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Article

Development and Characterizations of Pullulan and Maltodextrin-Based Oral Fast-Dissolving Films Employing a Box–Behnken Experimental Design

1
College of Pharmaceutical Sciences, Soochow University, Suzhou 215123, China
2
Department of Molecular and Cellular Therapeutics, Royal College of Surgeons in Ireland (RCSI), D02YN77 Dublin, Ireland
3
The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Basic Medicine and Cancer (IBMC), Chinese Academy of Sciences, Hangzhou 310022, China
4
Department of Internal Medicine and Nanomedicine, California Innovations Corporation, San Diego, CA 92037, USA
*
Authors to whom correspondence should be addressed.
Academic Editor: Piotr Kurcok
Materials 2022, 15(10), 3591; https://doi.org/10.3390/ma15103591
Received: 18 March 2022 / Revised: 22 April 2022 / Accepted: 29 April 2022 / Published: 18 May 2022
(This article belongs to the Special Issue Polymer-Based Nanoparticles for Drug Delivery Applications)
Migraine is a neurological disorder characterized by severe headaches, visual aversions, auditory, and olfactory disorders, accompanied by nausea and vomiting. Zolmitriptan (ZMT®) is a potent 5HT1B/1D serotonin receptor agonist frequently used for the treatment of migraine. It has erratic absorption from the gastrointestinal tract (GIT), but its oral bioavailability is low (40–45%) due to the hepatic metabolism. This makes it an ideal candidate for oral fast dissolving formulations. Hence, the current study was undertaken to design and develop oral fast-dissolving films (OFDFs) containing ZMT for migraine treatment. The OFDFs were formulated by the solvent casting method (SCM) using Pullulan (PU) and maltodextrin (MDX) as film-forming agents and propylene glycol (PG) as a plasticizer. The strategy was designed using Box–Behnken experimental design considering the proportion of PU:MDX and percentage of PG as independent variables. The effectiveness of the OFDF’s was measured based on the following responses: drug release at five min, disintegration time (D-time), and tensile strength (TS). The influence of formulation factors, including percent elongation (%E), thickness, water content, moisture absorption, and folding endurance on ZMT-OFDFs, were also studied. The results showed a successful fabrication of stable ZMT-OFDFs, with surface uniformity and amorphous shape of ZMT in fabricated films. The optimized formulation showed a remarkable rapid dissolution, over 90% within the first 5 min, a fast D-time of 18 s, and excellent mechanical characteristics. Improved maximum plasma concentration (C max) and area under the curve (AUC 0–t) in animals (rats) treated with ZMT-OFDFs compared to those treated with an intra-gastric (i-g) suspension of ZMT were also observed. Copolymer OFDFs with ZMT is an exciting proposition with great potential for the treatment of migraine headache. This study offers a promising strategy for developing ZMT-OFDFs using SCM. ZMT-OFDFs showed remarkable rapid dissolution and fast D-time, which might endeavor ZMT-OFDFs as an auspicious alternative approach to improve patient compliance and shorten the onset time of ZMT in migraine treatment. View Full-Text
Keywords: oral fast-dissolving film; maltodextrin; pullulan; propylene glycol; Zolmitriptan; drug delivery oral fast-dissolving film; maltodextrin; pullulan; propylene glycol; Zolmitriptan; drug delivery
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MDPI and ACS Style

Shah, K.A.; Gao, B.; Kamal, R.; Razzaq, A.; Qi, S.; Zhu, Q.-N.; Lina, S.; Huang, L.; Cremin, G.; Iqbal, H.; Menaa, F.; Cui, J.-H. Development and Characterizations of Pullulan and Maltodextrin-Based Oral Fast-Dissolving Films Employing a Box–Behnken Experimental Design. Materials 2022, 15, 3591. https://doi.org/10.3390/ma15103591

AMA Style

Shah KA, Gao B, Kamal R, Razzaq A, Qi S, Zhu Q-N, Lina S, Huang L, Cremin G, Iqbal H, Menaa F, Cui J-H. Development and Characterizations of Pullulan and Maltodextrin-Based Oral Fast-Dissolving Films Employing a Box–Behnken Experimental Design. Materials. 2022; 15(10):3591. https://doi.org/10.3390/ma15103591

Chicago/Turabian Style

Shah, Kiramat Ali, Binbin Gao, Robia Kamal, Anam Razzaq, Sun Qi, Qiu-Ning Zhu, Song Lina, Linyu Huang, Grainne Cremin, Haroon Iqbal, Farid Menaa, and Jing-Hao Cui. 2022. "Development and Characterizations of Pullulan and Maltodextrin-Based Oral Fast-Dissolving Films Employing a Box–Behnken Experimental Design" Materials 15, no. 10: 3591. https://doi.org/10.3390/ma15103591

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