Optimasi Tablet Levofloksasin yang Mengandung Bahan Pengikat PVP K-30 dan Disintegran Vivasol

Abstract

ABSTRACT:The aim of this research was to get optimal formula of levofloxacin tablet prepared with variation of PVP K-30 as binder and vivasol as disintegrant. The making of levofloxacin tablets was done by wet granulation. Tablet was prepared with various levels of PVP K-30 and disintegrant vivasol, compressed using a hydraulic press with 12 mm punch diameter, for 3 seconds. Physical quality (hardness, friability, and disintegration time) and dissolution rate of tablet was evaluated. The optimization of the formula was done by factorial design of 22 factorial experiments with 2 factors (PVP K-30 and vivasol) and 2 levels (2% and 4%). Optimization results showed that elevated levels of PVP K-30 increased tablet hardness, reduced friability of tablet, decreased disintegrating time, and increased dissolution rate of levofloxacin tablets. Meanwhile, elevated levels of vivasol increased the hardness of tablets, decreased the disintegrating time of tablets, decreased the dissolution rate of levofloxacin tablets, but did not affect the friability of tablets. In conclusion, the optimal tablet that meet the specifications of physical quality (hardness, friability, and disintegrating time) and dissolution rate was made by 2.4 to 3.7% of PVP K-30 and 2.0 to 3.2% vivasol as shown in the feasible area of design space. ABSTRAK:Penelitian ini bertujuan mendapatkan formula yang optimal tablet levofloksasin yang dibuat dengan variasi PVP K-30 sebagai pengikat dan vivasol sebagai disintegran. Metode pembuatan tablet levofloksasin dilakukan secara granulasi basah. Formula tablet dibuat dengan variasi PVP K-30 dan disintegran vivasol, dikempa menggunakan alat hidrolik press dengan puch diameter 12 mm, selama 3 detik. Evaluasi mutu fisik (kekerasan, kerapuhan, dan waktu hancur) dan laju disolusi tablet. Optimasi formula dilakukan dengan desain faktorial 22 yaitu eksperimen faktorial dengan 2 faktor (PVP K-30 dan vivasol) dan 2 level (2% dan 4%). Hasil optimasi menunjukkan bahwa peningkatan kadar PVP K-30 meningkatkan kekerasan tablet, menurunkan kerapuhan tablet, dan menurunkan waktu hancur tablet, serta meningkatkan laju disolusi dari tablet levofloksasin. Peningkatan kadar vivasol meningkatkan kekerasan tablet, tidak mempengaruhi kerapuhan tablet, dan menurunkan waktu hancur tablet, serta menurunkan laju disolusi tablet levofloksasin. Kesimpulan penelitian ini menunjukkan bahwa tablet yang optimal serta memenuhi spesifikasi dari mutu fisik (kekerasan, kerapuhan, dan waktu hancur) dan laju disolusi ditunjukkan pada daerah feasible dari design space yaitu kadar PVP K-30 antara 2,4 sampai 3,7 % dan kadar vivasol 2,0 sampai 3,2%.

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“…Table 2 shows the properties of ketoconazole tablet from four formulations. Tablet hardness of all formulations fell in value between 4.6 to 5.0 kP that within range of acceptable value (Fatmawati et al, 2017). The friability of ketoconazole tablets were mostly below 1% and met specification required (Winarti et al, 2017), except for F1.…”