Advanced Pharmaceutical Technology & Research

Nephrotoxicity: Role and significance of renal biomarkers in the early detection of acute renal injury Marwa S Al-Naimi, Huda A Rasheed, Nawar R Hussien, Hayder M Al-Kuraishy, Ali I Al-Gareeb Journal of Advanced Pharmaceutical Technology & Research 2019 10(3):95-99 Nephrotoxicity is defining as rapid deterioration in the kidney function due to toxic effect of medications and chemicals. There are various forms, and some drugs may affect renal function in more than one way. Nephrotoxins are substances displaying nephrotoxicity. Different mechanisms lead to nephrotoxicity, including renal tubular toxicity, inflammation, glomerular damage, crystal nephropathy, and thrombotic microangiopathy. The traditional markers of nephrotoxicity and renal dysfunction are blood urea and serum creatinine which are regarded as low sensitive in the detection of early renal damage. Thus, the detection of the initial renal injures required new biomarkers which are more sensitive and highly specific that gives an insight into the site of underlying renal damage. Kidney injury molecule-1, Cystatin C, and neutrophil gelatinase-associated lipocalin sera levels are more sensitive than blood urea and serum creatinine in the detection of acute kidney injury during nephrotoxicity.

Advances in orally targeted drug delivery to colon Nagina Belali, Nasrul Wathoni, Muchtaridi Muchtaridi Journal of Advanced Pharmaceutical Technology & Research 2019 10(3):100-106 Colon-specific drug delivery is critical for treating diseases of colon, such as colon cancer, amoebiasis, irritable bowel syndrome, and inflammatory bowel disease. This study reviews the effects of targeted oral drug delivery on patient by measuring the accurate administration of the drug to specific disease spot, thus enhancing the therapeutic efficacy and provides better therapeutic outcomes. Medically targeted delivery to colon produces local effect on the diseases and hinders the systemic toxic effects of drugs. The delivery of therapeutics to the specific diseased part of colon has its merits over systemic drug delivery, albeit has some obstacles and problems. Colon drug delivery can be used to create both systemic and local effects. Many advanced approaches are used, such as conventional methods for drug release to colon, delayed release dosage forms, nanoparticles, carbon nanotubes, dendrimers, and alginate coated microparticles. This concise review summarizes and elaborates the details of different techniques and strategies on targeted oral drug delivery to colon as well as studies the advantages, disadvantages, and limitations to improve the application of drug in the part of the affected colon.

Effect of hibiscus sabdariffa on blood pressure in patients with stage 1 hypertension Majid Jalalyazdi, Javad Ramezani, Azadeh Izadi-Moud, Fereshteh Madani-Sani, Shokufeh Shahlaei, Shirin Sadat Ghiasi Journal of Advanced Pharmaceutical Technology & Research 2019 10(3):107-111 Using different drug regimens has been proved to have effective effects on lowering blood pressure, but the adverse effects of long-term usage such medications is evident. According to recent trend in suing herbal and traditional medicines, researchers have been focused on evaluating the effect of different herbals on managing hypertension. The aim of the present study is the evaluation of the antihypertensive effect one of these herbs, sour tea (Hibiscus sabdariffa), on stage one hypertension. Patients with stage one hypertension who were diagnosed by a cardiologist has been included in the present clinical trial after giving informed consent. The patients were divided into two groups. The control and case group received the same lifestyle and dietary advices for controlling blood pressure. The case group received two standard cup of sour tea every morning for 1 month. The blood pressure of both groups was documented at baseline and at the end of the study and the results were analyzed using SPSS software. A total of 46 patients participated in this study and there was no significant difference in terms of age and body mass index between groups. There was a significant reduction in systolic blood pressure in both groups, but the mean reduction in systolic and diastolic blood pressure was significantly higher in the case group (P = 0.004 and P < 0.001, respectively). Using H. sabdariffa as sour tea two times a day can be effective in managing blood pressure in stage one hypertension along with lifestyle and dietary modification.

