MICROMERITIC STUDY OF AZADIRACHTA INDICA HERBAL TABLET WITH ITS EVALUATION

ABOUT AUTHORS
*Ladi Alik kumar , Dash Priyadarshini , Nayak Chandan , Barri Prasanta kumar   Gayatri Institute of Science and Technology,
Gunupur, Rayagada,765022, Odisha
*alikkumar3@gmail.com

ABSTRACT
Neem is a large, dense evergreen tree in India growing 10-105m tall leaves divided into numerous leaflets. It has great healing power, acts as purifier, helps in treatment of eczema, leprosy and epiphoram.
The aim of the present work is to improvise the flow ability of herbal powders and minimized processing problems of herbal drug tablet. Macroscopic character of neem tree bark is thick, rough, brown in colour. leaf is alternate estipulate and are closely clustered towards the ends of the branches.
Micromeritic study is done using bulk density and tapped density, porosity, compressibility index, Carr’s index and Hausner’s ratio.
Preparation of extract of neem tablet is done by weight granulation method. It can be evaluated by weight variation, hardness test, friability test and disintegration test.
After all the evaluation is done, the prepared neem leaf passes all the Q.C test.

REFERENCE ID: PHARMATUTOR-ART-2513

INTRODUCTION
Neem is very common tree in India. It is a large evergreen dense tree growing 10-50meter tall leaves of this tree are divided into numerous leaflets each resembling a full grown leaf.

The neem tree played in ayurvedic medicines and agriculture since time immemorial. It is indigenous to south Asia, where up to twenty million trees line the roads. The trees occur naturally in the Deccan peninsula, but is cultivated all over India

HEALING POWER:
Neem tree is generally considered to be an air purifier and preventive against malarial fever,acne,pimples and cholera. All parts of the tree possess medicinal properties.

ECZEMA:
The bark of the neem tree is used in the treatment of eczema.About 25gms each of this bark and the mango bark should be boiledin about 1 litre of water and the vapour allowed to ferment the affected part.After the fermentation the affected part should be anointed with ghee.

LEPROSY:
The sap of the neem tree has been found effective in leprosy when taken in daily doses of 60gms.Simultaneously the patient’s body should be massaged with sap.This regimen should be continued for 40 days.If the sap is not available.12gm of neem leaves and three decigrams pepper can be ground in water and taken.

MALARIA:
An infusion or a decoction of the fresh leaves is a bitter vegetable tonic and alternatives, especially in chronic malarial fevers because of its action on the liver.It should be taken in doses of 15 to 60 grams.

EPIPHORA:
The leaves are beneficial in treating epiphora that is watering of the eyes in which tears flow into the cheeks due to the obstruction of lacrimal duct.About 250gms of leaves should be boiled in one and a quarter litre of water until only a quarter litre of water is left.

AIM OF THE PRESENT WORK:[7]
To improvise the flowability of herbal powders and minimisethe processing problems of herbal drug tablets.

DRUG PROFILE:
Azadirachta Indica-
Sanskrit-nimba, Hindi-limba,Gujarat- limba, Telugu-vepa, Tamil-vepa, Malayalam-vepa

HABITAT:
Neem is a native tree of India, atropical tree especially suited to semi-aridcondition. It is now grown in many Asian countries and in tropical region of thewestrian hemispheres. Neem is considered to be part of India’s genetic biodiversity. It is medium tree having short straight bole,furrowed,dark brown to grey bark,dense rounded crown of pinnate leaves.Native to India and other South Asia countries.Neem is widely planted and naturalised in semiarid- areas of throughout Asia and Africa.

MACROSCOPIC CHARACTERS:[1]
BARK:- Moderately thick,rough,brown in colour longitudinally and obliquely furrowed internally starch white ,laminated with characteristics odour/smell of neem and bitter in taste.
LEAVES:- Alternate estipulate,imparipinnate leaflets 20-25cmin length lanceolate closely clustered towards the ends of branches, serrate margin green, bitter.
SEEDS:-Nimbin , Nimbi din , Azadirachtin

MATERIALS AND METHODS:[10]
Materials used-
1.neem leaf powder
2.lactose
3.starch
4.talc
5.magnesium stearate
6.gum acacia

INSTRUMENTS USED IN THE PRESENT STUDY:[6]
1.Vimsaurograph
2.Enarreposograph
3.Bulk density apparatus
4.Pyconometer
5.Standard sieves
6.Cadmach single punch table
7.Monsanto hardness tester
9.Roche friability test apparatus

