Fast Dissolving Tablets: Formulation Strategies, Disintegration Mechanisms, and Emerging Innovations

Fast-dissolving tablets (FDTs), also referred to as orally disintegrating tablets (ODTs) or mouth-dissolving tablets, represent one of the most innovative and patient-friendly oral drug delivery systems developed in recent pharmaceutical research. These solid dosage forms are designed to disintegrate and dissolve rapidly in the oral cavity—typically within seconds to a few minutes—without the need for water, thereby offering significant advantages over conventional tablets and capsules, especially for patient groups with swallowing difficulties such as pediatric, geriatric, psychiatric, and dysphagic populations.  The core objective of FDT development is to enhance patient compliance and convenience by enabling simple administration under normal conditions without the prerequisite of liquid intake. This quality is particularly beneficial for individuals who may be traveling, bedridden, or experiencing nausea, where access to water may be limited or swallowing reflexes compromised. Additionally, FDTs contribute to faster onset of therapeutic action and potentially improved bioavailability, as drug absorption can begin through the rich vascular network of the oral mucosa before gastric passage, which may partially bypass first-pass metabolism.  Recent review articles emphasize that the success of FDT formulations largely depends on advancements in excipient technology—particularly superdisintegrants—and manufacturing techniques. These include approaches such as direct compression, lyophilization (freeze-drying), spray drying, and patent-protected methods like Zydis and AdvaTab, which aim to achieve rapid disintegration while maintaining acceptable mechanical strength and taste masking. The past five years of research have focused not only on optimizing formulation strategies but also on overcoming persistent challenges such as balancing rapid disintegration with structural integrity, taste masking, and stability under environmental stress. Recent studies also explore novel excipients and natural superdisintegrants to further improve dissolution rates and patient acceptability. Overall, FDTs continue to gain prominence in pharmaceutical science due to their therapeutic advantages, market potential, and adaptability to diverse drug molecules, making them a pivotal focus of current and future drug delivery research

Fig 1: A pictorial representation of fast-dissolving tablets

Mechanism of Action of Fast Dissolving Tablets

1. Basic Definition & Functional Principle

Fast dissolving tablets (FDTs), also known as orally disintegrating tablets (ODTs), are solid oral dosage forms designed to rapidly disintegrate and/or dissolve in the oral cavity without the need for water, usually within seconds to under 60 seconds. This rapid disintegration facilitates quick release of the active pharmaceutical ingredient (API), improving onset of action and patient compliance, especially in pediatric, geriatric, and dysphagic patients. Mechanistically, the action of FDTs is not a single “biochemical reaction” like a drug’s pharmacological mechanism; instead, it’s a physical disintegration and dissolution process driven by excipient behaviour and tablet architecture.

2. Core Mechanisms Involved in Rapid Disintegration

Studies and recent reviews consistently point to multiple physical mechanisms that contribute to the rapid breakup of tablets in the oral cavity once saliva contacts them:

A. Swelling of Superdisintegrants

Superdisintegrants such as crospovidone, sodium starch glycolate, croscarmellose sodium, and others rapidly absorb saliva and swell, generating internal stress that physically disrupts the tablet matrix. This swelling force is considered one of the primary drivers of tablet breakup.

Active uptake of water → expansion → pressure inside tablet → structural disruption.

B. Capillary Action / Water Wicking

Hydrophilic disintegrants create capillary pathways within the tablet that draw saliva deep into the core. This wicking replaces air in pores with fluid, weakening interparticle bonds and hastening disintegration. Critical first step before swelling can initiate fully.

C. Deformation Recovery

During compression, some disintegrant particles undergo deformation. Once wetted, they recover their original shape, expanding and aiding tablet breakup. This mechanism is particularly relevant for disintegrants like crospovidone that do not swell extensively.

D. Particle/Particle Repulsion

Entrapped water increases electrostatic repulsion between particles, especially in non-swelling disintegrants. Repulsive forces help break intermolecular attractions within the tablet matrix.

E. Heat of Wetting & Effervescence (Supporting Mechanisms)

Heat of wetting: small exothermic energy release on water uptake creates local stresses that contribute to breakup.

Effervescence: reaction of certain excipients (e.g., bicarbonates with acids) generates gas (CO?), further helping disintegration.

These mechanisms are not universal but can significantly speed up disintegration in specific formulations.

