ORODISPERSABLE TABLETS

Over a decade, the demand for development of orally disintegrating tablets (ODTs) has enormously increased as it has significant impact on the patient compliance. Orally disintegrating tablets offer an advantage for populations who have difficulty in swallowing. It has been reported that Dysphagia (difficulty in swallowing) is common among all age groups and more specific with pediatric, geriatric population along with institutionalized patients and patients with nausea, vomiting, and motion sickness complications. ODTs with good taste and flavor increase the acceptability of bitter drugs by various groups of population. Orally disintegrating tablets are also called as orodispersible tablets, quick disintegrating tablets, mouth dissolving tablets, fast disintegrating tablets, fast dissolving tablets, rapid dissolving tablets, porous tablets, and rapimelts. However, of all the above terms, United States pharmacopoeia (USP) approved these dosage forms as ODTs. Recently, European Pharmacopoeia has used the term orodispersible tablet for tablets that disperses readily and within 3 min in mouth before swallowing. The US Food and Drug Administration Center for Drug Evaluation and Research (CDER) defines in the Orange Book an ODT as "A solid dosage form containing medicinal substance or active ingredient which disintegrates rapidly usually within a matter of seconds when placed upon the tongue." The disintegration time for ODTs generally ranges from several seconds to about a minute. The European Pharmacopoeia however defines a similar term, orodisperse, as a tablet that can be placed in the mouth where it disperses rapidly before swallowing. These tablets are distinguished from conventional sublingual tablets, lozenges, and buccal tablets which require more than a minute to dissolve in the mouth. In the literature, ODTs also are called orally disintegrating, orodisperse, mouth-dissolving, quick-dissolve, fast-melt, and rapiddisintegrating tablets and freeze-dried wafers. Recent market studies indicate that more than half of the patient population prefers ODTs to other dosage forms and most consumers would ask their doctors for ODTs (70%), purchase ODTs (70%), or prefer ODTs to regular tablets or liquids (>80%). These responses may, in part, be attributed to

known ODT advantages such as ease of administration, ease of swallowing, pleasant taste, and the availability of several flavors. ODTs also offer clinical advantages such as improved safety and, in some cases, improved efficacy and other broader indications. At present, ODTs are the only quick-dissolving dosage form recognized by FDA and listed in Approved Drug Products with Therapeutic Equivalence Evaluations (also called the Orange Book).ODTs are more widely available as over-the-counter products for the treatment of allergies and cold and flu symptoms. The target population has expanded to those who want convenient dosing anywhere, anytime, without water. Orally disintegrating tablets offer all advantages of solid dosage forms and liquid dosage forms along with special advantages, which include:
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As ODTs are unit solid dosage forms, they provide good stability, accurate dosing, easy manufacturing, small packaging size, and easy to handle by patients. No risk of obstruction of dosage form, which is beneficial for traveling patients who do not have access to water. Easy to administer for pediatric, geriatric, and institutionalized patients (specially for mentally retarded and psychiatric patients) Rapid disintegration of tablet results in quick dissolution and rapid absorption which provide rapid onset of action. Medication as "bitter pill" has changed by excellent mouth feel property produced by use of flavors and sweeteners in ODTs. Bioavailability of drugs that are absorbed from mouth, pharynx, and oesophagus is increasd. Pregastric absorption of drugs avoids hepatic metabolism, which reduces the dose and increase the bioavailability.

Despite these advantages, the application of this technology is limited by the amount of drug that can be incorporated into each unit dose. For lyophilized dosage forms, the drug dose must be lower than 400 mg for insoluble drugs and less than 60 mg for soluble drugs, because they dissolve quickly. ODTs cannot provide controlled or sustained release, except those that contain slow-dissolving, microparticulate-coated drugs, which quickly disperse and are swallowed.