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    Öğe
    Development of rasagiline mesylate loaded solid lipid nanoparticles in a thermosensitive mucoadhesive gel: Formulation design using DoE, in-vitro and ex-vivo characterization
    (Marmara Univ, 2021) Toksoy, Mahmut Ozan; Tirnaksiz, Fahriye Figen
    Rasagiline mesylate (RM) is a selective irreversible MAO-B inhibitor used in the treatment of Parkinson's disease. This study was designed to prepare and optimize RM loaded solid lipid nanoparticles (RM-SLNs) in a thermosensitive mucoadhesive gel (RM-SLNs-GEL). RM-SLNs were prepared combining Gelucire 50/13 (10%), Labrasol (0.3%) Cremophor RH40 (12%) with a mixing rate and time of 500 rpm, 45 min. Mucoadhesive gels were prepared combining Poloxamer 407 and HPMC E5 (15.5% + 0.25%). Optimized formulation (RM-SLNs-GEL) was evaluated for sol-gel transition temperature, viscosity, mucoadhesive force, particle size and distribution, SEM imaging, in-vitro drug release and ex-vivo drug permeation. It was found that optimal formulation had a suitable gelation temperature at 31 degrees C +/- 0.2 degrees C. It was observed that the system was fluid during nasal application at 25 degrees C and viscous at nasal temperature at 32 degrees C. RM-SLNs-GEL has shown particle size, polydispersity index (PDI), % encapsulation efficiency (EE%); 253 nm, 0.282, 37.8% respectively. Ex-vivo permeation study exposed significant enhancement of permeability of RM-SLNs-GEL across mucosa than RM loaded thermosensitive gel (RM-GEL). Our results show that RM-SLNs-GEL formulation could be a potential drug delivery system for the treatment of Parkinson's disease.
  • Küçük Resim
    Öğe
    Katı lipit nanopartiküller ve beyne özgü ilaç taşıyıcı sistem olarak uygulamaları
    (Ankara Üniversitesi Eczacılık Fakültesi, 2021) Toksoy, Mahmut Ozan; Tırnaksız, Fahriye Figen
    Amaç: Son 20 yılda nanoteknolojik gelişmeler ile birlikte ilaç moleküllerinin beyne hedeflenmesine yönelik çalışmalarda artış gözlenmektedir. Beyin, kan dolaşımından kendine özgü bir bariyer ile ayrılmıştır. Kan-beyin bariyeri olarak adlandırılan bu yapı astrosit, perisit, endotel hücreleri ve bunlar arasında bulunan sıkı bağlantılardan oluşmaktadır. Moleküllerin beyne geçişini engelleyen enzimatik aktivitenin yanında, beynin sistemik dolaşımdan kan-beyin bariyeri ile ayrılması, terapötik moleküllerinin beyne geçişini olumsuz etkilemektedir. Bu yüzden merkezi sinir sistemi rahatsızlıklarında tedavi zorlaşmakta, terapötik etki azalmakta veya gözlenememektedir. Bu durumu anlamak ve olası sorunları giderebilmek için beynin ve kan-beyin bariyerinin yapısı bilinmeli, ilaç moleküllerinin geçiş mekanizmaları aydınlatılmalıdır. Beyne hedeflemede ilaç taşıyıcı sistemlerin önemi günden güne artmaktadır. Üretilen sistemler arasında katı lipit nanopartiküllerin kolay üretimi, biyo-uyumluluğu, biyo-bozunabilirliği açısından diğer sistemlere göre avantajları bulunmaktadır. Bu derlemede, kan beyin bariyerinden bahsedilmesi, beyne ilaç hedefleme yöntemlerinin açıklanması ve beyne ilaç moleküllerinin hedeflenmesinde katı lipit nanopartiküllerle yapılan çalışmalardan söz edilmesi amaçlanmıştır. Sonuç ve Tartışma: İlaç moleküllerinin beyne hedeflenmesinde kan-beyin bariyeri en büyük engeldir. Bu engeli aşabilmek amacıyla geliştirilen sistemlerden biri de katı lipit nanopartiküller olmuş, sayısız çalışmalarla etkinliği kanıtlanmıştır. Hedefleme ile merkezi sinir sistemi rahatsızlıklarında ilaçların etkinliğinin arttırılabileceği görülmüştür.
