Formulation and Quality Control of Orally Disintegrating Tablets (ODTs): Recent Advances and Perspectives

Abstract

Orally disintegrating tablets (ODTs) rapidly disintegrate or dissolve in the oral cavity without using water. Demand for ODTs has increased, and the field has overgrown in the pharmaceutical industry and academia. It is reported that ODTs have several advantages over other conventional tablets. Since some of them are absorbed from the mouth, pharynx, and esophagus as the saliva passes down into the stomach, in such cases, the bioavailability of the drug improves meaningfully. Furthermore, the immediate release property of ODTs makes them a popular oral dosage form in patients with swallowing challenges, children, and for cases with a need for rapid onset of action. The current review article explains the features of active ingredients and excipients used in the formulation of ODTs, discusses multiple ODT formulation and preparation techniques with their merits and demerits, and also, offers remedies for problems associated with ODTs. Moreover, quality control steps and required considerations are presented.

Smart intraoral systems for advanced drug delivery

“…Traditional intraoral drug delivery systems mainly include solid formulations (e.g., the orally disintegrating tablets), semisolid formulations (e.g., the creams and ointments), and liquid formulations (e.g., the sprays, mouthwashes, and breath fresheners) 44,45 . Orally disintegrating tablets would be rapidly crushed under the saliva exposure, followed by saliva mixture and quick swallow, which attenuated the swallowing difficulties in some mentally ill patients, children, and the elderly 46 . Due to the simplicity and low cost of the manufacturing process, solid dosage forms are highly popular types of oral drug formulations, and commercial products include, for example, commercial tranylcypromine and loratadine disintegrating tablets.…”

“…44,45 Orally disintegrating tablets would be rapidly crushed under the saliva exposure, followed by saliva mixture and quick swallow, which attenuated the swallowing difficulties in some mentally ill patients, children, and the elderly. 46 Due to the simplicity and low cost of the manufacturing process, solid dosage forms are highly popular types of oral drug formulations, and commercial products include, for example, commercial tranylcypromine and loratadine disintegrating tablets. In comparison to the solid formulation, the administrative approaches of semisolid preparations are more flexible, assisted by a finger or a syringe to retain onto oral mucosal surfaces.…”

Puzzle out Machine Learning Model-Explaining Disintegration Process in ODTs

“…However, ODTs have gained more attention as preferred solid drug dosage forms due to their increased convenience and compliance compared to conventional tablets and capsules [ 1 ]. These key trends appear to have fueled the market, which was estimated to have reached 10% of the compound annual growth rate in 2018 [ 2 ]. Drug manufacturers are turning to ODTs as a drug dosage form of choice for BCS (Biopharmaceuticals Classification System) class I and III compounds, where the challenge of delivering a drug does not lie in poor solubility.…”

“…Highly soluble APIs (active pharmaceutical ingredients) along with rapidly disintegrating tablets provide faster dissolution, leading to the increased bioavailability of drugs and the quick onset of action. Recently, the industry not only successfully applied many ODTs formulations to introduce new delivery format to patients, formats such as Benadryl ® (Diphenhydramine), Lamictal ® ODT (lamotrigine), Zofran ® (Ondansetron), or Olanex Instab ® (Olanzapine) [ 2 ], but also introduced ODTs as an intended drug dosage formulation, e.g., Nurtec ® ODT (rimegepant) or Evekeo ® (amphetamine sulfate) ODT. The choice of excipients with rapidly disintegrating tablets is crucial for palatability; the optimization of the composition of ODTs is directed to obtain a clean mouth feeling or creaminess.…”

Rapid oral transmucosal delivery of zaleplon–lavender oil utilizing self-nanoemulsifying lyophilized tablets technology: development, optimization and pharmacokinetic evaluation

“…Fast-disintegrating tablets (FDTs), also known as orodispersible tablets (ODTs), are an alternative to traditional oral capsules and tablets (Chinwala, 2020 ). The Center for Drug Evaluation and Research of the United States Food and Drug Administration described the ODT as ‘a solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue’ in the Orange Book (Ghourichay et al., 2021 ). ODTs are ‘uncoated tablets intended to be placed in the mouth, where they disperse rapidly before being swallowed’, according to the European Pharmacopeia, and they should dissolve within 3 minutes (Sharma, 2013 ).…”