Pembentukan Dispersi Padat Efavirenz - Crospovidone

Fajriani, Aisyah (2015) Pembentukan Dispersi Padat Efavirenz - Crospovidone. Diploma thesis, Universitas Andalas.

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Abstract

ABSTRAK Efavirenz merupakan non-nucleosid reverse transcriptase inhibitor (NNRTI) yang digunakan untuk mengatasi infeksi human immunodeficiency virus (HIV) tipe 1. Efavirenz termasuk kedalam obat kelas II berdasarkan biopharmaceutical classification system (BCS) dimana diperlukan upaya untuk meningkatkan kelarutan dan laju disolusi untuk meningkatkan bioavailabilitas oralnya, salah satu caranya adalah dengan pembentukan dispersi padat. Pada penelitian ini telah dilakukan pembentukan dispersi padat efavirenz - crospovidone dengan metoda pelarutan menggunakan etanol 96 %. Karakterisasi dispersi padat dilakukan dengan analisa difraksi sinar-X, Differential Thermal Analysis (DTA), Scanning Electron Microscopy (SEM), Fourier Transform Infrared (FTIR) dan analisa distribusi ukuran partikel, kemudian dibandingkan dengan campuran fisik dan komponen murni. Uji kelarutan sampel dilakukan dalam air suling bebas CO2 menggunakan orbital shaker dan laju disolusi sampel dilakukan dalam air suling bebas CO2 dengan sodium lauryl sulphate (SLS) 0,5% w/v. Hasil uji kelarutan menunjukkan bahwa kelarutan dispersi padat 1:1 ; 1:2 ; 2:1 (12,2071µg/mL ; 14,0522µg/mL ; 8303µg/mL) lebih tinggi dibandingkan dengan campuran fisik 1:1 ; 1:2 ; 2:1 (9,3786µg/mL ; 10,1532µg/mL ; 7,4899µg/mL) dan efavirenz murni memiliki kelarutan paling rendah (6,9765µg/mL). Dari hasil pengujian ANOVA satu arah untuk efisensi disolusi dari ketujuh sampel memperlihatkan hasil yang bermakna atau berbeda nyata dimana signifikansi dari uji ANOVA adalah 0,000 (P<0,05), dimana efisiensi disolusi dispersi padat 1:1 ; 1:2 ; 2:1 (42,9456% ; 35,3712% ; 48,1877%) lebih rendah dibandingkan dengan efavirenz murni (47,2471%), sedangkan campuran fisik 1:1 ; 2:1 ; 1:2 menunjukkan efisiensi disolusi paling tinggi (62,9245% ; 55,9456% dan 54,5427%). Kata kunci: Efavirenz, Crospovidone, Dispersi Padat, Kelarutan, Efisiensi disolusi ABSTRACT Efavirenz is a non-nucleosid reverse transcriptase inhibitor (NNRTI) approved for the treatment of human immunodeficiency virus (HIV) type I infection. Acording to BCS, efavirenz is classified into class II, which is necessary to increase its solubility and dissolution rate to enhance its oral bioavailability. One way to achieve that is solid dispersion formation. In this research, preparation of solid dispersion of efavirenz - crospovidone with solvent method using ethanol 96% had been done. The solid dispersion characterization of was carried out using X-ray diffraction, Differential Thermal Analysis (DTA), Scanning Electron Microscopy (SEM), Fourier Transform Infrared (FTIR) and particle size distribution analysis. The result were compared to physical mixture and pure compound. The solubility test was performed in CO2-free aquadest using an orbital shaker while dissolution rate was studied in CO2-free aquadest with Sodium Lauryl Sulphate (SLS) 0.5 % w/v. The result of solubility test showed that solubility of solid dispersions 1:1 ; 1:2 ; 2:1 (12,2071µg/mL ; 14,0522µg/mL ; 8303µg/mL) were higher than the physical mixture 1:1 ; 1:2 ; 2:1 (9,3786µg/mL ; 10,1532µg/mL ; 7,4899µg/mL) and pure efavirenz have the lowest solubility (6,9765µg/mL). From the results of the one-way ANOVA test for dissolution efficiency of the seven samples showed different results where the significance of the ANOVA is 0.000 (P<0.05), where the dissolution efficiency of solid dispersion 1:1 ; 1:2 ; 2:1 (42.9456 % ; 35.3712 % ; 48.1877 %) were lower than pure efavirenz (47.2471 %) , where as the physical mixture of 1:1 ; 2:1 and 1:2 shows the highest dissolution efficiency (62.9245 % ; 55.9456 % and 54.5427 %). Key words : Efavirenz, Crospovidone, Solid dispersion, Solubility, Dissolution efficience

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