Vol.:(0123456789)
Polymer Bulletin
https://doi.org/10.1007/s00289-018-2503-y
1 3
ORIGINAL PAPER
Design, characterization and evaluation of oral fast
dissolving polymeric flms of isradipine inclusion complex
Sayed H. Auda
1,2
· Abdullah H. Al‑Omrani
1
· Fars K. Alanazi
1
·
Mohamed M. Badran
1,3
· Faiyaz Shakeel
1
Received: 13 March 2018 / Revised: 8 August 2018 / Accepted: 27 August 2018
© Springer-Verlag GmbH Germany, part of Springer Nature 2018
Abstract
This study aimed to enhance the dissolution rate of isradipine and to avoid the
problem of frst-pass metabolism using oral fast dissolving flms (OFDFs). Isradi-
pine was complexed with hydroxypropyl-beta-cyclodextrin (HP-β-CD) using the
solvent co-evaporation technique to produce an isradipine inclusion complex with
increased solubility. This complex was evaluated for its solubility and dissolution
behavior compared with the free drug. Then, the inclusion complex was formulated
in OFDFs. The fabricated flms were evaluated for their drug content uniformity,
surface pH, thickness, tensile strength, percent elongation, disintegration time and
in vitro drug release profle. Additionally, Fourier transform infrared spectroscopy
and diferential scanning calorimetry were utilized to characterize the medicated
flms and the corresponding physical mixture as well as the individual components.
The results indicated that the inclusion complexation of isradipine enhances its sol-
ubility and dissolution rate. Films were found to be faint yellow, elastic, compat-
ible and palatable and to have acceptable tensile strength. The complexed drug with
HP-β-CD in the presence of a high level of disintegrants enhanced the drug dissolu-
tion compared to the plain flm.
Keywords Isradipine · Hydroxypropyl-β-cyclodextrin · Inclusion complex · Oral
fast dissolving flms · Polymers
* Faiyaz Shakeel
faiyazs@fastmail.fm; fsahmad@ksu.edu.sa
1
Department of Pharmaceutics, College of Pharmacy, King Saud University, P.O. Box 2457,
Riyadh 11451, Saudi Arabia
2
Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Al-Azhar
University, Asyût, Egypt
3
Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Al-Azhar
University, Cairo, Egypt