Rajesh KAZA, Prasanna Raju YALAVARTHI, Nagaraju RAVOURU

Valsartan’ın Hızlı Çözünen Filmlerinin Tasarımı ve Karakterizasyonu

Son zamanda araştırmacılar hızlı çözünen valsartan filmler (FDF) ve onların geliştirilmesine odaklandılar. Valsartan filmler, farklı HPMC'ler (E5, E50, K4M) kullanılarak çözücü döküm metodu ile hazırlandı. Altı valsartan film formülasyonu (FV1-FV6) hazırlandı ve kalınlık, gerilme gücü, uzama, ağırlık değişimi, katlanmaya dayanım, etken madde içerik tekdüzeliği ve yüzey pH'sı gibi fiziksel özellikleri değerlendirildi ve başarılı sonuçlar verdi. Etken maddenin formülasyondaki geçimliliği FTIR ve DSC çalışmaları ile onaylandı. Formülasyonlar dağılma, in vitro etken madde salımı ve spontan hipertansif ratlarda (SHR) farmakodinamik çalışmalara maruz bırakıldı. HPMC ve valsartanın guar gum ile katı dispersiyonunu ağırlıkça 1:4 oranında içeren FV5 formülasyonu 57 saniye dağılma süresi ve 10 dakikada %95.95 etken madde salımı ile mükemmel film oluşum özellikleri gösterdi ve en iyi formül olduğu bulundu. Optimize edilen film formülasyonu (FV5) 40 C°/%60 relatif nemde bekletildiğinde 45 günden fazla mükemmel stabilite gösterdi. FDF valsartan film'in SHR'lerde farmakodinamik çalışması daha iyi terapotik etkiyi kanıtladı

Design and Characterization of Fast Dissolving Films of Valsartan

Recently researcher’s focused on valsartan fast dissolving films (FDF) and their development. Valsartan films were prepared by solvent casting method using different grades of HPMC (E5, E50 and K4M). Six formulations (FV1-FV6) of valsartan films were prepared and evaluated for their physical characteristics such as thickness, tensile strength, elongation, weight variation, folding endurance, drug content uniformity and surface pH and gave satisfactory results.The compatibility of the drug in the formulation was confirmed by FTIR and DSC studies. The formulations were subjected to disintegration, in vitro drug release and pharmacodynamic studies on spontaneous hypertensive rats (SHR). Formulation FV5 was found to be best formulations which contain HPMC E5 and valsartan solid dispersion with guar gum at weight ratio of 1:4 showed excellent film forming characteristics such as disintegration time of 57 sec and percentage drug release 95.95% within 10 minutes. The optimized film formulation (FV5) showed excellent stability over 45 days when stored at 40°C/60% relative humidity. The pharmacodynamic study of valsartan FDF in SHR proved the better therapeutic efficacy

Tam Metin

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