PREPARATION AND IN VITRO EVALUATION OF BUTENAFINE HCL NANOSUSPENSION NIBRAS MAHDI NAEEM, OMAR SAEB SALIH International Journal of Applied Pharmaceutics, 2026 Objective One of the significant problems associated with poorly soluble drugs is low bioavailability. Butenafine HCl is classified as BCS Class II by the biopharmaceutical classification system, with low solubility and high permeability. Objectives: Formulation as a nanosuspension is an attractive and promising alternative to solve low solubility problems and low bioavailability Methods: A nanosuspension of Butenafine HCL was generated utilizing a bottom-up method through the solvents/anti-solvents procedure characterized by particle size analysis, polydisperse index, and entrapment efficacy, and then the selected formula was described by dissolution testing, differential scanning calorimetry, X-ray powder diffraction, FTIR, and FESEM. Nanosuspensions were prepared via the solvent/anti-solvent procedure, using different polymer types and ratios. Results: Butenafine solubilized in PBS with 1% soluplus, PVP, PEG 400, and poloxamer was 14.32 ±0.011,6±0.01,10.48±0.012, and 2.025±0.001.To form a nanosuspension with particle sizes ranging from 78 to 516 ±0.01 nm, entrapment up to 96%, and a Drug content of 99%. Particle size of optimum formula, consisting of Butenafine HCL and soluplus® in a ratio of drug: stabilizer (Soluplus®):co-stabilizer (PEG400) is (1:8:2.5) measured in nanostructure, and it was equal to 78.3±0.03 with a PDI 0.2511±0.13, which is in the nanosized range, drug content of optimum formula 99.6±0.013, and entrapment was 96±0.012. Osmolarity adjusted to a range of 280 to 310 mOsm/Kg. The release of the drug after 120 min was 95%. FTIR spectra show a distinct peak for the drug, indicating no chemical interaction between BF and Soluplus®.DSC shows a slight shift in the melting point to 220.50 °C due to the presence of cryoprotectants. PXRD shows amorphous formation due to nanosuspension, and FESEM shows the size and shape of the nanosuspension, in which the size of the particle by FESEM was 72.9nm, which is close to the measured particle size. The stability study of the optimal formula after three months showed a particle size of 78 nm at 5 °C and 80nm at 25 °C . Conclusions: Using soluplus as a stabilizer at various concentrations successfully produced a nanosuspension of Butenafine HCl.The best formula, consisting of Butenafine HCL and soluplus® in a ratio of drug: stabilizer (Soluplus®):co-stabilizer (PEG400) is 1:8:2.5,
Itracanazole-loaded Spanlastics: Preparation, In-vitro Characterization and Antifungal Activity Study Lina S. Hussein, Omar Saeb Salih, Saba Abdulhadi Jabir Current Drug Therapy, 2026 Introduction: This study investigates the process of loading itraconazole (ITCZ) into span-lastic nanovesicles, which may increase its permeability and bioavailability. The objective of this study was the formulation and characterization of itraconazole-loaded spanlastics (ITCZ -SPs). Methods: Itraconazole-loaded spanlastics (ITCZ -SPs) were formulated using the ethanol injection method. The composition of the formulation included Tween 60 as an edge activator in various ratios and Span 60 as a nonionic surfactant. These formulations employed Soluplus as a stabilizer. Particle size (PS), polydispersity index (PDI), and entrapment efficiency (%EE) were all considered in the evaluation process, and then zeta potential was applied to the formulation. Additionally, this formula-tion was compared with capsules from three different companies that are currently available on the market. Results: The selected formulation showed a particle size of about 99 nm, an EE of about 81%, a PDI of about 0.263, and a zeta potential of -26.07 ± 0.89 mV. Among the tested samples, only the optimal formulation exhibited a distinct response against C. tropicalis at a 100% concentration, compared to the samples of the marketed drug. Conclusion: When combined, ITCZ-SPs significantly enhanced the solubility and permeability of ITCZ, offering a promising nanoplatform for hydrophobic drug delivery.
