Orally Disintegrating Tablets: A Complete Guide to Manufacturing and Packaging

Imagine taking a tablet without a glass of water. You simply place it on your tongue, and within seconds, it breaks down and becomes easy to swallow. This is the basic idea behind orally disintegrating tablets (ODTs).

Orally disintegrating tablet has become an important dosage form for medicines that need to be easy to administer. For children, the older, and people who have difficulty in swallowing, ODT is more suitable than conventional tablets.

The convenience of an ODT comes with additional manufacturing and packaging requirements. Unlike conventional tablets, an ODT must combine rapid disintegration, sufficient mechanical strength, and adequate stability. These directly influence the choice of formulation, manufacturing process and equipment.

This article is to take you through the complete process of manufacturing and packaging orally disintegrating tablets.

1. What Are Orally Disintegrating Tablets?

This section is to introduces what orally disintegrating tablets are, how they achieve rapid oral disintegration, and which patient groups can benefit most from this dosage form.

1.1 How Do Orally Disintegrating Tablets Work?

Designed to disintegrate rapidly in the oral cavity, orally disintegrating tablet can be absorbed without chewing or water.

When an ODT is placed on the tongue, saliva begins to wet the tablet. Water then penetrates into its porous structure, weakening the interparticle bonds and activating disintegrating excipients. The tablet rapidly breaks apart into smaller particles, allowing the resulting material to be swallowed.

1.2 Who Are Orally Disintegrating Tablets Designed For?

The characteristics of orally disintegrating tablets make them particularly useful for people who may have difficulty swallowing conventional tablets.

By simplifying administration, ODTs can help address some practical barriers to taking medication. The FDA specifically identifies pediatric and geriatric patients, people with impaired swallowing, and certain patients for whom compliance may be difficult as potential populations that can benefit from this dosage form.

• Children: Young children may have difficulty swallowing intact tablets and may resist taking medicines that require water. An ODT can provide a more convenient dosage form.
• Older Adults: Swallowing difficulties can become more common with age. With ODT, they can digest the tablet without swallowing.
• People with Dysphagia: Patients with swallowing difficulties may benefit from a dosage form that rapidly breaks down in the mouth.

orally disintegrating tablets

2. ODT Manufacturing and Packaging in Pharmaceutical Industry

From a pharmaceutical manufacturing perspective, manufacturers of orally disintegrating tablet need to consider market demand, regulatory requirements, material properties, manufacturing technology, equipment, and packaging protection as an integrated system.

2.1 Market Significance

Traditional tablets remain one of the most widely used oral dosage forms, but they require patients to swallow a relatively intact solid dosage form, usually with water. This can be hard for specific groups. ODTs address this limitation by providing a dosage form that can rapidly disintegrate in the mouth.

For pharmaceutical companies, this creates several potential advantages.

• Improved Patient Convenience: The ability to take a tablet without water can make medication administration simpler.
• Support for Patient Compliance: A more convenient dosage form may help reduce some practical barriers associated with conventional tablets.
• Product Differentiation: ODT technology gives pharmaceutical companies another route for developing differentiated formulations and dosage forms.
• Broader Patient Applications: The dosage form can be particularly relevant to pediatric, geriatric, and dysphagic populations, as well as situations where convenient administration is important.

2.2 Regulatory and Quality Requirements

Orally disintegrating tablets have stricter performance requirements than conventional tablets because they are designed to disintegrate rapidly in the oral cavity. Therefore, manufacturers need to control not only the quality of the active pharmaceutical ingredient (API), but also critical attributes such as disintegration, dissolution, dosage uniformity, mechanical strength, and moisture stability.

For manufacturers targeting major pharmaceutical markets, the U.S. FDA/USP framework and EU GMP/European Pharmacopoeia (Ph. Eur.) are among the most important references.

United States: FDA

In the United States, the FDA published the Guidance for Industry: Orally Disintegrating Tablets, which provides specific recommendations for the development of ODT products.

Rapid disintegration is one of the most important requirements. According to FDA, in-vitro disintegration time of ODTs is around or within 30 seconds. The guidance also discusses factors such as tablet size, weight, solubility of formulation components, and mechanical strength. For example, the FDA generally recommends an ODT tablet weight of no more than 500 mg, unless a higher weight can be appropriately justified.

Europe: EU GMP

In Europe, ODT manufacturing must comply with applicable EU GMP requirements, which are provided in EudraLex Volume 4. The GMP framework covers production, quality control, premises, equipment, hygiene, documentation, contamination prevention, and process control.

For equipment and manufacturing processes, EU GMP Annex 15 – Qualification and Validation is particularly important. It requires manufacturers to identify critical aspects of facilities, equipment, utilities, and processes and demonstrate that they are appropriately qualified and validated. This is directly relevant to ODT production equipment such as milling machine, granulator, fluid-bed dryer, tablet press machine, and packaging machine.