  • Küçük Resim
    Öğe
    Quality by Design approach for development and characterization of gabapentin-loaded solid lipid nanoparticles for intranasal delivery: In vitro, ex vivo, and histopathological evaluation
    (Mashhad University of Medical Sciences, 2024) Toksoy, Mahmut Ozan; Aşır, Fırat; Güzel, Mert Can
    Objective(s): ”Quality by Design” (QbD) is a novel approach to product development that involves understanding the product and process, as well as the relationship between critical quality attributes (CQA) and critical process parameters (CPP). This study aimed to optimize the gabapentin-loaded solid lipid nanoparticle formulation (GP-SLN) using a QbD approach and evaluate in vitro and ex vivo performance. Materials and Methods: The GP-SLN formulation was created using the microemulsion method by combining Gelucire 48/16, Tween 80, and Plurol Oleique CC 497. The Box-Behnken experimental design was adopted to investigate the effects of independent factors on dependent factors. The GP-SLN formulation was assessed based on particle size and distribution, zeta potential, morphology, entrapment efficiency, release kinetics, permeation parameters, stability, and nasal toxicity. Results:The nanoparticles had a cubical shape with a particle size of 185.3±45.6 nm, a zeta potential of -24±3.53 mV, and an entrapment efficiency of 82.57±4.02%. The particle size and zeta potential of the GP-SLNs remained consistent for 3 months and followed Weibull kinetics with a significantly higher ex vivo permeability (1.7 fold) than a gabapentin solution (GP-SOL). Histopathology studies showed that intranasal administration of the GP-SLN formulation had no harmful effects. Conclusion: The current study reports the successful development of a GP-SLN formulation using QbD. A sustained release of GP was achieved and its nasal permeability was increased. Solid lipid nanoparticles with optimum particle size and high entrapment efficiency may offer a promising approach for the intranasal delivery of drugs.
  • [ X ]
    Öğe
    Quality by Design approach for developmentand characterization of gabapentin-loaded solid lipid nanoparticles for intranasal delivery: In vitro, ex vivo , and histopathological evaluation [2]
    (Mashhad Univ Med Sciences, 2024) Toksoy, Mahmut Ozan; Asir, Firat; Guzel, Mert Can
    Objective(s): Quality by Design (QbD) is a novel approach to product development that involves understanding the product and process, as well as the relationship between critical quality attributes (CQA) and critical process parameters (CPP). This study aimed to optimize the gabapentin-loaded solid lipid nanoparticle formulation (GP-SLN) using a QbD approach and evaluate in vitro and ex vivo performance. Materials and Methods: The GP-SLN formulation was created using the microemulsion method by combining Gelucire 48/16, Tween 80, and Plurol Oleique CC 497. The Box-Behnken experimental design was adopted to investigate the effects of independent factors on dependent factors. The GPSLN formulation was assessed based on particle size and distribution, zeta potential, morphology, entrapment efficiency, release kinetics, permeation parameters, stability, and nasal toxicity. Results: The nanoparticles had a cubical shape with a particle size of 185.3 +/- 45.6 nm, a zeta potential of -24 +/- 3.53 mV, and an entrapment efficiency of 82.57 +/- 4.02%. The particle size and zeta potential of the GP-SLNs remained consistent for 3 months and followed Weibull kinetics with a significantly higher ex vivo permeability (1.7 fold) than a gabapentin solution (GP-SOL). Histopathology studies showed that intranasal administration of the GP-SLN formulation had no harmful effects. Conclusion: The current study reports the successful development of a GP-SLN formulation using QbD. A sustained release of GP was achieved and its nasal permeability was increased. Solid lipid nanoparticles with optimum particle size and high entrapment efficiency may offer a promising approach for the intranasal delivery of drugs.
  • [ X ]
    Öğe
    Solid lipid nanoparticles and applications as brain specific drug delivery systems
    (University of Ankara, 2022) Toksoy, Mahmut Ozan; Tırnaksız, Fahriye Figen
    Objective: In the last 20 years, with the nanotechnological developments, there has been an increase in studies aimed at targeting drug molecules to the brain. The brain is separated from bloodstream by a unique barrier. This structure, called the blood-brain barrier, which consists of astrocytes, pericytes, endothelial cells and tight junctions between them. Apart from the enzymatic activity that prevents the passage of molecules to the brain, the separation of the brain from the systemic blood circulation by the blood-brain barrier negatively affects the passage of therapeutic molecules. The structure of the brain and the blood-brain barrier must be known and the penetration mechanisms of drug molecules to the brain must be elucidated. In this review, we aimed to mention the blood-brain barrier and drug targeting methods to the brain. Also, importance of the solid lipid nanoparticles in targeting drug molecules to the brain will be emphasized. Result and Discussion: Blood-brain barrier is the biggest obstacle in targeting drug molecules to the brain. One of the systems developed to overcome this obstacle is solid lipid nanoparticles. It has been observed that the effectiveness of drugs in central nervous system disorders can be increased by targeting.