Abstract
Objective: The aim of the proposed study was formulation and in vitro/ vivo evolution of solid dispersions of glipizide with gum Aegle marmelos. Methods: The phase solubility of glipizide in 0.1N HCl was investigated in the presence of different concentrations of gum Aegle marmelos. The solid dispersions (SDs) of glipizide with gum Aegle marmelos were formulated using solvent evaporation method at ratios of 1:1, 1:2, and 1:5 (glipizide: gum Aegle marmelos). Dissolution studies were conducted. The physicochemical characterization of the formulations was performed by using Fourier-transform infrared (FTIR) spectroscopy, differential scanning calorimetry (DSC) and X-ray diffraction (XRD). Subsequently, bioavailability of pure glipizide, solid dispersion and marketed product was performed in rat. Results: Glipizide solubility increased as the concentration of gum Aegle marmelos in 0.1N HCl was raised. The solubility study indicates spontaneous drug solubilization, which is supported by negative values of Gibb's free energy (ΔGotr). Glipizide rate of dissolution was increased in SDs containing gum, and the rate increased as the concentration of gum in the SDs increases. After preparing SDs and physical mixtures with gum, the mean dissolution time (MDT) of glipizide decreases considerably. FTIR spectroscopy study revealed that stability and the absence of a well-defined glipizide-gum interaction. The amorphous condition of glipizide in SDs of glipizide with gum was revealed by DSC and XRD studies. Conclusion: The DSC and XRD studies indicate conversion of drug from crystalline to microcrystalline or amorphous form after formulation of solid dispersion with Aegle gum. The solid dispersion of glipizide with Aegle gum (893.04±25.5) showed better therapeutic activity compared to pure glipizide (535.65±11.5) and marketed formulation (767.5±13.6).
Highlights
Bael, (Aegle marmelos) is oldest medicinally treasured tree species in the Globe as per Charak Samhita and called as Golden Apple [1]
Solubility of glipizide is significantly affected by the presence of Aegle gum in 0.1N HCl
The improvement of solubility of the drug after the formation of solid dispersion might be attributed to the reduction of particle aggregation of the drug, absence of crystallinity, increased wettability and dispersibility and alteration of the surface properties of the drug particles
Summary
Bael, (Aegle marmelos) is oldest medicinally treasured tree species in the Globe as per Charak Samhita and called as Golden Apple [1]. Aegle gum shows therapeutic effects and it can be used as pharmaceutical excipients for formulation of various dosage forms as it consists of polysaccharide like D-galactose, Lrhamnose, L-arabinose and D-glucuronic in molar ratio of 9:3: 1:3 [9]. Yogesh Joshi et al, has reported that Aegle marmelos gum can be used for sustained release matrix tablets [11]
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