PRELIMINARY TECHNOLOGICAL EVALUATION OF GRANULATED MATERIALS FOR A COMBINED ENTEROSORBENT IN CAPSULES

Background. The technological properties of granulated components determine whether they can be dosed into hard capsules. Aim. To conduct a preliminary evaluation of particle-size distribution, density characteristics, flowability, and within-batch uniformity of filled-capsule mass for pectin–inulin granules, activated-carbon granules, and their mixture. Materials and methods. One laboratory batch was studied. Pectin–inulin granules were prepared by wet granulation with 70% ethanol; AU-K activated-carbon granules were calibrated by sieving. The granulates were combined in a 1:1 mass ratio. Particle-size distribution, bulk and tapped density, Carr index, Hausner ratio, and angle of repose were determined. Ten filled size 0 capsules were weighed individually. Results. The cumulative proportion recorded on the 1.0–2.0 mm sieves was 85.0% for pectin–inulin granules, 67.6% for AU-K granules, and 80.1% for the final mixture. Bulk density ranged from 0.420 to 0.500 g/mL, tapped density from 0.435 to 0.530 g/mL, Carr index from 3.45 to 5.66%, Hausner ratio from 1.04 to 1.06, and angle of repose from 26.0° to 32.8°. The mean gross mass of a filled capsule was 0.410 ± 0.008 g (mean ± SD; n = 10; CV = 1.99%). With a mean empty-shell mass of approximately 0.090 g, the calculated mean net fill mass was approximately 0.320 g. Conclusion. Within the investigated laboratory batch, particle-size distribution, density characteristics, flowability, and within-batch uniformity of the gross filled-capsule mass were considered satisfactory, supporting continued development of the capsule dosage form. Keywords: pectin, inulin, activated carbon, wet granulation, particle-size distribution, flowability, hard capsules.

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