Alexandria, Egypt
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PubMed | Alexandria University, Pharco Corporation and Green Clinical Research Center
Type: | Journal: Drug design, development and therapy | Year: 2016

This is the second and final report for our study designed to compare two generic sofosbuvir products for the degree and speed of virologic response to a dual anti-hepatitis C virus (HCV) treatment protocol. We aimed to test the applicability of the early virus response kinetics and the very rapid virologic response (vRVR) rate as quick outcome measures for accelerated comparative efficacy studies and as a foundation for a personalized response-guided therapy.Fifty eligible chronic HCV patients were randomized to either one of two generic sofosbuvir products (Gratisovir or Grateziano) at a daily dose of one 400 mg tablet plus a weight-based ribavirin dose. Data were compared between the groups for early virus response kinetics and vRVR rates in relation to the rates of final sustained virologic response at week 12 posttreatment (SVR12).The Log10 transformed virus load (Log polymerase chain reaction) curves showed fairly similar rapid decline during the first 2 weeks, with no significant difference between the groups at four analysis points throughout the study by repeated-measures factorial analysis of variance test (P=0.48). The SVR12 rates were 96% (95% confidence interval, 79.6%-99.9%) in Gratisovir group (24/25) and 95.7% (95% confidence interval, 78%-99.9%) in Grateziano group (22/23). There was no statistically significant difference found by exact test (P>0.999). There was a significant association between the vRVR and the SVR12, with 100% positive predictive value (38/38 of those who had vRVR, achieved a final SVR12) and 82.6% sensitivity (among the total 46 with SVR12, 38 were having vRVR).We can conclude from our study that the early HCV response kinetics and the vRVR rates could be used as sensitive quick markers for efficacy (with a very high positive predictive value for SVR12), based on our accelerated comparative efficacy research model. This might open the way for new models of accelerated equivalence efficacy studies along with the bioequivalence kinetics studies to test a generic drug against a reference. Also, the early response kinetics and the vRVR might be used as qualifiers for a personalized course of treatment. This could shorten unnecessarily long treatment courses in rapid responders and might help to avoid relapses in slow responders.


Yakoot M.,Green Clinic and Research Center | Salem A.,Alexandria Helmy Medical Center | Yousef S.,Alexandria Helmy Medical Center | Helmy S.,Pharco Corporation
Drug Design, Development and Therapy | Year: 2014

Background: Renal colic is typically characterized by the sudden onset of severe pain radiating from the flank to the groin and its acute management in emergency departments essentially aims at rapid pain relief. Spasmofen® is a brand of Amriya Pharmaceutical Industries in the form of rectal suppositories containing ketoprofen 100 mg and hyoscine butylbromide 10 mg. This combination is intended for the rapid relief of severe colicky pain in the renal system, hepatobiliary system, or gastrointestinal tract. This trial aims to compare a single-dose of Spasmofen rectal suppository to a single intravenous (IV) ketorolac tromethamine 30 mg/2 mL dose in patients with acute renal colic. Methods: A total of 80 eligible consecutive patients presenting to the emergency departments of two medical centers with acute renal colic were included in the study. Eligible patients who signed the informed consent were randomly assigned into two treatment groups: an experimental group (Spasmofen group) who received one Spasmofen rectal suppository plus an IV injection of 2 mL of normal saline solution; and a control group (ketorolac group) who received one ketorolac 30 mg/2 mL ampoule IV plus one placebo suppository. Treatment success, defined as a change in the verbal rating score from severe or moderate pain to none or mild at 60 minutes after the dose, was compared between groups using the chi-square/Fisher's exact test. Percentage reductions in visual pain analog scale (VPAS) scores at 15 and 60 minutes after the dose were compared between groups using the Z-test for proportions. Results: Successful treatment at 60 minutes occurred in 35 of 40 (87.5%) of Spasmofen-treated patients and in 33 of 40 (82.5%) of ketorolac-treated patients. The difference was not statistically significant by Fisher's exact test (P=0.755). The mean percentage reduction of VPAS after 15 minutes was 61.82% in the Spasmofen-treated group and 64.76% in the ketorolac-treated group. The difference was also not statistically significant by the Z-test for proportions (P=0.795). Sixty minutes after being treated, Spasmofen was associated with a statistically significant greater reduction in VPAS (mean% reduction =92.36%) than ketorolac (75.06%; P=0.0466). Conclusion: Single-dose Spasmofen rectal suppository might be a safe and effective first-aid treatment for the emergency department relief of acute renal colic. © 2014 Yakoot et al.


