A fast-dissolving CBD tablet designed for easier anxiety treatment

Quality by Design-Driven Formulation Development of Cannabidiol Orally Disintegrating Tablets.

Scientifica • • Highly Relevant
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AI Summary

This study developed cannabidiol (CBD) orally disintegrating tablets using a Quality by Design (QbD) approach. The goal was to create a patient-friendly tablet that breaks apart quickly in the mouth and could support CBD delivery for anxiety treatment. The researchers evaluated how tablet pressure and the amounts of two inactive ingredients—microcrystalline cellulose and croscarmellose sodium—affected tablet quality.

The selected formulation contained 4% CBD, or 10 mg per tablet, along with 35% microcrystalline cellulose and 1% croscarmellose sodium, and was compressed at 1400 pounds per square inch. It had a hardness of about 5 kg-force, disintegrated in 13–15 seconds, and had approximately 0.3% friability, indicating that it was both quick-dissolving and mechanically stable. Laboratory testing found CBD content and assay results between 90% and 100%, while approximately 76% dissolved within 3 hours in the test solution. The study developed and verified the tablet formulation, but it did not test whether the tablets actually reduce anxiety in patients.

💡 Key Findings

1
A Quality by Design approach successfully produced CBD orally disintegrating tablets with the targeted quality characteristics.
High
80%
2
The optimized tablets contained 10 mg of CBD and disintegrated in 13–15 seconds, offering a potentially convenient format for users who have difficulty swallowing conventional tablets.
High
80%
3
The formulation showed approximately 0.3% friability and about 5 kg-force hardness, suggesting a balance between tablet durability and rapid disintegration.
Good
75%
4
Laboratory testing found CBD content and assay results between 90% and 100%, with approximately 76% dissolved within 3 hours in the stated test solution.
Good
75%
5
The study supports formulation feasibility, but does not provide clinical evidence that the tablets treat anxiety.
High
90%

📄 Original Abstract

The development of cannabidiol (CBD) orally disintegrating tablets (ODTs) is effective in treating anxiety in a patient-friendly manner. The application of Quality by Design (QbD) enhances the efficiency and robustness of the pharmaceutical development of CBD ODTs. The objective of this work was to develop a formulation for CBD ODTs using a QbD-driven approach. Quality target product profile, critical quality attributes, and an initial risk assessment were identified and evaluated. Subsequently, a Box-Behnken design was employed to analyze the effects of varied compression force, the quantity of microcrystalline cellulose, and the quantity of croscarmellose sodium to create a design space and control space. Results indicated that the design and control spaces produced tablets with hardness ranging from 4 to 6 kg-force, a disintegration time (DT) ≤ 30 s, and a friability ≤ 1%. All formulations contained 4% CBD (or 10 mg per tablet). The optimal formulation consisted of 35% microcrystalline cellulose and 1% croscarmellose sodium and was compressed at 1400 pounds per square inch. This formulation exhibited a hardness of approximately 5 kg-force, a DT of 13-15 s, and a friability of approximately 0.3%. Verification data confirmed the accuracy of the predictions made by computer software. The content uniformity and assay determined using validated high-performance liquid chromatography ranged between 90% and 100%. CBD was released from the CBD ODT in 1% sodium lauryl sulfate solution, with approximately 76% dissolved within 3 h in the dissolution study. In conclusion, the QbD-driven approach successfully facilitated the formulation development of CBD ODTs with the desired properties for the treatment of anxiety in a patient-friendly manner.

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