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Designing and Characterization of Ramipril Spherical Agglomerates
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| Author:
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INDRA INDRA, SUNDANI NURONO SOEWANDHI, SALEH WIKARSA, YUDA PRASETYA NUGRAHA, VEINARDI SUENDO
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| Abstract:
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The pharmaceutical industry prefers the direct compression method with the aim of a more economical tablet production process. Spherical agglomeration is a new particle engineering technique that can meet the criteria for direct compression. The purpose of this study was to observe the effect of variations in stirring speed and the amount of binder liquids on formation of directly compressible agglomerates of ramipril, an antihypertension drug. Ramipril agglomerates were prepared using ethanol-water-diethyl ether crystallization system. Ethanol performs as a good solvent, water as anti-solvent for ramipril, and diethyl ether as binding liquid for agglomeration process. The prepared agglomerates were subjected for micromeritics and mechanical properties. The agglomerates exhibit better flowability, higher bulk density, and improved tabletability compared to untreated ramipril. Light microscope and scanning electron microscope show spherical shape agglomerates of ramipril with the particle size of 2.35 ± 0.58 mm. A solid state characterization study conducted by powder X-ray diffractometer and differential scanning calorimeter revealed that there was a decrease in crystallinity and the absence of polymorphism phenomena. Determination of the processing conditions plays an important role in preparing the spherical agglomeration of ramipril and a suitable solution for altering the properties of the material for direct compression.
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| Keyword:
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direct compression, ramipril, spherical agglomerates, tabletability.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2020.12.02.426
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| Download:
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