Shimaa Ashmawy
@tanta.edu.eg
Scopus Publications
- Dry co-processing of Velpatasvir for Enhancing its Pharmaceutical and Biopharmaceutical Properties
Shaimaa S. Mahmoud, Gamal M. El Maghraby, Ahmed A. Donia, Taher M. Yassin, Shimaa M. Ashmawy
Journal of Pharmaceutical Innovation, 2026 - Enhancement of Lurasidone Hydrochloride Dissolution and Pharmacodynamic Properties Via Co-crystal and Eutectic Formation
Maysa A. Hussien, Sally E. Abu-Risha, Ebtessam A. Essa, Gamal M. El Maghraby, Shimaa M. Ashmawy
Journal of Pharmaceutical Innovation, 2025
Purpose Lurasidone hydrochloride (HCl) is an atypical antipsychotic used for bipolar depression. However, as a Biopharmaceutics Classification System (BCS) Class II drug, it has low solubility, leading to limited oral bioavailability. This study aimed to enhance the dissolution rate and bioavailability of lurasidone HCl by modifying its crystalline structure through co-processing with weak acidic compounds, namely citric acid and nicotinic acid. Methods Lurasidone HCl was co-processed with excipients using the wet co-grinding technique at different molar ratios. The prepared formulations were characterized by differential scanning calorimetry (DSC), Fourier-transform infrared spectroscopy (FTIR), and X-ray powder diffraction (XRD) to investigate solid-state modifications. Dissolution studies were conducted to evaluate the impact of co-processing on drug release. The optimum ratio for each co-former was selected for in vivo assessment of oral bioavailability using the forced swim test (FST) to evaluate antidepressant activity. Results DSC, FTIR, and XRD confirmed the formation of a lurasidone HCl-citric acid co-crystal, while a eutectic mixture was proposed for lurasidone HCl-nicotinic acid formulations. Dissolution studies demonstrated a two-fold increase in dissolution efficiency compared to unprocessed lurasidone HCl. FST evaluation showed increased immobility durations of 1.7-fold for raw lurasidone HCl, 2.9-fold for the marketed product (Elbaluran®), 2.19-fold for the co-crystal formulation (F3), and 3.08-fold for the eutectic mixture formulation (F7), respectively. Conclusion Citric acid and nicotinic acid effectively enhanced lurasidone HCl dissolution and bioavailability through co-crystallization and eutectic formation, respectively, offering a promising approach for optimizing its therapeutic efficacy. - Nanoemulsion for enhanced absorption and anti-tumor activity of dasatinib
Dina A. Eltahan, Rania K. Eid, Shimaa M. Ashmawy, Gamal M. El Maghraby
Journal of Drug Delivery Science and Technology, 2025 - Enhanced dissolution and antibacterial potential of cinacalcet hydrochloride via ternary solid dispersions
Aya E. Radwan, Ebtessam A. Essa, Engy Elekhnawy, Amal A. Sultan, Shimaa M. Ashmawy
Pharmaceutical Development and Technology, 2025
Cinacalcet hydrochloride (HCl), a calcium-sensing receptor agonist used to treat hyperparathyroidism, suffers from poor solubility, reducing its bioavailability. Recently, cinacalcet HCl has been probed for repurposing as antibacterial agent. This work investigates cinacalcet HCl's potential as an antibacterial agent and provides a formulation to improve the drug dissolution. Solid dispersion formulations using Poloxamer 407, with and without Soluplus®, were prepared via solvent evaporation and hot melt congealing methods. The resulting formulations were analyzed using differential scanning calorimetry, FTIR spectroscopy, X-ray powder diffraction, and dissolution studies. These formulations significantly enhanced cinacalcet HCl dissolution compared to the unprocessed form, achieving up to a 15-fold increase in Q5 (percent of cinacalcet HCl dissolved after 5 minutes). The dissolution efficiency rose from 28% for the pure drug to 94.8% and 87.8% for formulations F6 and F7, respectively. Microbiological evaluations confirmed the antibacterial effect of cinacalcet HCl, which was notably increased in the Poloxamer 407 and Soluplus® hybrid formulation (F7) with a MIC of 64-128 µg/ml. Antibiofilm activity was also observed, with qRT-PCR indicating downregulation of biofilm genes (icaA, icaD, and fnbA). This study introduces a cinacalcet HCl formulation prepared using a scalable, green approach, demonstrating significant potential for antimicrobial applications. - Fabrication and Characterization of Amisulpride Nanofibers for Enhanced Oral Pharmacodynamic Properties
Shimaa Mohamed Ashmawy, Maysa Abdallah Hussien, Sally El Sayed Abu-Risha, Gamal Mohamed El Maghraby, Amal Ali Elkordy, et al.
