Indranil KumarYadav et al. / Journal of Pharmacy Research 2009, 2(8),1281-1283 Research Article Available online through ISSN: 0974-6943 www.jpronline.info Evaluation of seed mucilage of Vigna mungo (L.) as a binder in tablet formulations Indranil KumarYadav *1, Durga Jaiswal1, Hari Pratap Singh2, Dinesh Chandra3 and D.A. Jain3 1. Rajiv Gandhi College of Pharmacy, Nautanwa, Maharajganj, India 2. A.N.D. College of Pharmacy, Babhanan, Gonda, India 3 .Institute of Pharmaceutical Sciences and Research Centre, Bhagwant University Ajmer-305001, India. Received on: 09-04-2009; Accepted on: 26-06-2009 ABSTRACT The present work reports extraction of seed mucilage of Vigna mungo. Physiochemical characterization such as swelling index, hydration capacity, powder porosity, loss on drying, pH and viscosity were studied. The seed mucilage of Vigna mungo has been evaluated for its granulating and binding properties in tablets, using paracetamol as a model drug. The seed mucilages of Vigna mungo was used in four different concentrations- 2.5, 5.0, 7.5 and 10%w/w. The granules were prepared by wet granulation technique. The prepared granules were evaluated for percentage of fines, average particle size, compressibility index and flow properties. The properties were compared with starch, which was used as a standard binder at 10% w/w concentration. The tablets were prepared and evaluated for hardness, friability, content uniformity, disintegration time and in vitro dissolution profiles. They had good physicochemical properties, and the drug release was more than 80% within 2h. All the formulations (F1, F2, F3, and F4) were subjected to stability studies for three months at 40°C temperature and with RH 75±5%, only F1 and F2 showed stability with respect to release pattern and other parameters. Hence, 2.5% and 5% concentrations of mucilage of Vigna mungo can be considered as ideal concentrations for preparation of tablets.

Keywords: Vigna mungo, Binder, Paracetamol tablet, Drug release.

INTRODUCTION An excipient is an inactive substance used as a carrier for the active large quantity of polysaccharides3. Hence the present work was at- ingredients of a medication. In addition excipients can be used to aid tempted to evaluate binding properties of seed mucilage of Vigna the process by which a product is manufactured. In general, the ac- mungo. tive substances may not be easily administered and absorbed by the MATERIALS AND METHODS: human body; they need to be put in some appropriate form with the The dehusked seeds of Vigna mungo were purchased from local mar- help of suitable excipients. Excipients are also sometimes used to ket. Paracetamol was used as a model drug in the study, and it was bulk up formulations with very potent active ingredients, to allow for purchased from Shriram Chemical Pvt. Ltd. Ghaziabad. All the chemi- convenient and accurate dosage.The natural materials do hold ad- cals and other reagents used in the study were of AR grade. vantage over the synthetic materials generally because they are non- Isolation of mucilage4: toxic, less expensive, and freely available. Natural materials further Mucilages are viscid; somewhat tenacious and adhesive liquid pre- can be modified to have tailor-made materials for drug delivery sys- pared with water as solvent. The mucilage was isolated from freshly tem and then can compete with the synthetic products available in dried and coarsely powdered dehusked seeds of Vigna mungo. To 1 the market . 20g of seed powder of Vigna mungo, 200ml of cold distilled water was Vigna mungo also referred to as the urd bean, urd, urid, black gram, added and slurry was prepared. The slurry was poured into 800ml of black lentil or white lentil is a bean grown in southern Asia. It is food boiling distilled water. The solution was boiled for 20 minutes under legume and belongs to family Leguminoseae. It is largely used to stirring condition in a water bath. The resulting thin clear solution 2 make dal from the whole or split, dehusked seeds . The seed flour of was kept overnight so that most of the proteins and fibers settled out. Vigna mungo swells and form gelatinous mass when it comes in The material was squeezed in a muslin bag to remove the marc from contact with water due to its hydrophilic nature. It is used as a binder the filtrate. The filtrate was poured into twice the volume of absolute in the preparation of batter for cooking “Imarti (Jahangiri)” in south ethanol with continuous stirring to precipitate the mucilage. The mu-

India. Under the Mughals in South Asia, sometimes in the building of cilage was separated and dried in an oven at temperature less than bridges use was made of lentils/daals such as Urad daal which is a 50oC. The dried mucilage was powdered in a ball mill and passed sticky daal and acted as a binder and strengthening material due to through #120 sieve using sieve shaker and stored in desiccator until further use. *Corresponding author. Physicochemical properties of mucilage: Tel.: + 91-19369171274 The physicochemical properties such as loss on drying, viscosity E-mail: [email protected] and swelling index were determined according to Indian pharmaco- poeial procedure5. The pH of the mucilage was determined using a digital pH meter.

