Publication: Steroid yapıda olmayan antienflamatuvar etken madde içeren ağızda dağılan tablet formülasyonlarının hazırlanması ve in-vitro değerlendirilmesi
Abstract
Steroid Yapıda Olmayan Antienflamatuvar Etken Madde İçeren Ağızda Dağılan Tablet Formülasyonlarının Hazırlanması ve In-Vitro Değerlendirilmesi Öğrencinin Adı: Ecz. Kemal Ozan ERDOĞANDanışman Adı: Dr. Öğr. Üyesi Sevinç ŞAHBAZAnabilim Dalı: Farmasötik TeknolojiAmaç: Konvansiyonel tabletlerin yaşlı, çocuk ve psikiyatri hastalarında veriliş yolunda uyunç sorunlarını gidermek için, suya veya çiğnemeye ihtiyaç duyulmaksızın ağız boşluğunda hızlı şekilde dağılma ve çözünme özelliği gösteren, ülkemizde preparatı bulunmayan aseklofenak ağızda dağılan tablet (ADT) formülasyonlarının hazırlanması ve in vitro değerlendirilmesi amaçlanmıştır. Gereç ve Yöntem: Çalışmada, 100 Bar ve 300 Bar basınç altında direkt basım yöntemi ile üretilen 6 farklı tablet formülasyonunda, Ac-Di-Sol, Kollidon CL ve Primojel süper dağıtıcıları çeşitliliği sağlamak amacıyla farklı oranlarda kullanılmıştır. Tabletlerde ağırlık sapması, çap ve kalınlık, sertlik, friabilite, etken madde miktar tayini, dağılma süresi ve çözünme hızı tayinleri yapılmıştır. Dağılma süresi tayini için, farmakopelerde yer alan dağılma testinin haricinde diğer yapılan birçok çalışmadan farklı olarak ADT’lerde daha hassas sonuçlar alınabilen Tekstür analiz cihazından yararlanılmıştır. Bulgular: 100 Bar basınç altında basılan tüm formülasyonlar, iki farklı dağılma süresi tayin yönteminde de 3 dakikadan kısa sürede dağılarak ideal ADT özelliğini gösterirken 300 Bar ile basılanlarda dağılma sürelerinin uzadığı görülmüştür. Tekstür analiz yönteminde en kısa sürede dağılma, ortalama 15,80 sn ile %10 Kollidon CL kullanılan K2-100 formülasyonunda gerçekleşmiştir. In vitro çözünme hızı tayininde ise K1-100 ve K2-100 formülasyonları, 15. dakikada % 85’ten fazla çözünerek en ideal grafiği vermiştir. Ağırlık sapması, çap ve kalınlık, sertlik, friabilite, etken madde miktar tayini sonuçları istenilen değerlerde çıkmış olup standart sapmaları düşük bulunmuştur. Sonuç: Bu çalışmada, optimum özelliklere sahip aseklofenak ADT formülasyonu üretilmiş ve uyunç sorunu yaşayan hastaların tedavilerinde daha kolay uygulanabilir bir yaklaşım geliştirilmeye çalışılmıştır.
Preparation and In-Vitro Evaluation of Oral Disintegrating Tablet Formulations Containing Nonsteroidal Anti-inflammatory AgentStudent Name: Ecz. Kemal Ozan ERDOĞANName of Supervisor: Dr. Öğr. Üyesi Sevinç ŞAHBAZDepartment: Pharmaceutical TechnologyObjective: In order to overcome the problems of compliance with the administration of conventional tablets to elderly, pediatric and psychiatric patients it was aimed to prepare and in vitro evaluation of aceclofenac orally disintegrating tablet (ODT) formulations, which do not have any preparation in our country, that have the ability to disintegrate and dissolve quickly in the oral cavity without the need for water or chewing.Materials and Methods: In the study, Ac-Di-Sol, Kollidon CL and Primojel superdisintegrants were used in different ratios in 6 different tablet formulations produced by direct compression method under both 100 Bar and 300 Bar pressure. Weight variation, diameter and thickness, hardness, friability, active ingredient quantity assay, disintegration time and dissolution rate were determined in the tablets. For the determination of disintegration time, unlike many other studies, apart from the disintegration test in the pharmacopoeias, the Texture analyser, which more sensitive results can be obtained in ODTs, was used.Results: All formulations pressed under 100 Bar pressure showed the ideal ODT feature by disintegrating in less than 3 minutes in two different disintegration time determination methods, while it was observed that the disintegration times were prolonged in those pressed with 300 Bar. In the Texture analysis method, the shortest disintegration occurred in the K2-100 formulation using 10 % Kollidon CL with an average of 15,80 seconds. In determination of in vitro dissolution rate, more than 85 % of K1-100 and K2-100 formulations dissolved in the 15th minute and they gave the ideal graph. Weight variation, diameter and thickness, hardness, friability, active ingredient quantity results were at the desired values and standard deviations were found to be low.Conclusion: In this study, aceclofenac ODT formulation with optimum properties was produced and a more easily applicable approach was tried to be developed in the treatment of patients with compliance problems.
Preparation and In-Vitro Evaluation of Oral Disintegrating Tablet Formulations Containing Nonsteroidal Anti-inflammatory AgentStudent Name: Ecz. Kemal Ozan ERDOĞANName of Supervisor: Dr. Öğr. Üyesi Sevinç ŞAHBAZDepartment: Pharmaceutical TechnologyObjective: In order to overcome the problems of compliance with the administration of conventional tablets to elderly, pediatric and psychiatric patients it was aimed to prepare and in vitro evaluation of aceclofenac orally disintegrating tablet (ODT) formulations, which do not have any preparation in our country, that have the ability to disintegrate and dissolve quickly in the oral cavity without the need for water or chewing.Materials and Methods: In the study, Ac-Di-Sol, Kollidon CL and Primojel superdisintegrants were used in different ratios in 6 different tablet formulations produced by direct compression method under both 100 Bar and 300 Bar pressure. Weight variation, diameter and thickness, hardness, friability, active ingredient quantity assay, disintegration time and dissolution rate were determined in the tablets. For the determination of disintegration time, unlike many other studies, apart from the disintegration test in the pharmacopoeias, the Texture analyser, which more sensitive results can be obtained in ODTs, was used.Results: All formulations pressed under 100 Bar pressure showed the ideal ODT feature by disintegrating in less than 3 minutes in two different disintegration time determination methods, while it was observed that the disintegration times were prolonged in those pressed with 300 Bar. In the Texture analysis method, the shortest disintegration occurred in the K2-100 formulation using 10 % Kollidon CL with an average of 15,80 seconds. In determination of in vitro dissolution rate, more than 85 % of K1-100 and K2-100 formulations dissolved in the 15th minute and they gave the ideal graph. Weight variation, diameter and thickness, hardness, friability, active ingredient quantity results were at the desired values and standard deviations were found to be low.Conclusion: In this study, aceclofenac ODT formulation with optimum properties was produced and a more easily applicable approach was tried to be developed in the treatment of patients with compliance problems.