The Thai Journal of Pharmaceutical Sciences
Abstract
Purpose: Fluocinolone acetonide (FA) preparations were developed in the forms of premicroemulsion concentrates and microemulsions and their stabilities were evaluated. Materials and Methods: A pseudoternary diagram of clove oil, surfactant mixture (containing polysorbate80: Polyethylene glycol 400 [PEG400] at the ratio of 2:1), and water was constructed for the formulation of FA premicroemulsion concentrates and microemulsions. Physical properties and chemical stabilities of the preparations were monitored in the absence and presence of three antioxidants. Their beyond-use dates were determined. Results and Discussion: The premicroemulsion concentrates and microemulsions containing polysorbate 80, PEG400, and clove oil successfully improved FA solubility. Average diameters of the microemulsions were in the range of 11–15 nm. The temperature increment induced the degradation of FA in both premicroemulsion concentrate and microemulsion systems. FA appeared more stable in the microemulsions than in the premicroemulsion concentrates, where FA remaining in microemulsions stored at 40°C were >95% after 6 months. Antioxidants used in this study did not show an ability to stabilize FA in the premicroemulsion concentrates and microemulsions compared to systems without antioxidants. Conclusion: 0.1% FA microemulsions with and without the addition of antioxidants were stable at the beyond-use date of 12 months. The FA microemulsions are promising candidates to be further investigated for clinical use.
Publisher
Faculty of Pharmaceutical Sciences, Chulalongkorn University
First Page
425
Last Page
531
Recommended Citation
Muangsiri, W.; Chukaewrungroj, P.; and Werawatganone, Pornpen
(2022)
"Preparation and stability of fluocinolone acetonide premicroemulsion concentrates and microemulsions for oral lichen planus treatment,"
The Thai Journal of Pharmaceutical Sciences: Vol. 46:
Iss.
4, Article 8.
Available at:
https://digital.car.chula.ac.th/tjps/vol46/iss4/8