MARSAL MOCHAMAD KAMIL, - (2026) OPTIMASI GRANULASI DAN KARAKTERISASI ASAM MEFENAMAT HASIL PROSES HIGH SHEAR MIXER DAN FLUID BED GRANULATOR TERHADAP EFISIENSI PENGEMPAAN TABLET. Masters thesis, Sekolah Tinggi Farmasi Indonesia.
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Abstract
Asam mefenamat merupakan zat aktif dengan kelarutan rendah dan sifat alir yang buruk, sehingga sering kali menurunkan efisiensi kecepatan mesin pada proses pengempaan tablet. Penelitian ini bertujuan untuk mendapatkan granul yang menunjang percepatan dan kelancaran proses pengempaan, memperoleh karakteristik fisik granul dari metode High Shear Mixer (HSM) dan Fluid Bed Granulator (FBG), serta menetapkan metode yang paling optimal. Pembuatan granul asam mefenamat dilakukan menggunakan HSM (dengan variasi waktu putar 2, 3, dan 4 menit) dan FBG (dengan variasi kecepatan spray 100 rpm dan 200 rpm). Karakterisasi granul meliputi evaluasi sudut istirahat, kerapatan ruahan, kerapatan mampat, compressibility index, Hausner ratio, dan moisture content. Granul kemudian dikempa menjadi tablet untuk dievaluasi parameter bobot, kekerasan, kerenyahan, kadar, disolusi, dan keseragaman sediaan. Hasil karakterisasi menunjukkan granul dari kedua metode memiliki sifat alir kategori sangat baik. Hasil evaluasi tablet menunjukkan bahwa perlakuan FBG 200 rpm memberikan laju disolusi yang superior (85,49%), tingkat akurasi dan presisi bobot yang masuk kategori World-Class Industrial Capability (Cpk = 1,51), nilai keseragaman sediaan (NP) 2,06, serta efisiensi waktu siklus operasional berkat sistem one-pot processing. Berdasarkan hasil tersebut, dapat disimpulkan bahwa metode FBG dengan kecepatan spray 200 rpm merupakan metode yang paling optimal untuk produksi tablet asam mefenamat skala komersial tanpa perlu melakukan perubahan formula. ------ Mefenamic acid is an active pharmaceutical ingredient characterized by low solubility and poor flowability, which often limits machine speed efficiency during the tablet compression process. This study aimed to produce granules that support faster and smoother compression processes, to determine the physical characteristics of granules produced by High Shear Mixer (HSM) and Fluid Bed Granulator (FBG) methods, and to identify the most optimal granulation method. Mefenamic acid granules were prepared using HSM (with rotation times of 2, 3, and 4 minutes) and FBG (with spray rates of 100 rpm and 200 rpm). Granule characterization included the evaluation of angle of repose, bulk density, tapped density, compressibility index, Hausner ratio, and moisture content. The granules were subsequently compressed into tablets and evaluated for weight, hardness, friability, assay, dissolution, and content uniformity. Characterization results indicated that granules from both methods exhibited excellent flow properties. Tablet evaluation demonstrated that the FBG 200 rpm treatment provided a superior dissolution rate (85.49%), weight accuracy and precision levels categorized as World-Class Industrial Capability (Cpk = 1.51), a content uniformity acceptance value (NP) of 2.06, and cycle time efficiency due to its onepot processing system. Based on these findings, it can be concluded that the FBG method with a spray rate of 200 rpm is the most optimal approach for the commercial-scale production of mefenamic acid tablets without necessitating formula modifications.
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | asam mefenamat, granulasi, high shear mixer, fluid bed granulator, efisiensi pengempaan. ----- mefenamic acid, granulation, high shear mixer, fluid bed granulator, compression efficiency |
| Subjects: | R Medicine > R Medicine (General) R Medicine > RS Pharmacy and materia medica |
| Divisions: | Program Studi Magister Farmasi > Tesis |
| Depositing User: | pustakawan - - |
| Date Deposited: | 02 Nov 2026 03:16 |
| Last Modified: | 02 Nov 2026 03:17 |
| URI: | http://repository.stfi.ac.id/id/eprint/4901 |
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