Available online at www.pharmresfoundation.com ISSN: 2229-3787 Journal of Advanced Pharmaceutical Research. 2011, 2(3), 128-134. Research paper Isolation and evaluation of Vigna mungo gum as a novel binder Hemant H Gangurde*, Mayur A Chordiya, Bhushan P Chordiya, Harish R Lukkad, Nayana S Baste, Vijay S Borkar Department of Pharmaceutics, SNJB’s Shriman Suresh Dada Jain College of Pharmacy, Neminagar, Chandwad, Nasik, Maharashtra,India. Corresponding author E.Mail: hhgangurde@gmail.com Received: Apr 18, 2011; Accepted: June 06, 2011 ABSTRACT India is gifted with great abundant variety of flora and fauna. Today, the whole world is increasingly interested in natural drugs and excipients. Natural materials have advantages over synthetic materials because they are non toxic, less expensive and freely available. Various gums like gelatin, acacia, alginic acid, guar gum, maize starch, and potato starch have been used as binder in pharmaceutical formulations. But still finding novel binder is useful in the pharmaceutical industry for manufacture of tablets. The present study was undertaken to find out the potential of gum extracted from Vigna mungo seeds as a binder in tablet formulations. Paracetamol was selected as model drug for this study. The gum was extracted from the seeds, and evaluated for solubility and flow properties. Gum was used as a binder at variant concentrations of 6, 8 and 10% w/v. The paracetamol tablets formulated using Vigna mungo seed gum (VMSG) were evaluated for general appearance, thickness, content uniformity, hardness, friability, disintegration time and drug release profile. Paracetamol tablets containing gelatin as standard binder were prepared and assessed comparatively. Results obtained indicate that VMSG performed as good as gelatin as a binder to paracetamol tablets. KEYWORDS: Binder, Vigna mungo seed gum, Paracetamol, gelatin. INTRODUCTION Binders are agents used to impart cohesive qualities to the powdered material during the production of tablets. They impart cohesiveness to the tablet formulation, which ensures that the tablet remains intact after compression as well as improving the free flowing quality (Sujja et al., 1996). Binders have been used as solutions and in dry form depending on the other ingredients in the formulations and the method of preparation. The choice of a particular binding agent from different sources have been evaluated and used as excellent binders in either mucilage or the dry powdered form (Kulkarni et al., 2002; Panda et al., 2006; Ibezim et al., 2008). Apart from starches, other natural gums, gelatin, sugar solutions, modified natural and synthetic polymers have been employed with considerable success as binders. In all evaluations, the type and binder concentrations have direct effect on the crushing strength, friability, disintegration time and tablet dissolution (Mahajan et al., 1988). depends on the binding force required to form granules Polymers of natural origin are more and its compatibility with the other ingredients economic as compared to synthetic/ semi synthetic particularly the active drug (Panda et al., 2008). Starches polymers. Owing to these characteristics of the 128 Available online at www.pharmresfoundation.com natural excipients their use in pharmaceutical formulations is much desirable. Black gram (Vigna mungo) also referred to as the Urad bean, Urad, urid, black gram, black lentil or white lentil is a bean grown in southern Asia. It is food legume and belongs to family Leguminoseae. The seed flour of Black gram swells and form gelatinous mass when it comes in contact with water due to its hydrophilic nature. It is used as a binder in the preparation of batter for cooking “Imarti (Jahangiri)” in south India (Mahajan et al., 1988). Under the Mughals in South Asia, sometimes in the building of bridges use was made of lentils/daals such as Urad daal which is a sticky daal and acted as a binder and strengthening material due to large quantity of polysaccharides (Yadav et al., 2009). These wide applications of seed flour of Black gram propose their strong hydrophilic nature, substantial