‘Safety Evaluation Of Microalgae In Rodents.’

Presented By;Mr. Sharad D.Khune

(M. Pharm Sem-III)

Guided by;

Dr. A.D. Kshirsagar

Associate and Head (Department of Pharmacology)

Padm. Dr. D. Y. Patil Institute of Pharmaceutical Sciences & Research,

Pimpri, Pune-411018

Introduction;Toxicology-

is a science of posions their source,chemicalcomposition,action,test for detectionand antitodes

Toxicologists talk about the target of a toxicant, theyare referring to the particular macromolecule, cell,organ or biochemical process that the toxicantdisrupts.

The way the toxicant is able to disrupt that process iscalled the mechanisnm of action the toxicant. Not alltoxicants are lethal. They may alsocause disease,tissue damage,genetic alterations, cancer, etc.

Continued….

Safety pharmacology- Definition- Saftey pharmacology is defined as those

studies that investigate the potential undesirable

pharmacodynamic effects of substance on physiological

functions in relation to exposure in theraputic range and

above.

On the basis of hierarchical systems of human body it is

divided in three category;

1.Core battery 2. follow up study

3. Supplemental study.

Microalgae-Microalgae are prokaryotic or eukaryotic photosynthetic

micro organism that grow rapidly and live in harsh

conditions due to their unicellular or simple multicellular

structure. Ex. eukaryotic microalgae is green algae

Chlorophyta.

Literature survey; The theraputic use of algae has a long history with

records dating back to the chinese ‘Ben cao’ , ayurveda

medicine and materia medica of Discurides (approx 70

AD)This use continues today.

The application of algae derived compounds in modern

medicine is still limited,however in last 15 years

compounds from microalgae such as caratenoids ,long

chain poly unsaturated fatty acids ,proteins are sold as

neutraceuticals.

for example spirulina plantesis is a good source of protein.

Algal pigments….

Continued…… Algae are proving to be a source of many potential new

drug and bioactive molecules with diverse

pharmacological activities.

Biological activities in algal natural compounds have wide

effect such as antibacterial,antifungal,antiviral,and

antioxidant activities.

Applications of algae..

Need of work…… Thus, as we have seen in literature survey there is need

of more use and commercial applications of microalgae to

satisfy the demands of increasing world population.

But, it is prime important to asses the pre-clinical

evaluation of new test substance on rodents before

practicized on humans.

Aim and objective…

A] To Study single dose acute oral toxicity study of Microlagea;

1. Cladophora ,

2. Spirogyra,

3. Sirogonium,

4. Chlorella ,

5. Scendesmus ,

B] To Study repeated dose oral toxicity (28 days)of Microlagea;

1. Cladophora .

C]To Study repeated dose oral toxicity (28 days)of Microlagea;

1. Spirogyra

Material and methods…..Collection of algal biomass

Selection of laboratory animal

Housing and diet of laboratory animal

Acclimatization of laboratory animal

Preparation of doses.

Number of animals and dose levels.

Procedure to be followed.

Observations and interpretation of results.

Material and methods……..A] study of single dose (14 Days) acute oral toxicity of algae and in

rats.(OECD guidelines 423);

The acute oral toxicity of algae and will be performed according toOECD guidelines 423.

The dose of 2000 mg/kg will be administered in female rats. Controlgroup will be administered with 1 ml/kg vehicle.

The effect of the extract on body weight and food waterconsumption of the test group will be done in comparison with thecontrol group.

Various parameters such as body weight, Food and waterconsumption FOB will be determined on the 0th, 7th, 14th day andrelative organ weight of the control and treated group will also bedetermined. (OECD guidelines, 423) Histopathology if available.

Material and method…….B] study of the sub-acute (28 days)oral toxicity of algae Cladophora ;

(OECD guidelines, 407).

Depending on the submaximal dose from single dose oral acute toxicity different doses of the algae will be selected for sub acute oral toxicity study and administered to the test group. period.Boththe male and female rat will be selected for the study.

Toxicity and mortality will be observed during the experimental period.

Physiological ,FOB parameters will be evaluated on 0th, 7th, 14th, 21st, 28th and 42ndday For control,test and reserved group.

Hematological, biochemical and Histopathology study will be carried to study the effect of the drug on the major organs. (OECD guidelines, 407).

Continued………C] Study of the sub-acute (28 days)oral toxicity of algae Spirogyra; (OECD

guidelines, 407). Depending on the submaximal dose from single dose oral acute

toxicity different doses of the algae will be selected for sub acute oral toxicity study and administered to the test group.Both the male and female rat will be selected for the study.

Toxicity and mortality will be observed during the experimental period.

Physiological ,FOB parameters will be evaluated on 0th, 7th, 14th, 21st, 28th and 42ndday For control,test and reserved group.

Hematological, biochemical and Histopathology study will be carried to study the effect of the drug on the major organs. (OECD guidelines, 407).

STATISTICAL ANALYSIS…..Statistical analysis will be done by one way ANOVA followed

by Dunnett’s test.

Data will be express as Mean ± SEM.

Hypothesis…. The aim of present work is to check the toxicity of algal

species and If,they are toxic they will be discarded.

Depending on results If they are safe ,we can proceed

further and use them as a animal feed, neutraceuticals,

feed additives,pharmacologically active biomolecules and

theraputic agents respectively.

Continued……..

REFERENCES…….. F.S.k .Barar Essentials of pharmacotherapeutics, Edition 5th, page no 1

Satish kumar , CNS safety pharmacology, CRIPS vol. 8 no.1,2007

Teresam, et al microalgae for biodiesel production andother application.Renewable and sustainable energy review14(2010)217-232

Sushil kumar etal , International journal of pharmcy andpharmaceutical sciences, vol 4, suppl. 2, 2012.

Michael borowitzka, pharmaceuticals from algae, journalof biotechnology.vol-2

El–barky et al, characterisation of neutraceuticalcompound in blue green algae spirulina maxima, journal ofmedicinal plant and research , vol 2(10),page no 292-300,oct 2008

M salzar et al, subchronic toxicity study in mice fedspirulina maxima , journal of ethnopharmacology, 62(1998)235- 241.

OECD Guideline for the testing of chemicals: Acute oraltoxicity (2001); 423

OECD Guideline for the testing of chemicals: Repeateddose 28 day oral toxicity study in rodents (2008); 407