Influence of binder type and process parameters on the compression properties and microbial survival in diclofenac tablet formulations

Abstract

The influence of binder type and process parameters on the compression properties and microbial survival in diclofenac tablet formulations were studied using a novel gum from Albizia zygia. Tablets were produced from diclofenac formulations containing corn starch, lactose and dicalcium phosphate. Formulations were analyzed using the Heckel and Kawakita plots. Determination of microbial viability in the formulations was done on the compressed tablets of both contaminated and uncontaminated tablets prepared from formulations. Direct compression imparted a higher plasticity on the materials than the wet granulation method. Tablets produced by wet granulation presented with a higher crushing strength than those produced by the direct compression method. Significantly higher microbial survival (p< 0.05) was obtained in formulations prepared by direct compression. The percent survival of Bacillus subtilis spores decreased with increase in binder concentration. The study showed that Albizia gum is capable of imparting higher plasticity on materials and exhibited a higher reduction of microbial contaminant in the formulations. The direct compression method produced tablets of reduced viability of microbial contaminant.Uniterms: Tablets/production. Tablets/microbial analysis. Direct compression/tablets production. Wet granulation/tablets production. Tablets/microbial contamination. Microbial survival/in tablets. Albizia gum/use/tablets production.A influência do tipo de ligante e os parâmetros do processo de propriedades de compressão e sobrevivência microbiana em comprimidos de diclofenaco foram estudados utilizando uma nova goma de Albizia zygia. Os comprimidos foram produzidos a partir de formulações de diclofenaco contendo amido de milho, lactose e fosfato bicálcico. As formulações foram analisadas usando os gráficos de Heckel e Kawakita. A determinação da viabilidade microbiana nas formulações foi feita nos comprimidos contaminados e não contaminados preparados a partir de formulações. A compressão direta confere maior plasticidade dos materiais do que o método de granulação úmida. Comprimidos produzidos por granulação úmida apresentaram maior força de esmagamento do que aqueles produzidos pelo método de compressão direta. Observou-se sobrevivência significativamente maior (p<0,05) em formulações preparadas por compressão direta. A sobrevivência percentual dos esporos de Bacillus subtilis diminuiu com o aumento da concentração do agregante. O estudo mostrou que a goma de Albizia é capaz de conferir maior plasticidade aos materiais e apresentou maior redução da contaminação microbiana nas formulações. O método de compressão direta produziu comprimidos com viabilidade reduzida de contaminantes microbianos.

A review: Pharmaceutical excipients of solid dosage forms and characterizations

“…Albizia gum is claimed as one of the binding agents that can improve the ingredient's softness, provide higher plasticity, and has a greater reduction in the viability of Bacillus subtilis spores, compared with gelatin. Tablets that contain Albizia gum were also found to have higher tensile strength than tablets that contain synthetic binding gels, resulting in tablets with good mechanical strength (Ayorinde et al, 2011).…”

Evaluation of Cedrela gum as a binder and bioadhesive component in ibuprofen tablet formulations

“…There was positive correlation between crushing strength and binder concentration ( Figure 5). The concentration and type of binder have been shown to affect the tensile strength of tablets (Itiola, 1991;Ayorinde et al, 2011). The effect of binder concentration can be due to the plasto-elastic property of the binding agent; the heat produced during compaction causes melting of asperities and of the binder, which, on cooling, solidifies to form strong solid bonds between the particles.…”

Effect of Process Parameters, Protectants and Carrier Materials on the Survival of Yeast Cells during Fluidized Bed Granulation for Tableting

“…Basically, tableting of dried microorganisms is challenging due to the high compression stresses that have to be applied. In general, the viability of microorganisms decreases with increasing compression stress [ 7 , 8 , 9 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 ]. However, previous data on the survival of microorganisms during tableting exist predominantly for lyophilized microorganisms [ 9 , 18 , 19 , 20 , 21 , 22 , 27 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 ] and are hardly available for fluidized bed granulated ones; however, at least some data are available for wet granulated and, e.g., oven-dried microorganisms [ 7 , 8 , 23 , 24 , 25 , 39 , 40 ].…”

“…In general, the viability of microorganisms decreases with increasing compression stress [ 7 , 8 , 9 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 ]. However, previous data on the survival of microorganisms during tableting exist predominantly for lyophilized microorganisms [ 9 , 18 , 19 , 20 , 21 , 22 , 27 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 ] and are hardly available for fluidized bed granulated ones; however, at least some data are available for wet granulated and, e.g., oven-dried microorganisms [ 7 , 8 , 23 , 24 , 25 , 39 , 40 ]. Considering, especially, the different product structures (physical mixture vs. granules and the typically high porosity and fragility of lyophilized products), the survival during tableting needs to also be addressed for granulated microorganisms.…”