Browsing by Author "Baloglu, Esra"

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Development and Characterization of Self-Assembling Sirolimus-Loaded Micelles as a Sublingual Delivery System
(Elsevier, 2022) Turkmen, Omer; Baloglu, Esra
The aim of this study was to develop self-assembling micelles of poorly water soluble potent immunosuppressant agent sirolimus (SRL) to enhance the solubility and mucosal permeability as stable aqueous formulations for sublingual administration. D-alpha-tocopheryl 1000 succinate (TPGS), soy phosphatidylcholine (SPC), and sodium cholate (NaC) were used to prepare the SRL-loaded micelles using the one-step self-assembly method. The mean hydrodynamic diameter of optimal micelles ranged from approximately 13 to 42 nm with low polydispersity index (PDI). The formulations possessed drug loading (DL) and drug encapsulation efficiency (EE) of around 18% and 99%, respectively. SPC caused an increase in mean hydrodynamic diameter and PDI of micelles, but no negative impact on DL and EE values was observed when used at concentrations of <= 25% (w/w) of amphiphiles. However, NaC caused a detrimental effect on the characteristics of micelles in every respect. Ex vivo permeation studies revealed that TPGS-based micelles without SPC were not able to enhance the permeation of SRL compared to the SRL solution through bovine sublingual mucosa. However, the incorporation of SPC into the micelles significantly increased the mucosal permeation of SRL compared to the SRL solution. The optimal formulations maintained their characteristics at 4 degrees C for at least 90 days. These results support the feasibility of SRL-loaded micelles as a sublingual delivery system.
Formulation and Evaluation of Fexofenadine Hydrochloride Orally Disintegrating Tablets for Pediatric Use
(Elsevier Science Bv, 2018) Turkmen, Omer; Senyigit, Zeynep Ay; Baloglu, Esra
Allergic rhinitis is a common disease in children which has considerable negative effects on the quality of life. Fexofenadine hydrochloride (FFH) is a second-generation oral antihistamine which has been widely perscribed for alleviating symptoms of AR in children. The aim of this study was to take the advantage of convenient direct compression method for preparation of Orally Disintegrating Tablets (ODTs) containing 30 mg FFH per tablet. Six ready-to-use commercial tablet excipients (F-Melt (R), Pearlitol (R) Flash, Pharmaburst (R) 500, Prosolv (R) Easytab SP, Ludiflash (R), Parteck (R) ODT (R)) were used for direct compression and suitability of these excipients were evaluated. ODTs could be successfully compressed with all the investigated excipients and all of the formulations exhibited acceptable crushing stregth, low friability and remarkably short disintegration time. The ODTs which were able to possess a disintegration time below 30 s were considered eligible for further studies. In vitro dissolution studies showed a complete release of the drug from ODTs made from Pharmaburst (R) 500 within 15 min. Short term stability results exhibited no significant change of the drug in tested formulations. In conclusion, FFH containing ODTs formulated with Pharmaburst (R) 500 were determined explicitly the most promising formulation when compressed at a force of 1000 kg.