The primary objective of the study was to investigate the effect of food on the pharmacokinetics of
MELOXICAM. Cmax, Tmax and AUC of MELOXICAM were defined as the main parameters for the assessment
of bioavailability and bioequivalence of MELOXICAM administered in fasting and fed conditions. The 90% CI
for the fed/fasting MELOXICAM did not contained within the acceptance interval (80, 125) and, therefore, it
can be concluded that the rate of systemic exposure to MELOXICAM does not fit the claim of bioequivalence
between administration in fasting and fed conditions. This study has demonstrated that all the
pharmacokinetic parameters of both the treatments were statistically different from each other. In the fed
condition the values of Cmax and AUC were decreased while Tmax increases than that of fasting which
demonstrated that the extent of systemic exposure to MELOXICAM was affected by the delay in absorption of
MELOXICAM in the presence of food. None of the study volunteers reported any serious adverse effects
throughout the study. The only two AEs reported were mild and not related to the study medication. The AEs
reported were, according to the study medical expert, related to the sampling procedure and were self
limiting and did not require any treatment. There was no change in the vital signs of the volunteers
throughout the study period. The presented data are of major importance in identifying the optimal dosing
regimen for future clinical trials with oral MELOXICAM. In our study, only one type of food (a standardized
continental breakfast) was evaluated; further studies are needed to assess the effects of foods with different
compositions and contents on the bioavailability of MELOXICAM.
Journal of Schizophrenia Research is a peer-reviewed, open access journal published by Austin Publishers. It provides easy access to high quality Manuscripts in all related aspects of a mental disorder often characterized by abnormal social behavior and failure to recognize what is real with common symptoms including false beliefs, auditory hallucinations, confused or unclear thinking, inactivity, and reduced social engagement and emotional expression. The journal focuses upon the latest research in finding causes, understanding mechanisms, diagnosis, prevention, management, prognosis, epidemiology, ancestral history and treatment of schizophrenia.
Austin Publishing Group is a successful host of more than hundred peer reviewed, open access journals in various fields of science and medicine with intent to bridge the gap between academia and research access.
Journal of Schizophrenia Research accepts original research articles, review articles, case reports, mini reviews, rapid communication, opinions and editorials on all related aspects of schizophrenia including, finding causes, understanding mechanisms, diagnosis, prevention, management, prognosis, epidemiology, ancestral history and its treatment.
Journal of Schizophrenia Research is a peer-reviewed, open access journal published by Austin Publishers. It provides easy access to high quality Manuscripts in all related aspects of a mental disorder often characterized by abnormal social behavior and failure to recognize what is real with common symptoms including false beliefs, auditory hallucinations, confused or unclear thinking, inactivity, and reduced social engagement and emotional expression. The journal focuses upon the latest research in finding causes, understanding mechanisms, diagnosis, prevention, management, prognosis, epidemiology, ancestral history and treatment of schizophrenia.
Austin Publishing Group is a successful host of more than hundred peer reviewed, open access journals in various fields of science and medicine with intent to bridge the gap between academia and research access.
Journal of Schizophrenia Research accepts original research articles, review articles, case reports, mini reviews, rapid communication, opinions and editorials on all related aspects of schizophrenia including, finding causes, understanding mechanisms, diagnosis, prevention, management, prognosis, epidemiology, ancestral history and its treatment.
SAFETY PHARMACOLOGY STUDIES AND DRUG DISCOVERY AND GIT SAFETY PHARMACOLOGY AND BIOMARKERS OF GIT SYSTEM AND GASTRIC EMPTYING AND MOTILITY AND TRANSIT TIME AND ADVERSE EFFECT ON GIT SYSTEM AND SCALE OF GI ADVERSE EFFECTS AND NEERAJ KUMAR
safety pharmacology is the branch of pharmacology specializing in detecting and investigating potential undesirable pharmacodynamic effects of a new chemical on physiological functions .
the content of this presentation is as follows
- introduction
- definition
- history
- ICH - guidelines
- refrences
Formic acid poisoning is widely used in the rubber industry in the state of Kerala. It has become a mode of suicide because of its easy availability. Our objective is to report immediate manifestations and management principles in the treatment of formic acid poisoning. Three cases are reported which presented to our Emergency Department. Out of the three patients, only one survived. Metabolic acidosis was the most common acid base abnormality observed in all the three cases. Formic acid poisoning carries a high risk of mortality and morbidity. Early correction of electrolyte imbalances holds the key to survival and preventing early complications such as cardiac arrest. Restriction should be put on the sale and the public should be made aware of its toxic manifestations and complications.
Ich (s5 r2) The International Council for Harmonisationof Technical Requireme...AMIT KUMAR
GUIDLINES FOR REPRODUCTIVE TOXICOLOGY,Strategies for reproductive toxicity assessment,The International Council for Harmonisation,of Technical Requirements for Pharmaceuticals for Human Use
The presentation is about the dose selection for laboratory animal toxicology drug testing, explaining staged and staggered approach of dose selection.
Safety pharmacology is a branch of pharmacology with its aim to predict the potential clinical risk profile of new chemical entities (NCEs).
It has the ability to predict the potential off-target drug effects on major organ systems which are associated with exposure in the therapeutic range and above.
As an essential part of the spectrum of drug discovery and development, safety pharmacology studies are generally conducted to determine the relative drug effect on main organs, including respiratory system, central nervous system, and cardiovascular system.Safety pharmacology is an essential part of the drug development process that aims to identify and predict adverse effects prior to clinical trials.
SP studies are described in the international conference on harmonization (ICH) S7A and S7B Guidelines.
SAFETY PHARMACOLOGY STUDIES AND DRUG DISCOVERY AND GIT SAFETY PHARMACOLOGY AND BIOMARKERS OF GIT SYSTEM AND GASTRIC EMPTYING AND MOTILITY AND TRANSIT TIME AND ADVERSE EFFECT ON GIT SYSTEM AND SCALE OF GI ADVERSE EFFECTS AND NEERAJ KUMAR
safety pharmacology is the branch of pharmacology specializing in detecting and investigating potential undesirable pharmacodynamic effects of a new chemical on physiological functions .
the content of this presentation is as follows
- introduction
- definition
- history
- ICH - guidelines
- refrences
Formic acid poisoning is widely used in the rubber industry in the state of Kerala. It has become a mode of suicide because of its easy availability. Our objective is to report immediate manifestations and management principles in the treatment of formic acid poisoning. Three cases are reported which presented to our Emergency Department. Out of the three patients, only one survived. Metabolic acidosis was the most common acid base abnormality observed in all the three cases. Formic acid poisoning carries a high risk of mortality and morbidity. Early correction of electrolyte imbalances holds the key to survival and preventing early complications such as cardiac arrest. Restriction should be put on the sale and the public should be made aware of its toxic manifestations and complications.
Ich (s5 r2) The International Council for Harmonisationof Technical Requireme...AMIT KUMAR
GUIDLINES FOR REPRODUCTIVE TOXICOLOGY,Strategies for reproductive toxicity assessment,The International Council for Harmonisation,of Technical Requirements for Pharmaceuticals for Human Use
The presentation is about the dose selection for laboratory animal toxicology drug testing, explaining staged and staggered approach of dose selection.