MICROMERITIC STUDY:[9]
Determination of angleof repose ESSAR repos graph.It is the maximum angle that is obtained between the free standing surface of the powerhead and the horizontal plane and defined by the equation-

Tanθ =2h/D
Where,
D=diameter of the conical flask
H=height of the conical flask
θ=Angle of repose

BULK DENSITY AND TAPPED DENSITY:
The bulk density was determined by pouring reweighed  and preserved powers(i.e neem leaf)into a 50ml glass graduated cylinder and the volume was measured and recorded as bulk volume ,the cylinder was tapped for 300 times or until power volume reached a minimum, volume was recorded as tapped volume ,the bulk density and tapped density were calculated as shown below and recorded in table.
Bulk density=mass/bulk volume
Tapped density=mass/tapped volume

POROSITY:
Porosity was determined using the data of true density and bulk density as follows-
E=(1-pb/pt)*100
Where is the bulk density of the power and is the true density of power.

COMPRESSIBILITY INDEX:
It is determined from tap density and bulk density by using the formula-

CARRS INDEX:
% of compressibility or car’s index=(tapped density-bulk density)/tapped density*100

HAUSNER’S RATIO:
Hausner’s ratio=tapped density / bulk density

OPTIMIZATION FORMULA:
Preparation of extract of neem tablet(300mg)
Formula no. 1(for 20 tablets)
Extract  -105mg
Starch  - 80mg
Dicalcium phosphate  -80mg
Polyvinylpyrrolidone   - 3mg (binding agent)
Methyl paraben   -  6mg
Sodium starch glycolate -  15mg
Propyl paraben   -  3mg
Magnesium stearate  -  3mg
Talc   -  3mg
Binder -  1%
Disintegrant – 5%

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MANUFACTURE SPECIFICATION -:
Size of the punch -  10mm round
Hardness -  6.04kg /cm²
Disintegration  -  15minutes
Friability   -  <1%
Description -  light brown tablet
Weight variation  - less than 4.5%

PROCEDURE(WET GRANNULATION METHOD)
Step-1 -:
Dissolve poly vinyl pyrrolidone in 3ml isopropyl alcohol, mix well, and make into clear transparentliquid.
Step-2 -:
Mix the extract with required quantity of starch and declaim phosphate and add the preservative, then, add the above binding solution to the mixture.
Step-3 -:
Pass the above and mass through sieve no -  16 to make into granules.
Step-4 -:
Allow the granules to dry at room temperature until the alcohol evaporates. Keep the granules in hot air over at 40 to remove all the moisture for 30min.
Step-5 -:
Sodium starch glycolate , magnesium stearate and talc are mixed with above granules in ascending order.

CONCLUSION -:
It comparison to above six formulations – 2 was most suitable for its hardness, dissolution time and cheaper and the formula – 2 complies with I.P specification.

EVALUATION -:
SOURCE -:
Neem – extract of azadirachta indica
Starch – SD fine chemical Mumbai
Magnesium stearate – SD fine chemical Mumbai
Talc – SD CHEMICAL MUMBAI.
PVP- SD fine chemical Mumbai
Sodium starch glycolate – SD fine chemical Mumbai
Punch machine – single punch CATMAC machine.
Dissolution instrument – six stage electronic dissolution made by TAB, MACHINE, MUMBAI, ELICO SL 164 DOUBLE BEAM UV VIS SPECTROPHOTOMER.
Hardness tester – Pfizer type tester
Friability tester – made by GROVER ENTERPRISES, DELHI

ELECTRONIC BALANCE –made by SHIMADZU PHILIPPINES MANUFACTURIG.

DISINTEGRATION INSTRUMENT - twelve tablet capacity, made by THERMONIC CAMPBELL ELECTRONICS MACHINES, MUMBAI

PROCEDURE (WET GRANULATION METHOD)
 Step-1 -:
Dissolve poly vinyl pyrrolidone in 3ml isopropyl alcohol, mix well, and make into clear transparent liquid.
Step-2 -:
Mix the extract with required quantity of starch and declaim phosphate and add the preservative, then add the above binding solution to the mixture.
Step-3 -:
Pass the above and mass through sieve no -  16 to make into granules.
Step-4 -:
Allow the granules to dry at room temperature until the alcohol evaporates. Keep the granules in hot air over at 40 to remove all the moisture for 30min.
Step-5 -:
Sodium starch glycolate, magnesium stearate and talc are mixed with above granules in ascending order.