Eldeen E.M.S.,Pharco Corporation | Etman M.A.,Alexandria University | Aboul-Enein H.Y.,Pharmaceutical and Drug Industries Research Division
Gazi University Journal of Science | Year: 2012

A simple, rapid and precise gas chromatographic method has been developed for simultaneous determination of seven volatile compounds namely alpha pinene, camphene, beta pinene, cineole, fenchone, borneol and anethol in urinary tract antiseptic soft gelatine capsule. The seven compounds were analysed by Gas chromatography-flame ionization detector (GC-FID) on a (5% diphenyl and 95% dimethylpolysiloxane) (30m x0.25mm x 0.25μm) column and Helium as a carrier gas. The injector and detector port temperatures were maintained at 200°C and 250°C respectively. Results of assay and recovery studies were statistically evaluated for its accuracy and precision. The correlation coefficient (r) values ranged from 0.997 to 0.9998. The detection limits ranged from 0.0015 to 0.014 mg ml -1. No interference from any components of pharmaceutical dosage forms was observed. According to the validation results, the proposed method was found to be specific, accurate and precise and could be applied to the simultaneous quantitative analysis of these seven volatile compounds in such pharmaceutical formulation.


Elgindy N.,Alexandria University | Elkhodairy K.,Alexandria University | Molokhia A.,PHARCO Corporation | Elzoghby A.,Alexandria University
Drug Development and Industrial Pharmacy | Year: 2011

Flutamide (FLT) is a poorly soluble anticancer drug. Therefore, lyophilized dispersions (LDs) of FLT with polyvinylpyrrolidone (PVP) K30, polyethylene glycol (PEG) 6000, and pluronic F127 were prepared via lyophilization monophase solution technique with the aim of increasing its dissolution rate. FLT showed an AL-type phase solubility diagrams with PVP and PEG, whereas AN-type diagram was obtained with pluronic. The amount of residual tertiary butyl alcohol, determined by gas chromatography, was 0.015-0.021% w/w. Differential scanning calorimetry and X-ray diffractometry revealed that FLT-polymer 1:1 LDs were partially amorphous, whereas the 1:3 and 1:5 LDs were completely amorphous. After 6 months storage, polymers under study inhibited FLT recrystallization maintaining its amorphous form. The particle size of FLT-polymer LDs was between 0.81 and 2.13 μm, with a high surface area (268.43-510.82 m2/g) and porosity (354.01-676.23 e-3 mL/g). Also, the poor flow properties of FLT could be improved but to a limited extent. FLT dissolution was significantly enhanced with the fastest dissolution that was achieved using pluronic. After 30min, about 66.52%, 78.23%, and 81.64% of FLT was dissolved from 1:5 FLT-PVP, PEG, and pluronic LDs, respectively, compared with only 13.45% of FLT. These data suggest that these polymers might be useful adjuncts in preparation and stabilization of amorphous immediate-release FLT LDs. © 2011 Informa Healthcare USA, Inc.


