The impact of low levels of amorphous material (&lt;5%) on the blending characteristics of a direct compression formulation

Mackin, Lesley; Sartnurak, Soisurin; Thomas, Iwan; Moore, Stephen

doi:10.1016/s0378-5173(01)00880-8

Cited by 49 publications

(18 citation statements)

References 12 publications

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“…Figure 7 shows the spray-dried powder from lactose/WPI solutions with 1% (w/w) citric acid, before and after ethanol washing. The Particle size analysis of powders has shown that the particle size of the processed powder after grinding is about 16±4 μm (D [3,2]), while the particle size of the spray-dried lactose/WPI powder before ethanol washing was 5±1 μm (D [3,2]). The D [4,3] values for these two powders are 47±2 and 110±9 μm, respectively.…”

Section: Sem Micrographsmentioning

confidence: 99%

“…Powder mixing is an important process in the production of solid drug mixtures for the pharmaceutical industry. Producing excipients with higher concentrations of surface asperities and larger specific surface areas for use in direct compression tableting techniques may significantly reduce problems of carrier/drug segregation during the handling of their mixtures [1][2][3][4].…”

Section: Introductionmentioning

confidence: 99%

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Developing a new production process for high-porosity lactose particles with high degrees of crystallinity

2015

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Section: Sem Micrographsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Developing a new production process for high-porosity lactose particles with high degrees of crystallinity

2015

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“…Pfeiffer et al (4,5) proposed that the particle size enlargement of salbutamol sulfate resulted from the moisture sorption-mediated recrystallisation of amorphous surfaces leading to agglomeration. These amorphous regions exist as disorders within the crystalline structure, which are created by the mechanical and thermal stresses during milling (1,(7)(8)(9). SEM analyses provided supporting evidence of agglomeration showing that particle growth was accompanied by the formation of new interparticle bridges (2)(3).…”

Section: Introductionmentioning

confidence: 98%

Anomalous Particle Size Shift During Post-milling Storage

Kwek

Tan

2007

Pharm Res

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Storage of milled adipic acid below the critical relative humidity led to localised disintegration from the agglomerate surface and particle size reduction, which was not influenced by moisture sorption or loss. This evidence supports that "stress relaxation" mechanism behind particle breakage of post-milled particles. Appropriate storage conditions are important in maintaining the stability of milled powders.

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“…1 Although milling has been known to cause a number of structural changes, such as crystal defects, 2,3 density of exposed groups at the particle surface, 4 and surface disorder, 5 all lead to a possible decrease in stability and alteration of their physicochemical properties. These different modes of structural changes can have an undesirable or unpredictable effect on common pharmaceutical operations, such as blending, 6 compression, 7 and dissolution, 8 due to changes in particle size, thermodynamic states, and/or the surface energy of the milled particulates.…”

Section: Introductionmentioning

confidence: 99%