binding property ISSN: 2229-3787 Extraction of gum (Yadav et al., 2009) Vigna mungo seeds were roasted at 70°C for 10 min to make the shell brittle. The seeds were then dehusked and the cotyledons were autoclaved in a 1% (m/V) solution of sodium metabisulphite at 121°C for 15 min. This helps inactivate the enzymes usually present and also reduces darkening. The cotyledons were then air dried, pulverized in a hammer mill and the flour obtained was soaked in a solution of 1% (m/V) sodium metabisulphite for 24 h and thereafter passed through a muslin cloth. The resultant filtrate was desolvated with acetone. This product of desolvation (VMSG) was dried in a hot air oven (Labin LI87D, India) and then pulverized. This gum and gelatin powder was tested for flow properties and the values were represented in table 1. All values were found to be satisfactory. and compatibility with the physiologic environment. Since matrix tablet is the easiest approach to design the Solubility determination (Tsige et al., 1993) sustained drug delivery system, we were interested in A 2% w/w dispersion of gum was prepared investigating the matrix forming ability of seed flour of in a 50 ml volumetric flask. The dispersion was Black gram in tablets for sustained drug delivery (Tsige shaken frequently for some time and allowed to et al., 1993). stand for about 8 h. It was then filtered with a filter MATERIALS AND METHODS paper and 30 ml of the clear filtrate evaporated to dryness in a preweighed dry crucible. The weight of Materials The seeds of Vigna mungo (Black gram) were purchased from local market. Paracetamol was used as a model drug in the study, and it was a kind of gift sample gum residue obtained was determined by difference. Solubility was calculated in g/dm3 and mg %. The same procedure was repeated for gelatin powder. Bulk and tapped densities (Schwartz et al., 1975) from Haffkine Ajintha Pvt. Ltd., Jalgaon. All the chemicals and other reagents used in the study were of AR grade. A 20.0 gm bulk volume sample of VMSG powder was transferred into 100 ml measuring cylinder and the volume, which was the mean of the reading from several sides, was calculated. The 129 Available online at www.pharmresfoundation.com ISSN: 2229-3787 cylinder was tapped for 250 times when there was no The angle of repose of powdered gum was observable decrease in volume. The bulk and tapped determined by the funnel method. The accurately densities were calculated as the mean of three weighed gum powder was taken in a funnel. The determinations from the equation: height of the funnel was adjusted in such a way that p= m/v Where p is density (g/cm3), m is the mass ( g ) of the data gum, v is the volume of the powder in the cylinder. the tip of the funnel just touched the apex of the heap of the powder. The powder was allowed to flow through the funnel freely onto the surface. The diameter of the powder cone was measured and angle of repose was calculated using the following Compressibility (Carr’s) Index equation: θ = tan –1 (h/r) The simplest method of measurement of free flow of powder is compressibility, an indication of the ease with which material can be induced to flow is given Where “h” and “r” are the height and radius of the powder pile respectively. by compressibility index (I) which is calculated as Preparation and evaluation of the granules follows, ρ − ρb I= t × 100 ρt ρ t indicates the tapped density; ρ b indicates the bulk density. The value below 15% indicates a powder which usually gives rise to excellent flow characteristics, whereas above 25% indicate poor flowability. Hausner’s Ratio (H) Aqueous solution of VMSG and gelatin in the concentrations of 6, 8 and 10 % w/v, were prepared with the aid of heat. Paracetamol and starch (as a diluent) were passed through sieve # 40 and mixed for 20 minutes using laboratory scale double (twin) cone mixer. Granules were prepared by wet granulation method using VMSG and gelatin solutions in concentration This is an indirect index of ease of powder flow. It is calculated by the following formula, Η= ρt ρb of 8, 10 and 12 % w/v, the damp mass was passed through sieve # 12 and granules were dried at 500 for 1hour in a tray drier. The dried material was then passed through sieve # 16. The prepared granules were then evaluated for moisture content analysis ρ t indicates the tapped density; ρ b indicates the and flow properties (by measuring angle of repose). bulk density. Lower Hausner’s ratio (<1.25) indicates The bulk and tapped densities were determined better flow properties than higher ones (>1.25). using bulk density apparatus. Compressibility index of Angle of repose (Liberman et al., 1989) the granules was determined by Carr’s compressibility index. 