2.3 Key Material Properties

The material properties of orally disintegrating tablet formulations directly affect their manufacturing process and make them different from conventional tablet formulations. The most important properties include flowability, compressibility, particle size, moisture sensitivity, and disintegration performance.

Flowability

Good flowability is essential for consistent feeding and die filling. However, some ODT formulations contain highly porous or low-density excipients, which may have poorer flowability. This can lead to inconsistent die filling and tablet weight variation, making powder preparation and mixing particularly important.

Compressibility

ODT should have sufficient mechanical strength, at the same time, it must keep porous for rapid disintegration. Excessive compression can reduce porosity and slow disintegration, while insufficient compression can result in fragile tablets. Therefore, compression force must be carefully optimized.

Particle Size and Distribution

Particle size affects powder flow, mixing uniformity, segregation, and compression behavior. A suitable and relatively consistent particle-size distribution helps ensure stable feeding and uniform tablet quality. Milling and sieving may therefore require tighter control than for some conventional tablet formulations.

Moisture Sensitivity

Many ODT formulations are sensitive to moisture. Moisture can change powder flowability, compressibility, and the performance of disintegrants, while also affecting the final tablet's stability and disintegration. Therefore, humidity control during processing and drying is particularly important.

Disintegration Performance

The formulation must contain materials that enable rapid water penetration and tablet breakup. The type and amount of superdisintegrant, the porosity of the formulation, and the compression conditions all influence the final disintegration performance. This requirement creates a key manufacturing challenge: the tablet must be strong enough for handling but porous enough to disintegrate rapidly.

2.4 Common Manufacturing Methods

Orally disintegrating tablets can be manufactured using different technologies depending on the properties, formulation characteristics, required disintegration performance, production scale, and cost. The most common methods include direct compression, granulation and compression, freeze-drying, molding, and sublimation.

3. Two Preferred ODT Manufacturing Processes and Related Equipment

The choice of orally disintegrating tablet manufacturing method should never be based on cost alone. It needs to balance material properties, stability requirements, production capacity, process complexity, and total manufacturing cost.

Among the available technologies, direct compression and granulation by compression are particularly attractive for conventional tablet manufacturing because both can be integrated into established solid-dose production lines. Let's look at these two processes in more detail.

3.1 Direct Compression

Direct compression is a relatively simple process in which the powder is compressed directly into tablets through tablet press machine without granulation. The basic process is milling, sieving, mixing, and tablet compression.

Three-dimensional mixer from rich packing

First, the raw materials pass through a milling machine to reduce particle size and break up agglomerates, by a sieving machine to remove oversized particles and achieve a more consistent particle-size distribution. The prepared powders are then transferred to a powder mixer, where mechanical movement distributes the API and excipients uniformly. V-type mixer and three-dimensional mixer are usually used.

V-type mixer from rich packing

After that, blended materials are fed directly into tablet press machine. The feeding system continuously fills the powder into the dies, with the fill depth controlling the tablet weight. The materials then undergo pre-compression to remove trapped air, by main compression to form the tablet. Finally, the lower punch rises to eject tablets from the die.

For ODTs, compression requires particular attention to balance mechanical strength and rapid disintegration. Excessive compression can reduce tablet porosity and slow disintegration, while insufficient compression may cause chipping or breakage. Therefore, parameters such as tablet weight, thickness, compression force, and hardness need to be properly optimized.

3.2 Wet Granulation and Compression

Granulation and compression follows a similar preparation and compression process, but adds wet granulation and fluid-bed drying to improve the flowability and compressibility of the formulation. The typical process is milling, sieving, wet granulation, fluid-bed drying, sizing, mixing, and tablet compression.

After milling and sieving, the powders enter a high-shear wet granulator. The rotating impeller mixes the materials with binder solution, and the chopper breaks and combines the material to form uniform wet granules. After that, the fine powder is turned into granules with better flowability as well as compressibility.

wet granulator

Then comes to fluid-bed dryer. In this process, heated and filtered air will pass through and fluidize the granules. The continuous contact between the drying air and wet granules promotes rapid and uniform moisture removal. Inlet air temperature, airflow, and drying time must be controlled to achieve the required residual moisture, as excessive or insufficient moisture can affect granule flow, tablet strength, and ODT disintegration.

The dried granules are then processed by a sizing machine to break up oversized agglomerates and obtain a suitable particle-size distribution. They are subsequently transferred to a mixer for blending with lubricants and other external-phase excipients before tablet compression.

