Development and Evaluation of Superdisintegrating Oral Tablets of Sumatriptan Succinate Using Direct Compression Technique

Abstract

Migraine is a chronic neurological disorder characterized by recurrent attacks of moderate-to-severe headache accompanied by nausea, vomiting, photophobia, and phonophobia. Rapid onset of therapy is essential for effective management of acute migraine attacks. Conventional oral tablets of sumatriptan often exhibit delayed therapeutic action due to the time required for tablet disintegration and gastric emptying. Superdisintegrating oral tablets (SDOTs) provide rapid tablet disintegration in the oral cavity, resulting in faster drug release, improved patient compliance, and enhanced convenience, particularly for patients experiencing nausea or difficulty swallowing during migraine episodes. The present study aimed to formulate and optimize superdisintegrating oral tablets of Sumatriptan succinate using direct compression and to evaluate the influence of different superdisintegrants on tablet performance.

Introduction

Migraine is a common neurological disorder that causes severe headaches, nausea, vomiting, and sensitivity to light and sound. Sumatriptan succinate, a selective serotonin (5-HT?B/?D) receptor agonist, is widely used for acute migraine treatment. However, conventional tablets often have a delayed onset of action and are difficult to swallow during migraine attacks due to nausea and vomiting. To overcome these limitations, this study developed superdisintegrating oral tablets (SDOTs) that rapidly disintegrate in the mouth without water, providing faster drug release, improved patient compliance, and quicker therapeutic action.

The tablets were formulated using the direct compression method with crospovidone, croscarmellose sodium, and Kyron T-114 as superdisintegrants. A three-level factorial Design of Experiments (DoE) was employed to optimize the concentrations of crospovidone and croscarmellose sodium, aiming to achieve rapid disintegration while maintaining adequate tablet hardness. Nine formulations were prepared and compared to identify the optimized formulation.

Extensive preformulation studies were conducted before tablet development. These included organoleptic evaluation, solubility testing, melting point determination, UV spectrophotometric analysis, and drug–excipient compatibility studies using FTIR and DSC. Sumatriptan succinate was found to be a white, odorless, free-flowing crystalline powder with good aqueous solubility, a melting point of approximately 168°C, and a maximum UV absorption (λmax) at 282 nm, confirming its suitability for direct compression and analytical estimation.

The powder blends were evaluated for bulk density, tapped density, angle of repose, Carr's index, and Hausner's ratio to ensure good flow and compressibility. The compressed tablets were assessed for weight variation, thickness, hardness, friability, disintegration time, drug content, and in vitro dissolution according to pharmacopeial standards. Dissolution studies were performed using the USP paddle method in phosphate buffer (pH 6.8), while the optimized formulation underwent accelerated stability testing under ICH guidelines for three months.

Conclusion

The present study successfully developed and optimized superdisintegrating oral tablets (SDOTs) of Sumatriptan succinate using the direct compression technique with a systematic Design of Experiments (DoE) approach. Preformulation studies confirmed the suitability of the drug for formulation development by demonstrating acceptable physicochemical properties, good aqueous solubility, and compatibility with the selected excipients as evidenced by FTIR and DSC analyses. The factorial experimental design effectively optimized the concentrations of crospovidone and croscarmellose sodium, which significantly influenced tablet disintegration time and mechanical strength. All prepared formulations exhibited satisfactory pre-compression flow properties and complied with pharmacopeial requirements for post-compression quality attributes. Among the investigated formulations, F9, containing 14 mg of crospovidone and 18 mg of croscarmellose sodium, was identified as the optimized formulation. It demonstrated excellent powder flow characteristics, acceptable hardness, low friability, rapid wetting and disintegration, uniform drug content, and a superior dissolution profile, releasing more than 90% of the drug within 5 minutes. Accelerated stability studies performed according to ICH guidelines confirmed that the optimized formulation remained physically and chemically stable throughout the three-month storage period without significant changes in tablet quality or drug content. Comparison with the marketed conventional tablet (Suminat® 50) further demonstrated the superiority of the developed superdisintegrating formulation. The optimized tablet exhibited markedly shorter wetting and disintegration times, faster drug release, improved mouthfeel, and eliminated the need for water during administration, thereby offering enhanced patient convenience and compliance, particularly for patients experiencing acute migraine attacks accompanied by nausea or dysphagia. The developed Sumatriptan succinate superdisintegrating oral tablet represents a promising patient-friendly dosage form capable of providing rapid drug release and improved therapeutic performance. The optimized formulation has the potential to improve the clinical management of acute migraine and may serve as a suitable alternative to conventional oral tablets. Further pharmacokinetic, bioavailability, and in vivo clinical studies are recommended to establish an in vitro–in vivo correlation and confirm its therapeutic advantages for future commercialization.

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Copyright

Copyright © 2026 Rutuja Dhotre, Dr. Vaishali Kate. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.