Fig 1.
Schematic diagram showing the process of interactive/ordered blending.
Fine aggregated API particles blended with coarse carrier/ excipient particles upon the application of strong mechanical force the fine API particles are deaggregted and get attracted to the surface of the excipient particles producing interactive/ ordered blended particles.
Fig 2.
Schematic showing the process of dry powder hybrid mixing.
Fine guest material (API) and coarse carrier (Excipient) are added to the high G-force processing vessel coupled with air blade (nitrogen gas) under highly controllable conditions to produce final interactive blend.
Table 1.
Summary of the validation process parameters for ergocalciferol using UV spectrophtometre at 265nm.
Table 2.
Flow properties of starch, pregelatinised starch (P.starch), MCC, ergocalciferol (Erg.) and micronised ergocalciferol (Mic Erg.) showing the particle size analysis parameters (X10, X50, X90, Span and volume mean diameter (VMD)), angle of repose (°) and the corresponding flow property.
Fig 3.
Scanning electron microscopy micrographs at 1000 times magnification of (a) starch (b) pregelatinised starch (c) MCC and (d) ergocalciferol.
Table 3.
Flow properties of cohesive starch, cohesive and non-cohesive pregelatinised starch and cohesive and non-cohesive MCC showing the particle size range (obtained upon sieving), angle of repose and the corresponding flow property.
Table 4.
Surface topography parameters and flow properties of the main excipients showing average roughness (Sa), mean square value of average roughness (Sq), maximum roughness height (Sy) particle radius (R), adhesion energy (AE), angle of repose (θ) and flow property (FP) (mean ± SD, n = 5).
Fig 4.
Interferometer topographical images of (A) cohesive MCC, (B) non-sieved starch, (C) cohesive starch, (D) non-sieved pregelatinised starch and (E) cohesive pregelatinised starch.
Fig 5.
Influence of carrier: Drug ratio and carrier particle size on content uniformity of ergocalciferol.
Blends are made of ergocalciferol and (A) pregelatinised starch (B) Starch & (C) MCC (non-sieved, cohesive and non-cohesive) blended at various ratios (1:5, 1:10, 1:20 and 1:50) using geometric blending for 1minute (mean± SD, n = 9).
Fig 6.
Influence of carrier: Drug ratio and carrier particle size on content uniformity of ergocalciferol.
Blends are made of ergocalciferol and (A) pregelatinised starch, (B) Starch & (C) MCC (non-sieved, cohesive and non-cohesive) blended at various ratios (1:5, 1:10, 1:20 and 1:50) using geometric blending for 5 minute (mean± SD, n = 9).
Fig 7.
Influence of processing time and carrier particle size on content uniformity of ergocalciferol.
Blends are made of ergocalciferol and (A) pregelatinised starch, (B) Starch & (C) MCC (non-sieved, cohesive and non-cohesive) blended at drug: carrier ratio of 1:50 using vigorous hand blending technique (mean± SD, n = 9).
Fig 8.
Influence of processing time, carrier type and carrier particle size on blend homogeneity as expressed in RSD.
Blends are made of ergocalciferol and carrier blended at drug: carrier ratio of 1:50 using vigorous hand blending technique (n = 3).
Fig 9.
Influence of processing time and carrier particle size on content uniformity of ergocalciferol.
Blends are made of ergocalciferol and (A) pregelatinised starch (non-sieved, cohesive and non-cohesive) (B) starch (non-sieved and cohesive) and (C) MCC (non-sieved, cohesive and non-cohesive) blended at drug: carrier ratio of 1:50 using interactive blending technique (mean± SD, n = 9).
Fig 10.
Influence of processing time, carrier type and carrier particle size on blend homogeneity as expressed in RSD.
Blends are made of ergocalciferol and carrier blended at drug: carrier ratio of 1:50 using interactive blending technique (n = 3).
Fig 11.
Influence of processing time and carrier type on content uniformity of ergocalciferol.
Blends are made of (A) 1% and (B) 0.5% ergocalciferol and non-sieved carrier (pregelatinised starch, starch and MCC) blended using interactive blending technique using the novel dry powder coater at 300rpm (mean± SD, n = 9).