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आयतन 15, मुद्दा 1 (2023)

शोध आलेख

Phytosomes: Review on Drug Delivery Approaches for Herbal Hepatoprotective

Himanshu Sehrawat* Sourabh Kosey and Junaid Tantray

The photo-phospholipid complexation technique has emerged as one of the most leading methods of improving bioavailability of phytopharmaceuticals having poor competency of solubilizing and crossing the biological membranes. Complexes between a pure phospholipid and a pure active substance are called phytosomes. Several plant actives in spite of having potent in vitro pharmacological activities have failed to demonstrate similar in vivo response. One of the newest and most popular lipid-based nano-carriers for delivering herbal-based drug is the nano-phytosome. Despite being created for medicinal uses, nano-phytosome technology has the potential to be used to food items to create unique functional meals. Compared to typical herbal extracts in dosage form, phytosomes exhibit superior absorption due to their water-soluble herbal extract and lipophilic outer layer, which results in better bioavailability and effects. Different methods have been adopted to formulate phospholipid complexes of plant extractives utilizing varying solvent systems, molar ratios of drug/phospholipids and different drying techniques. Some methods of formulating such drug-phospholipid complexes have been patented as well. However, the stability of phyto-phospholipid complexes is still a matter of concern which needs attention. But still a number of products exploiting this technique are under clinical trials and some of them are now in market. The current review highlights key finding of recent years with our own viewpoints which can give the new directions to this strategy as well as study also includes advancements in the technical aspects of phyto-phospholipid formulations which have been done in recent past with future challenges.

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An Open Label, Balanced, Randomized, Two Treatments, Two Sequences, Two Periods, Single Dose, Cross Over, Oral Bioequivalence Study of Vildagliptin 50 Mg Tablets of Abbott Laboratories De Colombia vs. Jalra (Vildagliptin) 50 Mg Tablets of Novartis Pharma Stein Ag, in Healthy, Adult, Human Subjects Under Fasting Condition

O. Arjun Arumugam*, Geetha Lakshmi G, Srinivas G, Nageswara Rao T, Hurtado-Colorado K, Perez-Perez M, Gavino-Gutierrez AM, Lara C, Higuera MJ and Penaloza

Vildagliptin is dipeptidyl peptidase 4 (DPP-4) inhibitors, that inhibits rapid and complete inhibition of DPP-4 activity, resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide) in the treatment of type 2 diabetes mellitus in adults. The purpose of this study was to evaluate the bioequivalence between Vildagliptin 50 mg Tablets of Abbott Laboratories de Colombia vs. JALRA (Vildagliptin) 50 mg Tablets of Novartis Pharma Stein AG, in healthy subjects under fasting condition. An open label, balanced, randomized, two treatments, two sequences, two periods, single dose, cross over study with washout period of 03 days under fasting condition was carried out in 42 male subjects in the age group of 19 to 43 years who met the study eligibility criteria, participated in the study and all the 42 subjects completed both periods of the study. The pharmacokinetic samples collected from subjects who completed the study were analysed to determine the plasma concentration of Vildagliptin using bio-analytical method. The 90% confidence interval of Cmax and AUC0-t were 89.32% - 104.32% and 94.52% - 101.11% respectively which were within the pre-defined acceptable limits and the test product is bioequivalent to the reference product.

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Cadmium and Lead Induced Proinflammatory Cytokine Polarization in Petroleum Products Occupationally Exposed Nigerians

Ehiaghe Alfred Friday, Mba Martins Douglas, Usiosefe Raphael Erhunmwunse, Uwaifo Nicholas Eghosa, Ehiaghe Joy Imuetiyan, Eremwanarue Aibuedefe Osagie and Digban Awharentomah Kester

The toxicological effects of petroleum product had been associated with various metabolic defects such as cardio-vascular attacks. But there is limited information about the cytokine responses of individual who are occupationally exposed to petroleum products in Nigeria. The study was aimed at evaluating the cytokine responses to the accumulation of cadmium, lead, zinc and copper in the petroleum products using blood levels of interleukin-1 alpha, interleukin-4, cadmium, lead, zinc and copper in occupationally exposed individuals in Abuja, Nigeria. The case-control study randomly selected sixty-three occupationally exposed (test group) and sixty non exposed individuals (control group). The occupationally exposed subjects, consisting of twenty-four automobile mechanics (AM), eighteen generator mechanics (GM) and twenty-one petrol station attendants (PSA) in filling stations who consented to participate in this study. Cytokine levels were determined by enzyme-linked immunosorbent assay method. Heavy metals were analyzed by atomic absorption spectrophotometer method. Full blood count was done using hematology autoanalyzer. All numerical results were analyzed with one-way ANOVA with post hoc multiple comparisons test while student’s t- test was used to compare independent variables. Cadmium levels were significantly higher in AM and PSA (p<0.002) while lead levels were significantly higher in AM and GM (p<0.04) as compared with the control group. Zinc and copper levels were significantly lower in AM and GM as compared with the control group (P<0.002) but within the acceptable levels. Granulocytes count was significantly higher in GM and PSA, whereas, red blood cells count and packed cell volume were significantly lower in GM and PA as compared with control group (p<0.001). IL-1 α and IL-4 levels were significantly higher in AM, GM and PSA as compared with the control group (p<0.01; 0.017) respectively. Regardless of profession, prolonged exposure to petroleum products tends to shift the cytokine balance toward a pro-inflammatory pattern. Thus, when handling such materials, personal protective equipment should be worn to avoid the accumulation of cadmium and lead, which might act as mediators.

शोध आलेख

Antioxidant Trace Elements Depletion Induces Proinflammatory Cytokines Polarization in Anti Diabetics Drug Naive Non Obese Male Type 2 Diabetic Nigerians

Ehiaghe Friday Alfred*

Type 2 diabetes (T2D) is a major risk factor for cardiovascular diseases and acute oxidative stress (OS) by high production of reactive oxygen species (ROS) related to the lipotoxicity and glucotoxicity processes. The study was aimed at evaluating the cytokine responses and antioxidant trace elements status using the blood levels of interleukin-1 alpha, interleukin-4, zinc nickel, magnesium, and chromium circulating among antidiabetics drug naïve non-obese male type 2 Diabetic Nigerians. A total of 124 subjects (aged between 20 and 40 year) were randomly studied, among these were 64 known cases of type 2 diabetes mellitus with a poor glycemic control index and 60 apparently healthy individuals with a good glycemic index. Student’s t- test was used to compare independent variables. Cytokine levels were determined by enzyme-linked immunosorbent assay method. Heavy metals were analyzed by atomic absorption spectrophotometer method. Full blood count was done using haematology autoanalyzer. The probability values less than 0.05 were considered significant. The levels of interleukin -1α were significantly higher in the diabetics group as compared with the control group (p<0.002), whereas, The levels of interleukin-4, packed cell volume, total white blood count, red blood cells, mean cell haemoglobin and mean cell haemoglobin concentration were significantly lower as compared with the control group (P<0.005). The levels of Manganese, Chromium, Nickel, Zinc were significantly lower in the diabetics group as compared with the control group (p<0.002). Depletion of antioxidant trace elements in T2D is linked to increased pro-inflammatory cytokines and may contribute to the development of diabetic complications. ATE supplementation may be able to prevent the observed cytokine imbalance.

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