Effect of the excipients on the solubility of Ibuprofen and Fluconazol
Understanding how excipients interact with an active pharmaceutical ingredient (API), whether acidic or basic, is crucial for improving physicochemical properties such as API solubility, thereby leading to enhancements in manufacturing processes and the quality of pharmaceutical formulations. For th...
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| Médium: | bachelorThesis |
| Jazyk: | eng |
| Vydáno: |
2024
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| Témata: | |
| On-line přístup: | http://repositorio.yachaytech.edu.ec/handle/123456789/801 |
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Přidat tag | Shrnutí: | Understanding how excipients interact with an active pharmaceutical ingredient (API), whether acidic or basic, is crucial for improving physicochemical properties such as API solubility, thereby leading to enhancements in manufacturing processes and the quality of pharmaceutical formulations. For this reason, this study focused on evaluating the impact of various excipients, including beta-cyclodextrin (BCD), carbomer (CBER), hydroxypropyl methylcellulose (HPMC), polyvinylpyrrolidone (PVP), and Oxalys tuberosa starch (OCAS), on the solubility of Ibuprofen (IBU) as an acidic API and Fluconazole (FLU) as a basic API in aqueous solutions at room temperature (25°C). In this context, mixtures with different proportions of excipient and API were evaluated, and the solubility of each combination was determined using the Flask Shaking Method. Reference values of IBU and FLU pKa and logS0 were considered to establish a pH favoring the neutral form of the compounds, and the HH model was constructed to compare reference intrinsic solubility with experimental solubility. Additionally, statistical tools such as correlation analysis, ANOVA, and Tukey's test were employed to validate the results. Findings indicate that BCD and certain percentages of PVP enhance the solubility of ibuprofen, while OCAS, CBER, and HPMC show no positive effect. On the other hand, the solubility of fluconazole is not increased by these excipients. Furthermore, differences were observed when comparing the behavior of IBU and FLU when interacting with the excipients during the study. Thus, these results underscore the importance of employing personalized strategies that consider the specific molecular characteristics of each compound, which could result in the development of tailored formulations to optimize the efficacy of each drug. |
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