3. Dissolution After Disintegration

Once the tablet rapidly breaks apart, two overlapping processes occur:

A. Rapid dispersion of drug particles

Tablet breakup releases fine particles into the saliva, greatly increasing surface area available for dissolution.

B. Dissolution in saliva & absorption pathways

Some drugs dissolve in saliva and may be absorbed across the oral mucosa (sublingual/buccal) bypassing first-pass metabolism. For many drugs, most of the dissolved API is swallowed and absorbed via the GI tract, but the increased surface area still accelerates systemic uptake.

4. Excipient & Formulation Strategies That Drive the Mechanistic Action

The rapid disintegration and dissolution of FDTs depend heavily on formulation design:

Superdisintegrant Selection & Concentration

Effective superdisintegrants are chosen based on their swelling capacity, porosity, and interaction with saliva. Optimal levels (~1–10%) balance rapid disintegration with mechanical strength.

Technologies like lyophilization, spray drying, or specialized co-processed excipients generate highly porous structures that facilitate water uptake and faster breakup.

Hydrophilic Soluble Components

Ingredients like mannitol improve wettability and mouthfeel while assisting fluid penetration.

5. Summary Mechanistic Pathway (Typical FDT in Mouth)

Saliva contact → capillary penetration into tablet pores.

Superdisintegrants absorb water → swelling and pressure build-up.

Deformation recovery and particle repulsion further break tablet into smaller fragments.

Rapid dissolution of fragments in saliva → drug release.

Swallowed API enters systemic circulation faster due to increased surface area and possible mucosal absorption

Methods of Preparation of Fast Dissolving Tablets (FDTs)

Fast-dissolving tablets (also called orally disintegrating tablets or ODTs) are designed to disintegrate or dissolve rapidly in the oral cavity without water, improving compliance and the onset of action. The key to manufacturing FDTs is creating a highly porous structure with formulation and processing choices that support rapid wetting and breakup.

1. Direct Compression (DC)

Description: The simplest and most widely used method due to ease of processing at an industrial scale.

Process: The drug, superdisintegrants, fillers, sweeteners, and other excipients are blended and directly compressed using standard tablet punches.

Advantages: Low cost, fewer process steps, minimal equipment.

Formulation Role: Choosing appropriate disintegrants (e.g., crospovidone, croscarmellose sodium) and porous excipients (e.g., mannitol) is critical.

Notes: Improved disintegrants and co-processed excipients have made DC especially suitable for FDTs.

2. Freeze Drying / Lyophilization

Description: Commonly used where very fast disintegration is needed.

Process: A drug/excipient solution or suspension is frozen and then sublimed under low pressure, removing water and creating a very porous matrix.

Advantages: Ultra-rapid disintegration due to high porosity.

Limitations: Expensive, time-consuming, and tablets may be fragile.

Typical Use: Often for heat-sensitive drugs or small-molecule APIs.

3. Tablet Moulding Method

Description: Creates a porous matrix by moulding rather than compressing tablets.

Process: A hydro-alcoholic binder solution with drug and excipients is poured into molds and dried, leaving tablets with built-in porosity.

Advantages: Good for heat-sensitive drugs and allows rapid dissolution.

Disadvantages: Often results in lower mechanical strength unless binders are optimized.

Variants: Inclusion of polymers (e.g., agar, soluble sugars) can improve structure.

4. Mass Extrusion

Description: Produces elongated excipient/drug extrudates that are cut to size as tablets.

Process: A mass of drug and excipients is plasticized with a solvent system and extruded, then sectioned.

Advantages: Produces tablets with good uniformity and rapid disintegration.

Utility: Better control of shape/size compared to moulding.

5. Spray Drying

Description: A porous powder is made by spray drying a solution or dispersion of drug/excipients.

Process: The liquid feed is atomized into hot drying air; solvent evaporation yields fine porous particles for tablet compression.

Advantages: Enhanced surface area and porosity support rapid dissolution.

Suitable For: Heat-sensitive drugs when parameters are controlled.

6. Sublimation

Description: Uses a volatile ingredient to create porosity.

Process: A volatile substance (e.g., camphor, ammonium bicarbonate) is mixed with drug/excipients and dried; the volatile component sublimes leaving voids.

Advantages: Improves porosity and thus disintegration.

Considerations: Requires careful choice of volatile agent.