Safety pharmacology is a branch of pharmacology with its aim to predict the potential clinical risk profile of new chemical entities (NCEs).
It has the ability to predict the potential off-target drug effects on major organ systems which are associated with exposure in the therapeutic range and above.
As an essential part of the spectrum of drug discovery and development, safety pharmacology studies are generally conducted to determine the relative drug effect on main organs, including respiratory system, central nervous system, and cardiovascular system.Safety pharmacology is an essential part of the drug development process that aims to identify and predict adverse effects prior to clinical trials.
SP studies are described in the international conference on harmonization (ICH) S7A and S7B Guidelines.
To accomplish a desired systemic effect, drug molecules must reach the systemic circulation after extravascular administration. The percent of the taken dose that reaches intact to the systemic circulation is called “bioavailability, BA”. Absolute Bioavailability compares the BA of the active drug in systemic circulation following non-intravenous administration
Assignment on Experimental Study- RCT and Non RCT, Observation Study: Cohort, Case Control, Cross sectional, Roles and responsibilities of Clinical Trial Personnel: Investigator, Study Coordinator, Sponsor, Contract Research Organization and its management Guidelines to the preparation of documents, Preparation of protocol, Investigator Brochure, Case Report Forms, Clinical Study Report Clinical Trial Monitoring-Safety Monitoring in CT
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
All manuscripts are subject to rapid peer review. Those of high quality (not previously published and not under consideration for publication in another journal) will be published without delay.
Clinical Studies - Foundational to the Drug Approval ProcessJohn Kriak
One of the key elements in gaining approval of a drug by the US Food and Drug Administration (FDA) involves clinical research. There are two primary avenues of such research: clinical trials and observational studies. The latter involves monitoring subjects within normal settings, with data gathered over time and health changes evaluated and compared with others in the group.
Extrapolation of in vitro data to preclinical and.pptxARSHIKHANAM4
Extrapolation of in vitro data to preclinical.
the topic is included in m.pharmacy 1st sem syllabus. which is essential for the study and that include the details about how you deal with the preclinical data that will help to decide the NOEAL and LOEAL, the humane dose of the drug can be calculated and further formation is also done.
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
All manuscripts are subject to rapid peer review. Those of high quality (not previously published and not under consideration for publication in another journal) will be published without delay.
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
All manuscripts are subject to rapid peer review. Those of high quality (not previously published and not under consideration for publication in another journal) will be published without delay.
Similar to Effect of food on pharmacokinetics of meloxicam ijsit 2.3.7 (20)
CHITINASE AS THE MOST IMPORTANT SECONDARY METABOLITES OF STREPTOMYCES BACTERISIJSIT Editor
Fungal phytopathogens pose serious problems worldwide in the cultivation of economi cally
important plants.
Chemical fungicides are extensively used in current agriculture.However, excessive use of chemical
fungicides in agriculture has led to deteriorating human health , environmental pollution, damaged to
ecosystem and development of pathogen resistance to fungicide.
Because of the worsening problems in fungal disease control , a serious search is needed to identify
alternative methods for plant protection, which are less dependent on chemicals and are more
environmentally friendly. Microbial antagonists are widely used for the biocontrol of fungal plant diseases.
Many species of actinomycates, particulary those belonging to the genus sterptomyces, are well known as
antifungal biocontrol agents that inhibit several plant pathogenic fungi.
Another way biological control has been developed as an alternative of chemicals to tock with plant
pathogenic fungi. Considering high presence of chitin in fungal cell wall, chitinase enzyme is camped as an
effective biocontrol agent against phytopathogenic fungi. Streptomyces bacteria are able to produce various chitinase enzymes, chitinases produced by streptomyces belong to the families 18 and 19 glycosyl hydrolases.
The antifungal activity is mostly shown by fomily 19 Chitinases. In comparison with bacterial family 18
chitinases, the specific hydrolyzing activity of chitinase 19 against soluble and in soluble chitinous substrates
has been markedly higher. Considering the importance of family to investigate antifungal potential of
streptomyces bacteria isolated from east Azarbijan region soils based on molecular identification of family 19
chitinase. encoding gene in these bacteria.
To aim the purpose 110 soil samples were collected from East Azarbaijan and 310 strepomyces
isolates were selected using macroscopic and microscopic observations. DNA genomic of all of the isolates
were extracted and PCR reactions was done using chitinase 19 designed primers as marker.
Totally isolates were selected with molecular selection and antagonistic test were done. One of the isolates
exhibit the most strong antifungal activity.
The strain was identified using 16srDNA gene, and the chitinase encoding gene were amplified partially to
prove the PCR selection. Finally the bacterium were introduced as potentially biological fertilizer.
MOLECULAR ANALYSIS OF BACTERIAL GENE CODING CHITINASE ENZYMES, FAMILY 19 STR...IJSIT Editor
Fungal phytopathogens pose serious problems worldwide in the cultivation of economically
important plants.
Chemical fungicides are extensively used in current agriculture.However, excessive use of chemical
fungicides in agriculture has led to deteriorating human health , environmental pollution, damaged to
ecosystem and development of pathogen resistance to fungicide.
Because of the worsening problems in fungal disease control , a serious search is needed to identify
alternative methods for plant protection, which are less dependent on chemicals and are more
environmentally friendly. Microbial antagonists are widely used for the biocontrol of fungal plant diseases.
Many species of actinomycates, particulary those belonging to the genus sterptomyces, are well known as
antifungal biocontrol agents that inhibit several plant pathogenic fungi.
Another way biological control has been developed as an alternative of chemicals to tock with plant
pathogenic fungi. Considering high presence of chitin in fungal cell wall, chitinase enzyme is camped as an
effective biocontrol agent against phytopathogenic fungi. Streptomyces bacteria are able to produce various chitinase enzymes, chitinases produced by streptomyces belong to the families 18 and 19 glycosyl hydrolases.
The antifungal activity is mostly shown by fomily 19 Chitinases. In comparison with bacterial family 18
chitinases, the specific hydrolyzing activity of chitinase 19 against soluble and in soluble chitinous substrates
has been markedly higher. Considering the importance of family to investigate antifungal potential of
streptomyces bacteria isolated from east Azarbijan region soils based on molecular identification of family 19
chitinase. encoding gene in these bacteria.
To aim the purpose 110 soil samples were collected from East Azarbaijan and 310 strepomyces
isolates were selected using macroscopic and microscopic observations. DNA genomic of all of the isolates
were extracted and PCR reactions was done using chitinase 19 designed primers as marker.
Totally isolates were selected with molecular selection and antagonistic test were done. One of the isolates
exhibit the most strong antifungal activity.
The strain was identified using 16srDNA gene, and the chitinase encoding gene were amplified partially to
prove the PCR selection. Finally the bacterium were introduced as potentially biological fertilizer.