Technetium-99m-labeled genistein as a potential radical scavenging agent Danni Ramdhani, Maula Eka Sriyani, Flamboyan Ayu Journal of Advanced Pharmaceutical Technology & Research 2019 10(3):112-116 The purpose of this study was to determine the optimum conditions for labeling genistein compounds with technetium-99m (99mTc) radionuclides and the percentage of purity obtained in accordance with the requirements of the United State Pharmacopeia. The method used is optimization of several parameters including pH, SnCl2.2H2O as reducing agents, genistein concentration, and incubation time. The results showed that the optimum conditions for labeling 99mTc-Genistein were obtained under conditions of pH 8, the amount of SnCl2.2H2O reducing agents was 30 μg, 0.5 mg genistein, and in 10 min. The optimization of this condition resulted in radiochemical purity in the labeling of 99mTc-Genistein compounds at 95.43% ± 0.85%. The radiochemical purity of the labeling of 99mTc-Genistein compounds has met the requirements of the United State Pharmacopeia as a compound marked for diagnosis of more than 90%.

Effect of cell-free fetal DNA on spontaneous preterm labor Rogaye Darghahi, Novshin Mobaraki-Asl, Zahra Ghavami, Farhad Pourfarzi, Saied Hosseini-Asl, Faranak Jalilvand Journal of Advanced Pharmaceutical Technology & Research 2019 10(3):117-120 Inflammatory phenomenon, including cell-free fetal DNA (cffDNA), is one of the various causes of preterm delivery. Always, there is a trend in the prediction and prevention of preterm labor. Herein, the aim of this study is to assess the value of cffDNA levels in serum of pregnant women for prediction of spontaneous preterm labor. A case–control study with nonrandomized convenience sampling was conducted. One hundred women qualifying for the study were enrolled. The participants were divided into two groups of healthy nulliparous pregnant women (n = 50) and nulliparous pregnant women experiencing preterm labor (n = 50). Then, venous blood was sampled from each participant and its plasma was separated and analyzed. The mean age of women in the experimental group was 22.90 years with the standard deviation of 4.04, while in the control group these two values were 23.78 and 4.37, respectively. In the experimental group, 29 patients (58%), and in the control group, 27 patients (54%) had cffDNA. The mean of the counted DNA in the experimental group was 2080/03 with the standard deviation of 909/792 while the same values for the control group were 1183/26 and 620/720, in the same order. The statistical analysis revealed that this difference was meaningful at P = 0.001. Furthermore, in the experimental group, cffDNA increased with increase in the age and the difference was meaningful. Finally, increasing pregnancy age in the experimental group led to an increase in the number of cffDNA (P = 0.001). The results of this study indicated that the cumulative frequency of preterm labor for women with positive cffDNA was significantly higher. High levels of cells' DNA in the serum of pregnant mothers increase the risk of spontaneous preterm labor. These observations may have implications for preterm labor.

Quantitative study of vimentin gene methylation in stool samples for colorectal cancer screening Behfar Pakbaz, Raheleh Jabinin, Narjes Soltani, Hossein Ayatollahi, Mohammad Reza Farzanehfar Journal of Advanced Pharmaceutical Technology & Research 2019 10(3):121-125 Due to importance of screening for colorectal cancer the present study was conducted and aimed at investigating the quantitative methylation of vimentin gene in stool, tumor tissue, and healthy tissue of patients with colorectal cancer (CRC) in comparison with healthy individuals. This is a case-control study in which we measures methylation of the vimentin in tumoral tissue, normal tissue and stool specimens were collected from forty-nine CRC patients as case group and stool and normal tissue specimens were collected from thirty healthy individuals as control group. There was no statistically significant difference in methylation of vimentin in normal tissue (P > 0.05) between the two groups. Moreover, the status of methylated or unmethylated vimentin gene in tumor and stool tissues in the case group was not significantly correlated with their mean age and sex (P > 0.05). This study showed that the specificity and sensitivity of vimentin methylation in stool of CRC patients are 100% and 60%, respectively. Furthermore, the methylation of vimentin in stool of CRC patients has a high-positive predictive value (100%). The results of this study suggested that methylation of the vimentin gene in the stool can be used as a specific marker for the detection and screening of CRC.

