Development of 2% Miconazole Oral Gel Formulation for Patients with Oral Candidiasis at Phaholpolpayuhasena Hospital

Abstract

Objective: To develop a standardized 2% miconazole oral gel formulation for the treatment of oral candidiasis.

Methods: This research and development (R&D) study was conducted over a six-month period and divided into four phases: 1) formulation development and preparation using three types of gelling agents carbomer 940, hydroxypropyl methylcellulose (HPMC) 4000, and sodium carboxymethylcellulose (sodium CMC) 1500-1800 at concentrations of 1%, 2%, and 3%; 2) physicochemical property testing, including general appearance, pH value, and viscosity; 3) stability testing and antifungal activity evaluation against Candida albicans; and 4) clinical application in patients. The study was carried out at the Pharmacy Manufacturing Unit, Phaholpolpayuhasena Hospital, Kanchanaburi Province.

Results: The base gel prepared with 2% sodium CMC 1500-1800 demonstrated the most suitable physical properties, being clear, odorless, and smooth in texture, with a pH of 6.9±0.1 and a viscosity of 180.0±0.0cPa·s. The formulation remained stable throughout the   6-month study period. When formulated with miconazole nitrate into a 2% miconazole oral gel, the preparation successfully inhibited C. albicans with an average inhibition zone diameter of 24.3 ± 0.8 mm and maintained stability for six months. Clinical application in 43 patients revealed that 41 patients (95.34%) were cured of oral candidiasis, one patient (2.32%) showed no change, and one patient (2.32%) experienced worsening symptoms.

Conclusion: The 2% miconazole oral gel formulation developed from 2% sodium CMC 1500-1800 as a gelling agent possesses appropriate pharmaceutical properties, effective antifungal activity, and excellent stability. This formulation can be manufactured in-hospital to improve patient access to essential medication.