THE EFFECTS OF HELPING BACTERIA (PSEUDOMONAS SPP.) IN NITROGEN GREEN BEANS F...IJSIT Editor
Some- bacteria settle in the rhizosphere of legume plants and enhance the performance of ribosome
bacteria to nitrogen fixation and nodulation. In this paper, we used four isolated from two species of
Pseudomonas containing P.putida, P.fluorescens Chao, P.Flouresence Tabriz, P.flouresence B119 and Rhizobium
leguminosarumbv.phaseoli. In a factorial experiment with complete randomized blocks were used 5 levels of
helping bacteria(Pseudomonas spp.) and two rhizobium levels, four replicates were employed. Jamaran418
green bean was utilized as host plant. At the end, nodulation, growth and plant’s nitrogen indexes were
measured. The results showed that all above mentioned helping bacteria enhance the growth and nodulation
performance of green bean. It should be said that P.putida had the highest effect on the green bean
nodulation increase along with rhizobium (130%) followed by P.fluorescens Tabriz, P. fluorescens Chao and
P.fluorescens B119, ( 83, 63 and 17%, respectively). Also, we observed 45, 33, 22 and 8% performance
increase under the effect of P.putida, P. fluorescens Chao, P. fluorescens Tabriz and P. fluorescens B119,
respectively.
ANTIMICROBIAL PROPERTY OF AQUEOUS AND PETROLEUM ETHER LEAF EXTRACTS OF JATRO...IJSIT Editor
The experiment was carried out to investigate the antimicrobial property of aqueous and Petroleum
ether leaf extracts of Jatrophacurcas against some gram positive micro-organisms: Staphylococcus aureus,
Bacillus subtilis and some gram negative micro-organisms: Escherichia coli, Salmonella typhi using
antibiotics; Gentamycin as control. The phytochemical screening of aqueous and petroleum ether extracts
showed the presences of cardiac glycosides, steroids and terpenes, tannins, phlobatannins, anthraguinones
and saponins. The disc diffusion techniques was used to test the sensitivity of the micro-organism to the
extracts of Jatrophacurcas the results obtained show mean zones of inhibition between (19 + 0.6mm) to (30 +
0.3mm) for aqueous extract and (24 + 0.5mm) to (35 + 0.8mm) for petroleum ether extract. Micro-organisms
showed sensitivity in the following order: E.coli;(17 + 0.3mm) and (25 + 0.8mm), S.aureus; (26 + 0.2mm) and
(28 + 0.6mm), B.subtilis; (16 + 0.1mm) and (20 + 0.7mm), and S.typhi (25 + 0.2mm) and (27 + 0.6mm) for
aqueous and petroleum ether extracts respectively. The minimum inhibition concentration (MIC) for both
extracts show that the extracts inhibited the growth of the entire test organism at concentration 0.6mg/ml.
This result thus suggests the potency of Jatrophacurcas as an antimicrobial agent especially at the
concentration employed.
BIO CHEMICAL EFFECT OF 1, 5-BIS (3, 5-DIMETHYLPYRAZOL-1-YL)-3- OXAPENTANE-DIA...IJSIT Editor
The present study provides evidence that 1,5-Bis (3,5-Dimethylpyrazol-1-yl)-3-oxapentane-diacetatocopper has an antidiabetic effect, as hypoglycemic agent and as antilipolytic agent, but with many abnormalities. It affected blood and liver biochemistry in rats. Sera of animals treated with 1,5-Bis(3,5-Dimethylpyrazol-1-yl)-3-oxapentane-diacetatocopper in the present study revealed a significant decrease in serum glucose and albumin, while reported a significant increase in ALT and AST. Moreover, significant decrease in body weight.
THE EFFECT OF ALSTONEA BOONEI STEM BARK PLUS CISPLATININDUCED RENAL INSUFFIC...IJSIT Editor
The bark of Alstoniaboonei stem was analysed for the medicinal and the effect of extracts on induced
renal insufficiency. The plant material was collected in August-September 2012 and Rats 100-150g body
weights were subjected to the study. Normal saline as control, Cisplatin, and cisplatin plus Alstoneiboonei
stem bark extract were administered and the result summary for serum creatinine in cisplatin treated Rats
(2.69±0.32mg/dl) and in Rats administrates cisplastin plus Alstoniaboonei stem bark extract
(2.5±0.01mg/dl) were elevated compared to saline control (1.89±0.89mg/dl). Serum urea in cisplatin treated
Rats was (38.4 ±2.98mg/dl) compared to Rats administrates with cisplatin plus the extract (38.4±2.98mg/dl)
and saline control (24.94±3.76mg/dl). The study indicates Alstoniaboonei stem bark extract reduced the
renal insufficiency in rats.
The study was carried out to investigate the effect of the aqueous extracts of
Myristicafragrans(Nutmeg), Murrayakoenigi(curry leaf) and Aframomummelegueta(Guinea pepper) on Some
Biochemical and haematologicalParameters. Sixteen (16) wister strain rats weighing between 130 – 180g
were divided into four (4) groups of four (4) rats each and for 21 days fed the following diets: Group A –
normal diet + myristicafragrans (Nutmeg) aqueous extract, Group B – normal diet + murrayakoenigi (curry
leaf) aqueous extract, Group C – normal diet + aframomummelegueta (Guinea pepper) aqueous extract, Group
D – normal diet (control). After a period of 21 days the rats were sacrificed and the serum was taken for the
following estimations: total protein, albumin, total bilirubin, direct bilirubin, aspartate transaminase, alanine
transaminase, alkaline phosphatase, total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol and
glucose. The whole blood was taken for packed cell volume and white blood cell count. The results indicated
that oral administration of myristicafragrans, murrayakoenigi and aframomummelegueta to rat’s exhibit
remarkable hypolipidaemic activity and lowering glucose concentration. The oral administration of these
three spices exhibit protein increasing activities compared with the control rats. The packed cell volume and
white cell values of all the rats decreased after feeding with experimental diet (aqueous extract) compare
with the control rats. It is clear from this study thatMyristicafragrans(Nutmeg), Murrayakoenigi(curry leaf)
andAframomummelegueta (Guinea pepper) contain significant amounts of phytochemicals and exhibit
hypolipidaemic activity when consumed.
THE INFLUENCE OF SILICONE ANTIFOAM FROM LEATHER AND DYING WASTE WATER EFFLUE...IJSIT Editor
This study investigates the influence of silicone antifoam agent on waste water from Gashash leather
and Nigerian Spinning and Dying industries (NSD). Waste water from the outlet of the industries were
collected and analyzed for physicochemical parameters. Silicone antifoam was added to the wastewater to
determine the impact of the silicone antifoam on turbidity and chemical oxygen demand (COD)
concentrations. The result shows that both turbidity and COD values significantly increased even when small
concentration of the silicone antifoam was added. Further, independent t-test was used to identify the
variance between the mean value of the wastewater from leather, spinning and dying industries, the results
indicated that there are no significant differences (observed t 0.544, critical t 2.015, and p value 0.589)
between the waste water in leather and dying industries.
