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2000
Volume 15, Issue 3
  • ISSN: 2210-3031
  • E-ISSN: 2210-304X

Abstract

Background

Oral fast-melting tablets (FMTs) have been gaining popularity due to their advantages in resolving swallowing issues of conventional oral tablets. Cocoa butter is an excipient of choice to develop FMT with an acceptable taste and faster onset of action of the drug.

Purpose

The present study aimed to prepare and characterize the amlodipine besylate-loaded cocoa butter FMTs.

Methods

Amlodipine besylate FMTs were prepared using a simple freezing (refrigeration) method. Cocoa butter (Form V) was used as the base to achieve a final tablet weight of 500 mg with drug and other functional excipients. The designed prototype tablet formulations were subjected to disintegration tests to determine the to determine the most robust batch. The formulation F4, containing 7% high-molecular-weight chitosan, exhibited the quickest disintegration time (DT) of 1.45 ± 0.10 min. Afterwards, the selected formulation, F4, was subjected to quality evaluation parameters.

Results

Fourier transform infrared spectroscopy (FTIR) studies revealed that there was no incompatibility between amlodipine besylate, cocoa butter, and other excipients. The average hardness of the F4 formulation tablet batch was found to be 2.69 ± 0.21 kg/cm2 and the friability was found to be 0.44%. The drug content in F4 tablets was found to be 102.38 ± 5.29% and showed an drug release of 94.30 ± 2.63% within 30 min. Over a six-month stability testing period, the chosen F4 formulation did not significantly change in terms of tablet average weight, disintegration time, drug content, and dissolution rate at 25°C ± 2°C/ 60% ± 5% relative humidity.

Conclusion

Selected formulation F4 with 7% of high molecular weight chitosan exhibited good physical properties, indicating the suitability of cocoa butter as a base to produce FMTs with the aid of a natural super-disintegrant.

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/content/journals/ddl/10.2174/0122103031299894240912092850
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Design and in vitro Evaluation of Cocoa Butter-based Amlodipine Besylate Fast Melt Tablets
Drug Deliv Lett 15, 288 (2025); https://doi.org/10.2174/0122103031299894240912092850
/content/journals/ddl/10.2174/0122103031299894240912092850
/content/journals/ddl/10.2174/0122103031299894240912092850
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  • Article Type:     Research Article
Keyword(s): Amlodipine besylate; chitosan; cocoa butter; disintegration time; fast melt tablets; in-vitro dissolution

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