"Design and Development of Phenytoin Rectal Suppository Containing Natural Polymers"

Authors

  • Samrat A Khedkar
  • Abhijeet B Survase
  • Salunke Vishal R

Keywords:

Phenytoin, Rectal Suppository, Natural Polymers, Sodium Alginate, Chitosan, Gelatin, Mucoadhesion, Controlled Drug Release, Epilepsy, Rectal Drug Delivery...

Abstract

The management of epilepsy often requires rapid and effective drug delivery, particularly in emergency situations or in patients who are unable to take oral medications due to unconsciousness, vomiting, dysphagia, or pediatric and geriatric conditions. Although phenytoin is a widely prescribed antiepileptic drug, its oral administration is associated with poor aqueous solubility, variable gastrointestinal absorption, delayed onset of action, and significant first-pass metabolism, which may compromise therapeutic efficacy. The present study aimed to design and develop a mucoadhesive rectal suppository of phenytoin using natural polymers to improve drug delivery, enhance patient compliance, and provide controlled drug release. The suppositories were formulated by the fusion molding method using sodium alginate, chitosan, and gelatin as natural polymers, while glycerin and PEG 400 were incorporated as plasticizer and solubilizer, respectively. Different polymeric formulations were prepared by varying the concentrations of the natural polymers to optimize the physicochemical and drug release characteristics. The prepared suppositories were evaluated for appearance, weight variation, hardness, friability, disintegration time, drug content uniformity, mucoadhesive strength, in vitro drug release, drug–polymer compatibility using FTIR and DSC, and stability under recommended storage conditions. The optimized formulation exhibited satisfactory physicochemical properties, acceptable mechanical strength, uniform drug content, controlled disintegration, enhanced mucoadhesion, and sustained drug release compared with other formulations. Compatibility studies confirmed the absence of significant interactions between phenytoin and the selected excipients, while stability studies demonstrated that the optimized formulation remained physically and chemically stable throughout the study period. Overall, the developed natural polymer-based phenytoin rectal suppository represents a promising alternative dosage form for the effective management of epilepsy, particularly in patients who cannot receive oral therapy. The formulation offers improved therapeutic performance, enhanced patient acceptability, and potential clinical utility as a safe and effective rectal drug delivery system..

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Published

2025-12-12

How to Cite

1.
A Khedkar S, B Survase A, Vishal R S. "Design and Development of Phenytoin Rectal Suppository Containing Natural Polymers". J Neonatal Surg [Internet]. 2025 Dec. 12 [cited 2026 Jul. 26];14(33S):1332-4. Available from: https://jneonatalsurg.com/index.php/jns/article/view/10456

Issue

Vol. 14 No. 33S (2025): Journal of Neonatal Surgery

Section

Original Article

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