Reversed-phase high-performance liquid chromatographic method development and validation for allyl isothiocyanate estimation in phytosomes of Brassica nigra extract Surendra S Agrawal, Tapasya Yallatikar, Pravina Gurjar Journal of Advanced Pharmaceutical Technology & Research 2019 10(3):126-131 A simple, specific, accurate, precise, and robust reverse-phase high-performance liquid chromatographic method has been developed and validated for the estimation of allyl isothiocyanate (AITC) in phytosomes of black mustard extract (Brassica nigra). The method was validated with respect to specificity, linearity, accuracy, precision, and robustness. The linearity was achieved over a range of 10–18 μg/mL and regression coefficient was obtained 0.9961. Accuracy of chromatographic method was evaluated by standard addition method; percentage recovery attained was 97.07 ± 0.008–103.66 ± 0.013. Relative standard deviation for intraday and interday precision was 0.02% and 0.22%, respectively. The limit of detection and limit of quantification of the AITC were found to be 0.0043 μg/mL and 0.01324 μg/mL, respectively. This result shows that the method was well validated. In the present study, the AITC content was found 0.0009% ± 0.014% in black mustard. This study reveals that the proposed high-performance thin-layer chromatography method is accurate, fast, and cost-effective for the routine estimation of AITC in the phytosome formulation.

Effect of Tribulus terrestris in mercuric chloride-induced renal accumulation of mercury and nephrotoxicity in rat Harlokesh Narayan Yadav, Uma Shankar Sharma, Surender Singh, Yogendra Kumar Gupta Journal of Advanced Pharmaceutical Technology & Research 2019 10(3):132-137 Mercury generates free radicals and subsequently increases oxidative stress, which leads to renal injury. Tribulus terrestris (TT) has good anti-inflammatory and antioxidant properties. Hydroalcoholic extract of different dose of TT was evaluated against mercuric chloride-induced nephrotoxicity. Rats (n = 6) were treated with TT at doses of 100, 200, and 300 mg/kg. Drugs were administered orally for 7 days. Single dose of mercuric chloride (5 mg/kg, intraperitoneal) on the 5th day caused significant elevation of blood urea nitrogen, serum creatinine, malondialdehyde, liver fatty acid binding protein, kidney injury molecule-1, and kidney mercury level and fall in glutathione, superoxide dismutase, glutathione peroxidase, and histopathological changes in disease control as compared to normal control group (P < 0.001). Dose of TT 200 and 300 mg/kg significantly (P < 0.001) prevented the renal injury, and mercury accumulation in kidney tissues significantly decreases in higher dose, i.e., 300 mg/kg as compared to control group. Our result indicates that the treatment of TT exerted significant protection against renal damage induced by mercuric chloride possibly due to its antioxidant and anti-inflammatory properties and by decreasing the renal accumulation of mercury.

A questionnaire-based study to assess the status and perspective of fixed-dose combination among the various stakeholders including regulators, clinicians, researchers, and industry Krishan Kumar Bhardwaj, K Bangarurajan, Tanveer Naved, Satyendra Kumar Rajput Journal of Advanced Pharmaceutical Technology & Research 2019 10(3):138-142 Fixed-dose combinations (FDCs) dominating the global market because of better compliance. However, irrational combination can lead to human-made menace in terms of development of resistance, tolerance, drug abuse, and economy encumbrance. The US Food and Drug Administration defines a combination product as “a product composed of any combination of a drug and a device or a biological product and a device or a drug and a biological product or a drug, device, and a biological product.” Unfortunately, many FDC being introduced in India are usually irrational. The need for the present study arises as the Indian drug regulatory system has been oscillating between central drug authorities versus state drug regulatory authorities. To assess the same fifty-six regulators and 70 other stakeholders including researchers, clinician, and industry people have exposed to 14 questions, and the same are used to get the insights of FDC among producers and consumers. All data were analyzed using Sigma plot Software. Data was presented in the form of percentage of response (responders vs. nonresponders, agree vs. disagree, yes vs. no). Most of the stakeholders (99%) stressed on Rule 122 to be strictly followed and same should be disseminated among all the stakeholders. Similarly, it was emphasized by more than 95% stakeholders that FDC contents should be tested as per official pharmacopoeia.

Alexandros Sfakianakis
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