Formulasi dan Evaluasi Sistem Dispersi Padat Ibuprofen dengan Polimer Dekstrosa dalam Sediaan Suppositoria

Abstract

Kata kunci : dekstrosa, dispersi padat, efisiensi disolusi, ibuprofen, supositoria A B S T R A K Berdasarkan klasifikasi BCS, ibuprofen tergolong ke dalam BCS kelas II yang memiliki kelarutan rendah dalam air. Metode dispersi padat telah banyak digunakan untuk meningkatkan laju disolusi obat dengan kelarutan rendah. Tujuan dari penelitian ini adalah untuk meningkatkan kelarutan ibuprofen menggunakan metode dispersi padat dengan polimer dekstrosa pada sediaan supositoria berbasis lemak cokelat. Penelitian dilakukan dengan membuat supositoria yang mengandung ibuprofen murni, dispersi padat ibuprofen: dekstrosa 1:1 dan 1:2. Pembuatan dispersi padat dilakukan menggunakan metode pelelehan. Karakterisasi yang dilakukan meliputi uji disolusi, XRD, waktu leleh dan keseragaman bobot supositoria. Hasil uji difraksi sinar X menunjukkan bahwa terjadi penurunan intensitas pola difraksi ibuprofen pada dispersi padat dibandingkan dengan ibuprofen murni yang menunjukkan terjadinya penurunan derajat kristalinitas. Pengujian disolusi menunjukkan bahwa jumlah ibuprofen yang terdisolusi selama 120 menit dan efisiensi disolusi pada menit ke-120 meningkat pada supositoria dengan sistem dispersi padat. Analisis statistik dengan Oneway Anova menunjukkan bahwa terdapat peningkatan persen terdisolusi dan efisiensi disolusi yang signifikan dari supositoria yang mengandung dispersi padat dibandingkan dengan ibuprofen murni. Dari hasil penelitian dapat disimpulkan bahwa penggunaan dekstrosa sebagai polimer hidrofilik dalam dispersi padat dapat meningkatkan profil disolusi pada sediaan supositoria berbasis lemak cokelat. Formula dispersi padat yang optimum dalam meningkatkan profil disolusi adalah pada perbandingan ibuprofen dan dekstrosa sebesar 1:2. Formulation and Evaluation of Ibuprofen Solid Dispersion using Dextrose as a Carrier in SuppositoriesKeywords: dextrose, dissolution efficiency, ibuprofen, solid dispersion, suppositories A B S T R A C T Based on Biopharmaceutical Classification System (BCS), ibuprofen belongs to class II which has a poor water solubility. Solid dispersion technique is widely used to improve dissolution rate of drugs with poor solubility. The aim of this study was to increase the solubility of ibuprofen by solid dispersion method in suppositories. Suppositories were prepared containing pure ibuprofen, solid dispersion of ibuprofen: dextrose in the ratio of 1:1 and 1:2. Solid dispersions were prepared by melting method. Suppositories were characterized by dissolution testing, X-ray diffraction, melting time and weight uniformity. The Xray diffraction test results showed that there is a decrease in intensity of peak diffraction of solid dispersion compared to pure ibuprofen which indicated a decrease of degree of crystallinity. The dissolution test results showed that the amount of the ibuprofen dissolved during 120 minutes and dissolution efficiency in 120 minutes from suppositories were improved using solid dispersion technique. Statistical analysis by Oneway Anova showed a significant increase in percentage of...

The Improvement of the Dissolution and Release Characteristics of Ibuprofen Suppository Through Inclusion Complexes with

“…The preparation of suppositories begins with the optimization of the base formula using variations in the concentration of cetylalkohol in cocoa butter with a weight of 3 grams using the cast molding method, as shown in Table 2. The composition of the best suppository base formula is determined based on the results of organoleptic evaluation and melting time test [18]. Next, the suppositories are made by counting the replacement numbers [18].…”

“…The composition of the best suppository base formula is determined based on the results of organoleptic evaluation and melting time test [18]. Next, the suppositories are made by counting the replacement numbers [18]. The suppository formulation contains the active substance of the IBP-BCD inclusion complex at all three mole ratios which is equivalent to a dose of 125 mg of IBP and pure IBP.…”

“…The suppository formulation contains the active substance of the IBP-BCD inclusion complex at all three mole ratios which is equivalent to a dose of 125 mg of IBP and pure IBP. The evaluation of the final preparation included organoleptic, weight variability, melting time, percent dissolution and dissolution efficiency compared to suppositories containing pure IBP [18].…”

“…Evaluation result data instatistical analysis using Oneway Anova, data normality test using Saphiro Wilk and data homogeneity test using Levene's test [18]. SIRES…”

“…The melting time test of the suppository base formula was carried out to evaluate the melting or dissolving time of the suppository base [18]. In this evaluation, it was found that the time varies depending on the concentration of cetylalkohol use on the base, the higher the concentration, the more the consistency of the base increases so that the melting time is longer.…”