Formulation and in-vitro evaluation of Tizanidine nanoparticle as a sublingual tablet Saba Abdulhadi Jaber, Maha Mahdi Ali, Manar Adnan Tamer, Omar Saeb Salih Journal of Advanced Pharmacy Education and Research, 2025 Tizanidine (TZ) is a selective α 2-adrenergic agonist used to relieve spasticity associated with spinal cord injury and multiple sclerosis. Despite its clinical utility, TZ is a Biopharmaceutics Classification System Class II drug with poor aqueous solubility and an oral bioavailability of about 13%, limiting efficacy. Polymeric nanotechnology was employed to enhance dissolution and absorption. TZ nanoparticles were prepared by a solvent–antisolvent method using carriers Soluplus® (SL) and Polox
Ultra HPLC method development and validation for the determination of meclizine in pharmaceutical formulation Omar Saeb Salih, Saba Abdulhadi Jaber, Halah Talal Sulaiman Journal of Advanced Pharmacy Education and Research, 2025 For meclizine, a straightforward, quick, and precise high-performance liquid chromatographic (HPLC) method is created, refined, and verified. Linearity, accuracy, and precision were the three criteria used to validate the method. In order to overcome the limitations of the UV approach for determining meclizine concentration, a novel technique called ultra-high-performance liquid chromatography (HPLC) was employed to measure the amount of meclizine in pharmaceutical samples. As a drug it used as
Impact of preparation techniques on formulation and characterization of captopril effervescent granules Ishraq K. Abbas, Marwah M. Hareeja, Saba Abdulhadi Jaber, Adnan Burhan Qader, Raffah Khamis Mahal, Omar Saeb Salih, Ahmed Abbas Hussein Journal of Advanced Pharmacy Education and Research, 2025 Captopril aqueous solution prepared using the drug as a powder dissolved in water was stable only for approximately twenty-seven days. The present work aimed to prepare captopril as stable dry solid effervescent granules that form a suitable swallowing aqueous liquid dosage for pediatrics. Six formulas were prepared, by wet, and; fusion methods, using different ratios of citric acid and tartaric acid with potassium bicarbonate as the effervescent base. The granules evaluation was done concerning their flowability, tapped density, bulk density
Preparation, Evaluation, and Histopathological Studies of Ondansetron-Loaded Invasomes Transdermal Gel Omar SALIH, Entidhar MUHAMMED Journal of Research in Pharmacy, 2024 Ondansetron is a serotonin receptor antagonist for treating nausea and vomiting. Its multiple daily doses and extensive first-pass metabolism faced parenteral and oral administration challenges. The transdermal route enhances its bioavailability as it bypasses the first-pass effect. Invasome vesicles improve the skin permeation of ondansetron via its unique components, lecithin, limonene, and ethanol, which are considered efficient permeation enhancers. The current study intends to develop a gel containing ondansetron as invasomes vesicles with appropriate texture and efficient skin penetration. Two gelling agents, hydroxypropyl methylcellulose K4M and carbopol 934P, were used at two concentrations (0.5 and 1%, w/w). Formulas were evaluated regarding pH, content uniformity, viscosity, spreadability, and ex vivo permeation. The selected formula (F3), which contained ondansetron (5%, w/w) and used carbopol 934P at (0.5%, w/w), was homogeneous, with proper viscosity (21,500 ± 390 mPa.s) at rest and enough spreadability (3.4 ± 0.45 cm). The ex vivo permeation showed permeation flux (Jss) was (280.4 ± 3.5 g/cm2.h) with a shorter lag time (0.5 ± 0.1 h). Characterization studies revealed nanosized vesicles (Dav. = 202.9 ± 0.5 nm) as spherical shapes dispersed within a gel matrix. In vivo, skin irritation and histopathology studies using male Wistar albino rats demonstrated that (F3) was biocompatible, with no irritation reported for six consecutive days. In conclusion, the invasomes gel of ondansetron utilizing carbopol (0.5%, w/w) was prepared for transdermal delivery, offering effective permeation and safe application. An invasomes-loaded gel is considered a novel formulation, giving an efficient and realistic therapeutic option for treating vomiting.