7. Nanotization / Nanoparticle Techniques

Description: Reducing drug particle size to the nanometer range to enhance surface area and dissolution.

Process: Nanoparticles are prepared (e.g., precipitation or milling), then incorporated into tablets.

Effect: Increased dissolution rate and improved uniformity.

Notes: More research reported recently as a formulation enhancement, but used in combination with traditional tablet manufacturing.

8. Patented / Advanced Commercial Technologies

Beyond basic methods, industry-specific platforms have been developed and patented in recent years to consistently achieve rapid disintegration with commercial robustness:

• Pharma burst Technology

Dry blending with co-processed excipients to yield tablets that dissolve in ~30–40 seconds. Excipient systems optimized for porosity and rapid wetting.

• Lyoc® Technology

Combines oil/water emulsions and freeze-drying, using inert fillers to control porosity and structural integrity. Tailored more for sensitive APIs.

• Flashtab Technology

Uses taste-masked microgranules prepared by techniques like coacervation or microencapsulation, then compressed normally. Provides palatable, rapid-release tablets with improved taste profiles

9. Spherical Agglomeration?

Spherical agglomeration (also called spherical crystallisation) is a particle engineering technique where fine crystals of a drug are transformed into larger, spherical aggregates in a controlled crystallization medium. These spherical particles usually show improved flowability, compressibility, solubility, and dissolution characteristics, making them very suitable for manufacturing FDTs by direct compression without complex granulation steps. Provides palatable, rapid-release tablets with improved taste profiles.

Key Points from Recent Reviews

Direct compression remains the most widely used industrially due to economic and simplicity benefits.

Freeze drying / lyophilization still dominates when maximum disintegration speed and porous structure are required but has practical limitations. Advanced patented technologies (e.g., Pharma burst, Lyoc, Flashtab) combine formulation science with industry expertise to optimize rapid dissolution and manufacturability.

Table 1: A small summary on the preparation of fast-dissolving tablets

FDTS Available From (2025-2001)

Table 2. Recent Research and Review Studies on Fast Dissolving Tablets (2001–2025)

Applications & Uses of Fast Dissolving Tablets (FDTs)

1. Improved Patient Compliance

Fast dissolving tablets are widely used to improve compliance, especially in patients who have difficulty swallowing conventional tablets and capsules — particularly pediatric, geriatric, and dysphagic patients (difficulty in swallowing). FDTs disintegrate in the oral cavity without water, making them convenient in outpatient and home settings

Use case: Children who cannot swallow large tablets; elderly patients with reduced saliva flow or swallowing reflex

2. Rapid Onset of Action

Because FDTs dissolve quickly in saliva and often allow pre-gastric absorption, drugs can enter systemic circulation more rapidly than conventional tablets. This means faster therapeutic effects — important in conditions requiring quick relief.

Use case: Pain relief (analgesics), anti-allergy medications, antiemetics, antihypertensives in acute conditions.

3. Enhanced Bioavailability

Many fast dissolving formulations can avoid or reduce first-pass metabolism by facilitating drug absorption through the oral mucosa. This can lead to enhanced bioavailability and sometimes improved efficacy of the active pharmaceutical ingredient (API).

Use case: Drugs that are extensively metabolized in the gut or liver, such as certain painkillers or CNS agents, may benefit from this property.

4. Convenience & Portability

FDTs can be taken anywhere and anytime without the need for water, increasing convenience for patients in travel, outdoor settings, or for those who lack easy access to fluids.

Use case: Motion sickness medications for travelers, quick relief antihistamines during allergy episodes.

5. Extended Therapeutic Areas

Recent review literature points toward expanding uses of FDTs beyond traditional small-molecule drugs into innovative areas such as:

• Central nervous system (CNS) disorders, where rapid action is desirable.
• Biologics, peptides, and vaccines — future applications anticipated as formulation and stabilization technologies improve.
• Research outlook: While still emerging, FDT formats may be adapted for complex molecules as excipient science advances

6. Taste-Masked & Sensory Enhanced Formulations

Use case: Pediatric formulations where palatability greatly affects compliance.

7. Special Populations & Situations

FDTs are especially valuable in:

• Mentally impaired patients who may not reliably swallow conventional tablets.
• Bedridden or uncooperative patients.
• Busy patients or those without water access (e.g., emergencies).

Table 3: Therapeutic Applications of Fast Dissolving Tablets