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"In pharmaceutical process, milling is a common process to produce particle in certain expectation size. Impact of milling process could lead to physical interaction. Dissolution rate will change as an impact of physical interaction. To observe physical interaction between methampyrone and phenylbutazone during milling process, isneeded to analyze its X-ray diffractogram, DSC thermogram and dissolution rate. Data of X-ray diffractogram, differential scanning calorimetry and dissolution test, showed that physical interaction occurred after 5,5 hours and 18 hours of milling and cause enhancement of dissolution rate of phenylbutazone. Dissolution rate ofmethampyrone was constant after 5,5 hours of milling. Decreasing dissolution rate of methampyrone occured after 18 hours of milling."

"Irbesartan merupakan obat yang termasuk ke dalam sistem klasifikasi biofarmasetika kelas dua dengan kelarutan yang rendah dan permeabilitas yang tinggi, sehingga kelarutan obat dan laju disolusi menjadi tahap penentu pada absorpsi obat. Penelitian ini bertujuan untuk mengetahui pengaruh Kolliphor®P 407 dan Gelucire® 44/14 sebagai peningkat disolusi terhadap laju disolusi irbesartan dalam sistem dispersi padat. Dispersi padat irbesartan dan bahan peningkat disolusi dibuat dengan perbandingan 1:1 menggunakan metode peleburan. Dispersi padat dikarakterisasi dengan uji disolusi, difraksi sinar-x (XRD), kalorimetri pemindaian diferensial (DSC), dan spektrofotometer infra merah (FTIR). Hasil uji disolusi dispersi padat dengan Kolliphor®P 407 dapat meningkatkan laju disolusi irbesartan sedangkan dispersi padat dengan Gelucire® 44/14 tidak dapat meningkatkan laju disolusi irbesartan. Hasil uji XRD dispersi padat irbesartan dengan Kolliphor®P 407 menunjukkan adanya penurunan intensitas kristalinitas dan pengecilan ukuran kristalit, sedangkan pada uji DSC menunjukkan adanya pergeseran puncak peleburan dan penurunan panas peleburan bila dibandingkan dengan irbesartan murni. Kesimpulan dari penelitian ini yaitu pembentukan dispersi padat dengan Kolliphor®P 407 mampu meningkatkan laju disolusi irbesartan. Peningkatan laju disolusi mencapai 3,15 kali dari irbesartan murni dengan efisiensi disolusi (ED)120 sebesar 84,96%.

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Irbesartan is a drug that belong to the Biopharmaceutical Classification System (BCS) class II with low solubility and high permeability, so the drug solubility and dissolution rate become the rate limiting step in drug absorption.

The aim of this study was to investigate the effect of Kolliphor®P 407 and Gelucire® 44/14 as a dissolution enhancer on the dissolution rate of irbesartan in solid dispersion system. Solid dispersion of irbesartan and dissolution enhancer were made with a ratio of 1: 1 by fusion method. Solid dispersion characterised with in vitro dissolution study, X-ray diffraction (XRD), differential scanning calorimetric (DSC) and infra red spectrophotometer (FTIR). The result of dissolution study shows that solid dispersion of irbesartan with Kolliphor®P 407 could enhance the dissolution rate of irbesartan, but solid dispersion with Gelucire® 44/14 could not enhance the dissolution rate of irbesartan.

The results XRD test of solid dispersion irbesartan with Kolliphor®P 407 showed a decrease in the intensity of crystallinity and reduction of cystallite size and the DSC test showed a shifting in the melting peak and decrease in heat of fusion when compared with pure irbesartan.

The conclusion of this study is the solid dispersion with with Kolliphor®P 407 could enhance the dissolution rate of irbesartan. Enhancement of the dissolution rate reached 3,15 times from pure irbesartan with dissolution efficiency (DE)120 84,96%."