Isolation and Evaluation of Binding Property of Sago Starch in Paracetamol Tablet

8/4/2019 Isolation and Evaluation of Binding Property of Sago Starch in Paracetamol Tablet

1/7

Publication Ref No.: IJPRD/2010/PUB/ARTI/VOV-2/ISSUE-1/MAR/008 ISSN 0974 9446

International Journal of Pharma Research and Development Online

www.ijprd.com1

ISOLATION AND EVALUATION OF BINDING PROPERTY OF SAGO STARCH INPARACETAMOL TABLET

Gangwar Satyam *, Singh Shivani,Garg Garima, Pawar Vivek, Sharma P.K.

Meerut Institute of Engineering and Technology,NH-58, Baghpat Byepass Road

Meerut (U.P.) India 25005Email: [email protected]

ABSTRACT:

In the following study starch obtained from the sago palm (Metroxylan sagu) was used as a binder indifferent concentrations in paracetamol tablets. The tablets were formed by wet granulation method byusing 2% w/v, 4% w/v, 6% w/v, 8% w/v and 10% w/v sago starch as binding agent. Formulatedparacetamol tablets were further evaluated for various parameters i.e. weight variation, hardness,

friability, disintegration time and in-vitrodrug release. The starch obtained from sago palm was found tohave a good binding property. The hardness and disintegration time of the tablets was found to beincreased with increase in starch concentration. Tablets with highest binder concentration showedmaximum hardness (7.0 kg/m2) and disintegration time (35.9 min) and minimum friability (0.59%). Afterone hour tablets with 2% w/v starch showed maximum drug release (98.74%) and tablets with 10% w/vstarch showed minimum drug release (71.90%).

Key Words: Starch, sago, binder, in-vitrodissolution, paracetamol.

INTRODUCTION AND MATERIALS & METHODS

INTRODUCTION

Sago palm (Metroxylan sagu) is a rich source of starch. sago palm contains high amount of starch [1].Starch from different sources is a well known tablet binder. Potato starch, corn starch and cassava starchare most commonly used. Binders are agents used to impart cohesive qualities to the powdered materialduring the production of tablets. They impart cohesiveness to the tablet formulation, which ensures thatthe tablet remains intact after compression as well as improving the free flowing quality. Binders havebeen used as solutions and in dry form depending on the other ingredients in the formulations and themethod of preparation. The choice of a particular binding agent depends on the binding force required toform granules and its compatibility with the other ingredients particularly the active drug. Starch from

different sources have been evaluated and used as excellent binders in either mucilage or the drypowdered form. Maize and potato starches have been in common use and recently cassava starch

Gangwar Satyam


2/7



www.ijprd.com2

appeared in the British Pharmacopoeia as an official starch for use as binder (British Pharmacopoeia,2001) [2, 3].Some authors have studied the use of starch obtained from different novel sources like: Godare, gingerand yam as a binder and disintegrant in solid dosage form [2, 4, 5]. In the present study starch wasisolated from the unriped sago pulp and the isolated starch was used as binder for the preparation ofparacetamol tablets. Wet granulation method was used for the preparation of tablets. The tablets were

then evaluated for the disintegration and in-vitrodissolution profile.

MATERIALS AND METHODSSago starch was purchased from local market. Sodium carboxy methyl cellulose, calcium carbonate,magnesium stearate, Talc (Central Drug House New Delhi).Paracetamol was kindly donated by UnicurePharmaceutical limited Roorkee India.

EVALUATION OF SAGO STARCH

Bulk and tapped density of starch

Exactly 50 gm of starch powder was weighed on chemical balance and transferred into a 100 mlmeasuringcylinder. The cylinder was dropped on a wooden platform from a height of 2.5 cm three timesat 2 secondinterval. The volume occupied by the starch recorded as the bulk volume. The cylinder wasthen tapped on thewooden platform until the volume occupied by the starch remained constant. Thiswas repeated three times for starch powder. The data generated were used in computing thecompressibility index for the starch.