130 Available online at www.pharmresfoundation.com The disintegration time of tablets was Formulation of Paracetamol Tablets Magnesium stearate, talc and Aerosil 200 were mixed with prepared granules (Table 3). These granules were punched to tablets using eight station 2D Rimek Minipress tablet compression machine (Karnavati Engineering Ltd.) at arbitrary pressure load unit of 6 ISSN: 2229-3787 determined according to the method described in the British Pharmacopoeia 1998. Six tablets were placed in each compartment of the disintegration apparatus, with water thermostated at 37 ± 10 C as the medium. The tablets were considered to have passed the test after the 6 tablets passed through the mesh of the tons. apparatus withinin 15 minutes. Evaluation of compressed tablets (Banker et al., 1987; Jaimini et., 2007) Dissolution Tests Drug release from different formulated The prepared tablets were evaluated for weight uniformity, hardness, thickness, friability, disintegration time, and assay. tablets was performed using USP XXII, type II apparatus. 900ml of 0.1 N HCl was dissolution medium; paddle was rotated at 75 rpm with bath Thickness temperature of 37 ± 10. At every 10 minutes interval The thickness of the tablets was determined 5 ml of sample was withdrawn from the dissolution using a Vernier caliper (Vashishat, Ambala Cantt., medium to maintain the volume constant. After Haryana, India). Five tablets from each batch were used filtration and appropriate dilution, the sample and average values were calculated. solutions were analyzed at 243 nm using a UV Uniformity of Weight Visible spectrophotometer. The amount of drug present in the samples was calculated. To study weight variation, 20 tablets of each formulation were weighed using an electronic balance RESULTS AND DISCUSSION (Shimadzu D455003609, Japan) and test was performed Comparative evaluation of VMSG with gelatin according to the official method. powder Hardness and Friability For each formulation, the hardness and friability The percentage Vigna of gum mungo using seeds yield acetone as high gum of tablets equivalent to 6.5g were determined using the precipitating solvent. The isolated gum and gelatin Monsanto hardness tester (Rolex, Chandigarh, India) and powder the Roche friabilator (Electrolab friabilator EF1W, physicochemical properties as per Pharmacopoeial Mumbai, India), respectively. guidelines. The specifications were set and the was characterized for various results are shown in Table no. 1. The VMSG Disintegration time exhibited a comparatively lower solubility than gelatin powder in cold water with values of 10.35 131 Available online at www.pharmresfoundation.com ISSN: 2229-3787 and 12.76 g/dm3respectively. The solubility result shows the range of 200 to 280 which indicate free flowing that both excipients are comparable. Interestingly there properties of granules. The moisture content of all is positive correlation between gum solubility and their formulations observed within limits (Table 2). binding/disintegrating efficiency in tablets. The low bulk Evaluation of tablet (Table 4) and tapped densities of both gelatin and VMSG indicate that both materials are not highly porous and are poor flowing powders. The non-free flowing nature of gelatin and VMSG were observed from the fact that their Hausner’s ratio of 1.21 and 1.27 respectively are greater than 1.2 which indicate low inter particulate friction in powder. However, VMSG possessed better flow properties than gelatin with