WATER INTAKE CHARACTERISTICS OF DIFFERENT SOIL TYPES IN SOUTHERN BORNO NIGERIA IJSIT Editor
The water intake characteristics of soils under arable crop practice were studied with a view to
obtaining useful information for the design of irrigation and drainage system and for effective soil
management techniques. Parameters determined; infiltration, hydraulic conductivity, permeability, bulk
density, particle density, porosity and moisture content. The textural class of the soils from the three sites
was found to be clay. The result obtained indicates that infiltration was high initially but decreases later. This
may be due to the soil reaching a saturation point. On the average the infiltration rate was observed to
decrease with time. The coefficient of permeability was found to be 9.26 x 10 , 7.66 x 10 and 2.15 x 10 cm/s
for site A, B and C respectively. Information on infiltration and permeability are useful tools in irrigation and
other engineering design.
DETERMINATION OF ENGINEERING PROPERTIES OF POMEGRANATE FRUIT TO CALCULATION ...IJSIT Editor
In avoiding damage to fruit species the permissible falling height and permissible static pressure are
of great importance. The former is important in planning harvesting and handling operations, the latter in
selecting the height of transport containers. Fruits are generally transported in containers. The static and
dynamic forces which then act on the fruit will cause damage if they exceed given value. The static force may
be calculated from the weight of the fruit column being transported while the dynamic load is a consequence
of vibration caused by transport. The permitted static load for a given fruit may be determined
experimentally. In this study, physical properties of interest were determined for fresh pomegranate fruit
then calculations for the design of a suitable height were conducted based on the measured properties using
Ross and Isaacs’s theory. Maximum height for packing and storing of fresh pomegranate fruit in the box was
determined to be less than 123 cm based on a rupture force of 40.7 N.
COMPARSION OF ANTIOXIDANT POTENTIAL OF DIMOCARPUS LONGAN LOUR. EXTRACTS AND ...IJSIT Editor
The present study was carried out to evaluate antioxidant activity of Dimocarpus longan stems
extracts and also to investigate the main phytoconstituents in the bio-active extract. N-hexane,
dichloromethane, ethyl acetate and methanol 80% extract were tested for free radical scavenging activity on
model reaction with stable 2,2-diphenyl-1-picrylhydrazyl radical (DPPH). The results showed that ethyl
acetate was the most active one as antioxidant agent and phytochemical analysis of that extract revealed the
presence of triterpenes, flavonoids, tannins and carbohydrates. The results may help to discover new
chemical classes of natural antioxidant substances that could serve as selective agents for infectious diseases.
DIRECT EXPANSION GROUND SOURCE HEAT PUMPS FOR HEATING AND COOLINGIJSIT Editor
This article is an introduction to the energy problem and the possible saving that can be achieved
through improving building performance and the use of ground energy sources. The relevance and
importance of the study is discussed in the paper, which, also, highlights the objectives of the study, and the
scope of the theme. This study discusses some of the current activity in the GSHPs field. The basic system and
several variations for buildings are presented along with examples of systems in operation. Finally, the GCHP
is presented as an alternative that is able to counter much of the criticism leveled by the natural gas industry
toward conventional heat pumps. Several advantages and disadvantages are listed. Operating and installation
costs are briefly discussed.
BIOMINERALISED SILICA-NANOPARTICLES DETECTION FROM MARINE DIATOM CULTURE MEDIAIJSIT Editor
Diatoms are unicellular algae the most spectacular among the microorganisms assemble into a
micro-shell with a distinct 3-D shape and pattern of fine nanoscale features. In this investigation, we present
results; Field Emission Scanning Electron Microscopy images show the presence of ordered arrays of silica
nanoparticles. A number of diatoms with partially opened valves were observed on the surface of the diatom,
which indicates that cell contents inside of diatoms could release the nanoparticles into the culture solution.
We believe that the film forming silica nanoparticles are either released by the diatoms during reproduction
or after cell death due to bacterial action. Further research will investigate whether the silica nanoparticles
are produced intracellular and then released or whether synthesis occurs in cell culture medium. This
approach provides an environmentally friendly means for fabricating silica nanoparticles for drug delivery,
disease diagnostics, artificial opal films, decorative coatings and novel optical materials.
COMPARATIVE STUDIES ON NUTRITIONAL VALUE OF NORMAL AND TUMOR TISSUE, SARDINE...IJSIT Editor
Fish are at present in high demand in food markets, they are widely consumed in many parts of the
world because they posses high protein content, saturated fat and also contain omega fatty acids known to
support good health. The present study deals with biochemical composition of common fish,Sardinella
longiceps. The proximate composition of protein, carbohydrate, lipid, amino acids and fatty acids were
studied. The results of proximate composition in S. longiceps showed the percentage of protein was high in
the normal and tumor infected fish tissue (29.15 &18.93%), followed by the carbohydrate (5.81 & 2.42 %)
and lipid (15.61 & 9.28 %). The percentage compositions of essential and non-essential amino acids are
presented in normal tissue and tumor infected tissue were found to be as 46.09 % & 41.47 % and 37.23% &
40.63%. In the analysis, the fatty acid profile by gas chromatography revealed the presence of higher amount
of PUFA (Linolenic acid 32.74 %) in normal tissue. The details of the vitamins detected in S. longicepstissue.
Among them, vitamin A was found in higher levels (91.16 mg/gm) at normal tissue. In the present study,
totally 5 macro minerals and 2 trace minerals were reported. The S. longiceps normal and infected tissue
contributed maximum sodium (289.6 mg/gm) and Potassium (166.5 mg/gm) of minerals. The result shows
that marine fish (S. longiceps) tissue is a valuable food recipe for human consumption, due to its high quality
protein and well-balanced amino acids fatty acids and vitamins and minerals.
ANTIFUNGAL ACTIVITY OF SELECTED MEDICINAL PLANT EXTRACS AGAINST PLANT PATHOG...IJSIT Editor
The aim of this work was to find an alternative to chemical fungicides currently used in the control
plant pathogenic fungi Rhizoctoniasolani ,ColletotrichummusaeandFusariumoxysporum,. The antifungal
activity of the methanol extracts of six medicinal plants used in native medicine in Sri Lanka is reported.All
plant extracts were screened for their fungistatic, fungicidal activities and minimum inhibitory dilution (MID)
against above fungi. The media amended with methanol and recommended fungicide for respective fungal
strain were consider as negative and positive control respectively.Results showed that radial growth in all the
three tested organisms was significantly impaired (p<0.05) by the addition of the extracts in the culture
medium used. The test fungi differed in their reaction to the different extracts but on the whole, growth
inhibition increased with the concentration of each extract. The most active extracts, shows a marked effect of
the 20% methanol extracts from sweet flag with inhibition values of 91%, 86% and 84 % for F. oxysporum,R.
solani and C.muceawhereas those from wild basil inhibited the growth of the same pathogens by 89%, 84%
and 74%.The results showed minimal inhibitory concentrations (MIC) were 5 % (v/v) for sweet flag and wild
basil and 20% (v/v) for all other plant crude extracts. Out of six plants extract screened, wild basil and sweet
flag showed more than 80% fungal inhibition after 6 hour immersion and other extracts could not exceed
60% inhibition after any exposure time. The study revealed that methanol crude extract of sweet flag and
wild basil exhibit strong fungistatic and fungicidal activities against tested fungi. These results support the
potential use of these plant extracts in the management of diseases caused by tested plant pathogenic fungi.