Swelling powerStarch was accurately weighed (2 g) into a dry tarred pre-weighed 250 ml centrifugal bottle. Distilledwater was added to give a total volume of water equivalent to 180 g. The starch was completelysuspended by stirring at 200 rpm using a magnetic stirrer. After taking out the stirrer, the bottle was

immediately placed in a temperature-controlled water bath at 85 0.20

C with continuously shaking at200 rpm for 30 minutes. The centrifugal bottle was then dried and placed on a balance followed by theaddition of distilled water to bring to a total weight of 200 g. After capping, the bottle was centrifuged for15 minutes at 1000xg for 15 minutes. To measure solubility, 50 ml of the supernatant was then pipettedand transferred into an evaporating petridish and dried overnight in a hot air oven at 105 oC. The driedresidue was then cooled in desiccators and weighed for soluble starch. To measure the swelling power,the residual supernatant was carefully removed and discarded. The bottle with the sediment paste wasthen weighed to give the weight of swollen starch granules. The result was expressed by the calculation.[6]

Paste clarity

The clarity (transmittance % at 650 nm) of sago starch paste was measured using the procedure of Kerrand Cleveland (1959) cited by Lim and Seib (1993). A 1% aqueous suspension of starch near neutral pHwas heated in a boiling water bath for 30 min with intermittent shaking. After the suspension was cooledfor 1 hr at 25 oC, the light transmittance at 650 nm was read against water blank. [6]

Gelatinization and pasting characteristics of starch [7]The moistened samples of starch powder were loaded into a capillary tube by means of intrusion.Thetemperature of gelling and the time from swelling to full gelatinization were measured with a melting pointapparatus.Pasting characteristics was observed by suspending 1g of starch in 10 ml of distilled waterand heating,with stirring,on a water bath.The time until paste formation was 3.8 0.5 min.

Gelling concentration of starch [7]Different concentrations of dry powder were mixed with distilled water by using laboratory stirrer and thegel forming concentrations were found out.


3/7



www.ijprd.com3

Limit tests for chlorides, sulphates and iron [8]It is highly impossible to remove all the impurities from pharmaceutical substances. So it is desirable ifthe substance is sufficiently pure and for this purpose Pharmacopoeias specify the limits upto whichvarious impurities can be tolerated. In limit tests, opalescence, turbidity or colour is compared with thefixed standards as prescribed in the Pharmacopoeias.

Measurement of diameter of starch grains [9]The diameter of starch grains was measured by using a eyepiece micrometer and a compoundmicroscope. Powder was stained with N/20 iodine, mounted on a microscopic slide using lactophenoland the diameter of starch grains was calculated randomly.

Total Microbial Load of the Isolated Starch [10]The total microbial load is an important parameter, which decides the suitability of a substance for use asan excipient in pharmaceutical dosage form. According to many Pharmacopoeias, for synthetic andsemisynthetic substances, the total aerobic count should not be more than 100 colonies forming unit(cfu) per gram, and the total fungal count (including yeast and moulds) should not exceed 50 cfu/g.

FORMULATION AND EVALUATION OF PARACETAMOL TABLETS

Formulation of Paracetamol tabletsFor the evaluation of the starch as binder, sodium carboxymethylcellulose was used as a disintegrant inthe prepared paracetamol tablet. The composition of tablet formulation containing paracetamol is given inTable 2.