Carr’s compressibility index of 13.88 and 15.33% respectively (Table 1). Three batches of tablets were prepared (as per formulae given in Table 3) using isolated gum of vigna mungo seed and gelatin powder at three different concentrations 6%, 8% and 10% w/w. Gelatin powder was used as standard binder for comparison. The prepared tablets were evaluated for weight uniformity, hardness, thickness, friability, disintegration time and dissolution study. The hardness of the tablet batches was within acceptable Table 1: Physical parameters of Extracted VMSG powder and gelatin powder. aValues are expressed as mean ± SD, n = 3. Properties VMSG Gelatin powder a powdera 12.76±0.39 Cold water solubity 10.35±0.55 (g/dm3) 0.556±0.04 0.510±0.05 Bulk density (g/ml) range between 6 - 7 Kg/cm2. It is observed that the hardness increased with increasing binder concentration. The tablet hardness was generally higher with the VMSG than gelatin at all concentrations of application, an indication that Tapped density (g/ml) Hausner’s ratio 0.680±0.02 0.659±0.04 lower concentration of vigna mungo than gelatin 1.21±0.03 1.27±0.02 could be used to achieve the same level of binding. Carr’s index (%) 13.88±0.23 15.33±0.31 The same trend was observed with the friability Angle of repose 24.59°±1.46 27.33°±1.46 recorded for the two binders. Gelatin and VMSG Evaluation of granules tablets recorded formulation The prepared gum granules were evaluated for moisture content analysis and flow properties in comparison with gelatin powder granules. The lower bulk and tapped densities exhibited by VMSG and gelatin granules shows that both granules were good flowing. From the Hausner’s ratio which are almost equal to 1.2 indicate free flowing granules. In case Carr’s compressibility index, all granules possess better flow properties. The angle of repose for granules was in below 1% (Table 4). friability Variations in in all weight uniformity were less with tablets prepared using VMSG as binder. The uniformity of weight also indicates probable uniformity of content. The disintegration time decreases with increasing concentration of binder. The comparative dissolution profiles of the paracetamol tablets prepared with VMSG and gelatin as binder is shown in Figure 1. In general, the amount of drug released decreased as the binder concentration increased. (Table 4) 132 Available online at www.pharmresfoundation.com ISSN: 2229-3787 Table 2. Evaluation of the granules using VMSG and gelatin as binder. Evaluation parameters Binder Angle of Repose (°) Bulk Density (g/ml) Tap Density (g/ml) V1 (6%) 20.64±0.78 0.5±0.07 0.62±0.04 VMSG V2 (8%) 26.76±1.34 0.55±0.03 0.62±0.04 V3 (10%) 21.39±1.07 0.5±0.04 0.55±0.05 G1 (6%) 27.58±0.89 0.45±0.05 0.5±0.03 Gelatin G2 (8%) 22.86±0.43 0.53±0.03 0.58±0.06 G3 (10%) 23.94±1.51 0.48±0.06 0.55±0.03 Carr’s Index (%) Hausner’s Ratio (%) Moisture content (%) 19.35±0.33 1.24±0.05 3.0 11.29±0.12 1.12±0.02 3.0 9.09±0.27 1.1±0.07 4.0 10.00±0.18 1.11±0.06 2.0 8.62±0.15 1.09±0.04 4.0 12.72±0.19 1.14±0.04 4.0 a Values are expressed as mean ± SD, n = 3. Table 4: Evaluation of Paracetamol tablet. Formulation Weight uniformity (mg)a 605±2.37 597±3.56 603±1.85 600±1.40 603±1.91 604±3.22 Thickness (mm) a Hardness (Kg/cm2) a Formulation Code Ingredients(mg/tab) Paracetamol (Active) Starch (Diluent) VMSG Gelatin Aerosil Talc Magnesium stearate Total weight per tablet (mg) V1 500 47 36 5 8 4 600 V2 500 35 48 5 8 4 600 V3 500 23 60 5 8 4 600 G1 500 47 36 5 8 4 600 G2 500 35 48 5 8 4 600 G3 500 23 60 5 8 4 600 Cumulative % drug release 6.3±0.14 4.2±0.2 0.53±0.06 6.6±0.15 4.2±O.5 0.65±0.04 6.7±0.27 4.1±0.3 0.39±0.08 6.0±0.16 4.2±0.4 0.31±0.06 6.4±0.31 4.1±0.2 0.44±0.03 6.9±0.25 4.2±0.1 0.59±0.05 a Values are expressed as mean ± SD, n = 3. Table 3: Formulation of tablet using VMSG and gelatin as 120 standard binder V1 V2 V3 G1 G2 G3 DT (sec.) a Friability (%)a Assay (%)a 22.2±30 27.7±20 39.6±20 26.5±40 32.0±45 45.7±30 99.7±0.79 100.2±0.53 99.9±0.81 100.7±0.72 99.20±0.48 98.5±0.33 100 V1 80 V2 V3 60 G1 G2 40 G3 20 0 0 10 20 40 60 80 100 Time (Min.) 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