Seifeldeen E.M.,Pharco Corporation | Etman M.A.,Alexandria University | Aboul-Enein H.Y.,National Research Center of Egypt
Journal of Liquid Chromatography and Related Technologies | Year: 2016

A rapid, accurate, and precise HPLC method has been developed for simultaneous determination of four contraceptive hormonal compounds namely ethinylestradiol (EE), drospirenone (DR), gestodene (GS), and levonorgestrel (LV) in oral contraceptive tablet dosage form. The chromatographic separation was achieved on a C18 (150 × 4.6 mm, 5) column; the mobile phase consists of acetonitrile: water (50:50, v/v) pumped at a flow rate of 1.0 mL/min; and UV detection was set at 200 nm. The limit of detection was 0.0086 μg/mL for (EE), 0.0397 μg/mL for (GS), 2.80 μg/mL for (DR), and 0.229 μg/mL for (LV), whereas the limit of quantitation (LOQ) was 0.028 μg/mL for (EE), 0.132 μg/mL for (GS), 9.500 μg/mL for (DR), and 0763 μg/mL for (LV), respectively. The correlation coefficient (r) values of the four compounds ranged from 0.99995 to 0.99999. The method was validated as per ICH guidelines and USP 34 for estimation of (EE), (DR), (GS), and (LV) in commercially available tablet dosage form. The validation results were found satisfactory. The proposed method can be useful in quality control of bulk manufacturing and pharmaceutical dosage forms. © 2016 Taylor & Francis.


Elgindy N.,Alexandria University | Elkhodairy K.,Alexandria University | Molokhia A.,PHARCO Corporation | Osman Elzoghby A.,Alexandria University
Drug Development and Industrial Pharmacy | Year: 2011

Context: Flutamide (FLT) has poor aqueous solubility and low oral bioavailability. Objective: Lyophilization monophase solution was used for preparing lyophilized dispersions of FLT with polyols and amino acids to increase its poor dissolution. Methods: Physical properties and dissolution behavior of their physical mixtures and lyophilized dispersions were investigated. Results and discussion: The carriers increased the aqueous solubility of FLT but to a limited extent with arginine and glycine showing a linear AL-phase solubility diagrams. Gas chromatography indicated that residual tertiary butyl alcohol was in range of 0.007-0.023% (w/w) in the dispersions. In all dispersions, the crystal structure of FLT was confirmed using differential scanning calorimetry, X-ray diffractometry, and scanning electron microscopy. However, the percent drug crystallinity was found to decrease with increasing the carrier content. Infrared spectroscopy revealed no interaction between drug and carriers. The particle size of FLT dispersions ranged between 0.61 and 1.81 μm, with a high surface area (293.93-465.37 m2/g) and porosity (447.69-754.33 e-3 mL/g). In addition, the poor flow properties of FLT were improved but to a limited extent. FLT dissolution from the dispersions was enhanced with 46.35% and 36.43% of FLT dissolved after 30 minutes from 1:5 FLT-mannitol and FLT-trehalose dispersions, respectively, compared with only 13.45% of pure FLT. On the other hand, after 30 minutes 38.57% and 46.78% of FLT was dissolved from 1:3 FLT-arginine and FLT-glycine dispersions, respectively. Conclusion: These data suggest that polyols and amino acids might be useful adjuncts in preparation of immediate-release formulations of FLT. © 2011 Informa UK, Ltd.


Elgindy N.,Alexandria University | Elkhodairy K.,Alexandria University | Molokhia A.,PHARCO Corporation | ElZoghby A.,Alexandria University
Journal of Nanomedicine and Nanotechnology | Year: 2011

Chitosan (CS) nanoparticles for the oral delivery of the protein, Human Serum Albumin (HSA) were prepared by two techniques (precipitation and ionic gelation) together with two anions (sodium sulfate or tripolyphosphate, TPP). HSA was loaded with CS nanoparticles by adsorption or entrapment loading protocols. The highest HSA association efficiency (93.43%) and loading capacity (58.65%) were obtained using ionic gelation technique with 0.1% w/v TPP as a crosslinker. The particle size of CS-HSA nanoparticles ranged between 100-320 nm with a high specific surface area (703-903 m2/g) and porosity (1060.99-1350.95 e-3ml/g). Incubation of nanoparticles with lysozyme led to a reduction of 243 nm in particle size within 3 h. CS nanoparticles was redispersible after one month storage. CS/TPP nanoparticles prepared by precipitation/protein entrapment technique slowly released 10.34% HSA over 5 days which is suitable for vaccine or protein delivery while 86.54% of HSA was released from nanoparticles prepared by precipitation/ protein adsorption technique after 8 hr which is suitable for rapid drug release. Using ionic gelation technique, CS/ TPP nanoparticles released 22.47-38.65% HSA over 5 days at 7:1 to 3:1 CS/TPP mass ratio, respectively. Both techniques retained the structural integrity of HSA after preparation and release processes which was proven via gel electrophoresis. © 2011 Elgindy N, et al.