Pharmacokinetic parameters of ondansetron in rats after oral solution and transdermal invasomes gel: A comparison study Omar Saeb Salih, Entidhar Jasim Al-Akkam Journal of Advanced Pharmacy Education and Research, 2023 This study aimed to attain a comparison in pharmacokinetic parameters of ondansetron after transdermal (as invasomes gel) and oral (as solution) routes. Ondansetron is a 5 ‐ hydroxytryptamine receptor antagonist used for chemotherapy and radiotherapy ‐ induced nausea and emesis. The study was performed using Wistar albino rats weighing 200 ±20 g divided into two groups (6 of each). A dose of 0.28 mg of ondansetron, equivalent to 140 µl, was administered as an oral solution for the f
Preparation, In vitro, and Ex vivo Evaluation of Ondansetron Loaded Invasomes for Transdermal Delivery Omar Saeb Salih, Entidhar J. Al-Akkam Iraqi Journal of Pharmaceutical Sciences, 2023 Invasomes are newly developed types of nanovesicles. A vesicular drug delivery system is considered one of the approaches for transdermal delivery to enhance permeation and improve drug bioavailability. Ondansetron is a serotonin receptor antagonist used for treating vomiting associated with different clinical cases. The study aimed to prepare invasomal dispersions for improving permeation of ondansetron across the skin with a controlled release pattern. Twenty-seven formulas of ondansetron-loaded invasomes were prepared by a modified mechanical dispersion method. These formulas were optimized by studying the effect of variables on entrapment efficiency. Vesicle size, polydispersity, zeta potential, in-vitro release and ex-vivo permeation studies were done for the optimized formulas. The selected formula was )F25( had )88.24%±0.04 (entrapment, (317.7 nm) vesicle size, (0.29) polydispersity, and (-31.5mV) zeta potential. In-vitro release study showed That (F25) had 75% release after (12) hrs., and dissolution followed the Korsmeyer-Peppas model with anomalous diffusion. Ex-vivo permeation study showed steady-state flux was 340.2 µg/cm2.hr with no lag time using rat skin tissue. A transmission electron microscope was done to visualize the selected formula. Invasomes are considered promising drug delivery systems for transdermal delivery of ondansetron, ensuring efficient permeation with a sustained release pattern.
Microneedles as A Magical Technology to facilitate Transdermal Drug Delivery: A Review Article Omar S Salih, Entidhar J. Al-Akkam International Journal of Drug Delivery Technology, 2022 Skin drug administration is the method used to provide drugs for local or systemic therapy, which is recognized for clinical usage. It is the third-largest method of medication delivery, after only intravenous administration and oral administration. Using a transdermal delivery method makes the administration easy, and blood concentration and adverse effects can be reduced. A microneedle is a micron-sized needle with a short height of no more than 500 micrometers and a width of no more than 50 micrometers. The needle comes into contact with the epidermal layer of the skin before it gets to the dermal layer, where there is no discomfort. Several materials, such as metals, inorganic, and polymer materials, are used to create microneedles. All different types of microneedles are employed in different scientific disciplines. In recent years, microneedles have been utilized as a drug delivery method to carry pharmaceuticals, genetic codes, proteins, and vaccinations. In chemotherapy, diagnostics, treatment, and immunotherapy, microneedles were utilized.
Formulation and evaluation of mucoadhesive buccal tablet of Anastrozole Mais Fadhel Mohammed, Zainab Ahmed Sadeq, Omar Saeb Salih Journal of Advanced Pharmacy Education and Research, 2022 The study is related to the formulation and evaluation of mucoadhesive buccal tablets of Anastrozole to enhance its bioavailability by avoiding 1st pass effect. The study succeeded in developing mucoadhesive buccal tablets containing two layers (mucoadhesive and backing layer) in a design that permits the unidirectional release of the drug. Tablets of Anastrozole were prepared by double direct compression method using (carbopol 934) as a primary mucoadhesive polymer, Sod.alginate, Na CMC, and HP
Study the sustain release effect of different polymers used in the formulation of aspirin-rosuvastatin tablets International Journal of Pharmacy and Pharmaceutical Sciences, 2015
Formulation and in vitro evaluation of rosuvastatin calcium niosomes International Journal of Pharmacy and Pharmaceutical Sciences, 2013
Effects of mucoadhesive polymers combination on the properties of lisinpril buccal tablets prepared by wet granulation method International Journal of Pharmacy and Pharmaceutical Sciences, 2013
RESEARCH OUTPUTS (PATENTS, SOFTWARE, PUBLICATIONS, PRODUCTS)
FORMULATION AND IN VITRO EVALUATION OF ROSUVASTATIN CALCIUM NIOSOMES.
