What are orodispersible tablets (ODTs)?

What are Orodispersible Tablets (ODTs)?

Orodispersible tablets (ODTs) are solid dosage forms that rapidly disintegrate in the mouth within seconds to minutes when placed on the tongue, dissolving in saliva without requiring water for swallowing. 1

Key Characteristics

• Rapid disintegration: ODTs disintegrate within 3 minutes (typically within seconds) in the oral cavity in the presence of saliva 1, 2
• No water required: These tablets dissolve completely in saliva, eliminating the need for additional water for administration 3
• Easy administration: The resulting paste or solution can be easily swallowed after disintegration in the mouth 2

Mechanism and Drug Delivery

• Dissolution process: When placed on the tongue, ODTs are instantly wetted by saliva, rapidly hydrate, and then disintegrate or dissolve to release the medication 4
• Absorption sites: The drug dissolved in saliva can be absorbed from multiple sites including the mouth, throat, upper esophagus, and stomach after swallowing 3
• Formulation basis: ODTs contain superdisintegrants in their formulation that enable rapid breakdown in the oral cavity 1

Clinical Applications and Patient Populations

ODTs are particularly valuable for patients who have difficulty swallowing conventional tablets or capsules. 3

Primary target populations include:

• Pediatric patients: Children who cannot swallow tablets easily 1, 3
• Geriatric patients: Elderly individuals with swallowing difficulties 1, 3
• Dysphagia patients: Those with difficulty or pain during swallowing, including GERD patients with severe erosive esophagitis and odynophagia 3
• Bedridden and emetic patients: Those unable to take conventional oral medications 4
• Patients with CNS disorders: Individuals with neurological conditions affecting swallowing 4

Specific Medical Applications

Eosinophilic Oesophagitis (EoE)

• Budesonide orodispersible tablets (1 mg twice daily) demonstrated clinicopathological remission in 57.6% of patients at week 6 versus 0% on placebo, increasing to 84% during open-label extension to 12 weeks 5
• Maintenance therapy: Orodispersible budesonide (0.5-1.0 mg twice daily) showed persistent remission in 73.5-75% of patients over 48 weeks compared to 4.4% with placebo 5
• Guideline recommendation: The British Society of Gastroenterology supports the use of orodispersible budesonide over other swallowed steroid formulations for both induction and maintenance treatment of EoE in adults 5

Cancer Pain Management

• Sublingual fentanyl ODT showed significant improvement in breakthrough pain intensity within 5 minutes of administration in 67.7% of episodes, with maximum effect within 30 minutes in 63% of episodes 5

Psychiatric Emergencies

• Risperidone ODT is used in combination with other medications for managing agitated pediatric patients, offering ease of administration in challenging clinical situations 5

Advantages Over Conventional Tablets

• Improved patient compliance: Statistics show four out of five patients prefer orally disintegrating dosage forms over conventional solid oral dosage forms 4
• Higher bioavailability: ODTs can achieve better bioavailability compared to conventional tablets due to absorption from multiple sites in the oral cavity and upper GI tract 3
• Reduced choking risk: Eliminates fear of choking associated with swallowing whole tablets 4
• Precise dosing: Maintains the dosing accuracy of conventional tablets while offering the ease of liquid formulations 4

Manufacturing Technologies

Conventional methods:

• Direct compression (most common) 1
• Wet granulation 1
• Molding 1

Advanced proprietary technologies:

• Zydis®, Orasolv®, Durasolv®, Wowtab®, Flashtab®, and others have been developed by pharmaceutical companies for ODT production 6
• Specialized techniques include freeze-drying, spray-drying, sublimation, and effervescent methods 1

Important Considerations

• Taste masking: Since ODTs dissolve directly in the mouth, taste is a critical factor requiring specific formulation approaches to mask bitter drugs 1
• Sustained-release potential: Newer technologies incorporating polymer-coated nanoparticles, stimuli-responsive polymers, and ion-exchange resins can provide sustained-release properties in ODT formulations 2
• Market growth: ODTs achieved revenues over $3 billion in 2006 with sustained 20% annual growth, demonstrating significant commercial value 2