International Journal of Current Pharmaceutical Research

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MATERIALS AND METHODS Sudarshan churna (SC) and Bhaskar lavan churna (BLC) were procured from local market. Crospovidone was gift sample from MAPLE biotech Pvt. Ltd. Pune, India and other substances used in the study ammonium bicarbonate, spray dried lactose, talc, poly vinyl pyrrolidone (PVP), and sodium lauryl sulphate (SLS) were purchased from S.D. Fine Chemicals, Mumbai. Aspartame was obtained from Cipla Pharma. Ltd. Vikroli, Mumbai. Other reagents were of analytical grade. Methods Preparation of fast dissolving tablets of sudarshan and bhaskar lavan churnas by vacuum drying technique: The fast dissolving tablets of sudarshan and Bhaskar lavan churnas were prepared by wet granulation method using aqueous solution of 1% w/w PVP as binder for all formulation. The granules are prepared by passing the damp mass through sieves # 16. The wet granules were then dried at 60 0C in hot air oven. Dried granules (22/44) were taken and mixed with spray dried lactose, aspartame, superdisintegrant and different concentration of ammonium bicarbonate in a plastic container followed by compression of blend on a 10‐station rotary punch‐tabletting machine (Rimek mini Press‐1) using 12mm concave punches at hardness of 4 to 4.50 kg/cm 2 prior to compression of granules in to tablets, tabletting properties such as angle of repose, % compressibility were determined for all the formulations. After compression the tablet were collected and vacuum dried at 60 0 C until a constant weight was obtained to ensure the compete removal of sublimable compound to make the tablet porous. Schematics figure of Vacuum drying method for designing of fast dissolving tablets is shown in Fig 1. Different formulations were prepared by vacuum drying technique compositions of which are given in Table 1. Table 1: Formulae used in the preparation of tablets containing sudarshan churna (sc) and bhaskar lavan churna (blc). Ingredients (mg/tab) SC1 SC2 SC3 BLC1 BLC2 BLC3 SC/BLC 500 500 500 500 500 500 Crospovidone 32.5 32.5 32.5 32.5 32.5 32.5 Spray dried Lactose 75.25 62.25 36.25 75.25 62.25 36.25 Ammonium bicarbonate 13 26 52 13 26 52 PVP 6.5 6.5 6.5 6.5 6.5 6.5 Talc 6.5 6.5 6.5 6.5 6.5 6.5 Aspartame 13 13 13 13 13 13 SLS. 3.25 3.25 3.25 3.25 3.25 3.25 Total weight 650 650 650 650 650 650 Evaluation of tablets All the formulated tablets were evaluated for weight variation, hardness, thickness, friability, wetting time, disintegration time and stability study. In the weight variation test, 20 tablets were selected at random and the average weight was calculated. Then, individual tablets were weighed and the weight was compared with an average weight. Pfizer hardness tester was used for the determination of hardness of the tablet. The tablet was placed in contact b/w the plungers and the handle pressed. The force of fracture was recorded. The thickness of the tablet was recorded during the process of compression using calipers (Mitotoyo Japan). The friability of tablets was determined using a Roche friabilator (Electrolab, EF2 friabilator). Two tablets from each batch takened and placed in the friabilator then operated for 100 revolutions. Then the tablets were dedusted and reweighed. Percentage friability was calculated using the formula, F = (1‐W0 / W) X 100 In the disintegration time study, the tablets were taken and introduced in each tube of disintegration apparatus and the tablet rack of the disintegration apparatus was positioned in to a 1 liter beaker containing 900ml of distilled water and time of disintegration was recorded at 37±20C. internal diameter 6.5cm) containing 5ml of distilled water. A tablet was placed on the paper and time for complete wetting of the tablets was measured in seconds. The stability study of the tablets was carried out according to ICH guidelines, by storing the tablets in stability chamber (Lab‐Care, Mumbai) at 40±2 In the wetting time study, a piece of tissue paper folded twice was