Challenges in Manufacturing Sublingual Tablets

Sublingual tablets are a specialized type of oral dosage form that is designed to be placed under the tongue, where the drug is rapidly absorbed into the bloodstream through the sublingual mucosa. While sublingual tablets offer several advantages, such as faster onset of action and avoidance of first-pass metabolism, their manufacturing presents specific challenges. Here are some of the key challenges in manufacturing sublingual tablets:

1. API Compatibility

Sublingual tablets often contain potent and sensitive active pharmaceutical ingredients (APIs). Ensuring compatibility between the API and excipients is crucial to maintain the drug’s stability and efficacy during the manufacturing

process and throughout the product’s shelf life.

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2. Taste and Palatability

Sublingual tablets are placed under the tongue, where they come into direct contact with the taste buds. It is challenging to formulate sublingual tablets with acceptable taste and palatability, as some APIs can have a bitter or unpleasant taste. Masking the taste of the drug while maintaining its efficacy is a significant challenge in sublingual tablet manufacturing.

3. Disintegration and Dissolution

Sublingual tablets must disintegrate rapidly when placed under the tongue to release the drug for absorption. Achieving fast disintegration while maintaining tablet integrity and mechanical strength is a technical challenge in manufacturing sublingual tablets.

4. Drug Loading and Dose Accuracy

Sublingual tablets are typically small in size, and ensuring accurate drug loading and uniformity is crucial to deliver the intended dose consistently. Achieving dose accuracy in small tablets can be challenging during the manufacturing process.

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5. Compression and Tableting

Sublingual tablets may require specific compression and tableting techniques to ensure that they have the appropriate hardness for handling and packaging while still disintegrating rapidly under the tongue. Balancing tablet hardness and disintegration rate is a critical challenge in the manufacturing process.

6. Moisture Sensitivity

Some APIs in sublingual tablets can be sensitive to moisture, which may lead to degradation and reduced shelf life. Ensuring proper packaging and handling to protect the tablets from moisture is a challenge in manufacturing sublingual tablets.

7. Regulatory Requirements

Sublingual tablets are considered a specialized dosage form, and regulatory requirements may differ from conventional oral tablets. Manufacturers must adhere to specific regulations and guidelines applicable to sublingual tablets, which can be a challenge in ensuring compliance and approval.

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Conclusion

Manufacturing sublingual tablets presents several challenges due to the need to achieve rapid disintegration, accurate dosing, taste masking, and compatibility of sensitive APIs. Overcoming these challenges requires careful formulation, specialized tableting techniques, and strict adherence to regulatory requirements. Despite the challenges, sublingual tablets offer significant benefits and are valuable in delivering certain medications with rapid and effective absorption.