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Compressional Behavior of a Mixture of Granules Containing High Load of Phyllanthus niruri Spray-Dried Extract and Granules of Adjuvants: Comparison between Eccentric and Rotary Tablet Machines

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Abstract

The purpose of this paper was to evaluate the compressional behavior of granules containing high load of a Phyllanthus niruri spray-dried extract in eccentric (ETM) and rotary (RTM) tablet presses. Tablets were constituted by spray-dried extract granules (SDEG, 92%), excipient granules (EXCG, 7.92%), and magnesium stearate (0.08%). SDEG was obtained by dry granulation and EXCG, composed of microcrystalline cellulose (62.9%) and sodium starch glycolate (37.1%), by wet granulation. Particle size distribution was fixed between 0.250 and 0.850 mm. Tablets did not evidence any mechanical failures, such as lamination or capping, or anomalous weight variation in either tablet machine types. Upper and lower tablet surface photomicrographs from ETM and RTM tablets showed differences in porosity and texture. Different RTM speeds suggested the visco-plastic behavior of the formulation, since, by slowing down rotation speeds, the tensile strength of the tablets increased significantly, but the porosity and disintegration time were not affected. Tablets produced in RTM showed lower friability and porosity than ETM tablets, which did not reflect on higher tensile strength. The EXCG distribution at upper and lower surfaces from ETM and RTM tablets was quantified by image analysis and evaluated through statistical methods. Spray-dried extract release was not influenced by the type of equipment or operational conditions to which the compacts were submitted. Construction and operation differences between both tablet presses influenced the final product, since tablets with similar tensile strength, made by distinct tablet machines, exhibited different quality parameters.

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Acknowledgments

The authors thank the Brazilian National Council for Scientific and Technological Development (CNPq) for financial support and Blanver-Colorcon/Brazil for providing the excipients Microcel MC 101 and Explosol.

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Authors and Affiliations

  1. Programa de Pós-Graduação em Ciências Farmacêuticas, UFRGS, Av. Ipiranga, 2752, 90610-000, Porto Alegre, Rio Grande do Sul, Brazil

    Bárbara Spaniol, Vinicius Claudino Bica & Pedro Ros Petrovick

  2. Faculdade de Farmácia, UFRGS, Av. Ipiranga, 2752, 90610-000, Porto Alegre, Rio Grande do Sul, Brazil

    Lisias Rafael Ruppenthal, Maria Ramos Volpato & Pedro Ros Petrovick

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  1. Bárbara Spaniol
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  2. Vinicius Claudino Bica
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  3. Lisias Rafael Ruppenthal
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  4. Maria Ramos Volpato
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  5. Pedro Ros Petrovick
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Correspondence to Pedro Ros Petrovick.

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Spaniol, B., Bica, V.C., Ruppenthal, L.R. et al. Compressional Behavior of a Mixture of Granules Containing High Load of Phyllanthus niruri Spray-Dried Extract and Granules of Adjuvants: Comparison between Eccentric and Rotary Tablet Machines. AAPS PharmSciTech 10, 1013–1023 (2009). https://doi.org/10.1208/s12249-009-9297-z

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