Journal of Pharmacy Research Vol.2.Issue 7.August 2009 1281-1283 Indranil KumarYadav et al. / Journal of Pharmacy Research 2009, 2(8),1281-1283 Table 1: Physicochemical evaluation of seed mucilage of Vigna mungo Parameter (s) Result (s) Loss on drying 11.60% Viscosity 28.50cps Swelling index 55.35 % pH 6.58 Table 2: Characterization of granules prepared using seed mucilage of Vigna mungo as binder Property (s) Seed mucilage of Vigna mungo as binder Starch Concentration 2.5% 5.0% 7.5% 10% 10% Percentage of fines 9.68 8.54 7.53 6.12 9.12 Mean particle size 0.42 0.41 0.43 0.42 0.44 Loose bulk density (g/cc) ±SD 0.478±0.05 0.462±0.05 0.444±0.03 0.448±0.06 0.454±0.05 Tapped bulk density (g/cc) ±SD 0.556±0.02 0.551±0.06 0.548±0.03 0.545±0.02 0.508±0.04 Angle of repose (0) ±SD 24.42° 23.64° 22.40° 21.56 ° 22.84° Compressibility index (%)±SD 14.02±0.12 16.15±0.15 18.97±0.2 17.79±0.2 10.63±0.30

Table 3: Evaluation of tablets prepared using seed mucilage of Vigna mungo as binder Property (s) Seed mucilage of Vigna mungo as binder Starch Concentration 2.5% 5.0% 7.5% 10% 10% Hardness (kg/cm2) ±SD 4.76±0.03 5.8±0.04 6.84±0.03 7.54±0.5 6.12±0.08 Friability (%) 0.77 0.61 0.24 0.14 0.26 Disintegration time (min:sec) 11:58 22:16 24:55 27:48 12:56 Content uniformity(%) ±SD 98.88±0.15 101.22±0.6 100.42±0.5 97.22 ±0.2 105.30±0.22

performed for 10 minutes until formation of wet mass with sufficient cohesiveness. The wet mass was forced through a no. 16 sieve (1180 120 µm) and dried at 500C in a hot air oven for 8-10 hours. The dried F1 granules were re-sieved through a no. 20 sieve (850 µm). The pre- 100 F2 pared granules were then evaluated for percentage of fines, particle 80 F3 size, bulk and tapped densities and flow properties (by measurement of angle of repose). The compressibility index was determined by 60 F4 Carr’s compressibility index7. Magnesium stearate and talc were mixed thoroughly with granules before compression. 40 F5 Preparation and evaluation of tablets: % Drug Release 20 The tablets were compressed by using single punch machine using 13mm flat- faced punches. The batch size of 100 tablets was pre- 0 pared. The prepared tablets were evaluated for content uniformity, 0 50 100 150 hardness, friability, disintegration time and in vitro dissolution pro- file using methods specified in Indian Pharmacopoeia5. Time (min) Accelerated stability study: Fig. 1: in vitro dissolution profile of paracetamol tablets prepared Accelerated stability study was carried out to observe the effect of with seed mucilage of Vigna mungo as binding agent. Legends: F1 temperature and relative humidity on prepared formulations (F1, F2, (2.5%); F2 (5%); F3 (7.5%); F4 (10%); F5 (10%) Starch F3 and F4), by keeping at 40°C, in airtight high density polyethylene Preparation and evaluation of granules: bottles for three months, at RH 75±5%. Physical evaluation and in Paracetamol was used as a model drug to formulate granules. Micro- vitro drug release was carried out after each month for three months. crystalline cellulose was used as disintegrant; lactose monohydrate RESULTS AND DISCUSSION: was used as filler, whereas magnesium stearate and talc were used as The dried and coarsely powdered seeds of Vigna mungo yielded lubricant. The mucilage solution of Vigna mungo was used as a 2.1% of mucilage. The physicochemical properties of seed flour of binder at 2.5%, 5%, 7.5% and 10% w/w concentrations. The binder Black gram were determined and shown in Table 1. The pH of muci- solution of Vigna mungo was prepared by adding distilled water to lage was found to be 6.33. Since the pH value is near to neutral, it may measured quantity of powdered mucilage with continuous stirring. be less irritating in gastrointestinal tract and hence was suitable for 8 The corn starch paste (10% w/w) was use as a standard binder for uncoated tablets . The prepared granules were evaluated for percent- comparative study. The granules were prepared by wet granulation age of fine, particle size and flow properties. The results are shown in process6. The different batches of batch size of 100 tablets were Table 2. It was observed that the percentage of fines was reduced as prepared. The drug, lactose monohydrate, microcrystalline cellulose the concentration of the mucilage was increased. The percentage of were mixed thoroughly and a sufficient volume of 2.5%, 5%, 7.5% fines was a little higher in granules prepared using 2.5% w/w mucilage and 10% w/w of binder solution of mucilage and corn starch paste as a binder. The mean particle size (0.40 to 0.44 mm) was found to be 9 (10% w/w) was added slowly to the powder blend, and kneading was satisfactory for preparation of tablets . The bulk densities of pre-

