Orodispersible films (ODFs) are the most novel and transformative carriers for the delivery of prescription drugs, probiotics, proteins/peptides, and vaccines. ODFs are particularly useful for pediatric and geriatric patients, patients with swallowing problems (dysphagia), subjects with Parkinson’s disease, mentally-retarded, and oral cancer patients [1]. 3D printing of ODFs using semisolid extrusion (SSE) is found to be advantageous over fused deposition modeling as it does not require hot melt extruders, can process wide variety of polymers, and can achieve higher drug loading. However, immiscibility between different polymers limits the full potential of ODFs from being explored. Therefore, the current study investigated the printability and compatibility of different polymers, plasticizers, and fillers for 3D printing of ODFs. Hydrophilic polymers such as hydroxypropyl methylcellulose of different viscosity grades, pullulan, gelatin, polyvinyl pyrrolidone, chitosan, and carbomers were assessed for its printability and compatibility with the sildenafil.

Sildenafil citrate is the most commonly used drug for the treatment of erectile dysfunction. It has poor aqueous solubility and undergoes extensive first-pass metabolism, causing low oral bioavailability of less than 40% [2]. Therefore, novel dosage forms are required to improve its oral bioavailability and achieve faster disintegration. Using HPMC E6, pullulan, and carbomers, good quality ODFs were obtained with higher drug loading. To increase the drug loading, multilayered ODFs consisting of different polymer layers were also investigated. Semisolid extrusion-based 3D printing was successfully utilized to produce smooth, thin, and flexible films. The drug loading capacity in pullulan-based films was up to 50 mg per 4cm². Sildenafil citrate was homogenously dispersed throughout the film. The 3D printed mesh-like films had remarkably shorter disintegration time compared to conventional films. Therefore, 3D printed sildenafil-loaded ODFs might be a promising alternative to sildenafil tablets for the treatment of male erectile dysfunction.

Keywords: Sildenafil citrate, 3D printing, orodispersible films

References

1. De Caro V, Giandalia G, Siragusa MG, et al. New prospective in treatment of Parkinson’s disease: studies on permeation of ropinirole through buccal mucosa. Int J Pharm. 2012;429(1–2):78–83.
2. Al-Ghazawi MA, Tutunji MS, Aburuz SM. (2010). The effect of pummel juice on pharmacokinetics of sildenafil in healthy adult male Jordanian volunteers. Eur J Clin Pharmacol 66:159–63.