OUTCOME OF TUNNELED CATHETERS IN HEMODIALYSIS PATIENTS: FIVE YEARS SINGLE CE...IJSIT Editor
Introduction: The tunneled hemodialysis catheters(THCs) are preferred for the patients who are expected to
poor survival and the attempts to arteriovenous fistulas (AVF) are failure. In our study,in hemodialysis
patients who are implemented tunneled catheter it is evaluated the mean duration for the catheters , their
complications and the factors which affect the period of the catheters.
Methods: At the Antalya Research and Education Center Hemodialysis Unit it is retrospectively evaluated the
data of 297 hemodialysis patients who are implemented tunneled catheter during 5 years .
Results: The mean duration time of the tunneled catheters has been 224.9+162.9 days. The duration time of
right internal jugular vein(RIJV) is considerably higher than left internal jugular vein(LIJV) and subclavian
veins (235.8+96.6 days). In diabetic hemodialysis patients, the duration time of the catheter is rather lower
than the other end stage renal disease reasons(184.4±72.1 days).
Conclusions: THCs must be considered as an alternative but not a permanent vascular access in hemodialysis
patients. Because of relatively short duration times than AVF, high infection risks and thrombosis , it must be
used only in patients who have problems with the creating permanent vascular access or patients with
expected low survival time. Moreover, it must be taken into consideration the duration time of the catheter is
low in diabetic hemodialysis patients. According to our results, catheter duration time was longer in RIJV than
in other insertion sites and RIJV must be preferred as first place to placement of THCs.
ANTIBACTERIAL ACTIVITY OF Citrus limonON Acnevulgaris (PIMPLES) IJSIT Editor
Research was carried out on antibacterial activity of Citrus limon on Acnevulgaris (Pimples). Samples
were obtained from individuals having Pimples, by swabbing their faces, backs and chests. Samples were
collected from Amanawa hospital in sokoto, Nigeria using Swab sticks. The sticks were transported to the
Microbiology Laboratory of the Usmanu Danfodiyo University Sokoto. Citrus limon juice was used at different
concentrations of (20%, 40%, 60%, 80% and 100%) on Propionibacteriumacnes, the bacteria that cause
Acnevulgaris (Pimples). The Citrus limon juice was found to be effective at all Concentrations used.
Conventional Cleanser was used as positive control, and it was only found to be effective at higher
concentrations of (60%, 80% and 100%) and was not effective at Lower Concentrations (20% and 40%). The
Minimum Inhibitory Concentration (MIC) of Citrulimon on Propionibacterium acnes was taken and presence
of growth was observed at concentrations of 20%, 40% and 60%, and absence of growth was observed at
80% and 100%. The minimum inhibitory concentration of conventional cleanser indicated the presence of
growth at 20% and 40% and absence of Growth at 60%, 80% and 100%. The Minimum bactericidal
Concentration (MBC) taken on Propionibacteriumacnes using both Citrus limon juice and cleanser all showed
absence of growth at all the concentrations used (20%, 40%, 60%, 80% and 100%). From the research
conducted it was observed that lemon juice have strong anti Acne vulgaris effect morethan the convensional
cleansers used for the treatment of Acne vulgaris.
COMPARATIVE STUDY ON HEAVY METAL CHARACTERISTICS OF LEACHATE FROM MUNICIPAL ...IJSIT Editor
Rapid urbanization and population growth are largely responsible for very high increasing rate of
solid waste in the urban areas, its proper management and recycling is major problems of Municipal
Corporation. The analytical analysis revealed that the leachate show high concentration of heavy metals viz.,
Pb, Zn, Fe, Mn and Cu. However, their high concentration in municipal solid waste leachate may cause
contaminants for environmental pollution. Therefore, present investigation deals with analyze the heavy
metals concentration in municipal solid waste leachate.
PHARMACOGNOSTICAL AND PHYTO–CHEMICAL EVALUATION OF RAKTADUSHTIHAR YOGAIJSIT Editor
The Rakta has vital role in the maintenance of health. If Rakta is in proper quantity and having desirable
qualities too, it promotes health, improves complexion, strength and vigor. Raktadushtihara Yoga was
formulated to assess its role in the management of Raktadushti. The present study deals with the
standardization of Raktadushtihara Yoga through the Pharmacognostical and pharmaceutical standards.
Organoleptic features of coarse powder were within normal range. The pH value was 6.5, water soluble
extract 46.9% w/w, methanol soluble extract 25.9%, ash value 8.73%, loss on drying 9.63% and average
weight was 512 mg. HPTLC was carried out after organizing appropriate solvent system in which maximum 2
spots were distinguished at 254 nm.
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
Honest Reviews of Tim Han LMA Course Program.pptxtimhan337
Personal development courses are widely available today, with each one promising life-changing outcomes. Tim Han’s Life Mastery Achievers (LMA) Course has drawn a lot of interest. In addition to offering my frank assessment of Success Insider’s LMA Course, this piece examines the course’s effects via a variety of Tim Han LMA course reviews and Success Insider comments.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
Effect of food on pharmacokinetics of meloxicam ijsit 2.3.7
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EFFECT OF FOOD ON PHARMACOKINETICS OF MELOXICAM
Suryakant Raikwar
CMJ University, Meghalaya
ABSTRACT
The primary objective of the study was to investigate the effect of food on the pharmacokinetics of
MELOXICAM. Cmax, Tmax and AUC of MELOXICAM were defined as the main parameters for the assessment
of bioavailability and bioequivalence of MELOXICAM administered in fasting and fed conditions. The 90% CI
for the fed/fasting MELOXICAM did not contained within the acceptance interval (80, 125) and, therefore, it
can be concluded that the rate of systemic exposure to MELOXICAM does not fit the claim of bioequivalence
between administration in fasting and fed conditions. This study has demonstrated that all the
pharmacokinetic parameters of both the treatments were statistically different from each other. In the fed
condition the values of Cmax and AUC were decreased while Tmax increases than that of fasting which
demonstrated that the extent of systemic exposure to MELOXICAM was affected by the delay in absorption of
MELOXICAM in the presence of food. None of the study volunteers reported any serious adverse effects
throughout the study. The only two AEs reported were mild and not related to the study medication. The AEs
reported were, according to the study medical expert, related to the sampling procedure and were self
limiting and did not require any treatment. There was no change in the vital signs of the volunteers
throughout the study period. The presented data are of major importance in identifying the optimal dosing
regimen for future clinical trials with oral MELOXICAM. In our study, only one type of food (a standardized
continental breakfast) was evaluated; further studies are needed to assess the effects of foods with different
compositions and contents on the bioavailability of MELOXICAM.
Keywords: Food effect bioavailability, HPLC, Bioequivalence studies.