Journal of Pharmacy Research Vol.2.Issue 8.August 2009 1281-1283 Indranil KumarYadav et al. / Journal of Pharmacy Research 2009, 2(8),1281-1283 pared granules were found to decrease slightly by increasing con- The stability study of optimized batch was carried out at 40oC-75% centrations of seed flour of black gram as a binder. This result may be RH. The tablets formulation F1 and F2 were found to be stable at such due to formation of larger agglomerates and the decrease in fines in condition and other parameters were found to be unaffected, but the the granules as increasing mucilage concentrations provide more bind- parameters of formulation F3 and F4 were out of pharmacopoeial lim- ing to the granules. The flow property of granules was determined by its. They exhibited more hardness and poor drug release pattern. measurement of angle of repose and compressibility index. The value From the present study, it can be concluded that seed mucilage of of angle of repose was found to be 21° to 25°. Hence all the granules Vigna mungo may be used as binding agent in tablet formulations. exhibited good flow properties. The results of compressibility index Seed mucilage of Vigna mungo (2.5 and 5.0%w/w concentrations) indicate a decrease in flowability with increasing mucilage concentra- can be used for the preparation of uncoated tablets. It can also be tions; however, all formulations show good flow properties. In gen- used for sustaining the drug release from tablets, since the prepared eral, compressibility index values up to 15% result in good to excel- tablets using seed mucilage of Vigna mungo produced a sticky film of lent flow properties. All these results indicate that the granules pos- hydration on the surface. sessed satisfactory flow properties and compressibility. ACKNOWLEDGEMENT: Four batches of 100 tablets were prepared using mucilage at four The authors are grateful to Shriram Chemical Pvt. Ltd. Ghaziabad, for different concentrations- viz., 2.5, 5, 7.5 and 10% (w/w). Starch paste providing paracetamol drug. We also thank Sun Pharmaceuticals, 10% (w/w) was used as standard binder for comparison. The pre- Vadodara, India for the gift samples of polymers. pared tablets were evaluated for hardness, friability, disintegration REFERENCES: time, content uniformity and in vitro dissolution profiles. The results 1. Desai A., Shidhaye S., Malke S. and Kadam V, Use of natural are shown in Table 3. release retardant in drug delivery system, Indian Drugs, 42 (9), 2005: 565-574. The hardness of tablets increased with increase in percentage of bind- 2. Parashar M.P. et al..Post harvested profile of Black gram, Govt. ing agent used. The tablets prepared with 10% mucilage showed more of India, Ministry of Agriculture (Department of Agriculture and hardness when compared to tablets prepared with 10% starch. The Cooperation) Nagpur, 2006, MRPC-71:5-9. 3. Minhas Salman, The Glory that was Hiran Minar, 2006 mucilage as a binding agent had given decrease in percentage friabil- (http://www.the-south-asian.com). ity values of tablets with the increase in concentration, but they did 4. Sumathi S. and Ray Alok R., Release behaviour of drugs from not vary significantly and were within pharmacopoeial limits. The Tamarind Seed Polysaccharide tablets, J Pharm Pharmaceut Sci, 5(1) 2002:12-18. mucilage as a binding agent had given increase in disintegration time 5. Indian pharmacopoeia, Govt. of India, Vol. 2,Controller Of Pub- with the increase in concentration, but all the values were within lications, New Delhi, , 1996: A-100. pharmacopoeial limits. At 10% concentration, the disintegration time 6. Banker, G.S. and Niel, R.A., In: Lachman L., Lieberman, A.H. and Joseph, L.K., Eds., Theory and Practice of Industrial was higher for the tablets in comparison to those prepared by using Pharmacy, 3rd Edn., Varghese Publishers, Mumbai, 1987, pp.297. 10% starch. All the batches of tablets exhibited good uniformity in 7. Summers M.P. and Aulton ME,Eds. In: Pharmaceutics-The sci- nd content. ence of dosage forms design, 2 edition, Churchill Livingstone, London, 1988, pp. 600. The in vitro dissolution profile is shown in Fig.1. It was found that 8. Ghule B.V., Darwhekar G.D. Jain D.K. and Yeole P.G, Evaluation the drug release decreased with increase in concentrations of muci- of binding properties of Eulophia campestris Wall. Mucilage. lage as a binding agent. This study showed that the drug release from Ind. J.Pharm. Sci., 68(5) 2006:566-569. 9. Martin Alfred, Physical Pharmacy, 4th edition, published by the tablets prepared using mucilage at four different concentrations Lippincott Williams & Wilkins, Maryland, USA, 1991, was more than 80% in 2 h. These tablets had given reduced diffusion pp. 423. of drug, since the tablets produced a sticky film of hydration on the 10. Yadav Indranil Kumar et al., Evaluation of Seed Flour of Vigna mungo (L.) based Sustained Release Matrix Tablets of surface. This may be the reason for reduced dissolution with increased Diclofenac Sodium, J Pharm Res, 2(5), 2009:834-838. concentration of binding agent which ultimately reduces drug release rate10. Source of support: Nil, Conflict of interest: None Declared

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