Preparation, in vitro evaluation, and stability studies of sodium risedronate microemulsions

Abdali, Tala; Hasian, Jameela

doi:10.33762/mjbu.2024.145749.1185

	Preparation, in vitro evaluation, and stability studies of sodium risedronate microemulsions
The Medical Journal of Basrah University
Article 6, Volume 42, Issue 1, June 2024, Pages 37-52 PDF (938.91 K)
Document Type: Research Paper
DOI: 10.33762/mjbu.2024.145749.1185
Authors
Tala Abdali^* ¹; Jameela Hasian²
¹Damascus University, Faculty of Pharmacy
²Pharmaceutics and Pharmaceutical Technology Department, Damascus University, Faculty of Pharmacy, Damascus, Syria.
Abstract
Introduction: Sodium Risedronate (SR) is a member of bisphosphonate drugs used for osteoporosis treatment. Albeit its well-known efficacy, SR suffers from low oral absorption (only 0.63%) and many adverse effects. The aim of the study: formulate and characterize oil-in-water microemulsion systems for the oral delivery of SR. Methods: Sunflower oil was used for the oil phase. Next, the solubility of SR in different surfactants and co-surfactants was detected. Three different ratios of (Tween 80/glycerin) microemulsions were studied: (2/1), (1/1), and (1/2). Regarding SR microemulsions, three different formulations: (2/1), (1/1), and (1/2) (Tween 80/glycerin) were characterized for their: transparency, conductivity, light transmission, refractive index, droplet size, dissolution tests, and intensive stability studies. Results: As Tween 80 and glycerin were the best surfactant/co-surfactant mixture, the higher surfactant ratio (Tween 80) had the largest microemulsion region in pseudo-ternary diagrams and a new detected phase (gels). SR microemulsions were transparent liquids of the o/w type. (2/1) formulation had the smallest droplet size (8nm) with good stability results across three diverse protocols. Followed by the (1/1) formulation (10.89 nm), though this formulation showed an overloading problem (0.4% SR) in stability tests. (1/2) formulation (19.21 nm) had the highest loading capacity (0.6% SR). Conclusion: The outstanding stability of the (2/1) (0.1% SR) formulation as a highly stable finished drug form or a potential step for further formulation development, along with the notable drug loading capacity of the (1/2) (0.6% SR) formulation, emphasize the significance of further studies to validate their efficacy and potentials.
Keywords
Keywords: Sodium risedronate; Microemulsion; Tween 80; Glycerin; Stability studies

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