Pharmaceutical Sciences, 2025
Background: Buccal route for drug administration has several advantages over oral route, such as improved systemic bioavailability via avoidance of first-pass metabolism and drug degradation in the gastro-intestinal tract. This work aims to improve the dissolution of amisulpride, anti-psychotic drug, employing nanofibers strategy through the development of fast dispersible oral films for buccal drug administration. Methods: Drug-loaded polymeric nanofibers were prepared with or without surfactants. Poly(vinylpyrrolidone) and poly(vinyl alcohol) were used as film former, while Poloxamer-188 and Cremophor® RH 40 were selected as surfactants. The film prepared by solvent casting was also prepared for comparison. Nanofiber mats were characterized by scanning electron microscopy (SEM), thickness and in vitro drug release. The optimized nanofibers mat was further characterized using differential scanning calorimetry (DSC), X-ray diffraction (XRD), pH value, disintegrating time and folding endurance. In vivo evaluation of the antidepressant effect was performed using forced swim test. Results: Nanofibers formation was confirmed by SEM. The average diameter ranged from 228.3±85.6 nm to 502.1±90 nm. In vitro dissolution reflected improved amisulpride dissolution from nanofibers compared to unprocessed drug. Cremophor® RH 40 was superior to Poloxamer-188 with a 4-fold increment in the percentage drug released after 5 min. Physical characterization indicated reduced drug crystallinity with suggested polymorphic transformation. The in vivo pharmacodynamic evaluation of the optimized nanofibers (using albino rats) indicated 2-fold reduction in the duration of immobility. Conclusion: Oral film for buccal administration employing nanofibers strategy was a useful tool to increase amisulpride dissolution, with subsequent improvement in bioavailability. - Intestinal Absorption Site-Guided Development and Evaluation of Oral Disintegrating Controlled Release Tablets of Mirabegron
Mohammed I. Ghanem, Shimaa M. Ashmawy, Gamal M. El Maghraby
AAPS Pharmscitech, 2024
The aim was to employ site-dependent absorption of mirabegron (MB) as a guide for fabrication of oral disintegrating controlled release tablet (ODCRT) which undergoes instantaneous release of loading fraction followed by delayed release of the rest of MB. The goal was to release MB in a manner consistent with the chronobiology of overactive bladder (OAB) syndrome. In situ rabbit intestinal permeability of MB was adopted to assess absorption sites. MB was subjected to dry co-grinding with citric acid to develop the fast-dissolving fraction in the mouth. Delayed release fraction was formulated by ethanol-assisted co-processing with increasing proportions of Eudragit polymer (S100) as pH responsive polymer. The developed dry mixtures underwent thermal (DSC) and physical (X-ray diffraction) characterization, in addition to in vitro release behavior. Optimized fast dissolving and delayed release formulations were mixed with tablet excipient before compression in ODCRT which was assessed for release profile using continuous pH variation. MB underwent preferential permeation through ileum and colon. Co-grinding with citric acid provided co-amorphous powder with fast dissolution. Co-amorphization of MB with Eudragit S100 (1:5) showed pH-dependent release to release most of the dose at pH 7.4. The developed ODCRT released 43.5% of MB in the buccal environment and retained MB at acidic pH to start release at pH 7.4. The study successfully fabricated ODCRT guided by site-dependent absorption. The ODCRT instantaneously released loading fraction to support the patient after administration with delayed fraction to sustain the effect. Graphical Abstract - Cinnamon oil-based self-emulsifying system for augmented dissolution and hypoglycemic efficacy of gliquidone
Mohamed El-Araby, Sanaa A. El-Gizawy, Shimaa M. Ashmawy, Gamal M. El Maghraby
Journal of Drug Delivery Science and Technology, 2024 - Investigation of the effect of verapamil on the regional absorption of sofosbuvir from rabbit intestine in situ
Nada M. Mohsen, Esmat E. Zein El-Din, Mohamed A. Osman, Shimaa M. Ashmawy
