Abstract
This article summarizes the advantages of orally disintegrating tablets (ODTs) as well as critical issues during evaluation of ODTs such as bioequivalence and challenges and limitations of ODTs and finally present and the future of ODTs. ODTs have received everincreasing demand and the field has become a rapidly growing area in the pharmaceutical industry. Upon introduction into the mouth, these tablets dissolve or disintegrate in the mouth in the absence of additional water. When ODTs are put on tongue they disintegrate instantaneously, releasing the drug which dissolve or disperses in the saliva. Some drugs are absorbed from the mouth, pharynx and esophagus as the saliva passes down in to the stomach. In such cases, bioavailability of a drug is significantly greater than those observed from conventional tablet dosage form. The advantages of mouth dissolving dosage form are increasingly being recognized in both, industry and academia. Their growing importance has been underlined recently when European Pharmacopoeia adopted the term “Orodispersible Tablet” as tablet that is to be place in the mouth where it disperses rapidly before swallowing. ODTs have some challenges but solutions to overcome these challenges were shown in this paper.
Highlights
IntroductionOral drug delivery is currently the gold standard in the pharmaceutical industry where it is regarded as the safest, the most convenient and most economical method of drug delivery with the highest patient compliance [1,2]
Oral drug delivery is currently the gold standard in the pharmaceutical industry where it is regarded as the safest, the most convenient and most economical method of drug delivery with the highest patient compliance [1,2].Oral route is the most preferred route of administration and tablet and capsules are the most preferred dosage forms, but several limitations of that kind of dosage forms like chocking and swelling discomfort in geriatric and pediatric patients [3,4].Orally disintegrating tablets have been developed and new orally disintegrating tablets (ODTs) technologies compensate many pharmaceuticals and patients’ needs, ranging from enhanced life-cycle management to convenient dosing for pediatric, geriatric, and psychiatric patients with dysphasia [5]
There are some definitions that made by pharmacopeias and agency as follows: Orodispersible tablets have been placed in the mouth where they disperse fast before being swallowed and they are uncoated tablets
Summary
Oral drug delivery is currently the gold standard in the pharmaceutical industry where it is regarded as the safest, the most convenient and most economical method of drug delivery with the highest patient compliance [1,2]. If the ODT test product is an extension to another oral formulation, a 3-period study is recommended in order to evaluate administration of the orodispersible tablet both with and without concomitant fluid intake. Blood samples were collected before dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after dosing This single-dose study of flurbiprofen 150 mg (three 50-mg tablets of each formulation) found that the test (flurbiprofen 50-mg ODT) and reference (flurbiprofen conventional 50-mg tablet) products met the regulatory criteria for bioequivalence in these fasting healthy Chinese male volunteers. Both formulations were generally well tolerated [30]. It was concluded that the two formulations are bioequivalent in their rate and extent of absorption and may be used interchangeably, without any prejudice of therapeutic effect [32]
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