Quantification of Compatibility Between Polymeric Excipients and Atenolol Using Principal Component Analysis and Hierarchical Cluster Analysis

Rojek, Barbara; Gazda, Maria; Wesołowski, Marek

doi:10.1208/s12249-021-02143-2

Cited by 6 publications

(2 citation statements)

References 29 publications

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“…Similarly, the optimal PCA model built for the DSC curves groups the samples based on some mutual thermal features observed in the DSC curves. 30 The corresponding loading plots (Fig. 5b and 5c) reveal that the model groups based on the main changes in the DSC curves, i.e., the changes in the melting peak of ibuprofen, such as its shift towards higher temperature, as well as changes in its symmetry or enthalpy, was already discussed previously.…”

Section: Multivariate Statistical Analysissupporting

confidence: 66%

Мultivariate analysis for rapid screening and prediction of solid-state compatibility in pharmaceutical preformulation studies-paving the road for machine learning

Cvetkovska Bogatinovska,

Geškovski,

Petrushevski

et al. 2024

Maced. J. Chem. Chem. Eng.

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Multivariate analysis models were developed to evaluate the results obtained from a compatibility study designed for ibuprofen with a large group of different types of excipients, as a possible approach for rapid screening of the incompatibility between the active pharmaceutical ingredient (API) and excipients. The solid-state characterization of the binary mixtures was performed by Fourier transform infrared spectroscopy (FTIR) and differential scanning calorimetry (DSC). Principal component analysis (PCA) and partial least squares-discriminant analysis (PLS-DA) using SIMCA® software were applied for evaluation of the experimentally obtained results. The optimal PCA model for the FTIR spectra explains 96.2 % of the variations in the dataset with good statistical indicators (R2X = 0.960, Q2 = 0.900), which was also the case for the PCA model for the DSC curves (R2X = 0.981, Q2 = 0.866). The applied PLS-DA models have shown similar behaviour to the PCA. Moreover, the main spectral variations in the FTIR spectra and the thermal events in the DSC data were attributed the highest variable importance for the projection (VIP) scores in the corresponding VIP plots, confirming the model capability for predicting ibuprofen interactions. Furthermore, the prediction power of the optimal models for FTIR and DSC experimental data was evaluated by the root mean square error of prediction (RMSEP) of 0.10 and 0.16, respectively. The obtained results demonstrated the potential of multivariate statistical analysis as a machine learning-based technique for screening and prediction of ibuprofen-excipients solid-state compatibility in the preformulation phase of the pharmaceutical development of dosage forms.

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Section: Multivariate Statistical Analysissupporting

confidence: 66%

Мultivariate analysis for rapid screening and prediction of solid-state compatibility in pharmaceutical preformulation studies-paving the road for machine learning

Cvetkovska Bogatinovska,

Geškovski,

Petrushevski

et al. 2024

Maced. J. Chem. Chem. Eng.

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“…A Shimadzu Model 8400 FTIR was used to scan the drug powder between wave numbers 4000-1cm and 400 cm -1 while utilizing air as a reference. 15…”

Section: Melting Pointmentioning

confidence: 99%

Formulation and Evaluation of Film-Coated Alalevonadifloxacin Mesylate Tablet using Opadry®

PK,

SA,

et al. 2023

IJPQA

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Purpose: In this work, film-coated tablets of the antibiotic alalevonadifloxacin mesylate (AFM) were made using Opadry® yellow as the film coating material, and their different parameters, including in-vitro drug release, were assessed. Method: Direct compression was used in the production of film-coated tablets of AFM. The film-coating substance was an aqueous coating dispersion that was opadry yellow. In 900 mL of 0.1N HCL solution, the film-coated tablets’ rate of dissolution was assessed. In-vitro drug release was also evaluated. The generated film-coated tablets’ stability was assessed in accordance with ICH recommendations. Result: The coated tablets were subjected to gastrointestinal pH testing to ascertain the effectiveness of the film coating, and high-performance liquid chromatography was used to assess drug release. The coated tablets were in perfect condition. The AFM release satisfied the study’s requirement of being at least after 30 minutes, 80% was dissolved in a 0.5% HCl solution. Conclusion: According to these results, opadry yellow aqueous film coating is a simple, repeatable, and affordable method for creating stable AFM film-coated tablets without changing the properties of the medication release.

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Implementation of Quality by Design (QbD) for development of bilayer tablets

Simão

Chaudhary

Ribeiro

2023

European Journal of Pharmaceutical Sciences

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Quantification of Compatibility Between Polymeric Excipients and Atenolol Using Principal Component Analysis and Hierarchical Cluster Analysis

Cited by 6 publications

References 29 publications

Мultivariate analysis for rapid screening and prediction of solid-state compatibility in pharmaceutical preformulation studies-paving the road for machine learning

Мultivariate analysis for rapid screening and prediction of solid-state compatibility in pharmaceutical preformulation studies-paving the road for machine learning

Formulation and Evaluation of Film-Coated Alalevonadifloxacin Mesylate Tablet using Opadry®

Implementation of Quality by Design (QbD) for development of bilayer tablets

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