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Preparation and in vitro Characterization of Sildenafil Citrate Oral Gel
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| Author:
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BASMA YAHYA AL-NAJJAR, MOHAMMED MOWAFAQ MOHAMMED
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| Abstract:
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Sildenafile Citrate (SC) is used for treatment of erectile dysfunction (ED) and Pulmonary Hypertension (PH) in adult and pediatric patients. Objective: The main aim of the study was to develop oral gel of SC for dysphagic, geriatric and pediatric patients who have difficulties with swallowing. Also, oral gel dosage form is convenient to take when there is no water nearby. Thus, this formulation is made for better patient compliance. Materials and Methods: Nine different formulations of sildenafil gel were prepared. The gel base was formulated by using various gelling agents (Hydroxypropylmethylcellulose (HPMC), agar, gelatin) in three different concentrations. Other ingredients were used to improve consistency, stability and palatability of the formulations. The other materials include citric acid, sodium benzoate, glycerine and sucrose. Gel formulations were characterized for appearance, viscosity, pH, syringeability, drug content, and drug release. Results: Among the nine formulations F4 that contain 2% w/v agar was selected as the optimized formulation. F4 showed the lowest viscosity (3325 cP) and hence F4 was syringeable through 22 gauze needle. Also, F4 had the highest drug content (98%) and the most compatible pH with oral cavity (4.48). Thus, F4 was chosen for drug release testing. It was found that F4 showed higher dissolution rate than SC tablet as indicated by their higher percent of drug release. SC gel dissolution reached 100% within 10 min, while SC tablet dissolution was less 85%. Conclusion: The optimized oral gel formulation is appropriate vehicle for drug delivery of SC.
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| Keyword:
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Erectile dysfunction, Oral gel formulation, pulmonary hypertension, Sildenafile
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2020.SP1.229
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| Download:
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