Many pharmaceutical preparations are applied in tablet, granule, powder, and liquid form. In general, a tablet design is in a form presented to patients to swallow or chew a precise dose of medication. However, especially geriatric and pediatric patients have difficulty chewing or swallowing solid dosage forms.4 Therefore, many children and elderly people are reluctant to take these solid dosage forms owing to fear of asphyxiation. Orally dissolving tablets (ODTs) have emerged to meet this need. However, for some patient populations, the fear of swallowing the solid dosage form (tablet, capsule), and the risk of asphyxiation remains despite short dissolution/disintegration times. Oral thin film (OTF) drug delivery systems are a preferable alternative under these conditions. The oral bioavailability of many drugs is insufficient due to the enzymes, common first-pass metabolism, and pH of the stomach. Such conventional drugs have been administered parenterally and have shown low patient compliance. Situations like these have paved the way for the pharmaceutical industry to develop alternative systems for the transportation of drugs by developing thin dispersible/dissolving films in the mouth. Fear of drowning, which may be a risk with ODTs, has been associated with these patient groups. Rapid dissolution/disintegration of OTF drug delivery systems is a preferable alternative to ODTs in patients with fear of asphyxiation. When they are placed on the tongue, OTFs are immediately wetted with saliva. As a result, they are dispersed and/or dissolved to release the drug for systemic and/or local absorption.
Oral disintegrating/dissolving films or strips can be defined as follows: “These are drug delivery systems that they are quickly releasing the drug by dissolving or adhering in the mucosa with saliva within a few seconds due to it contains water-soluble polymers when it placed in the mouth cavity or on the tongue”. The sublingual mucosa has high membrane permeability due to its thin membrane structure and high vascularization. Due to this rapid blood supply, it offers very good bioavailability. Enhanced systemic bioavailability is owing to skipping the first-pass effect and better permeability is owing to high blood flow and lymphatic circulation. In addition, the oral mucosa is a very effective and selective route of systemic drug delivery because of the large surface area and ease of application for absorption.6 In general, OTFs are characterized as a thin and flexible polymer layer, with or without plasticizers in their content. They can be said to be less disturbing and more acceptable to patients, as they are thin and flexible in their natural structure. Thin films are polymeric systems that provide many of the requirements expected of a drug delivery system. In studies, thin films have shown their abilities such as improving the initial effect of the drug and duration of this effect, decreasing the frequency of dosing, and increasing the effectiveness of the drug. With thin-film technology, it can be beneficial to eliminate the side effects of drugs and reduce common metabolism procured by proteolytic enzymes. Ideal thin films should possess the desired properties of a drug delivery system, such as a suitable drug loading capacity, rapid dispersion/dissolution, or prolonged application and reasonable formulation stability. Also, they must be nontoxic, biodegradable and biocompatible.
According to the American Food and Drug Administration (FDA), OTF is defined as “including one or more active pharmaceutical ingredients (APIs), a flexible and non-brittle strip that is placed on the tongue before passing into the gastrointestinal tract, aiming for a quick dissolution or disintegration in the saliva”. The first prescribed OTF was Zuplenz (Ondansetron HCl, 4-8 mg) and was approved in 2010. Suboxon (buprenorphine and naloxan) quickly followed as the second approved. Statistics show that four out of five patients choose orally dissolving/disintegrating dosage forms over traditional oral solid dosage forms.7 At present, in many prescription and over-the-counter product groups, especially in cough, cold, sore throat, erectile dysfunction disorders, allergic reactions, asthma, gastrointestinal disorders, pain, snoring complaints, sleep problems, and multivitamin combinations, etc. OTFs are available and continue to increase.13 Fast-dissolving oral films have many advantages over other solid dosage forms, such as flexibility and increased efficacy of the API. Also, oral films have dissolution and disintegration with very little saliva fluid in less than one minute compared with ODTs.1
An OTF should have the following ideal features
-It should taste good
-Drugs should be very moisture resistant and soluble in the saliva
-It should have appropriate tension resistance
-It should be ionized in the oral cavity pH
-It should be able to penetrate the oral mucosa
-It should be able to have a rapid effect
OTF’s advantages over other dosage forms
-Does not require water use
-Can be used safely even when access to water is not possible (such as travel)
-No risk of suffocation
-Easy to apply
-Easy application to mental and incompatible patients
-There is little or no residue in the mouth after application
-Bypasses the gastrointestinal tract and thus increasing bioavailability
-Low dosage and low side effects
-It provides more accurate dosage when compared to liquid dosage forms
-No need to measure, which is an important disadvantage in liquid dosage forms
-Leaves a good feeling in the mouth
-Provides rapid onset of effects in conditions requiring urgent intervention, for example, allergic attacks such as asthma and intraoral diseases
-Improves the absorption rate and amount of drugs
-Provides enhanced bioavailability for less water-soluble drugs, especially via giving a large surface area while rapidly dissolving
-Does not prevent normal functions such as speaking and drinking
-Offers administration of drugs with a high risk of disruption in the gastrointestinal tract
-Has an expanding market and product variety
-Can be developed and placed on the market within 12-16 months
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Post time: Dec-01-2021