MANUFACTURE SPECIFICATION -:
Size of the punch  -  10mm round
Hardness    -  6.04kg /cm²
Disintegration  -  15minutes
Friability  -  <1%
Description   -  light brown tablet
Weight variation  - less than 4.5%

EVALUATION -:
Methodology: Extract of neem tablet

MATERIALS USED –
Volumetric flask,pipette, glass rod,beaker, stand, funnel, balance.

INSTRUMENTS USED –
Electronics balance, slide clipper, Monsanto hardness tester, roach fribilator, disintegration test apparatus, dissolution test apparatus, UV spectrophotometer.

WEIGHT VARIATION -:
20 tablet are weight first.
Individual weights are performed
Average weight is done by dividing total weight to the total number of tablets.
The percentage deviation is carried out by total weight of the total number of tablet.

HARDNESS TEST -:
The table was kept in hard ness tester.
Then pressure was applied up to breaking of tablet.

Note the pressure.

FRIABILITY TEST –:
10 tablets were taken in apparatus. Set for 100 rotations at speed of 25 r.p.m. wt. of 10 tablet were taken before and after being subjected to rotation.
Deviation was calculated as –
Percentage friability = wn – wo *100/wn

DISINTIGRATION TEST -:
SIX TABLETS WERE TAKEN AND TEST WAS PERFORMED.
TEMPRETURE IS 37ᴼC.
The medium is distilled water .

RESULT AND DISCUTION -:
The micromeritic properties of the power viz angle of repose (38.214) was determined using conventional method. Carr’s index (31.847) and Hausner’s ratio (1.467) were determined using tap density apparatus.  The powders of size # 85 were subjected to wet granules.

The moisture content of the granules was 4.5% which is optimum for processing of tablet dosage form. the most important factor affecting the bulk density and flow properties is the interparticulateinteraction. Particle properties and the optimal presence of water diminish the cohesiveness of the powder, resulting in an increased bulk density and enhanced flow ability. angle of repose (27.064), Carr’s index (22.51) and Hausner’s ratio (1.29) revealed that they are well within the theoretical limit for processing into tablets.

Compressibility or the amount of densification due to tapping cohesiveness or how fast or easily the final packing state was achieved indicate good flow ability and small cohesiveness. The tablet was subjected to various quality control test such as weight variation, hardness, friability and disintegration test. weight variation was within the permissible limit (5%) as per I.P.  hardness of the tablet (electro lab digital hardness tester Mumbai) was 2.3kg / cm² the loss in weight due to friability was 0.6% disintegration time of the tablet was 5.3min .

Hence the prepared neem leaf tablet passes all the Q.C test for table.

CONCLUSION : - A study of micromeritic property and compaction of the neem leaf powder and granules revealed a significant improvement in the flow ability and compactibility. Huckle’s plots explain the compaction characteristics of Azadirachta Indica. kawakita analysis the flow ability and cohesiveness based on this systematic approach, a tablet formulation could be developing successfully for Azadirachta Indica leaf powder. Hence the present study recommends the current needs to generate similar data for different herbal drugs or Ayurvedic formulation which is highly essentially in industrial application.

BIBLIOGRAPHY-
1.C.K.Kokate A.P.Purohit , s.bgokhale.Pharmacognosy ,18th edition, Jan 2004, page 260-261, 342-344,514-516.
2. The useful plants of India new delhi. Page-64.  
3.Compendium of Indian medicinal plants vol –1 , vol-2 , vol-3 ,  vol -4 . having  pages 50,  85 87.
4. Indian medicinal plants . vasu vol-1 page-218
5. Medicinal plants vol-1 By Bently and Trimen. Pg-62
6. Prerscott, j.k and Barnum. R.A pharmaceutical technclogy,2000 60-64.
7. Martin A Eds Physical pharmacy ,4th edition ISE, Williams and willikns, page-200 ,44
8. Hausner trans metalla ,soc AIME, 1961,222,1001-1008.
9. C.V.S.Subrahnanam , test book of physical Pharmacy ,4th edition 2001 page-423
10.ALFRED MARTIN–PHYSICAL PHARMACY 4th  EDITION 2001 ,PG-423

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