Publication: Verapamil hidroklorür içeren oral yoldan dağılan filmlerin hazırlanması ve değerlendirilmesi
Abstract
Amaç: Bu tez çalışmasında etken madde olarak Verapamil HCl içeren, konjestif kalp yetmezliği, hipertansiyon, migren, anjina ve supraventriküler taşiaritmi semptomu vb. görülen hastalarda hızlı, etkili ve kolay kullanımı olan ağızda dağılan film (ADF) formülasyonlarının oluşturulması amaçlanmıştır.Gereç ve Yöntem: Çalışmamızın ilk aşamasında Verapamil HCl’nin fizikokimyasal özellikleri olarak erime derecesi, FT-IR, UV spektrum ve çözünürlük analiz çalışmaları yapılmıştır. Ardından Pullulan, Lycoat, HPMC polimerleri ile plastifiyan ajanlar kullanılarak ön ADF formülasyonları en yaygın yöntem olarak kullanılan çözücü dökme yöntemiyle hazırlanmıştır. Daha sonra formülasyonlara dağıtıcı ajanlar da eklenerek Verapamil HCl içeren ADF formülasyonları hazırlanmıştır. Çalışmanın devamında uygun bulunan ADF’lere morfolojik analizler, verim, dağılma süresi, in vitro salım çalışmaları, katlanma, şişme, kütle tekdüzeliği, kalınlık ve içerik tekdüzeliği tayini karakterizasyon çalışmaları yapılmıştır. Sonuçlar istatistiksel olarak değerlendirilmiştir.Bulgular: Verapamil HCl’nin fizikokimyasal analizleri ve uygun bulunan ADF’lerin karakterizasyon çalışmaları yapılmış ve başarılı veriler elde edilmiştir.Sonuçlar: Çalışma kapsamında uygun olduğu değerlendirilen 3 adet ADF formülasyonu F-25, F-26 ve F-29 başarıyla hazırlanmıştır.
The Aim: The aim of the present study is to provide fast, effective and easy to use oral disintegrating film (ODF) formulations containing Verapamil HCl as an active ingredient in patients with congestive heart failure, hypertension, migraine, angina and supraventricular tachyarrhythmia symptoms and so on.Materials and Methods: In the first stage of the study, the physicochemical properties of Verapamil HCl, melting degree, FT-IR, UV spectrum and solubility analysis studies were performed. Subsequently, ODF formulations were prepared using Pullulan, Lycoat, HPMC polymers and plasticizing agents by solvent casting method which is the most common method. ODF formulations containing Verapamil HCl were then prepared by adding dispersing agents to the formulations. Morphological analyzes, yield, disintegration time, in vitro release studies, folding, swelling, mass uniformity, thickness and content uniformity characterization studies were carried out for ODFs, which were found to be suitable for further study. The results of the study were evaluated statistically. Findings: Physicochemical analyzes of Verapamil HCl and characterization studies of suitable ADFs were performed and successful data were obtained.Results: 3 ADF formulations F-25, F-26 and F-29 were evaluated successfully.
The Aim: The aim of the present study is to provide fast, effective and easy to use oral disintegrating film (ODF) formulations containing Verapamil HCl as an active ingredient in patients with congestive heart failure, hypertension, migraine, angina and supraventricular tachyarrhythmia symptoms and so on.Materials and Methods: In the first stage of the study, the physicochemical properties of Verapamil HCl, melting degree, FT-IR, UV spectrum and solubility analysis studies were performed. Subsequently, ODF formulations were prepared using Pullulan, Lycoat, HPMC polymers and plasticizing agents by solvent casting method which is the most common method. ODF formulations containing Verapamil HCl were then prepared by adding dispersing agents to the formulations. Morphological analyzes, yield, disintegration time, in vitro release studies, folding, swelling, mass uniformity, thickness and content uniformity characterization studies were carried out for ODFs, which were found to be suitable for further study. The results of the study were evaluated statistically. Findings: Physicochemical analyzes of Verapamil HCl and characterization studies of suitable ADFs were performed and successful data were obtained.Results: 3 ADF formulations F-25, F-26 and F-29 were evaluated successfully.