authors

Fatemeh Samaeifar¹, Andrea Casci Ceccacci², Sanjukta Bose Goswami³, Line Hagner Nielsen⁴, Ahmad Afifi⁵, Kinga Zór⁶, Anja Boisen⁷

Affiliations

¹ The Danish National Research Foundation and Villum Foundation's Center for Intelligent Drug Delivery and Sensing Using Microcontainers and Nanomechanics (IDUN), Department of Micro- and Nanotechnology, Technical University of Denmark, Denmark; Department of Electrical and Computer Engineering, Malek Ashtar University of Technology, Tehran, Iran. Electronic address: fsamaeifar@yahoo.com.
² The Danish National Research Foundation and Villum Foundation's Center for Intelligent Drug Delivery and Sensing Using Microcontainers and Nanomechanics (IDUN), Department of Micro- and Nanotechnology, Technical University of Denmark, Denmark. Electronic address: acc@capres.com.
³ The Danish National Research Foundation and Villum Foundation's Center for Intelligent Drug Delivery and Sensing Using Microcontainers and Nanomechanics (IDUN), Department of Micro- and Nanotechnology, Technical University of Denmark, Denmark. Electronic address: sbos@nanotech.dtu.dk.
⁴ The Danish National Research Foundation and Villum Foundation's Center for Intelligent Drug Delivery and Sensing Using Microcontainers and Nanomechanics (IDUN), Department of Micro- and Nanotechnology, Technical University of Denmark, Denmark. Electronic address: lihan@nanotech.dtu.dk.
⁵ Department of Electrical and Computer Engineering, Malek Ashtar University of Technology, Tehran, Iran. Electronic address: afifi@mut.ac.ir.
⁶ The Danish National Research Foundation and Villum Foundation's Center for Intelligent Drug Delivery and Sensing Using Microcontainers and Nanomechanics (IDUN), Department of Micro- and Nanotechnology, Technical University of Denmark, Denmark. Electronic address: kinzo@nanotech.dtu.dk.
⁷ The Danish National Research Foundation and Villum Foundation's Center for Intelligent Drug Delivery and Sensing Using Microcontainers and Nanomechanics (IDUN), Department of Micro- and Nanotechnology, Technical University of Denmark, Denmark. Electronic address: anja.boisen@nanotech.dtu.dk.

PMID: 31077764
DOI: 10.1016/j.ijpharm.2019.05.010

Abstract

Assessing physical stability of drugs is important both in the development as well as in the production phase in the pharmaceutical industry. We used nanomechanical infrared (NAM-IR) spectroscopy based on photothermal response of a nanomechanical resonator, to investigate the solid state forms of tadalafil (TAD), under various storage conditions in sub-micron thin films. The amorphous TAD was stable, when kept at normal storage conditions of 24 °C, 45% relative humidity (RH) and shielded from light, however, it crystallized after four days when it was at stress storage conditions (40 °C, 70% RH, and direct sunlight). Additionally, we found that the signals recorded with NAM-IR were comparable with the attenuated total reflectance Fourier transform infrared spectroscopy (ATR-FTIR) and that NAM-IR proved to be a suitable and time efficient method when evaluating TAD in sub 500 nm layers.

Keywords: Amorphous; Crystalline; NAM-IR; Resonator; Tadalafil.

MeSH terms

Drug Delivery Systems*
Drug Stability
Drug Storage
Humidity
Phosphodiesterase 5 Inhibitors / chemistry*
Spectrophotometry, Infrared
Sunlight
Tadalafil / chemistry*
Temperature

Substances

Phosphodiesterase 5 Inhibitors
Tadalafil