PRE- AND POST-MARKETING CONTROL OF DRUG QUALITY AT THE NATIONAL HEALTH LABORATORY, BAMAKO-MALI

Background and Objectives: In a world marked by the spread of counterfeiting and substandard drugs, often without active ingredients or falsified active ingredients, greater vigilance by pharmaceutical regulatory authorities is necessary. The National Health Laboratory (LNS), in accordance with its mission, takes samples throughout the country in order to ensure their quality control. Methods: Samples were taken in certain regions and the district of Bamako and analyzed according to the standards of the United State Pharmacopoeia (USP), British Pharmacopoeia (BP) and International Pharmacopoeia (IP)by identification and assay methods. Products that do not meet the required specifications described by these pharmacopoeias are declared non-compliant. Results: This allowed us to analyze a total of 617 samples with 11 cases of non-compliance for a rate of 2%. The causes of the non-conformities were due to the absence of an active ingredient, an under-dosage of the active ingredient and technical and regulatory defects. Conclusion: After one year of activity, our results showed that out of a total of 617 drug samples collected and analyzed, 606 were compliant with a rate of 98% against 11 cases of non-compliance or 2% (p ≤ 0,05). The causes of the non-compliance were due to the absence of an active ingredient, an under-dosage of the active ingredient and technical and regulatory defects. Peer Review History: Received: 20 November 2021; Revised: 18 December; Accepted: 31 December, Available online: 15 January 2022 Academic Editor: Dr. Asia Selman Abdullah, Pharmacy institute, University of Basrah, Iraq, [email protected] UJPR follows the most transparent and toughest ‘Advanced OPEN peer review’ system. The identity of the authors and, reviewers will be known to each other. This transparent process will help to eradicate any possible malicious/purposeful interference by any person (publishing staff, reviewer, editor, author, etc) during peer review. As a result of this unique system, all reviewers will get their due recognition and respect, once their names are published in the papers. We expect that, by publishing peer review reports with published papers, will be helpful to many authors for drafting their article according to the specifications. Auhors will remove any error of their article and they will improve their article(s) according to the previous reports displayed with published article(s). The main purpose of it is ‘to improve the quality of a candidate manuscript’. Our reviewers check the ‘strength and weakness of a manuscript honestly’. There will increase in the perfection, and transparency. Received file: Reviewer's Comments: Average Peer review marks at initial stage: 5.5/10 Average Peer review marks at publication stage: 7.0/10 Reviewers: Dr. Govind Vyas, Compliance & Regulatory Officer Inva-Tech Pharmaceuticals LLC, New-Jersey, USA, [email protected] Dr. Muhammad Zahid Iqbal, AIMST University, Malaysia, [email protected] Dr. Bilge Ahsen KARA, Ankara Gazi Mustafa Kemal Hospital, Turkey, [email protected] Dr. Mohammad Bayan, Faculty of Pharmacy, Philadelphia University, P.O. Box: 1 Philadelphia University 19392 Jordan, [email protected] Similar Articles: ASSESSMENT OF COMMUNITY PHARMACIST AWARENESS ON ADVERSE DRUG REACTION (ADR) AND PHARMACOVIGILANCE REPORTING SYSTEM IN KHARTOUM LOCALITY, SUDAN THE EFFICIENCY OF INEFFICIENCY: MEDICINE DISTRIBUTION IN SUDAN

Evaluation of the In Vitro Cytotoxicity of Silver Nanoparticles on PBMC Cells Using MTT Assay

Background: Silver Nanoparticles are extensively studied by the scientific community for therapeutic applications. With respect to the fundamental pillars of bioethics “Primum non nocere” equal emphasis should be given to evaluate the toxicological perspectives of Silver nanoparticles. This study aims at evaluating the InVitro cytotoxic effects of Silver nanoparticles synthesized using hesperidin. Aim: To study the In Vitro cytotoxicity of silver nanoparticles on PBMC cells using (3-(4,5-Dimethylthiazol-2-yl)-2, 5-diphenyltetrazolium bromide (MTT) assay. Methods: Synthesized silver nanoparticles at various concentrations are incubated with peripheral blood mononuclear cells (PBMC). After 24 hours MTT is added to the mixture to evaluate the cell viability post incubation. Yellow MTT (a tetrazole) which is reduced to purple formazan in the mitochondria of living cells. The absorbance of this colored solution can be quantified by measuring at 570 nm by a spectrophotometer. This reduction takes place only when mitochondrial reductase enzymes are active, and therefore conversion can be directly related to the number of viable (living) cells. Results: ?.Conclusion: Silver Nanoparticles do not exhibit any significant cytotoxicity on PBMCs and also there were no dose dependent trends in the results.

In Vitro and In Vivo Approaches for Screening the Potential of Anti Cancer Agents: A Review

Background: Anticancer drug development is a tedious process, requiring several in vitro, in vivo, and clinical studies. To avoid chemical toxicity in animals during an experiment, it is necessary to envisage toxic doses of screened drugs in vivo at different concentrations. Several in vitro and in vivo studies have been reported to discover the management of cancer. Materials and Methods: This study has focused on bringing together a wide range of in vivo and in vitro assay methods, developed to evaluate each hallmark feature of cancer. Result: This review provides elaborated information about target-based and cell-based screening of new anticancer drugs in the molecular targeting period. This would help to incite an alteration from the preclinical screening of pragmatic compound-orientated to target-orientated drug selection. Conclusion: Selection methodologies for finding anticancer activity have importance for tumor-specific agents. In this study, advanced rationalization of the cell-based assay is explored along with broad applications of the cell-based methodologies considering other opportunities also.

