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Hashem F.M.,Helwan University | Al-Sawahli M.M.,Holding Company for Biological Products and Vaccines | Nasr M.,Helwan University | Ahmed O.A.A.,King Abdulaziz University | Ahmed O.A.A.,Minia University
International Journal of Nanomedicine | Year: 2015

Background: This work focuses on the development of atorvastatin utilizing zein, a natural, safe, and biocompatible polymer, as a nanosized formulation in order to overcome the poor oral bioavailability (12%) of the drug. Methods: Twelve experimental runs of atorvastatin–zein nanosphere formula were formulated by a liquid–liquid phase separation method according to custom fractional factorial design to optimize the formulation variables. The factors studied were: weight % of zein to atorvastatin (X1), pH (X2), and stirring time (X3). Levels for each formulation variable were designed. The selected dependent variables were: mean particle size (Y1), zeta potential (Y2), drug loading efficiency (Y3), drug encapsulation efficiency (Y4), and yield (Y5). The optimized formulation was assayed for compatibility using an X-ray diffraction assay. In vitro diffusion of the optimized formulation was carried out. A pharmacokinetic study was also done to compare the plasma profile of the atorvastatin–zein nanosphere formulation versus atorvastatin oral suspension and the commercially available tablet. Results: The optimized atorvastatin–zein formulation had a mean particle size of 183 nm, a loading efficiency of 14.86%, and an encapsulation efficiency of 29.71%. The in vitro dissolution assay displayed an initial burst effect, with a cumulative amount of atorvastatin released of 41.76% and 82.3% after 12 and 48 hours, respectively. In Wistar albino rats, the bioavailability of atorvastatin from the optimized atorvastatin–zein formulation was 3-fold greater than that from the atorvastatin suspension and the commercially available tablet. Conclusion: The atorvastatin–zein nanosphere formulation improved the oral delivery and pharmacokinetic profile of atorvastatin by enhancing its oral bioavailability. © 2015 Hashem et al.

Atta H.M.,Al - Azhar University of Egypt | El-Sayed A.S.,Cairo University | El-Desoukey M.A.,Cairo University | Hassan M.,Cairo University | El-Gazar M.,Holding Company for Biological Products and Vaccines
Journal of Saudi Chemical Society | Year: 2012

Natamycin "polyene" antibiotic was isolated from the fermentation broth of a Streptomyces strain No. AZ-55. According to the morphological, cultural, physiological and biochemical characteristics, and 16S rDNA sequence analysis, strain AZ-55 was identified as Streptomyces lydicus. It is active in vitro against some microbial pathogens viz: Staphylococcus aureus, NCTC 7447; Bacillus subtilis, NCTC 1040; Bacillus pumilus, NCTC 8214 ; Micrococcus luteus, ATCC 9341; Escherichia coli, NCTC 10416; Klebsiella pneumonia, NCIMB 9111; Salmonella typhi and Pseudomonas aeruginosa, ATCC 10145; S. cerevisiae, ATCC 9763; Candida albicans, IMRU 3669; Aspergillus flavus, IMI 111023; Aspergillus niger, IMI 31276; Aspergillus fumigatus, ATCC 16424; Fusarium oxysporum; Alternaria alternata and Rhizoctonia solani. The active metabolite was extracted using chloroform (1:1, v/v) at pH 7.0. The separation of the active ingredient of the antifungal agent and its purification were performed using both thin layer chromatography (TLC) and column chromatography (CC) techniques. The physico-chemical characteristics of the purified antibiotic viz. color, melting point, solubility, elemental analysis (C, H, N, O and S) and spectroscopic characteristics (UV absorbance and IR, mass & NMR spectra) have been investigated. This analysis indicates a suggested empirical formula of C 33H 47NO 13. The chemical structural analysis with spectroscopic characteristics confirmed that the compound produced by S. lydicus, AZ-55 is Natamycin "polyene" antibiotic. © 2012.

Motawi T.K.,Cairo University | Rizk S.M.,Cairo University | Ibrahim I.A.-R.,Cairo University | El-Emady Y.F.,Holding Company for Biological Products and Vaccines
Cell Biochemistry and Function | Year: 2014

