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Fig 1.

Contour plot of standard error of design of optimization batches (% Friability).

Optimum predicted response value for friability (in percent) when the change in two variables (MCC pH 102 and pregelatinized starch) occurred.

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Fig 1 Expand

Fig 2.

Contour plot of standard error of design of optimization batches (Disintegration time).

Predicted response value of disintegration time (in minutes) upon alteration in two variables (MCC pH 102 and pregelatinized starch).

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Fig 2 Expand

Fig 3.

3D surface plot of standard error of design of optimization batches (% Friability).

3D surface plot visualization of friability responses as a function of variables (MCC pH 102 and pregelatinized starch).

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Fig 3 Expand

Fig 4.

3D surface plot of standard error of design of optimization batches (Disintegration time).

Graphical visualization of disintegration time responses as a function of variables via a 3D surface plot.

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Fig 4 Expand

Table 1.

Drug-drug compatibility study of aspirin & clopidogrel bisulphate.

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Table 1 Expand

Fig 5.

Linearity curve between concentration versus peak area in a combined solution.

The calibration curve shows linearity over the concentration range of 60–0.117μg/ml for aspirin and 80–0.156 μg/ml for clopidogrel.

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Fig 6.

Chromatograms of drug-drug compatibility (60/80 μg/ml).

A) Day 1st; B) Day 7th; C) Day 21st sample.

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Fig 7.

Differential Scanning Calorimetry (DSC) study of aspirin and clopidogrel.

a) Aspirin; b) Clopidogrel bisulphate; c) Physical mixture of aspirin & clopidogrel bisulphate.

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Fig 8.

FTIR spectra of clopidogrel, aspirin and their physical mixture.

Clopidogrel ‐ Characterize the unique absorption bands; Aspirin- indicates principal functional group; Clopidogrel + Aspirin ‐ Physical mixture is to characterize their molecular compositions and interactions assessment.

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Fig 9.

FTIR spectra of aspirin formulations.

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Fig 10.

FTIR spectra of clopidogrel & aspirin combination formulations.

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Table 2.

Preformulation studies of active and excipients.

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Table 3.

Pre-formulation studies of prototype formulations of aspirin.

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Table 4.

Pre-formulation studies of prototype formulations of clopidogrel bisulphate.

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Table 5.

Design of prototype formulations for aspirin & clopidogrel.

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Table 6.

Analysis of pharmaceutical parameters of combined formulated tablets of A & CB.

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Fig 11.

Graphical presentation of % release of clopidogrel from optimize combine formulation.

Release profile of clopidogrel from different individual formulations (F1-F9).

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Fig 12.

Graphical presentation of dissolution data of aspirin from optimize combine formulation.

The drug release profile of aspirin from different individual formulations (A1-A9) when constructing a graph between release percentage versus time.

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Table 7.

Comparative data of dissolution models parameters of marketed brands & F8.

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Fig 13.

Graphical presentation of First order release of clopidogrel from CPB and marketed brands. F8- represents the release profile of Clopidogrel from the Check Point Batch (CPB); STD1CB- represents the release profile of Clopidogrel from one of the marketed brands of the medication; STD2CB- represents the release profile from 2nd marketed brand and STD3CB- illustrates the rate of drug release from 3rd marketed brand over time.

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Fig 14.

Graphical presentation of First-order release of aspirin from CPB and marketed brands.

F8 represents the release profile of aspirin from the Check Point Batch (CPB); STD1A- represents the % release of aspirin from 1st marketed brands; STD2A- illustrates the rate of drug release from 2nd brand and STD3A- from the 3rd marketed brand over time.

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Fig 15.

Graphical presentation of Hixson-Crowell release of clopidogrel from CPB and marketed brands.

Dissolution profiles of check point batch (F8) for clopidogrel compared with dissolution profile of commercial tablets (STD1CB, STD2CB, STD3CB) after 60 minutes.

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Fig 16.

Graphical presentation of Hixson-Crowell release of aspirin from CPB and marketed brands.

Dissolution profiles of checkpoint batch (F8) for aspirin compared with dissolution profile of commercial tablets (STD1CB, STD2CB, STD3CB) after 60 minutes.

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Table 8.

Stress study (at 60 °C) of optimized prototype Formulation (CPB).

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