Optimization of enzymatic hydrolysis of Pleurotus ostreatus derived proteins through RSM and evaluation of nutritional and functional qualities of mushroom protein hydrolysates

Pleurotus ostreatus (Jacq.) P. Kumm., the second most widely cultivated oyster mushroom was grown on paddy straw, which is cheap and readily available waste material. After harvesting and drying, nutritional, and antinutritional composition of P. ostreatus were estimated using the standard assay methods. Tannin and phytic acid were present in very negligible amount (0.095 ± 0.027 mg/g and 0.150 ± 0.083 mg/g, respectively), whereas oxalate and cyanide were absent in whole mushroom. In fact, P. ostreatus was hydrolysed with commercially available proteinase K, pepsin and trypsin with different concentrations of the enzymes (0.05%, 0.10% and 0.15%), at different temperatures (30 °C, 40 °C and 50 °C) for different time periods (60, 90 and 120 min) to get the mushroom protein hydrolysates. Degree of hydrolysis and protein content varied from 4.29 ± 1.12% to 99.42 ± 0.02% and from 0.25 ± 0.07 mg/mL to 3.22 ± 0.12 mg/mL, respectively. Maximum degree of hydrolysis and the highest protein content of protein hydrolysate was obtained when using 0.15% proteinase K, at 50 °C for 120 minutes. Mushroom protein hydrolysates thus obtained exhibited improved functional characteristics such as foaming capacity, foaming stability and emulsifying property than the unhydrolysed mushroom. Based on the result of the present study, the mushroom protein hydrolysates could be served as useful ingredient for food and nutraceutical applications.

Ever-Expanding NGLY1 biology

The cytosolic peptide:N-glycanase (PNGase; NGLY1 in humans) is a deglycosylating enzyme that is widely conserved in eukaryotes. This enzyme is involved in the degradation of misfolded N-glycoproteins that are destined for proteasomal degradation in the cytosol, a process that is called endoplasmic reticulum (ER)-associated degradation (ERAD). Although the physiological significance of NGLY1 remained unknown until recently, the discovery of NGLY1 deficiency, a human genetic disorder bearing mutations in the NGLY1 gene, has led to explosive research progress regarding the functional characterization of this enzyme. For example, it is now known that NGLY1 can also act as an “editing enzyme” to convert N-glycosylated asparagine residues to aspartate residues, thus introducing negative charges into a core peptide and modulating the function of the target molecule. Diverse biological processes have also been found to be affected by compromised NGLY1 activity. In this special issue, recent research progress on the functional characterization of NGLY1 and its orthologues in worm/fly/rodents, assay methods/biomarkers useful for the development of therapeutics, and the comprehensive transcriptome/proteome of NGLY1-KO cells as well as patient-derived cells are discussed.

Donor-Derived Cell-Free DNA to Diagnose Graft Rejection Post-Transplant: Past, Present and Future

Donor-derived cell-free DNA (dd-cfDNA) is a non-invasive biomarker that is more sensitive and specific towards diagnosing any graft injury or rejection. Due to its applicability over all transplanted organs irrespective of age, sex, race, ethnicity, and the non-requirement of a donor sample, it emerges as a new gold standard for graft health and rejection monitoring. Published research articles describing the role and efficiency of dd-cfDNA were identified and scrutinized to acquire a brief understanding of the history, evolution, emergence, role, efficiency, and applicability of dd-cfDNA in the field of transplantation. The dd-cfDNA can be quantified using quantitative PCR, next-generation sequencing, and droplet digital PCR, and there is a commendatory outcome in terms of diagnosing graft injury and monitoring graft health. The increased levels of dd-cfDNA can diagnose the rejection prior to any other presently used biochemistry or immunological assay methods. Biopsies are performed when these tests show any signs of injury and/or rejection. Therefore, by the time these tests predict and show any unusual or improper activity of the graft, the graft is already damaged by almost 50%. This review elucidates the evolution, physiology, techniques, limitations, and prospects of dd-cfDNA as a biomarker for post-transplant graft damage and rejection.

Characterization of NADP-dependent L-arginine dehydrogenase as a novel amino acid dehydrogenase and its application to an L-arginine assay

Purpose: The primary aim of this study was the purification and characterization of an NADP-dependent L arginine dehydrogenase (L-ArgDH, EC 1.4.1.25) as a novel amino acid dehydrogenase from Pseudomonas veronii. We then applied the enzyme to an L-arginine assay. Methods: An L-ArgDH gene from P. veronii JCM11942 was amplified by PCR using primers based on the N and C-terminal sequences inferred from a putative L-ArgDH gene (PverR02_12350) found in the P. veronii genome. The L-ArgDH activity of the product expressed in Escherichia coli was confirmed, after which the enzyme was purified, characterized, and applied to an L-Arg microassay. Results: The P. veroniiJCM11942 gene was expressed in E. coli, and the gene product exhibited strong NADP dependent L-ArgDH activity. The crude enzyme was unstable but was stabilized by the presence of 10% glycerol under neutral pH conditions. The enzyme was purified to homogeneity through a single Ni-chelate affinity chromatography step and consisted of a homodimeric protein with a molecular mass of about 65 kDa. The enzyme selectively catalyzed L-arginine oxidation in the presence of NADP, with maximal activity at pH 9.5. The apparent Km values for L-arginine and NADP were 2.5 and 0.21 mM, respectively. A simple colorimetric microassay for L-arginine was achieved using the enzyme. Conclusions: The L-ArgDH gene from P. veronii JCM 11942 was successively expressed in E. coli. The product exhibited NADP-dependent L-ArgDH dehydrogenase activity, and the enzyme was purified and characterized as a novel amino acid dehydrogenase. Furthermore, a simple colorimetric assay for L-arginine using L-ArgDH was achieved. Conflict of interest: The authors declare that they have no competing interests.