ABSTRAK
Film cepat hancur merupakan suatu bentuk sediaan padat yang larut atauhancur dalam 1 menit dalam rongga mulut dengan adanya air liur tanpa minumatau dikunyah. Penelitian ini bertujuan untuk membuat dan mengkarakterisasisediaan film cepat hancur salbutamol menggunakan maltodekstrin suksinatsebagai eksipien. Maltodekstrin suksinat yang diperoleh dari suksinilasimaltodekstrin menggunakan anhidrida suksinat memiliki derajat substitusi 0,18± 0,01; pH (5% larutan dalam akuades) 6,76 ± 0,03; kadar air 7,33 ± 0,21 %;ukuran partikel 355 – 710 µm; laju alir 4,51 ± 0,301 g/detik; indeksmengembang selama 4 menit 17,99%; viskositas (25%) 29,14 cps. Film cepathancur yang menggunakan maltodekstrin suksinat 5% memberikan bobot 24,16 ±2,1 mg; ketebalan 101,5 ± 5,025 µm; waktu hancur 41,5 ± 5,5 detik; kadar air50,66 ± 0,09 %; kadar salbutamol sulfat 2,10 ± 0,03 mg/film; pH 5,87 ± 0,03;pelepasan obat selama 1 menit 105,43 ± 0,68%; tensile strength 7,097 ± 0,582kg/cm2; elongasi 1,5 ± 0,1 %; fluks penetrasi rata-rata 1,314 µg/cm2.menit;sesuai uji kesukaan 66,67% responden menyukai penampilan film; 13,33%responden menyukai rasa film serta waktu hancur rata-rata sebesar 13,47 ± 3,23detik. Dapat disimpulkan bahwa eksipien maltodekstrin suksinat dapat digunakansebagai eksipien pembentuk film cepat hancur.
ABSTRACT
Fast disintegration film was the solid dosage form which dissolve ordisintegrate in 1 minute with saliva without water or chewing. The purposes ofthis research were to prepare and characterize of salbutamol fast disintegrationfilm containing maltodextrin succinate as an excipient. Maltodextrine succinatewas obtained from succinilation of maltodextrine using succinat anhidride. Themaltodextrine succinate had the characterized as follows : degree of substitution(DS), 0.18 ± 0.01; pH (5% in aquadest), 6.76 ± 0.03; moisture content, 7.33 ±0.21%; particle size, 355-710 µm; flow rate, 4.51 ± 0.31 g/secon; swelling index17.99% and viscosity (25%) 29.14 cps. The fast disintegration film thatcontaining maltodextrine succinate 5% had weight 24.16 ± 2.1 mg; thickness,101.5 ± 5.025 µm; disintegration time, 41.5 ± 5.5 secon; moisture content, 50.66 ±0.09%; assay, 2.10 ± 0,03 mg/film; pH, 5.87 ± 0.03; in vitro drug release, 1minute, 105.43 ± 0.68 %; tensile strength, 7.007 ± 0.582 kg/cm²; elongation, 1.5± 0.1%; penetration flux 1.314 µg/cm2.minute. According to hedonic test,66.67% like the film appearence , 13.33% like the flavour, and disintegration timewere 13.47 ± 3.23%. The result of this study showed that maltodextrine succinatecan be used as excipient for fast disintegration film . |
T35158-Nina Rustiana.pdf :: Unduh