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Fig 1.

Rosuvastatin 3D structure.

In orange are shown the carbon atoms, blue the nitrogen atoms, yellow the sulphur atom, in cyan the fluorine atom and the polar oxygen and hydrogen atoms in red and white, respectively.

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Fig 1 Expand

Fig 2.

Method structure of the study.

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Fig 2 Expand

Fig 3.

SeDeM diagram for the calculated parameters (r).

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Fig 3 Expand

Table 1.

Conversion factors to obtain “r values”.

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Table 1 Expand

Table 2.

Composition of tablet formulation expressed in mg per tablet.

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Table 2 Expand

Fig 4.

SEM of rosuvastatin calcium and selected excipients.

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Fig 4 Expand

Fig 5.

DSC rosuvastatin calcium and selected excipients.

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Fig 5 Expand

Fig 6.

DSC binary (1:1) mixtures of rosuvastatin and excipients.

(A) DSC of rosuvastatin, lactose monohydrate and physical mixture. (B) DSC of rosuvastatin, cellulose microcrystalline and physical mixture. (C) DSC of rosuvastatin, calcium phosphate and physical mixture. (D) DSC of rosuvastatin, PVPP and physical mixture. (E) DSC of rosuvastatin, magnesium stearate and physical mixture.

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Fig 6 Expand

Fig 7.

TGA rosuvastatin calcium.

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Fig 7 Expand

Fig 8.

FT-IR rosuvastatin calcium.

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Fig 8 Expand

Fig 9.

FT-IR binary (1:1) mixtures of rosuvastantin and excipients.

(A) Physical mixture rosuvastatin and dibasic calcium phosphate. (B) Physical mixture rosuvastatin and lactose monohydrate.

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Fig 9 Expand

Fig 10.

PXRD rosuvastatin calcium.

In red is shown the PXRD of pure rosuvastatin calcium, pink the PXRD of marketed tablets, blue the PXRD of mixture drug-excipients, green the PXRD of tablets under study.

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Fig 10 Expand

Fig 11.

SeDeM rosuvastatin for the calculated parameters (r).

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Fig 11 Expand

Table 3.

Parameters and tests used by the SeDeM method.

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Table 3 Expand

Table 4.

Pharmaceutical technological characteristics of rosuvastatin tablets.

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Table 4 Expand

Fig 12.

Dissolution rate of rosuvastatin calcium tablets.

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Fig 12 Expand