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عضویت

فهرست مطالب ali mehramizi

  • Golnoosh Alipour Haris, Nayyereh Ayati, Ali Mehramizi, Peivand Ghasemzadeh, Mahshid Arabi, Shekoufeh Nikfar
    Background

    Sumatriptan is one of the leading medicines in migraine treatment. This study aimed to evaluate the cost-effectiveness (in the context of Iran) of sumatriptan nasal spray versus its oral tablet for treating migraine headaches.

    Methods

    A systematic review of the literature was performed to evaluate the clinical effectiveness of sumatriptan nasal spray compared to its oral tablet. The search was conducted in five major scientific databases from 1990 to December 2018. The effectiveness outcomes were 2-h pain relief and 24-h recurrence rate, which then were translated into Quality-Adjusted Life-year (Qaly). Local costs data were identified based on official tariffs in Iran’s public and private sectors, with ratios of %80 and %20, respectively. Costs were converted from Iranian Rial rates (IRR) to US Dollars (USD), using the currency exchange rate of 42000 IRR/USD. A 1-year decision tree was adopted for the economic evaluation, conducted from a payer perspective in the Iranian healthcare setting. The final results were presented by Incremental Cost-Effectiveness Ratio (ICER), which showed the extra cost for one additional QALY gained. ICER was compared to Iran’s national willingness to pay (WTP) threshold, which is 2709 USD. The robustness of the results was analyzed using Deterministic Sensitivity Analysis (DSA).

    Results

    The results showed that sumatriptan nasal spray (20 mg, for $0.714 per puff) compared to sumatriptan oral tablet (50 mg, with a weighted mean price of $0.238) had an incremental QALY of 0.028 and incremental cost of $0.21 per attack, per person-year. ICER was calculated to be 2617 USD/QALY, which is below Iran’s national WTP threshold. DSA results showed that the model is mainly sensitive to the price of sumatriptan nasal spray.

    Conclusion

    Sumatriptan nasal spray was a more cost-effective medicine than sumatriptan oral tablet in Iranian patients with migraine.

    Keywords: Sumatriptan nasal spray, Sumatriptan oral tablet, Migraine, Cost-utility, Cost-Effectiv}
  • Mitra Tohidi, Majid Ramezani*, Ali Mehramizi

    A rapid, simple, precise, accurate, and environmentally friendly spectrophotometric method was developed and validated for simultaneous determination of Sacubitril and Valsartan in their combined dosage form, using continuous wavelet transform (CWT) and zero-crossing techniques without using organic solvents and the timeconsuming extraction step. Initially, UV spectra of two pure components in water were processed via various mother wavelet families. Then, applying zero-crossing technique, the optimum points were found to obtain appropriate calibration curves for each point. The calibration curves were linear for both Sacubitril and Valsartan. The validation of these methods was investigated by analyzing several synthetic mixtures with known concentrations. Applying oneway analysis of variance (ANOVA) test and Fisher pairwise comparisons, the following were found to yield the best results Discrete Meyer (dmey) wavelet functions with scaling factor of 61 at 232 nm and Symlet5 (sym5) with 48 at 232 nm for Sacubitril and Meyer (meyr) with 50 at 272 nm, meyr with 59 at 247 nm, Daubechies (db5) with 53 at 237 nm, and sym5 with 59 at 226 nm for Valsartan. The mean recovery values in synthetic mixtures were between 99.09% and 101.16% using the proposed methods, where relative standard deviation (RSD) not more than 1.23% proved to have good precision. The obtained results from the commercial tablets, applying the developed methods, were compared to those yielded by HPLC method by one-way ANOVA test. According to the results, they were in good agreement and showed no significant differences, thereby suggesting successful determination in accordance with green chemistry.

    Keywords: Continuous wavelet transform, Zero-crossing technique, Sacubitril, Valsartan, Simultaneous determination, Environmentally friendly spectrophotometric method}
  • Hadis Soroush, Fatemeh Ghorbani, Bidkorbeh *, Seyed Alireza Mortazavi, Ali Mehramizi
    The aim of this study was to prepare orally disintegrating tablets (ODTs) containing dexamethasone (DEX) by direct compression method with sufficient hardness and rapid disintegration time. In order to save time, money, and human resources in designing and improvement of formulation, the statistical software Design Expert is used. Box–Behnken response surface methodology was applied to evaluate and optimize the effects of concentrations of three excipients, Kollidon CL-SF (X1), Pearlitol SD200 (X2), and Prosolv SMCC (X3) as independent factors on four responses: percentage of drug released after 5 min, disintegrating time, hardness, and friability. Thirteen formulations offered by the Box–Behnken design were prepared by direct compression method and ultimate weight of 200 mg, while the amount of DEX was 4 mg. All formulations were characterized for parameters such as diameter, hardness, weight, thickness, friability, and disintegration time. Following the statistical results, the effects of independent variables on responses were evaluated and the optimum formulation regarding acceptable responses consisted of 15% Kollidon, 39.66% Pearlitol, and 7.5% Prosolv which showed 95.28% release of the drug after 5 min, disintegrating time of 30 sec, 6.1 kg hardness, and 0.12% of friability with an acceptable taste as the optimized formulation.
    Keywords: Orally disintegrating tablet, Design of experiment, Dexamethasone, Optimization}
  • Amirhosein Morovati, Alireza Ghaffari, Lale Erfani Jabarian, Ali Mehramizi
    Guaifenesin, a highly water-soluble active (50 mg/mL), classified as a BCS class I drug. Owing to its poor flowability and compressibility, formulating tablets especially high-dose one, may be a challenge. Direct compression may not be feasible. Bilayer tablet technology applied to Mucinex®, endures challenges to deliver a robust formulation. To overcome challenges involved in bilayer-tablet manufacturing and powder compressibility, an optimized single layer tablet prepared by a binary mixture (Two-in-one), mimicking the dual drug release character of Mucinex® was purposed. A 3-factor, 3-level Box-Behnken design was applied to optimize seven considered dependent variables (Release “%” in 1, 2, 4, 6, 8, 10 and 12 h) regarding different levels of independent one (X1: Cetyl alcohol, X2: Starch 1500®, X3: HPMC K100M amounts). Two granule portions were prepared using melt and wet granulations, blended together prior to compression. An optimum formulation was obtained (X1: 37.10, X2: 2, X3: 42.49 mg). Desirability function was 0.616. F2 and f1 between release profiles of Mucinex® and the optimum formulation were 74 and 3, respectively. An n-value of about 0.5 for both optimum and Mucinex® formulations showed diffusion (Fickian) control mechanism. However, HPMC K100M rise in 70 mg accompanied cetyl alcohol rise in 60 mg led to first order kinetic (n = 0.6962). The K values of 1.56 represented an identical burst drug releases. Cetyl alcohol and starch 1500® modulated guaifenesin release from HPMC K100M matrices, while due to their binding properties, improved its poor flowability and compressibility, too.
    Keywords: Binary mixture, Bilayer tablets, High dose modified release tablets, Highly water-soluble drug, Poor compressibility}
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