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Transformation model to green HPLC methods for lipophilic acidic compounds based on isoeluotropic series of elution solvents
(Elsevier BV, 2025-06)
Trifunovska, Bojana Vulovska
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Atanasova, Ana
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Antovska, Packa
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Lazova, Jelena
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FT-NIR models for predicting film quality parameters in titanium dioxide-free tablet coatings
(Elsevier BV, 2025-02-01)
Gorachinov, Filip
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Koviloska, Monika
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Tnokovska, Katerina
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Atanasova, Ana
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Antovska, Packa
This study leverages Fourier Transform Near-Infrared (FT-NIR) spectroscopy to monitor the coating process of pharmaceutical tablets using PVA-based TiO2-free films, with talc and iron oxides as opacifiers. By employing a combination of multivariate analytical techniques, the correlation between film coating progression and film thickness was evaluated. Assessment of coating thickness for different coating levels was performed by optical microscopy. Additionally, using colorimetric analysis by scanner method, the color progression for different coating levels was evaluated and expressed as the a* value from CIELAB color space. The coordinate value a* showed predictable changes with the progression of the coating process and film thickness values, indicating its utility as a robust reference method for quality control and process optimization. The predictive capability of the OPLS models, validated against measured film thickness and the a* value, demonstrated low prediction errors and confirmed the models' effectiveness in distinguishing coating levels and accurately predicting film coating progression. The OPLS model used knowledge-based peaks of interest, which were further confirmed by loading and coefficient plots. The study demonstrated that film thickness, as a destructive, and a* value from CIELAB color space, as a non-destructive reference method for coating progression could be used during a controlled pharmaceutical coating process for product quality assessment and pharmaceutical process endpoint determination.
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Non-compendial vs compendial analytical tests - a powerful tool for predicting in vitro similarity of highly viscous oral suspension
(Macedonian Pharmaceutical Association, 2019)
Kazandjievska, Elena
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Antova, Iva
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Mitrevska, Slavica
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Dimkovski, Aleksandar
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Dimov, Elena
<jats:p>In vitro dissolution profiles are increasingly used to evaluate drug release characteristics of pharmaceutical products. The dissolution methods is expected to be an appropriate tool for checking consistency of the pharmaceutical attributes by discriminating similarities and dissimilarities between different drug formulations. Expansion in development of novel “special” dosage forms, due to the manner in which these dosage forms release the active pharmaceutical ingredient, usually requires applying non-compendial dissolution strategy that differs from the traditional compendial recommendations. For demonstrating sameness in the dissolution profile, in vitro drug release comparison between test and reference product of highly viscous oral suspension by applying non-compendial peak vessel against conventional hemispheric vessel was demonstrated in this study. All reference batches exhibited high variability in dissolution data when using hemispheric vessel due to forming mound compact mass at the bottom of the vessel. Different strategies for samples manipulation, before and during dissolution period, were performed in order to eliminate additional variabilities. Modifications of conventional USP 2 apparatus such as using peak vessel provided with more reproducible and reliable result for distinguishing in vitro similarities between different formulations of oral suspensions. Misinterpretation of dissolution data can lead to negative impact on product development. Taking time to observe and evaluate what is happening to the product in the vessel during dissolution is of curtail consideration for proper selection of the dissolution strategy. Keywords: oral suspensions; in-vitro release; hydrodynamic variability; USP apparatus 2/ Paddle apparatus; peak vessel</jats:p>
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Formulation development of prolonged-release matrix tablets - factors influencing drug dissolution rate
(Macedonian Pharmaceutical Association, 2020-10-29)
Ali Memed, Oja
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Hadzieva-Gigovska, Maja
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Kuneski, Dejan
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Trajanovska, Eleonora
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Antovska, Packa

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