Abstract
Objective: The objective of the present investigation is to prepare zolmitriptan (ZOL) mouth dissolving films (MDFs) and to investigate the influence of formulation variables on physicomechanical, chemical, and drug release properties of the prepared MDFs.
 Methods: The MDFs were prepared by solvent casting technique using wet film applicator. The impact of hydroxypropyl methylcellulose of different viscosity grades (hydroxy propyl methyl cellulose [HPMC] E3, E5, and E15), plasticizers (glycerol and polyethylene glycol [PEG]-400), and solubilizing agents (polyvinyl pyrrolidone [PVP K30] and sodium lauryl sulfate [SLS]) on physicomechanical, chemical, and drug release properties were evaluated. The MDFs were also characterized by Fourier-transform infrared spectroscopy, differential scanning calorimetry, and X-ray diffractometry studies.
 Results: The MDFs prepared were transparent and smooth and showed no recrystallization. The tensile strength of the MDFs increased significantly with an increase in polymer viscosities, and about a 2.63-fold increase in tensile strength was observed for HPMC E15 MDFs compared to E3, whereas an increase in film thickness resulted in brittle MDFs with low tensile strength. Similar results were observed with percent elongation and folding endurance of the MDFs. In vitro, drug release studies indicate that higher film thickness and polymer viscosities delayed the MDF disintegration and, in turn, the ZOL release. Addition of PVP K30 and SLS to HPMC E3 formulations resulted in 1.66- and 1.53-fold increase in ZOL release rates.
 Conclusion: Overall, F7 formulation showed quicker disintegration (within 11 s) and ZOL release rates (within 180 s) along with good physicomechanical properties. These results indicated that the disintegration and drug release of ZOL can be enhanced to a greater extent by optimizing formulation variables in MDFs.
Highlights
The design of age-specific dosage forms stays to be a challenging task due to the wide range of pharmaceutical and clinical lookouts that must be considered in the design of dosage forms [1]
No work was published so far detailing the influence of formulation variables such as film thickness, plasticizers, and polymer viscosities on physicomechanical properties such as tensile strength, the percent elongation of ZOL mouth dissolving films (MDFs) along with thorough evaluation on drug loading effect on crystallization, and characterization using photographic, differential scanning calorimetry (DSC) and X-ray diffractometry (X-RD) studies
Preparation of ZOL MDFs Initially, placebo MDFs were prepared with different polymers such as hydroxypropyl methylcellulose (HPMC) (E3, E5, and E15) methylcellulose, sodium carboxymethyl cellulose (Na CMC), and sodium alginate using polyethylene glycol (PEG)-400 and glycerol as plasticizers and assessed for film forming capacities and appearance
Summary
The design of age-specific dosage forms stays to be a challenging task due to the wide range of pharmaceutical and clinical lookouts that must be considered in the design of dosage forms [1]. Conventional oral drug delivery systems such as tablets and capsules may not fulfill the necessities of pediatric and geriatric patients due to their differential abilities in swallowing the dosage forms [3,4]. In this context, the novel mucosal delivery systems have gained popularity in which the mouth dissolving films (MDFs) are the new and novel drug delivery systems for the peroral delivery of drugs to overcome patient impediments [5], and on contact with saliva, it dissolves within a few seconds without the need of the water making them suitable for pediatric and geriatric patients [6]. The present investigation was aimed at the formulation and evaluation of ZOL MDFs for physicomechanical, chemical, and drug release properties
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