Benzidamin Hidroklorür İçeren Hyaluronik Asit Bukkal Filmlerinin Formülasyon, Optimizasyon ve İn-Vitro Değerlendirilmesi

Amaç: Mukoadezif bukkal filmler, artmış hasta uyumu ile hem lokal hem de sistemik dolaşıma ilaç geçişini sağlayan sistemlerdir. Bu çalışmanın amacı, mukozal ülser üzerindeki antiinflamatuvar etki için film oluşturucu ajan olarak hyaluronik asit (HA) ve plastizer olarak gliserin (Gly) kullanarak benzidamin hidroklorür (BNZ) içeren bukkal film geliştirmektir. Gereç ve Yöntemler: Farklı HA ve Gly konsantrasyonlarının etkisi 23 faktöryel tasarım kullanılarak analiz edilmiştir. HA ve Gly oranı bağımsız faktörler seçildi ve mukoadezyon, gerilme kuvveti, kopmada uzama ve temas açısı değerleri bağımlı faktörler olarak seçildi. Dokuz farklı film formülasyonu çözücü dökme yöntemi ile sabit BNZ konsantrasyonunda (% 0,15) hazırlandı. Film formülasyonlarının mekanik, mukoadezyon özellikleri değerlendirildi ve temas açıları hesaplandı. BNZ salım profilleri, yapay tükrük çözeltisinde (pH 6.8) gerçekleştirildi. Bulgular: Film formülasyonlarının hepsi çözücü dökme yöntemi ile başarıyla hazırlanmıştır. HA konsantrasyonunun % 0,5'ten %2'ye yükseltilmesi, film formülasyonlarının mekanik ve mukoadezif özelliklerini artırmıştır. Gly ilavesi kopma gerilim değerlerini düşürmesine rağmen kopma uzaması değerlerini yaklaşık 10 kat arttırmıştır. Tüm formülasyonlar 60 dakikada % 60'tan fazla BNZ salmıştır. Sonuç: BNZ içeren HA oral mukoadezif filmlerin oral ülserlerin tedavisi için umut verici bir formülasyon olduğu sonucuna varılmıştır.

Anahtar Kelimeler:

Benzidamin hidroklorür, hyaluronik asit, bukkal film, çözücü dökme yöntemi

Formulation, Optimization, and In-Vitro Evaluation of Hyaluronic Acid Buccal Films Containing Benzydamine Hydrochloride

Aim: Mucoadhesive buccal films provide drug delivery for both local and systemic circulation with increased patient compliance. The objective of this study was to develop a buccal film containing benzydamine hydrochloride (BNZ) by using hyaluronic acid (HA) as a film-forming agent and glycerin (Gly) as a plasticizer for the anti-inflammatory effect on the mucosal ulcer. Material and Methods: The effects of different concentrations of HA and Gly on responses were analyzed using 23 factorial design. The HA and Gly ratio were selected as independent factors, and work of mucoadhesion, tensile strength, elongation at break, and contact angle values were chosen as dependent factors. Nine different film formulations were prepared at constant BNZ concentration (0.15%) by solvent casting method. Mechanical and mucoadhesion properties of film formulations were evaluated, and also contact angles were calculated. The BNZ release profiles were evaluated in simulated saliva solution (pH 6.8). Results: All film formulations were successfully prepared by solvent casting method. Increasing HA concentration from 0.5 to 2 % raised the mechanical and mucoadhesion properties of film formulations. Although the addition of Gly decreased the tensile strength values, it increased the elongation at break values about ten times. All formulations released more than 60 % BNZ in 60 mins. Conclusion: It is concluded that HA oral mucoadhesive film formulations containing BNZ are promising for treating oral ulcers.

Keywords:

Benzydamine hydrochloride, hyaluronic acid, buccal film, solvent casting method,

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