Abstract
FORMULATION AND EVALUATION OF CHLORHEXIDINE EMULGEL AS NOVEL DRUG DELIVERY SYSTEMS
Mahmoud Mahyoob Alburyhi*, Tawfeek A. A. Yahya, Maged Alwan Noman, Abdalwali Ahmed Saif
ABSTRACT
Background: Chlorhexidine is a synthetic cationic bis-biguanide compound used as a topical antiseptic. It is classified as a broad-spectrum antimicrobial agent with potent bactericidal and bacteriostatic activity against Gram-positive and Gram-negative bacteria. Emulgel, combining the hydrophilic properties of gels with the biphasic structure of emulsions, offer enhanced solubility, stability, controlled release, and mucosal penetration. Additionally, Gels further offer ease of application, high spreadability, and good patient acceptability. Additionally, Emulgels further offer ease of application, high spreadability, and good patient acceptability. Clove oil, a natural analgesic, anti-inflammatory, and antimicrobial agent, also improves taste, promoting better compliance. Methods: Three formulations of Emulgel were developed using Carbopol 974, Xanthan Gum, and HPMC as gelling agents. Methylparaben and propylparaben served as preservatives, while propylene glycol, glycerin, sucralose, triethanolamine, tween was included as excipients for stability and patient-friendly characteristics and clove oil as a multifunctional additive. Formulations were evaluated for physicochemical properties, viscosity, spreadability, mucoadhesive strength, drug content, swelling index, microbial contamination, and storage stability. A mucosal irritation test was also performed to assess safety and tolerability of the formulations upon application. Results: Emulgel formulation F3 exhibited optimal viscosity, spreadability, and mucoadhesive strength among the Emulgel group and was flavored with strawberry for enhanced acceptability. Drug content was found to be 99.05%. Microbial testing confirmed the sterility of key formulations (F1, F2, and F3), and all maintained physical and chemical stability over time. Sensory evaluation revealed improved taste and patient acceptability in clove oil and flavored formulations. Conclusion: The optimized Emulgels formulation, containing Chlorhexidine, and clove oil, represents a promising and effective approach for managing oral bacterial infections. It offers antimicrobial activity, enhanced muco-adhesion, and improved sensory qualities, including taste and texture. The inclusion of a tri-polymer base significantly contributes to the rheological performance and stability of the formulation. These attributes support better patient comfort, compliance, and therapeutic outcomes while minimizing systemic side effects and irritation common in oral drug delivery. It was concluded that the best Emulgel Formulation F3 was found to be optimal viscosity, spreadability, percent of drug content 99.05%, and mucoadhesive strength among the Chlorhexidine Emulgels formulations NDDS. Formulation scientist from his experience and knowledge have to significantly in the preformulation study stage and is an important factor in the NDDS (Novel Drug Delivery Systems) product development process.
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