Orally disintegrating films: A modern expansion in drug delivery system

Abstract

Over the past few decades, tendency toward innovative drug delivery systems has majorly increased attempts to ensure efficacy, safety and patient acceptability. As discovery and development of new chemical agents is a complex, expensive and time consuming process, so recent trends are shifting toward designing and developing innovative drug delivery systems for existing drugs. Out of those, drug delivery system being very eminent among pediatrics and geriatrics is orally disintegrating films (ODFs). These fast disintegrating films have superiority over fast disintegrating tablets as the latter are associated with the risks of choking and friability. This drug delivery system has numerous advantages over conventional fast disintegrating tablets as they can be used for dysphasic and schizophrenic patients and are taken without water due to their ability to disintegrate within a few seconds releasing medication in mouth. Various approaches are employed for formulating ODFs and among which solvent casting and spraying methods are frequently used. Generally, hydrophilic polymers along with other excipients are used for preparing ODFs which allow films to disintegrate quickly releasing incorporated active pharmaceutical ingredient (API) within seconds. Orally disintegrating films have potential for business and market exploitation because of their myriad of benefits over orally disintegrating tablets. This present review attempts to focus on benefits, composition, approaches for formulation and evaluation of ODFs. Additionally, the market prospect of this innovative dosage form is also targeted.

Orodispersible films: Towards drug delivery in special populations

“…In the absence of regulatory guidelines and due to the novelty of the dosage form, typical film potential Critical Quality Attributes (pCQA) have been described in recent publications (Borges et al, 2015a;Irfan et al, 2015). Oral films should have appropriate mechanical strength to endure both the stress of the manufacturing pipeline, and folding during postproduction, while maintaining the targeted disintegration and drug release profile.…”

“…Mechanical characterisation studies should include measurement of thickness, tensile strength, elongation at break, tear resistance, folding endurance, and Young's modulus (Irfan et al, 2015). Stability during all manufacturing stages must be carefully studied beforehand and monitored throughout.…”

Taste Masked Oral Fast Dissolving Sublingual Strips of Rizatriptan Benzoate for Migraine Therapy

“…On the other hand, problems related to the friability may arise during the handling, transportation, and storage of the ODTs due to their high porosity, low mechanical strength and low density (8). These drawbacks of the ODTs can be overcome using fast dissolving sublingual strips (FDSSs) (9).…”

Plasticizers: A Vital Excipient in Novel Pharmaceutical Formulations

“…Orally disintegrating films have potential for business due to their enormous benefits over orally disintegrating tablets. 13 Glycerol, phthalate derivatives like dimethyl, diethyl and dibutyl phthalate, Propylene glycol, low molecular weight PEG, Citrate derivatives such as tributyl, triethyl, acetyl citrate, triacetin and castor oil are some of the commonly used plasticizers in the concentration of 0-20%w/w of dry polymer weight. However cracking, splitting and peeling of the film might occur with the inappropriate use of plasticizer.…”