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INTRODUCTION
With increasing generic substitution, food– drug interaction studies have gained considerable
importance. [1-8] Food–drug interaction studies focus on the effect of food on the release and absorption of a
drug. In view of dramatic and clinically relevant food effects observed with certain Theophylline sustained
release formulations, bioequivalence between a Test and a Reference formulation under only one nutritional
condition, e.g. fasting, is by no means sufficient to allow generic substitution.[9-12] The reported food effects,
with AUC increases of 100 % and decreases of 50 % for certain formulations, are far beyond the usually
accepted 25 % increase and 20 % decrease in bioequivalence studies between formulations.[13] The CPMP
(2001) guidance on bioequivalence also addresses this issue with particular emphasis on controlled release
formulations. The FDA (2002) guidance recommends a study comparing the bioavailability under fasting and
fed conditions for all orally administered modified release drug products. Modified release formulations
include two essentially different types of release modifications, so-called ‘prolonged release’ formulations and
‘delayed release’ formulations.
Understanding the possible clinical implications of taking medicines with or without a meal is
important for achieving quality use of medicines. Although the effect of food is not clinically important for
many drugs, there are food–drug interactions which may have adverse consequences. Often these
interactions can be avoided by advising the patient to take their medicines at the same time with respect to
meals.[14-25]
SUBJECT AND METHOD
Twenty (20) male volunteers were screened out of that Eighteen (18) were considered eligible as per
protocol. Out of eighteen subjects sixteen subjects successfully completed both the studies i. e. fasting and fed,
as two subjects were dropped out during the study. Samples from all the male subjects who completed both
the periods of the study were analyzed. The blood samples were used for pharmacokinetic analysis of
MELOXICAM.
The subjects were examined within 15 days prior to their first administration of study medication
and assessed for their eligibility to participate. No clinically relevant abnormalities in physical examinations
and blood and urine analysis were reported in subjects who were included in the study. Results from
hematological and clinical biochemistry laboratory data indicating that one or more values were outside the
“normal range” did not necessarily lead to exclusion of a subject from the study. At the discretion of the
principal investigator, certain laboratories values outside the “normal range” could be repeated two times. If
the value returned to within the “normal range” for the particular laboratory test, or if the study physician
considered the repeated laboratory value to be at an acceptable level in relation to the “normal range”, the
subject was considered eligible, with respect to hematological and clinical chemistry criteria, to participate in
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the study.
The post-study safety evaluation included obtaining hematological and clinical biochemistry
laboratory data. Post-study laboratory data with values outside the “normal range” were not necessarily
repeated to establish if and when those variables returned to within the “normal range”. The variables were
reviewed against the clinical background, other relevant information and their relevance to the administered
study drug, before a decision was taken to repeat the values in question. The results of the pre- and post-
study laboratory data are included in the CRF where the study physician’s assessments on the relevance of all
variables outside the “normal range” are documented.
Vital signs and physical examinations showed no marked changes throughout the study. All the other
subjects who participated in the study were declared healthy at the post-study examination, except those
subjects who failed to follow-up for further post study laboratory examination. Pathological findings
observed during the post-study laboratory tests were documented in the CRF. Laboratory tests found to be
marginally outside the normal range were considered not to be of clinical relevance. All subjects enrolled in
the study underwent safety assessments until the completion of the study. To the principal investigator’s
knowledge, all subjects refrained from using any prescription and over the counter medications, for two and
one weeks respectively, before the first administration of study medication and for the duration of the study,
with the exception of the study medication taken on clinic days. No moderate or serious adverse events (AEs)
were reported to the investigators. Potential recall bias of AEs in this study was not likely because only one
dose of each formulation was administered during each treatment; subjects were under medical surveillance
in the clinical unit.
This study was carried out as per the ICH (Step 5), ‘Guidance for Good Clinical Practices (GCP)’150
and the principles of Declaration of Helsinki (Scotland, October 2000).151 The MGM Institute of Biosciences
and Technology, Independent Ethics Committee (IEC) has reviewed and approved the protocol and the
Informed Consent Form (ICF) for this study.
This was a randomized, open label, 2-way crossover study in 18 healthy, male subjects. The
screening consent & study consent were taken respectively before drug application. Thereafter, subject’s
medical records were documented and physical examination was conducted. Inclusion eligibility was also
based on successful completion of a clinical health evaluation, which consisted of a personal interview; a
complete physical examination (BP, pulse, weight, temperature, and respiratory rate); laboratory testing that
included a complete blood cell count and urine analysis. Testing was performed by Shrikrushna Pathology
Laboratory, Samarth nagar, Aurangabad, (MS) INDIA 431005. Subjects were excluded if laboratory values
were significantly above or below the reference range and/or if all tests had not been performed. In addition,
the laboratory data were reviewed by the investigators of the clinical unit prior to the enrollment of the
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subjects. Subjects were compensated for their participation.
The subjects were hospitalized for 12 h before and until 48 h after dosing. After an overnight fast of
at least 12 h, each volunteer received single oral doses (150 mg MELOXICAM) of either under fasting
conditions or immediately after a high fat breakfast. Wash-out periods of at least 1 week between the
treatments were maintained. A standardized meal was served to all subjects 4 h after dosing followed by
standardized meals 7 and 11 h after dosing. Conditions were chosen in accordance with international
requirements for food interaction studies.
Blood samples (1x 3 mL) will be collected by the intravenous route using heparinized disposable
syringes at the following times: Pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 14.0,
16.0, 20.0, and 24.0 hours post-dose after drug administration. The blood samples will be collected in
vacutainers containing EDTA as anticoagulant and immediately centrifuged at 3000 rpm for 15 min and
divided in two aliquots immediately after receiving the blood samples from all the subjects. The separated
plasma samples will be stored at or below -20oC until analyzed. A validated HPLC method will be employed
for the estimation of MELOXICAM in human plasma.
Vital signs, ECG and laboratory parameters were repeatedly determined during the hospitalization
phase. Subjective well being was monitored by asking for adverse events in a non leading manner and by
documentation of spontaneously reported adverse events. These were classified according to their severity
and potential relationship to the study drug. Any concomitant medication taken during the course of the
study was documented.
The following Pharmacokinetic parameters of MELOXICAM were calculated:
Cmax: Maximum measured plasma concentration over the entire sampling period, directly obtained from the
experimental data of plasma concentration versus time curves, without interpolation.
Tmax: Time of maximum measured plasma concentration (Cmax). If maximum value occurs at more than one
point, Tmax is defined as the first point with this value in each period.
AUC0-t: Area under plasma concentration versus time curve from time of dosing to time of the last
quantifiable concentration, as calculated by the linear trapezoidal method.
Individual plasma concentration VS time curves were constructed; Cmax and Tmax were directly
obtained from these curves. AUC from time 0 (baseline) to 24 hour (AUC0–24) was calculated using the
trapezoidal rule. Extrapolation of AUC from baseline to infinity (AUC0–∞) was calculated as follows: AUC0-∞ =
AUC0–24 + (C24/ke) where C24 was defined as concentration at 24 hours.
