Abstract

Co-processing is currently of interest in the generation of high-functionality excipients for tablet formulation. In the present study, comparative analysis of the powder and tableting properties of three co-processed starches prepared by three different methods was carried out. The co-processed excipients consisting of maize starch (90%), acacia gum (7.5%) and colloidal silicon dioxide (2.5%) were prepared by co-dispersion (SAS-CD), co-fusion (SAS-CF) and co-granulation (SAS-CG). Powder properties of each co-processed excipient were characterized by measuring particle size, flow indices, particle density, dilution potential and lubricant sensitivity ratio. Heckel and Walker models were used to evaluate the compaction behaviour of the three co-processed starches. Tablets were produced with paracetamol as the model drug by direct compression on an eccentric Tablet Press fitted with 12 mm flat-faced punches and compressed at 216 MPa. The tablets were stored at room temperature for 24 h prior to evaluation. The results revealed that co-granulated co-processed excipient (SAS-CG) gave relatively better properties in terms of flow, compressibility, dilution potential, deformation, disintegration, crushing strength and friability. This study has shown that the method of co-processing influences the powder and tableting properties of the co-processed excipient.

Conclusions

A comparative study was carried out to evaluate the effect of different co-processing methods on the powder and tableting properties of a co-processed excipient consisting of MS (90%), ACA (7.5%) and CSD (2.5%). The methods of co-processing evaluated generated SAS-CD (co-dispersion), SAS-CF (co- fusion) and SAS-CG (co-granulation) as co-processed excipients. Characterization of the powder properties of the three excipients revealed similarities in the flow parameters, particle density and moisture content while differences were observed in the particle size, dilution potential and LSR which can be attributed to the method of co-processing. FT-IR analysis did not reveal any chemical change occurring in the material as a result of the method of co-processing. Compaction and tableting properties of the three excipients showed that SAS-CG exhibited a greater degree of plastic deformation owing to the lower yield pressure obtained in comparison to the other two excipients. This facilitated the formation of tablets with sufficient mechanical strength, rapid disintegration and minimal friability.

Summarily, the findings reveal that SAS-CG produced by co-granulation performed better in terms of powder, compaction and tableting properties owing to the effect of particle size, bulk density, surface properties and deformation behavior modulated by the method of co-processing. This study therefore highlights the importance of selecting a robust method for co-processing that will deliver the desired functionality in tableting.

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