Wet granulation and compressionWet granulation method was used for all tablet production. The calculation is made for 30 tablets in eachbatch. In case accurately weighed quantities of each ingredient were mixed in a mortar and anappropriate quantity of the starch mucilage was added as a granulating agent and mixed for 20 min in a

mortar. The damp mass was sieved with sieve no. 22 and dried at 500

c oven for 6 hrs. The driedgranular mass was passed through sieve no. 40 to obtain uniform sized granules. The different batchesof the granules specified amount of the disintegrant i.e. sodium CMC were then mixed with calculatedequal quantity of magnesium stearate (0.5%) and talc (0.5%) then compressed into tablets underconstant pressure with a sixteen station rotary tablet machine.[11]

EVALUATION OF TABLETS

Hardness testFive tablets were selected at random from each batch to perform this test. Pfizer hardness tester (Elite,Mumbai, India) was used to measure the hardness. Tablet was placed between spindle and anvil of the

tester and the calibrated scale adjusted to zero, then applied a diametric compression force on the tabletand the position on the calibrated scale at which the tablet broke was recorded in kg units. A meanhardness was calculated for each batch.

Weight uniformity testTwenty tablets from each batch were selected randomly and weight individually using a highly sensitiveelectronic balance. Their mean weights were calculated for each batch.

Friability testTen tablets were selected at random, dusted and weighed together using electronic balance and thenplaced in the friabilator. The machine was operated for 4 min at 25 rotations per min and then stopped.

The tablets were dusted and again reweighed. The percentage losses were calculated for each batch ofthe tablets.


4/7



www.ijprd.com4

Disintegration timeThe method specified in the USP/NF (1980) was used. Disintegration medium used was 100 ml of 0.1 NHCl maintained at temperature between 35 and 39C throughout the experiment. Five tablets selected atrandom from each batch were placed one in each of the cylindrical tubes of the basket but no disc wasused. The time taken for each tablet to break up into small particles and pass out through the mesh was

recorded. Mean disintegration time was calculated for each batch.

In vitrodissolution testThe in vitro dissolution test of the compressed paracetamol tablet was performed using USP 2nddissolution apparatus. Phosphate buffer (pH7.4) was used as dissolution medium. The temperature wasmaintained at 372 0c using rotation speed 100 rpm. Samples were withdrawn at regular intervals up to1hour, replacing equal amount of fresh dissolution medium (phosphate buffer pH 7.4). Samples wereanalysed using UV spectrophotometer and % cumulative drug release was calculated.

RESULTS AND DISCUSSION :

Table 1 shows the physical properties of sago starch. The prepared tablets of paracetamol with sagostarch as binder were evaluated for parameters such as avg. weight variation, hardness, friability,disintegration, drug content, T50%, T70%. Sago starch showed significant binding property. Table-1 showsthe various properties of sago starch powder. The angle of repose of sago starch indicates its poor flowproperty. The tablet properties are shown in table-3. The average weight variation of the formulatedtablets was found to be within acceptable limits. The hardness of the tablets increased with the increasein binder concentration. The friability was found to be decreased as the binder concentration increases.The friability of first two batches was exceeding the acceptable friability limits (more than 1%) but the

friability of tablets containing more than 4% of binder was within limits. The disintegration time, time torelease 50% of drug (T50%) and time to release 70% of drug (T70%) were found to be increased with theincreasing concentration of sago starch.

CONCLUSION

It can be observed from the results that tablets prepared using the sago starch as binder showedsignificant hardness and friability. Thus on the basis of the study it can be concluded that the starchobtained from sago palm possesses significant binding properties. So it can be used as tablet binder inpharmaceutical formulations.

ACKNOWLEDGEMENTS

Authors thanks to Unicure Pharmaceutical limited Roorkee India for providing the drug sample. We alsothank the Director, Department of Pharmaceutical Technology MIET, Meerut for providing necessaryfacilities and guidance for conducting the research.

REFERENCES

1. Metroxylon sagu (sago palm), Plant Profile, Plants Data Base, United States Department ofagriculture; Natural Resources Conservation Resources.

(http://plants.usda.gov/java/profile?symbol=MESA2).2. Ibezim EC, Ofoefule SI, Omeje EO, Onyishi VI, Odoh UE, The role of ginger starch as a binder in

acetaminophen tablets, Scientific Research and Essay. 2008, 3 (2) : 46-50.