Geometric means of the pharmacokinetic parameters Cmax and AUC0-t were used to calculate the
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formulation ratios. These values were expressed as point estimates. 90% confidence interval for the ratio of
study formulations was calculated for the log transformed pharmacokinetic parameters [Cmax, and AUC0-t]
using ANOVA output from the analysis of log-transformed data. 90% confidence interval then formed the
basis for concluding the equivalence of study formulation. If the point estimate of geometric mean ratio and
confidence intervals for the entire log transformed pharmacokinetic parameters [Cmax and AUC0-t] are
entirely included in the range of 80-125%, then the treatments was claimed to be bio-equivalent. [26-42]
ANALYTICAL METHOD [43-49]
HPLC Method development for pure meloxicam:
Today the development of a method of analysis is usually based on prior art or existing literature,
using the same or quite similar instrumentation. It is rare today that an HPLC – based method is developed
that does not in some way relate or compare to existing, literature-based approaches. The development of
any new or improved method usually tailors existing approaches and instrumentation to the current analyte,
as well as to the final needs or requirements of the method. Method development usually requires selecting
the method requirements and deciding on what type of instrumentation to utilize and why. The extraction
reported to detect MELOXICAM was liquid-liquid extraction.
They were reported for the determination of MELOXICAM and its related substances in biological
fluids like plasma, blood, and urine only but, very few methods have been reported for its determination in
bulk and solid (tablet) dosage forms by reversed phase high-performance liquid chromatographic (RP-HPLC)
method. However, these methods presented some disadvantages such as being of low sensitivity, time
consuming, and costly. This study was designed to develop a simple and reliable method to quantitate
MELOXICAM in a relatively short time with high linearity. Therefore, this study involves the development of
simple and rapid isocratic RP-HPLC method which can be employed for the routine analysis of MELOXICAM.
The established method was validated with respect to specificity, linearity, precision, accuracy, and
ruggedness.
Reagents:
Water : Milli-Q / HPLC Grade
Ortho phosphoric acid (88%) : GR Grade
Trimethyl amine : GR Grade
Acetonitrile : HPLC Grade
Methanol : HPLC Grade
The linearity of the response of drug was verified from 1 g/ml to 10 g/ml concentrations. The
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calibration graphs were obtained by plotting the response versus the concentration.
Preparation of Mobile Phase:
The separation was carried out under isocratic elution with mobile phase was a mixture (75
volumes) of 1.4 mL of ortho-phosphoric acid in 1000 mL of water and adjust the pH 3.0 by using triethyl
amine and acetonitrile (25 volumes), was filtered through 0.4 μm nylon membrane filter before use.
Chromatographic Conditions:
Column : C8 column (250 mm × 4.6 mm), 5-μm particle size SS column
Flow : 1.0 ml/min
Wavelength : 220 nm
Injection volume : 20µl
Standard Preparation:
A standard stock solution of 50 mg of MELOXICAM in mobile phase was prepared in a volumetric
flask. From this stock solution, about 10 mL was diluted to 100 mL with mobile phase.
HPLC METHOD DEVELOPMENT FOR MELOXICAM TABLET DOSAGE FORM
Preparation of sample solution for MELOXICAM in tablet dosage form:
Twenty tablets were weighed and crushed to a fine powder. The powder equivalent of 50 mg of
MELOXICAM was taken in a 100-mL volumetric flask containing mobile phase and kept sonication for 10 min
and made up to mark with mobile phase. The resultant mixture was filtered through 0.45 μm nylon filter. The
desired concentration for the drug was obtained by accurate dilution, and the analysis was followed up as in
the general analytical procedure.
Evaluation of system suitability:
The column efficiency determined for the MELOXICAM peak from the standard preparation should
not be less than 5000 theoretical plates and tailing factor for the same peak should not be more than
2.0.
The percentage relative standard deviation for five replicate injections of standard preparations
should not be more than 2.0.
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Labeled amount (mg) Amount added (mg)
Amount recovered
(mg)
% Recovery
150.0 40.40 40.38 99.95
150.0 50.90 51.30 100.79
150.0 60.10 59.68 99.29
Table 4: Recovery studies of MELOXICAM
Specificity
Weight of sample
(g)
Time (h)
RT of
MELOXICAM
RT of degraded Product
Acid stress (0.5
N)
0.305
0 4.300 4.308
8 4.301 4.310
Base stress (5
N NaOH)
0.305
0 4.325 4.317
8 4.322 4.314
Peroxide stress
(3 % H2O2)
0.305
0 4.233 4.217
8 4.244 4.221
Table 5: Recovery studies of MELOXICAM
Assay calculation for MELOXICAM Tablet formulations:
% Assay
Where,
AT1 : Average area counts of MELOXICAM peak in sample preparation.
AS : Average area counts of MELOXICAM peak in standard preparation.
W : Weight of MELOXICAM working standard, in mg.
P : Potency of MELOXICAM working standard, on as is basis.
LC : Label claim of MELOXICAM in mg / gm
W1 : Weight of sample in gm
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Factor Level Retention Time
Flow Rate (mL/min):
0.9 -1 4.675
1.0 0 3.833
1.1 +1 3.825
pH of mobile phase:
2.9 -1 3.667
3.0 0 3.675
3.1 +1 4.808
Percentage acetonitrile in the mobile phase:
22.5 -1 3.800
25.0 0 3.792
27.5 +1 5.233
Table 6: Robustness characteristics of MELOXICAM
Table 7: Determination of Precision for HPLC system validation
Sr. No.
Percentage assay value for
Precision
1 99.43
2 99.64
3 99.60
4 99.08
5 99.20
6 100.12
Mean 99.50
RSD 0.36
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Sample
No.
Assay of MELOXICAM as % of labeled amount
Analyst-I (Intra-day precision) Analyst-II ( Inter-day precision)
1 99.43 99.73
2 99.62 99.20
3 99.50 99.88
4 99.18 99.57
5 99.22 100.00
6 100.10 99.23
Mean 99.50 99.60
RSD 0.38 0.27
Table 8: Determination of Precision for HPLC method validation
Formulation Level %Recovery %RSD*
MELOXICAM Tablet
formulation
50% 99.20 0.2834
100% 99.90 0.3050
150% 99.60 0.3491
Table 9: Recovery Studies for HPLC method validation
* RSD of six observations
Formulation Amount
% label claim %RSD*
Labeled Found
MELOXICAM Tablet
formulation
150 mg 147.9 mg 98.60 0.2223
Table 10: Analysis of Formulation for HPLC method validation
* RSD of six observations
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Statistic
Cmax
(ng/mL)
Tmax
(h)
AUC
(0-t)
(ng*h/mL)
AUC
(0-inf)
(ng*h/mL)
Kel
(1/h)
t1/2
(h)
T lag
(h)
Mean 201.28 2.21 1823.87 2333.79 0.08 6.95 0.31
GeoMean 188.22 2.06 1595.73 1903.17 0.07 5.87 0.31
Median 180.76 2.30 1493.85 1638.87 0.08 5.31 0.19
Minimum 83.58 1.15 707.66 777.13 0.02 3.02 0.00
Maximum 375.59 4.59 3976.97 6792.34 0.13 19.88 0.77
S.D. 100.40 1.17 1287.33 2201.47 0.04 6.46 0.26
Range 381.48 4.50 4270.93 7858.09 0.15 22.04 1.00
%CV 38.2 40.5 54.0 72.2 43.0 71.1 64.4
N 18 18 18 18 18 18 18
Table 11: Summary Table of Descriptive Statistics of Pharmacokinetic Variables of Fed study.
