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  • Küçük Resim
    Yayın
    A quality by design study of the use of microfluidic nanoprecipitation for the generation of sub-100 nm drug nanocrystals
    (Elsevier, 2026) Pirinçci Tok, Yağmur; Abukhamees, Shorooq; Fitaihi, Rawan; Demiralp, Burcu; Özsoy, Yıldız; Craig, Duncan
    Although drug nanocrystals have attracted considerable interest within the pharmaceutical industry, there remain issues with the production of nanocrystals with a size below 100 nm. The aim of the present study is to develop a stable, reproducible Canagliflozin (CFZ) sub-100 nm nanosuspension system using microfluidic nanoprecipitation and Quality by Design (QbD) techniques. By means of the circumscribed central composite design (CCCD), critical parameters of the microfluidic nanoprecipitation process and nanosuspension formula tion components were optimised. Optimal CFZ nanosuspension with Z-average of 89.52 ± 3.30 nm, PDI of 0.12 ± 0.01 and drug content of 92.49 ± 0.03 % was successfully fabricated using Soluplus as a stabiliser. An increase in saturation solubility corresponding to approximately 250 times the value of the pure CFZ in water was noted. The optimised CFZ nanosuspension was solidified by freeze-drying and electrospraying. Overall, the study has demonstrated that by using a combination of microfluidics and QbD it is promising to generate stable sub-100 nm nanocrystals with high yield, and narrow size distribution and favourable stability.
  • Küçük Resim
    Yayın
    Influence of drying methods on redispersibility and dissolution of canagliflozin nanocrystals: A comparative approach
    (MDPI Publishing, 2026) Pirinçci Tok, Yağmur; Demiralp, Burcu; Güngör, Sevgi; Sarıkaya, Ali Osman; Aldeniz, Emre Erol; Dude, Udaya Kumar; Özsoy, Yıldız
    Background/Objectives: Canagliflozin (CFZ) is the first sodium glucose co-transporter 2 (SGLT-2) inhibitor and is characterized by poor water solubility and permeability, resulting in low oral bioavailability. In this study, a CFZ nanosuspension (CFZ-NS) was converted into a solid form to improve the physical stability of CFZ nanocrystals (CFZ-NCs) and to enable formulation as a tablet dosage form. Methods: To achieve adequate redispersibility of dried CFZ-NCs, fluid bed granulation and spray-drying methods were employed, and the effects of critical process parameters were investigated. The stability of spray dried nanocrystal tablets (NCs-SD-TAB) was evaluated over a three-month period under storage conditions of 25 ± 2 ◦C with 60 ± 5% relative humidity (RH) and 40 ± 2 ◦C with 75 ± 5% RH. Results: The highest redispersibility index (94%) was obtained using the spray-drying method. Tablets prepared with spray-dried NCs-SD-TAB exhibited a significantly higher in vitro dissolution rate under non-sink conditions compared with control tablets prepared using unprocessed CFZ with the same excipients, as well as the marketed product. NCs-SD-TAB showed an approximately three-fold increase in drug release at 15 min in 0.1 N HCl, with a pH 4.5 acetate buffer and pH 6.8 phosphate buffer, which simulate gastrointestinal pH conditions, relative to the marketed product. Conclusions: Overall, these results indicate that nanocrystal technology represents a promising approach for CFZ as an improved oral drug-delivery system, primarily due to its solubility enhancement capabilities.
  • Kapalı Erişim
    Yayın
    The effect of different granulation amounts of kollicoat MAE 30DP® on ODT CQAs using risk assessment
    (Marmara University, 2026) Pirinçci Tok, Yağmur; Demiralp, Burcu; Al-Mohaya, Mazen; Özsoy, Yıldız
    Orally disintegrating tablets (ODTs) improve patient compliance, but they present challenges in terms of masking the bitter taste of active pharmaceutical ingredients such as dexketoprofen trometamol (DEX). The study aimed to develop palatable DEX ODTs by granulating drug with Kollicoat MAE 30DP® to create a physical barrier. Using a quality by design (QbD) approach, an initial risk assessment identified Prosolv® ODT G2, Emdex®, and Magnasweet® MM100 and tablet compression pressure as critical variables. A Box-Behnken design was employed to prepare 26 formulations, systematically evaluating the impact of these variables across low and high polymer concentrations. The results showed that although high concentrations of Kollicoat MAE 30DP initially delayed the dissolution rate, this barrier effect did not affect the final extent of drug release. Disintegration was predominantly governed by compression pressure, which altered tablet porosity, whereas PROSOLV® ODT G2 significantly influenced the overall dissolution profile. By optimizing the superdisintegrant-to-binder ratio, high-polymer formulations successfully overcame the initial retardation, consistently exceeding an 85% cumulative release at 30 minutes.