5/7



www.ijprd.com5

3. Wurzburg OB, Modified starches: properties and uses.CRC press. Boca Raton, FL, 1986.

4. Adane M, Abdel-mohsen MG, Marian TG, Evaluation and optimization of godare starch as a binder

and disintegrant in tablet formulations, Ethiop Pharm J. 2006, 24 : 106-115.

5. Ibezim EC, Ofoefule SI, Omeje EO, Odoh UE, Performance of starch obtained from Dioscorea

dumetorium as disintegrant in sodium salicylate tablets, Afr. J Pharm.Pharmacol. 2008, 2 (3) : 52-58.

6. Singh AV, Nath LK, Evaluation of binder property of moth bean starch in compressed solid dosage

form, Int.J.Pharm Tech Res. 2009, 1 (2) : 365-368.7. Adebayo AS, Itiola OA, Journal of Pharmaceutical Technology. 2003, 80

8. Belsare D.P., Inorganic Pharmaceutical Chemistry, 1 Edition, Career Publications, Nashik, 2007, 61-

62.

9. Kokate C.K. Practical Pharmacognosy, 1V Edition,Vallabh Prakashan, Delhi. p 112.

0. Indian Pharmacopoeia, Vol. 2, Govt. of India, Controller of Publications, New Delhi, 1996, A-100.

1. Wattanachant S, Muhammad SKS, Mat Hashim D, Rahman RA, Suitability of sago starch as a base

for dual-modification, Songklanakarin J. Sci. Technol. 2002, 24(3) : 431-438.

TABLES AND GRAPHS:

Table 1: physicochemical properties of sago starch

Properties Sagostarch

Bulk density (g/cm3) 0.57142Tapped density (g/cm3) 0.76923Carrs index (%) 25.7513

Angle of repose (0) 32.39Swelling power 26.10Paste clarity (%) 8.47Viscosity (Pascal) 34.16Yield stress (Pascal) 57.493% solubility% Loss on dryingDiameter of starch grains()Gelatinisationtemperature(0c)Gelling concentration

(%w/v)Total microbial loadLimit test(chloride)Limit test(sulphate)Limit test(Iron)

0.562.24.5-12.468-732-5Absence

PassPasspass

Table 2: Formula of prepared paracetamol tablet

S.No. Ingredient Amount

1 Paracetamol (mg) 2502 Na CMC (disintegrant %) 7.53 Starch (binder %) 2,4,6,8,10


6/7



www.ijprd.com6

4 Talc (%) 0.55 Magnesium stearate (%) 0.5

Table 3: Evaluation of Paracetamol tablets

S.No. 2% 4% 6% 8% 10%

1

234

56

7

Avg. Weightvariation (%)Hardness(kg/f)Friability(%)Disintegrationtime(min)Drugcontent(mg)

T50%(min)T70%(min)

1.23%

5.51.3421.1

248.7324.7

38.4

2.07%

5.91.2123.3

248.9428.0

43.6

1.92%

6.30.9026.4

249.0929.7

46.6

2.51%

6.60.7129.3

248.0535.0

54.2

1.57%

7.00.5935.9

249.1539.5

59.4

Table 4: In-vitrodissolution data of paracetamol tablets

% cumulative drug releaseS.No. Time(min) 2% 4% 6% 8% 10%

1 0 0 0 0 0 0

2 10 20.9322 18.9844 16.7438 13.8928 10.1234

3 20 39.3452 31.184 28.3883 25.3494 17.83784 30 63.4567 56.8938 51.9383 47.9478 40.9732

5 40 74.0839 66.7284 63.9831 55.9839 51.0987

6 50 85.9037 78.9484 74.2942 67.1893 62.8937

7 60 98.7364 90.1384 83.1223 77.1398 71.9038


7/7



www.ijprd.com7

Isolation and Evaluation of Binding Property of Sago Starch in Paracetamol Tablet

Documents

Transcript of Isolation and Evaluation of Binding Property of Sago Starch in Paracetamol Tablet