Statistic Cmax
(ng/Ml)
Tmax
(h)
AUC
(0-t)
(ng*h/mL)
AUC
(0-inf)
(ng*h/mL)
Kel
(1/h)
t1/2
(h)
T lag
(h)
Mean 89.26 3.51 1312.55 1572.23 0.07 5.43 0.48
GeoMean 76.20 4.66 1079.07 1412.74 0.06 6.29 0.49
Median 77.62 4.59 1246.55 1444.09 0.06 5.98 0.38
Minimum 40.29 1.55 459.60 548.77 0.02 3.09 0.00
Maximum 147.10 9.19 2540.90 4365.39 0.13 21.08 1.15
S.D. 40.32 2.48 778.96 1405.16 0.04 5.08 0.34
Range 139.53 9.98 2718.96 4985.92 0.15 23.51 1.50
%CV 37.8 37.6 48.8 63.5 40.8 55.9 53.4
N 19 19 19 19 19 19 19
Table 12: Summary Table of Descriptive Statistics of Pharmacokinetic Variables of fasting study
Method precision was evaluated by carrying out the independent assays of MELOXICAM. The sample
of known concentration was injected thrice for every formulation. The relative standard deviation was then
calculated.
Accuracy or recovery test was studied by adding known amount of drug in the blood samples. The
recovery was performed at about 50%, 100% and 150% of MELOXICAM. The method used in determining the
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accuracy of the samples was adopted to prepare the samples for the recovery studies. The solutions were
analyzed and the percentage recoveries were calculated.
Table 13: Summary Table (ANOVA) of the Main Study Results for fed and fasting studies.
Parameter
(Log transformed)
Geo-Mean ratio
(fed /fasting)
90% Confidence limit (0.8-1.25) Conclusion
(fed vs fasting)Lower Upper
Cmax 0.526 0.4819 0.5736 Not equivalent
AUC(0-t) 0.883 0.7950 0.9551 Not Equivalent
Table 14: Summary Table of the Comparative Bioavailability Data for fed and fasting conditions
VALIDATION OF HPLC METHOD FOR MELOXICAM TABLET FORMULATION
Preparation of sample solution for MELOXICAM in tablet dosage form:
Twenty tablets were weighed and crushed to a fine powder. The powder equivalent of 50 mg of
MELOXICAM was taken in a 100-mL volumetric flask containing mobile phase and kept sonication for 10 min
and made up to mark with mobile phase. The resultant mixture was filtered through 0.45 μm nylon filter. The
desired concentration for the drug was obtained by accurate dilution, and the analysis was followed up as in
the general analytical procedure.
Parameter
Fed fasting F
(treatment)
Infe-
rence
PMean CV% Mean CV%
Cmax
(ng/mL)
118.611 37.8 252.945 38.2 81.926 S 1.37e-017
Tmax
(h)
6.59 37.6 2.889 40.5 - S -
AUC(0-t)
(ng*h/mL)
2546.240 48.8 2782.655 54.0 5.0362 S 0.0045
AUC(0-inf.)
(ng*h/mL)
2851.89 63.5 2948.791 72.2
N/A N/A N/A
t1/2
(h)
5.089 55.9 5.080 71.1 N/A N/A N/A
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PK Parameters Fed Fasting
Cmax (ng/mL)MeanSD 116.611+40.32 272.945+100.40
AUC(0-t) (ng*h/mL) GeomeanSD 1379.668+778.96 2274.615+1287.33
AUC(0-inf) (ng*h/mL)GeomeanSD 1795.558+1405.16 2516.244+2201.47
Tmax(h)MedianSD 6.00+2.48 3.00+1.17
Kel(1/h)MeanSD 0.091+0.03 0.102+0.04
t1/2MeanSD 5.089+5.08 5.080+6.46
T lag (h)MeanSD 0.632+0.34 0.403+0.26
Table 15: Summary of comparative pharmacokinetic data of feds and fasting studies
Figure 1: Combined Pharmacokinetic Time Vs Concentration Profile in fasting and fed conditions for all
subjects
Sample Injection Procedure:
Six injections of each of the MELOXICAM sample were injected into the chromatographic system. The
chromatograms were recorded and the peak area counts were measured for the MELOXICAM peak.
Specificity / Purity plots:
The MELOXICAM samples prepared as per the above mentioned methodology were foremost
0
20
40
60
80
100
120
140
160
180
200
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17
Concinmcg/ml
Time in Hrs
Combined Mean Pharmacokinetic Time Vs Concentration Profile for all Subjects
Fasting
Fed
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analyzed for the purity of the samples and the purity peaks were obtained.
Figure 2: Spectrum Index Plot of MELOXICAM by HPLC
Figure 3: Chromatogram of MELOXICAM
System Precision:
Six replicates of the standard solution were injected into the HPLC system and the area of the peak
and RSD was calculated.
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Method Precision:
Assay of method precision (intraday precision) was evaluated by carrying out six independent assays
for both formulations of MELOXICAM. The intermediate precision (inter-day precision) of the method was
also evaluated using two different analysts, systems and different days in the same laboratory.
Figure 4: Linearity graph of MELOXICAM at 205 nm by HPLC
Accuracy (Recovery test):
Accuracy of the developed method was studied by recovery experiments. The same solutions were
analyzed for percentage recovery studies at three levels (50%, 100% and 150%) for each formulation. The
assay results were expressed as percentage of label claim of amount of MELOXICAM found in the tablet
formulations.
These solutions were analyzed for its percentage drug contents with respect to label claim, by a
single analyst six times a single day and by another analyst once a day for six days, to calculate the percentage
precision of the method.
RESULTS
This study has demonstrated that all the pharmacokinetic parameters of both the treatments were
statistically different from each other. In the fed condition the values of Cmax and AUC were decreased while
Tmax increases than that of fasting which demonstrated that the extent of systemic exposure to MELOXICAM
was affected by the delay in absorption of MELOXICAM in the presence of food. None of the study volunteers
y = 65505x - 1130.
R² = 1
0.00
100000.00
200000.00
300000.00
400000.00
500000.00
600000.00
700000.00
1 2 3 4 5 6 7 8 9 10
Area
Meloxicam Concentration in μg/ml
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reported any serious adverse effects throughout the study. The only two AEs reported were mild and not
related to the study medication. The AEs reported were, according to the study medical expert, related to the
sampling procedure and were self limiting and did not require any treatment. There was no change in the
vital signs of the volunteers throughout the study period. The presented data are of major importance in
identifying the optimal dosing regimen for future clinical trials with oral MELOXICAM. In our study, only one
type of food (a standardized continental breakfast) was evaluated; further studies are needed to assess the
effects of foods with different compositions and contents on the bioavailability of MELOXICAM.
CONCLUSION
This study has demonstrated that all the pharmacokinetic parameters of both the treatments were
statistically different from each other. In the fed condition the values of Cmax, AUC and Tmax increases than
that of fasting which demonstrated that the extent of systemic exposure to MELOXICAM was affected in the
presence of food.
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