Diabetic peripheral neuropathy (DPN) is one of the most common diabetic chronic complications. There is an increased attention directed towards the role of angiogenic factors including vascular endothelial growth factor (VEGF) and anti-angiogenic factors including soluble endoglin (sEng) as contributors to diabetic microvascular complications including neuropathy. The purposes of this study were to determine the role of these angiogenesis regulators in the prognosis of DPN. The study group included 60 patients with type 2 diabetes mellitus (T2DM) and 20 clinically healthy individuals. The patients were divided into two groups. Group I included 20 T2DM patients without peripheral neuropathy, and Group II consisted of 40 T2DM patients with DPN. In all groups, plasma VEGF, sEng and endothelin-1 (ET-1), nitric oxide and ET-1 mRNA were estimated. Plasma levels of VEGF, sEng, ET-1 and nitric oxide were significantly elevated in diabetic patients (Groups I and II) compared with healthy control subjects, with a higher increase in their levels in patients with DPN compared with diabetic patients without peripheral neuropathy. Measurement of plasma levels of angiogenesis-related biomarkers in high-risk diabetic patients might identify who later develop DPN, thus providing opportunities for early detection and targets for novel treatments. © 2013 John Wiley & Sons, Ltd.

Sheraba N.S.,Holding Company for Biological Products and Vaccines | Yassin A.S.,Cairo University | Amin M.A.,Cairo University
BMC Research Notes | Year: 2010

Background. The staphylococci are one of the most common environmental isolates found in clean room facility. Consequently, isolation followed by comprehensive and accurate identification is an essential step in any environmental monitoring program. Findings. We have used the API Staph identification kit (bioMérieux, France) which depends on the expression of metabolic activities and or morphological features to identify the Staphylococcus isolates. The API staphylococci showed low sensitivity in the identification of some species, so we performed molecular methods based on PCR based fingerprinting of glyceraldehyde-3-phosphate dehydrogenase encoding gene as useful taxonomic tool for examining Staphylococcus isolates. Conclusions. Our results showed that PCR protocol used in this study which depends on genotypic features was relatively accurate, rapid, sensitive and superior in the identification of at least 7 species of Staphylococcus than API Staph which depends on phenotypic features. © 2010 Yassin et al; licensee BioMed Central Ltd.

PubMed | Holding Company for Biological Products and Vaccines
Type: Evaluation Studies | Journal: The Journal of pharmacy and pharmacology | Year: 2010

The objectives of this study were to develop an intranasal insulin gel using Carbopol homogenization rather than neutralization and to examine the effectiveness of the gel compared with a subcutaneous injection.Four factors, namely the molecular weight of polyethylene glycol (PEG), the concentration of Carbopol, the temperature of preparation and the type of absorption enhancer, were evaluated for their effect on viscosity and in-vitro insulin release. Bioavailability of insulin from selected formulations was compared with an intranasal solution and subcutaneous injection in rabbits.Increasing the molecular weight of PEG and Carbopol concentration increased the gel viscosity and changed the release mechanism from diffusion to case II transport. Applying heat during preparation resulted in a lower viscosity gel and increased the in-vitro insulin release. Among the two enhancers studied, sodium deoxycholate resulted in a higher viscosity gel than Tween 80. In vivo, the intranasal gel showed a stronger and longer hypoglycaemic effect with 1.7- and 3.1-fold higher maximum decrease in blood glucose level and area above the curve, respectively, compared with the subcutaneous injection.The homogenized Carbopol intranasal gel could be an efficient noninvasive way for insulin delivery but selection of gel components and method of preparation are critical for achieving the most desired effect.

PubMed | Holding Company for Biological Products and Vaccines
Type: Journal Article | Journal: Chang Gung medical journal | Year: 2012

Varicella-zoster virus (VZV) is the etiologic agent of two diseases, varicella (chicken pox) and zoster (shingles). Varicella is a self- limited infection, while zoster is mainly a disease of adults. The present study was conducted to isolate VZV from clinically diagnosed children using cell cultures and compare the activity of liquorice powder extract, an alternative herbal antiviral agent, with acyclovir and interferon alpha 2a (IFN-2a) against the isolated virus.Forty-eight VZV specimens, 26 from vesicular aspirates and 22 from vesicular swabs, from children clinically diagnosed with varicella were isolated on the Vero cell line. Isolates were propagated and identified with specific antiserum using indirect immunofluorescence and immunodot blotting assays. The growth kinetics of the viral isolates was studied. The antiviral activity of liquorice powder extract, acyclovir (ACV) and IFN-2a was evaluated against the isolated virus.VZV was successfully isolated in 4 of the 48 specimens, all from vesicular aspirates. The growth kinetics of the viral isolates was time dependent. The inhibitory activity of liquorice powder extract (containing 125 g/ml glycyrrhizin) when compared to ACV (250 g/ml) and IFN-2a is the lowest.VZV isolates were successfully isolated and propagated using Vero cells. Isolates were identified using indirect immunofluorescent and immunodot blotting techniques. Growth kinetics of the isolates revealed an increase in the viral infectivity titer relative to time. Glycyrrhizin in the crude form has low antiviral activity against VZV compared with acyclovir and interferon.

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