Optimizing Formula of Fast Disintegrating Tablets Ketoprofen β-Cyclodextrin Inclusion Complex with Sodium Starch Glycolate and Crospovidone as The Superdisintegrants
Nurul Hidayati(a*), Rahmi Nurhaini(a), T. N. Saifullah Sulaiman(b)
a) Department of Pharmacy, College of Health Sciences Muhammadiyah Klaten, Jl Ir Soekarno KM 1 Buntalan 57419, Indonesia
*nurulhidayati1983[at]gmail.com
b) Department of Pharmacy, Gadjah Mada University Bulaksumur, Karang Malang, Caturtunggal, Kec. Depok, Kabupaten Sleman, Daerah Istimewa Yogyakarta 55281
Abstract
Ketoprofen has low solubility in water with unpleasant taste. Efforts to improve solubility and taste are by forming inclusion complexes using β-cyclodextrin. In its development to release ketoprofen quickly, fast disintegrating tablets (FDT) were prepared. The speed of drug release is influenced by the speed of disintegration tablets. The combination of sodium starch glycolate (SSG) and crospovidone (CP) combines swelling and wicking action which speeds up the disintegration of tablets. This study aims to obtain the optimum value of the combination of both in order to obtain FDT with optimum evaluation parameters according to the requirements. The study made 8 run FDT directly with variations in the concentration of SSG 2–8% and CP 2-5%. Evaluations carried out at each run included flow velocity tests, uniformity of preparation, hardness, friability, disintegration time, wetting time and dissolution. Data were analyzed using simplex lattice design method. The optimum formula predicted results are verified by analysis of one sample t-test. The results showed increasing the proportion of SSG increases hardness, disintegration time and wetting time and decreases fragility of FDT. The optimum formula found at combination of 2% SSG and 5% CP with optimum physical properties and percent release.
Keywords: Fast Disintegrating Tablets; Ketoprofen; Inclusion Complex; β-Cyclodextrin; Sodium Starch Glycolate; Crospovidone
Topic: Pharmaceutical