EQUIVALENCE STUDY OF IMMEDIATE RELEASE TABLETS OF BETA BLOCKER DRUG

Objective: The therapeutic equivalence of generic brands is a great challenge for manufacturers. This study aimed to evaluate the bioequivalence of four different generic brands of atenolol tablets under biowaiver conditions. Methods: Physiochemical properties of the tablet products namely uniformity of weight, hardness, disintegration, and drug content were assessed. The dissolution profiles of atenolol tablets were conducted in pH 1.2, 4.5, 6.8 and 7.6 buffers using USP dissolution apparatus II. Similarity and difference factors were calculated. Finally, four kinetic models have been offered to describe the release characteristics of atenolol under experiment conditions. Results: All tablets showed accepted physiochemical characters. Dissolution profiles revealed that G2 showed the highest similarity to innovator (f2 91.86) in pH 7.6. Dissolution kinetics of G2 at the same pH could be best described as Higuchi model of release.  Conclusion: The study showed that excipients and manufacturing practices play an important role in marketing biowaiver generic products meet the international regulatory bodies criteria

BIOWAIVER STUDY OF IMMEDIATE RELEASE GLIMEPIRIDE TABLETS

Objective: Demonstrating therapeutic equivalency regarding the efficacy and safety among originator products and generics is a key step in permitting the marketing of generic products. The study aimed to evaluate the bioequivalence of five different generic brands of Glimepiride tablets under biowaiver conditions. Methods: The quality of the tablet products, including uniformity of weight, friability, and disintegration test, was assessed using the United State Pharmacopeia (USP) general monograph for the tablet dosage form. The content of glimepiride in the tablets was measured using UV spectrophotometer at the wavelength 229 nm. The release of Glimepiride from the tested and originator tablet products was evaluated using the dissolution profiles conducted in HCI buffer pH 1.2, and phosphate buffer pH 6.4 and 7.8 by USP dissolution apparatus II. The bioequivalence of test products was assessed using the similarity and difference factors.  Results:The tested products complied to USP requirements for quality standards; all the products show rapid disintegration, D1 show higher time (Three minutes) while D3 show lower time (28 seconds). The content of test products was (104.68, 93.75, 97.21, 97.03, and 102.10) for D1, D2, D3, D4, and D5 , respectively, compare to 103.70 for OB. Dissolution profiles revealed that the highest similarity to the originator was showed in pH 6.4; f2 ranged (74.5-68.4) for all the tested products and low similarity in pH 7.8; f2 ranged (45.2-64.7). Conclusion: The study showed that the generic products has noticeable similarity with the originator brand and it can be interchangeable

Clinical and Biochemical Assessment of Lycopene Gel Combined With Nanohydroxyapatite Graft in Treatment of Grade II Furcation Defects: A Randomized Controlled Clinical Study

Background: This study aimed to evaluate the effects of lycopene gel, as a natural antioxidant, mixed with a nanohydroxyapatite graft (NHG) covered by an occlusive resorbable collagen membrane (CM) in the surgical treatment of grade II furcation defects and on the gingival crevicular fluid (GCF) levels of 8-hydroxydeoxyguanosine (8-OHdG), as a marker of oxidative injury. Methods: In this randomized controlled clinical study a total of 24 patients with grade II furcation defects were randomly assigned into three equal groups. Furcation defects in group I were managed with lycopene gel mixed with NHG and CM, group II with NHG and CM, and group III with open flap debridement only. Site-specific changes in clinical parameters including probing depth (PD), vertical clinical attachment level (VCAL), horizontal clinical attachment level (HCAL), radiographic maximum vertical depth (MAX V), and maximum horizontal depth (MAX H) were measured at baseline and six months postoperatively. Gingival crevicular fluid levels of 8-OHdG were analyzed using enzyme-linked immunosorbent assay (ELISA) at baseline, one week, and three months. Results: Surgical management of grade II furcation defects resulted in a significant reduction in PD and 8-OHdG levels and a gain in CAL, MAX V, and MAX H in all groups. The differences between lycopene treated sites compared to NHG and CM alone were not significant at six months but demonstrated significantly superior clinical parameters compared to open flap debridement alone. Conclusion: Lycopene does not confer a benefit when combined with NHG in the surgical treatment of grade II furcation defects

Dark septate endophytes (DSEs) responses to abiotic stress and their role in alleviation of salt stress in tomato

International audienc

Extent of compatibility of stress tolerance and melanin production in dark septate endophytes (DSEs)

International audienceDark septate endophytes (DSEs) are a group of endophytic fungi that colonize the root tissues of host plant without causing disease symptoms. They are characterized by their morphology of melanized and septate hyphae. This group of root endophytes is a polyphyletic form-group of ascomycetes, and contains conidial as well as sterile fungi that colonize roots intracellularly or intercellularly. Our objectives in the current study are: (i) to study the responses of three model DSEs, Periconia macrospinosa, Cadophora sp. and Leptodontidium sp. to abiotic stress; salt and heat stresses, (ii) to identify the biosynthesis pathway for melanin production by using melanin inhibitors and (iii) to understand the relation between DSEs performance under abiotic stress and melanin biosynthesis. Growth and morphology on different culture media subjected to heat and salt stresses suggested that these endophytes have a high tolerance to abiotic stress. We found that 1,8-dihydroxynaphthalene (DHN) pathway was used for melanin biosynthesis in the current model DSEs and melanin content increased by the presence of salt stress. Based on different BLAST and alignments, genes which are speculated to be involved in DHN pathway were identified and their expressions were determined under salt and heat stress

Establishment of dark septate endophytes (DSEs) as supplements in peat-free substrates

International audienc

Stress acclimatization and melanin production of dark septate endophytes

International audienc

LncRNA HULC and miR-122 Expression Pattern in HCC-Related HCV Egyptian Patients

Hepatocellular carcinoma (HCC) is a highly prevalent malignancy. It is a common type of cancer in Egypt due to chronic virus C infection (HCV). Currently, the frequently used lab test is serum α-fetoprotein. However, its diagnostic value is challenging due to its low sensitivity and specificity. Genetic biomarkers have recently provided new insights for cancer diagnostics. Herein, we quantified Lnc HULC and miR-122 gene expression to test their potential in diagnosis. Both biomarkers were tested in the sera of 60 HCC patients and 60 with chronic HCV using real-time RT-PCR. miR-122 was highly expressed in HCV patients with a significant difference from the HCC group (p = 0.004), which points towards its role in prognosis value as a predictor of HCC in patients with chronic HCV. HULC was more highly expressed in HCC patients than in the HCV group (p = 0.018), indicating its potential use in screening and the early diagnosis of HCC. The receiver operating characteristic (ROC) curve analysis showed their reliable sensitivity and specificity. Our results reveal that miR-122 can act as a prognostic tool for patients with chronic HCV. Furthermore, it is an early predictor of HCC. LncRNA HULC can be used as an early diagnostic tool for HCC