Daru Journal of Pharmaceutical Sciences, 2022 - Influence of piperine and omeprazole on the regional absorption of Daclatasvir from rabbit intestine
Shimaa M. Ashmawy, Dina A. Eltahan, Mohamed A. Osman, Ebtessam A. Essa
Biopharmaceutics and Drug Disposition, 2022
The study assessed the site dependent intestinal absorption of Daclatasvir and investigated the effects of piperine and omeprazole on such absorption utilizing in situ rabbit intestinal perfusion technique. The intestinal absorption of Daclatasvir was assessed in four segments: duodenum, jejunum, ileum, and colon. The effect of co‐perfusion with omeprazole was monitored through the tested anatomical sites. The effect of piperine, a P‐glycoprotein (P‐gp) inhibitor on Daclatasvir absorption from jejunum and ileum was tested. The results showed that Daclatasvir was incompletely absorbed from the rabbit small and large intestine. The absorptive clearance per unit length (PeA/L) was site dependent and was ranked as colon > duodenum > jejunum > ileum. This rank is the opposite of the rank of P‐gp intestinal content suggesting possible influence for P‐gp. Co‐perfusion with omeprazole increased PeA/L and this was evidenced also with reduced the L95% of Daclatasvir from both small and large intestinal segments. Significant enhancement in Daclatasvir absorption through jejunum and ileum was shown in presence of piperine. Daclatasvir showed site dependent intestinal absorption in a manner suggesting its affection by P‐gp efflux. This effect was inhibited by piperine. Co‐administration of Daclatasvir with omeprazole can enhance intestinal absorption a phenomenon which requires extension to human pharmacokinetic investigation. - Cubosomes for Enhancing Intestinal Absorption of Fexofenadine Hydrochloride: In situ and in vivo Investigation
Amal A Sultan, Nourhan F El Nashar, Shimaa M Ashmawy, Gamal El Maghraby
International Journal of Nanomedicine, 2022
Purpose The aim of this work was to probe cubosomes for enhanced intestinal absorption and oral bioavailability of poorly absorbable fexofenadine HCl (FEX-HCl). Materials and Methods Two cubosomal systems were fabricated utilizing glyceryl mono-oleate, a lyotropic mono lamellar lipid as oil phase and poloxamer407 as stabilizer at weight ratios of 8:2 and 7:3. The morphology of cubosomes was researched using transmission electron microscopy (TEM) and particle size was measured using photon correlation spectroscopy. FEX-HCl release was monitored in vitro. The effect of cubosomal encapsulation on intestinal absorption was assessed using in situ rabbit intestinal perfusion technique. Carrageenan induced rat paw edema model was utilized to monitor in vivo anti-inflammatory effect before and after cubosomal encapsulation. Results TEM revealed the existence of spherical and polygonal nanostructures arranged in honeycomb organization. Size measurement reflected nanoparticles with reduced size at higher poloxamer concentration. Release studies revealed liberation of FEX-HCl from cubosomes based on Higuchi kinetics model. The intestinal permeability data indicated incomplete absorption of FEX-HCl from simple aqueous solution with P-glycoprotein efflux contributing to this poor intestinal absorption. Incorporation of FEX-HCl in cubosomes enhanced membrane transport parameters. The intestinal absorption did not correlate with drug release suggesting that drug release is not the rate limiting with possible intact cubosomal transport. Cubosomal encapsulation of FEX-HCl significantly enhanced its in vivo anti-inflammatory efficacy compared to the aqueous FEX-HCl dispersion. Conclusion Cubosomes are promising novel carriers for enhancing intestinal absorption of FEX-HCl. Intact FEX-HCl-cubosomal absorption is possible via trans-lymphatic pathway but this requires further investigations. - Regional difference in intestinal drug absorption as a measure for the potential effect of P-glycoprotein efflux transporters
Shimaa M Ashmawy, Sanaa A El-Gizawy, Gamal M El Maghraby, Mohamed A Osman
Journal of Pharmacy and Pharmacology, 2019 - D-glucose elicits significant increase in the oral bioavailability of model BCS class III drugs in the rabbit
Shimaa M. Ashmawy, Mohamed A. Osman, Sanaa A. El-Gizawy, Gamal M. El Maghraby
Journal of Drug Delivery Science and Technology, 2019