Finally, the tablet press machine for compression into tables. As with direct compression, the compression force must be optimized to provide sufficient mechanical strength without excessively reducing the porosity required for rapid disintegration.

Compared with direct compression, this process provides better control over flowability and compressibility, but requires additional equipment, longer processing time, and stricter control of granulation and drying conditions.

High speed press machine from rich packing

4. ODT Packaging: From Tablets to Finished Products

Once tablet compression is complete, the orally disintegrating tablet is not yet a finished pharmaceutical product. Packaging becomes especially important because the material characteristics that allow an ODT to absorb saliva and disintegrate rapidly can also make the product more vulnerable to environmental moisture.

For many ODT products, blister packaging is a common option, particularly when individual-dose protection and moisture protection are important. Two common choices are Alu-PVC blister pack and Alu-Alu pack.

4.1 Alu-PVC and Alu-Alu Blister Packaging

Alu-PVC blister packaging uses PVC or PVDC-coated PVC as the forming film and aluminum foil as the lidding material. PVC provides good formability and transparency, while PVDC can provide improved moisture and oxygen barrier properties compared with standard PVC. This structure offers good visibility, flexible cavity design, relatively low packaging cost, and high production efficiency, making it a widely used option for conventional solid dosage forms.

As for Alu-Alu blister packaging, aluminum materials are u applied for both the forming and the lidding side. Because the product is enclosed by aluminum-based barrier materials, Alu-Alu blister packs provide excellent protection against moisture, oxygen, and light, as well as strong protection from external environmental conditions.

Alu-Alu is particularly suitable for orally disintegrating tablets because many ODT formulations are moisture-sensitive and rely on a carefully controlled porous structure. Exposure to moisture during storage can change the physical properties of the tablet, affect its mechanical strength and disintegration behavior. The high barrier performance of Alu-Alu packaging helps minimize moisture ingress and maintain the ODT's intended performance throughout its shelf life.

Therefore, although Alu-PVC/PVDC remains a practical and economical choice for many ODT products, Alu-Alu is generally the preferred option especially when moisture protection is a critical requirement.

Alu-PVC and Alu-Alu blister pack

4.2 From Tablet Press Machine to Blister Packing Machine and Cartoning Machine

Throughout the whole production line, after tablet compression, the orally disintegrating tablets can be transferred directly to downstream processing including tablet deduster and metal detector, and packaging equipment including blister packing machine and cartoning machine.

After tablet press machine, the tablets first pass through a tablet deduster, which gently removes loose powder and particles from the tablet surface. A metal detector can then be integrated into the line to detect and automatically reject tablets containing metallic contamination, helping improve product safety and quality control.

The tablets then enter the blister packing machine. The machine forms the cavities, accurately feeds the tablets into each cavity, applies the aluminum lidding foil, seals the blister, and then cut blister packs as required.

After blister packaging, the blister packs are transferred to the cartoning machine. The machine automatically opens and forms flat carton blanks, inserts the blister packs and information leaflet into the cartons, and closes the cartons to produce the final packaged product.

This integrated process connects tablet compression, dedusting and metal detection, blister packaging, and cartoning, reducing manual handling and improving production efficiency. For ODT products, proper control throughout the entire line helps maintain tablet integrity while providing reliable protection and convenient packaging.

Rich packing’s blister cartoning line

Rich packing’s blister cartoning line

5. Conclusion

Orally disintegrating tablets are widely used in pharmaceuticals, nutraceuticals, and other healthcare products. Their ability to disintegrate rapidly in the mouth provides greater convenience while maintaining the benefits of solid oral dosage forms. Direct compression and granulation by compression are two widely used approaches for industrial production.

For ODT manufacturers, it is of great importance to choose the right equipment and manufacturing process according to production needs. Rich Packing can provide machinery throughout the whole manufacturing and packaging line, including milling machine, sieving machine, powder mixer, wet granulator, fluid-bed dryer, sizing machine, tablet press machine, tablet deduster, metal detector, blister packing machine, and cartoning machines.

We also offer complete pharmaceutical manufacturing and packaging solutions based on each customer’s formulation, production capacity, tablet characteristics, packaging requirements, and factory conditions. Our technical team can evaluate your requirements and provide professional recommendations and customized solutions to help you achieve stable, efficient, and reliable ODT production.

6. FAQs

7. References

1. U.S. Food and Drug Administration (FDA). Guidance for Industry: Orally Disintegrating Tablets. December 2008. Center for Drug Evaluation and Research (CDER). 
2. European Commission. EudraLex – Volume 4: EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. 
3. Formulation and Quality Control of Orally Disintegrating Tablets (ODTs): Recent Advances and Perspectives. 
4. Recent Formulation Advances and Therapeutic Usefulness of Orally Disintegrating Tablets (ODTs).