Κατεύθυνση Βιομηχανική Φαρμακευτική
Library of the School of Science

2021-12-14

2021

Kritsivela Eirini

Ρέκκας Δημήτριος, Αναπληρωτής Καθηγητής, Τμήμα Φαρμακευτικής, Εθνικό Καποδιστριακό Πανεπιστήμιο Αθηνών

« Προκαταρκτική Μελέτη Ανάπτυξης Φαρμακευτικού Προϊόντος με τη Χρήση Πειραματικού Σχεδιασμού »

Greek

"Preliminary Study of Pharmaceutical Product Development Using Experimental Design"

Perampanel is an antiepileptic active pharmaceutical ingredient (API), which is not soluble in water. In particular, in aqueous solutions with pH>1,2 , this active ingredient is practically insoluble. For this reason, an emulsion was chosen as a formulation to be tested for its ability to enhance the solubility of this API at preformulation stage. For the preparation of the emulsion, olive oil was used as the dispersed phase, in which the API dispersion took place, while in the aqueous phase HPMC E6 and HPMC E4M were added as emulsifiers, viscosity enhancers and surfactants. In addition, a film was prepared from the emulsion and its contribution to the API’s solubility was studied. Preliminary dissolution studies were performed to compare the formulations. After the evaluation of the results, a process parameter design (using DoE) was applied to the emulsion to determine the statistically significant factors affecting the solubility of the API. In particular, a two-level, full factorial design for three factors took place using Design Expert software. Formulations with different %content in olive oil, HPMC E6 and HPMC E4M were prepared for this purpose and the dissolution studies were performed. The % drug dissolved at 20, 60 and 120 minutes were selected as responses. Finally, emulsions with different contents of those given by Design Expert were prepared, in order to test model’s predictability.

Science

Health Sciences

design of experiments, dissolution study, olive oil, perampanel, film, emulsion

No

0

Yes

34

76

File access is restricted until 2024-12-16.

https://pergamos.lib.uoa.gr/uoa/dl/object/2968696