placed in a petridish (with 0C/75 ± 5%RH for three months. At the end of each month tablets were tested for disintegration time and wetting time. RESULTS AND DISCUSSION Flow properties of sudarshan and bhaskar lavan powders were analyzed before compression to tablets. The high values of angle of repose (SC≥42.22 and BLC≥41.17) and % compressibility (SC≥55.66 and BLC≥52.48) clearly indicates that both churnas were not free flowing powders. So in order to improve flow properties of powders a lubricant (talc) and glident (SLS) were incorporated into the churna powders. Even after addition of lubricant and glident also, there was no improvement in flow property of churnas. That is why, the powder blends of sudarshan and bhaskar lavan churnas were converted into the granules by using aqueous solution of 1% w/w PVP. The values of pre‐compression parameters of both churnas granules evaluated were within prescribed limits and indicated good free flowing property (Table 2). Then granules were compressed into tablets on a 10‐station rotary punching machine (Rimek mini Press‐1) using 12mm concave punch. Table 2: Precmpressional parameters of granules Formulation Angle of repose Compressibility Bulk density Tapped density Hausner’s Ratio Code (Ө) (±SD), n=3 (%) (±SD), n=3 (gm/cc) ± SD, n=3 (gm/cc) ± SD, n=3 ± SD, n=3 SC 1 23.65 (0.22) 16.66 (0.72) 0.43 (0.006) 0.55 (0.02) 1.27 (0.03) SC 2 24.22 (0.52) 17.72 (0.52) 0.44 (0.007) 0.52 (0.02) 1.18 (0.04) SC 3 23.70 (0.62) 19.54 (0.55) 0.45 (0.004) 0.51 (0.01) 1.13 (0.03) BLC 1 22.49 (0.92) 18.59 (1.22) 0.44 (0.006) 0.54 (0.02) 1.22 (0.03) BLC 2 23.52 (0.72) 18.33 (0.92) 0.42 (0.004) 0.53 (0.01) 1.26 (0.03) BLC 3 21.58 (0.55) 19.22 (0.99) 0.44 (0.002) 0.55 (0.02) 1.25 (0.04) Note: Values in parenthesis are standard deviation (±SD) In all formulations, the hardness test indicates good mechanical strength. Hardness of tablets decreased with increase in the amount of volatile component 14 (Fig 2‐3). Friability of all the formulations less than 1%, it indicates that the tablets had good mechanical resistance. The wetting time and disintegration time values decreased with increase in the concentration of volatile component (Fig 2‐3). It may be due to their lowest hardness and the maximum porous structure was responsible for faster water uptake, hence it facilitates wicking action of crospovidone in bringing about faster disintegration 15 (Table 3). Vacuum drying techniques use to prepare highly porous compressed tablets (mentioned in Fig 1) that were rapidly soluble in saliva. Crospovidone containing tablets rapidly exhibit high capillary activity and pronounced hydration with a little tendency to gel formation 16 and thus disintegrate tablets rapidly. 37
Hardness(kg/cm) 5 4 3 2 1 0 SC1 SC2 SC3 Formulation Code Fig 2: Graphical representation of hardness and disintegration whiletablets containing sudarshan churna Hardness(kg/cm) 5 4 3 2 1 0 BLC1 BLC2 BLC3 Formulation Code Fig. 3: graphical representation of hardness and disintegration while tablets containing bhaskar lavan churna. Table 3: postcompression parameters of fast dissolving tablets Formulation code Weight variation (%) (±SD), n=20 Hardness (kg/cm 2) (±SD), n=6 Friability (%) (±SD), n=10 SC1 0.7 (2.22) 4.50 (0.00) 0.12 (0.06) 55 (0.35) 30 (0.03) SC2 0.3 (1.00) 4.25 (0.40) 0.16 (0.01) 48 (0.05) 28 (0.22) SC3 0.9 (0.92) 4.00 (0.50) 0.24 (0.04) 20 (0.18) 18 (0.25) BLC1 0.3 (0.52) 4.55 (0.19) 0.29 (0.01) 45 (0.44) 40 (0.30) BLC2 0.7 (1.50) 4.50 (0.25) 0.32 (0.06) 37 (0.40) 38 (0.40) BLC3 0.8 (2.25) 4.00 (0.70) 0.50 (0.10) 18 (0.03) 20 (0.50) Note: Values in parenthesis are standard deviation (±SD) Table 4: Weight of tablet before and after vacuum drying Formulation Before vacuum drying(mg) After vacuum drying(mg) SC1 650 638 SC2 650 625 SC3 650 600 BLC1 650 639 BLC2 650 622 BLC3 650 601 70 60 50 40 30 20 10 0 60 50 40 30 20 10 0 Disintegration time(sec) (±SD), n=6 Disinegration time(sec) Disinegration time(sec) Wetting time (sec) (±SD), n=3 38
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