Elgindy N.,Alexandria University | Elkhodairy K.,Alexandria University | Molokhia A.,Pharco Corporation | Elzoghby A.,Alexandria University
European Journal of Pharmaceutics and Biopharmaceutics | Year: 2010

Flutamide (FLT), an anticancer drug for prostatic carcinoma, has poor aqueous solubility and low oral bioavailability. This study describes the ability of β-cyclodextrin (βCD) and hydroxypropyl-β-cyclodextrin (HPβCD) to form complexes with flutamide with enhanced solubility and dissolution rate in vitro. FLT-CD lyophilized dispersions (LDs) were prepared via lyophilization monophase solution technique using tertiary butyl alcohol (TBA) as a cosolvent. FLT showed an AL-type phase solubility diagram consistent with a linear increase in drug solubility as a function of CD concentration. Gas chromatography indicated that the LDs contain 0.02-0.03% w/w residual TBA. Based on the data from differential scanning calorimetry (DSC) and X-ray diffractometry (XRD), FLT was fully amorphous in 1:5 FLT-HPβCD LD as indicated by complete disappearance of FLT endothermic and diffraction peaks. The Fourier transform infrared (FTIR) spectra indicated that a FLT-CD interaction took place in the lyophilized complex. The particle sizes of 1:1 FLT-βCD and FLT-HPβCD LDs were 0.92 and 0.82 μm, with a high surface area (484.55 and 705.68 m2/g) and porosity (769.46 and 1020.99 e-3ml/g), respectively. The dissolution rate of FLT from its CD complexes was enhanced significantly. After 30 min in 0.1 N HCl, about 73% and 86% of FLT were dissolved from 1:5 FLT-βCD and FLT-HPβCD LDs, respectively, compared to only 13.45% of pure drug. No endothermic peak corresponding to FLT melting was detected in 1:5 FLT-HPβCD LD after storage at 20 °C and 45% relative humidity for 90 days thus indicating the stability of this binary system. These data suggest that cyclodextrins might be useful adjuncts in preparation of immediate-release formulations of FLT. © 2009 Elsevier B.V. All rights reserved.


Trademark
Pharco Ltd. | Date: 2014-12-15

Air sterilisers, air purifying apparatus and machines, air purifiers, air humidifiers, air humidifying apparatus, air dehumidifiers, air cleaning apparatus, air cleaning units, apparatus for purifying air.


We aimed in this interim report to compare two registered generic sofosbuvir products for the degree and speed of virologic response to a dual antiviral treatment protocol within the first 2 weeks of treatment.Data collected during the period of this interim report from the first 25 patients randomized to either one of two generic sofosbuvir products (Grateziano or Gratisovir) at a daily dose of one 400 mg tablet plus a weight-based ribavirin dose were analyzed for both the degree and speed of virus load reduction at the end of 1 and 2 weeks from starting treatment.The baseline Log10 transformed virus load (Log polymerase chain reaction) showed a fairly similar marked and significant reduction in both groups by more than 4 and 5 Logs at the end of week 1 and 2 of starting treatment, respectively. The differences between the two treatment groups at both analysis points were not statistically significant (P>0.05) by repeated measures factorial analysis of variance test. The differences in proportions of patients with ultra-rapid virologic response at the end of week 1 and very-rapid virologic response at the end of week 2 in both groups were also not statistically significant (P>0.05).We can conclude from this interim report that the two generic products Gratisovir and Grateziano are almost equally fast and efficacious in reducing the hepatitis C virus load in our study setting.

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