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        Promising Ternary Dry Powder Inhaler Formulations of Cromolyn Sodium: Formulation and In Vitro-In Vivo Evaluation

        Ahmed Abd Elbary,Hanan. M. El-laithy,Mina I. Tadros 대한약학회 2007 Archives of Pharmacal Research Vol.30 No.6

        Glucose monohydrate and sorbitol were evaluated as alternative carriers to á-lactose monohydrate in dry powder inhalations. Cromolyn sodium (CS) - carrier binary formulae were prepared and tested in vitro by aerosolization via a twin stage impinger using three types of inhaler devices; Spinhaler, Aerolizerand Handihaler. Glucose monohydrate and sorbitolcontaining formulae that were inhaled via a Handihaler showed significantly higher drug fine particle fractions (P<0.001) than that of the same formulae aerosolized via other devices. Upon storage of the prepared formulae under uncontrolled humidity, that may be encountered during storage and use, marked reductions in these fractions were observed. Incorporation of an optimum Aerosil 200 concentration, as a ternary component, minimized this effect. A urinary excretion pharmacokinetic method was used to evaluate the bioavailability of the selected ternary formulae, inhaled via a Handihaler, relative to the marketed Intal Spincaps , inhaled via a Spinhaler. It was found that the relative bioavailability percentages of the developed formulae were more than twice that of the marketed one suggesting possible future utilization of these more effective ternrry formulae using the more efficient Handihaler inhaler device.

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        The effect of immediate neoadjuvant electromotive instillation of mitomycin C with Bacillus Calmette–Guérin versus BCG alone in non-muscle-invasive bladder cancer: A randomized controlled trial

        Abdalla El Azab,Ahmed Abd Elbary,Aly El Faqeh M. Okasha,Hatem Aboulkassem,Ashraf Saad Zaghloul,Riham Mohamed Karkeet,Ibrahim Abdelrahman 대한비뇨의학회 2023 Investigative and Clinical Urology Vol.64 No.6

        Purpose: The clinical effect of neoadjuvant intravesical instillation of chemotherapy immediately before transurethral resection of bladder tumors (TURBT) has been a subject of recent research. The aim of this study was to assess the effect of immediate neoadjuvant electromotive instillation of mitomycin C before transurethral resection for patients with non-muscle-invasive urothelial bladder cancer. Materials and Methods: Our study was a randomized clinical trial carried out on 50 patients diagnosed with non-muscle-invasive urothelial bladder cancer. Patients were classified into two groups: Group I consisted of 25 patients who received neoadjuvant electromotive drug administration of mitomycin C before TURBT and intravesical bacille Calmette–Guerin (BCG) per week for 6 weeks; Group II consisted of 25 patients who were treated with TURBT followed by intravesical BCG per week for 6 weeks alone (standard of care). Patients were followed up at 3, 6, 12, and 18 months by cystoscopy. Results: Patients who received neoadjuvant electromotive drug administration of mitomycin C before TURBT in combination with BCG had a low recurrence rate compared with those who received BCG alone (12.0% vs. 48.0%, respectively; p=0.012) and a longer disease-free interval (88.0% vs. 52.0%, respectively; p=0.012). Four patients developed progression to muscle-invasive disease (16.0%) in the BCG alone group. However, this difference was not statistically significant (p=0.516). Regarding adverse effects, there were no statistically significant differences between the groups. Conclusions: Neoadjuvant intravesical electromotive drug administration of mitomycin C before TURBT is safe; reduces recurrence rates and enhances the disease-free interval compared with TURBT followed by BCG alone.

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