PENGEMBANGAN DAN KARAKTERISASI MEBENDAZOL NANOKRISTAL SERTA FORMULASI BENTUK SEDIAAN TABLET

• Main Author: Dzakwan, Muhammad
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/45763
• Institution: Institut Teknologi Bandung

Introduction : About 40 % or more of the new active compound in the pharmaceutical field poor solubility in water. Drugs which are in the Biopharmaceutical Classification System (BCS) II have low solubility and high permeability. To improve the physico-chemical properties, decreasing particle size to nanometer scale is promising approach. One method to produce nanoparticle is topdown method with High Pressue Homogenization (HPH). In this study, mebendazole was used as a drug model to sudy the effects of nanonization using various of stabilizers and homogenization cycles on particle size reduction. Furthermore, mebendazole nanocrystal was formulated into tablet dossage form by dirrect compression and wet granulation method and its dissolution velocity was evaluated. Methode : Mebendazole nanosuspension was developed by varying the types of stabilizers such as : SLS, polysorbat 80, poloxamer P188, PVA, pharmacoat 603 and methocel. Variations in the number cycles was also performed to obtain particle size in the range of 200 –300 nm. Characterizations have been carryed out including to : size and particle size distribution, crystal state, morphology and physical stability for 1 month at room temperature (?30 O C). The most stable nanosuspension of mebendazole then incorporrated into tablet by dirrect compression and wet granulation method. Evaluation nanosuspension and tablets were performed according to standart requirements. Dissolution test of mebendazole tablets was carried out using USP apparatus type II for 2 hour at 37 ± 0,5 O C. Results : Mebendazole nanosuspension stabilized by PVA 2% generated relative stable nanosuspension during study and no change in the mebendazole crystanility. Decrease in particle size of nanocrystal to the scale of 200 –300 nm increased dissolution rate and kinetic solubility. Dissolution velocity of mebendazole nanocrystal tablet better than mebendazol microrystal and a marketed tablet. Conclusions: Development of mebendazole nanocrystal using PVA as a stabilizer increased the kinetic solubility and dissolution velocity of its powder and tablet dossage form.