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Potassium sorbate is a 2,4 hexadienoic acid potassium salt. This is used as a mold or yeast inhibitor and can be specifically termed as a food preservative. PHARMACEUTICAL ASSESSMENT Strength, pharmaceutical form, route of administration, container and pack sizes The product contains 500mg of paracetamol in tablet form for oral administration, the product is available without prescription. In accordance with the reference product the finished product will be available in packs of 8, 12, 16 tablets packed in aluminium/PVC blister strips. Drug Substance The manufacturers of the Active Ingredient have provided satisfactory Certificates of Suitability for the production of paracetamol. Paracetamol complies with the BP/EP monograph and a satisfactory specification for Paracetamol applied by finished product manufacturer has been provided. The specification is identical to that applied to the reference product and the proposed suppliers are identical to that of the reference product. Finished Product The qualitative composition of the tablets is paracetamol, pregelatinised maize starch, sodium metabisulphite, magnesium stearate and water. The formula used is identical to that of the reference product. The finished product specification is identical to that of the reference product. No animal products are used in the formulation of this product and the product complies with the EU guidelines Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products.. Manufacture The manufacturing process and in-process controls and validated batch sizes are as described for the reference product. No bioequivalence data have been submitted with this application. The product is manufactured to the same formulae and by the same process as the reference product. Analytical methods used are identical to that of the reference product. Shelf-life The shelf-life of the product is 5 years in the original packaging with the direction “do not store above 25 °C” and is the same as the reference product. Magnesium stearate, also called octadecanoic acid, magnesium salt, is a white substance, powder which becomes solid at room temperature. It has the chemical formula Mg(C18H35O2)2. It is a salt containing two equivalents of stearate (the anion of stearic acid) and one magnesium cation (Mg2+). Magnesium stearate melts at about 120 °C, is not soluble in water, and is generally considered safe for human consumption at levels below 2500 mg/kg per day.[1] In 1979, the FDA's Subcommittee on GRAS (generally recognized as safe) Substances (SCOGS) reported, "There is no evidence in the available information on ... magnesium stearate ... that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when they are used at levels that are now current and in the manner now practiced, or which might reasonably be expected in the future."[2] Magnesium stearate is often used as a anti-adherent[3] in the manufacture of medical tablets, capsules and powders.[4] In this regard, the substance is also useful, because it has lubricating properties, preventing ingredients from sticking to manufacturing equipment during the compression of chemical powders into solid tablets; magnesium stearate is the most commonly used lubricant for tablets. 1. Paracetamol/Acetaminophen ( Active ingredients) 2. Maize Starch (Binder) 3. Croscarmellose (Desintegrant) 4. Nipagin/Methyl Paraben (Preservative) 5. Nipasol/Propyl Paraben (Preservative) 6. Purified Water 7. Talc (antisticking) 8. Silicon Dioxide Colloidal (antiadherent) 9. Magnesium Stearate (Lubricants) 10. Materials and Methods 11. Materials: 12. Paracetamol (Micro labs Pharmaceuticals Ltd., 13. Puducherry), Maize Starch, Gelatin, 14. M.C.C.P (Tristar Formulations Ltd., Puducherry), 15. Magnesium Stearate, Lactose, Di calcium Phosphate 16. (Caplein Point Laboratories, Puducherry). 17. Methods: 18. Isolation of Starch from Manihot esculenta: 19. Wash potatoes thoroughly with water to remove 20. adhering soil and earthy matter and reduce to fine 21. slurry with water in a blender. Pass the slurry through 22. shaking sieves in order to remove the cell debris and 23. other impurities. Allow the milky liquid to settle down. 24. Decant the supernatant liquid. Wash the starch 2-3 25. times with distilled water with constant stirring. 26. Centrifuge the milky liquid, dry it in oven at a low 27. temperature and powdered. 28. Preparation of Paracetamol Tablets Using Manihot 29. esculenta Starch as Binder: 30. Sieving and Weighing of the ingredients. Weights of 31. the ingredients were used as 32. Paracetamol, Starch (Manihot esculenta), Gelatin, 33. Sodium benzoate, Micro Crystalline Cellulose powder 34. and Magnesium stearate. 35. Granulation: 36. Preparation of Starch Paste: 37. Preparation of Starch solution: 38. 16.2 gms of starch was taken in a beaker and 24ml of 39. hot water was added and stirred well to make 40. suspension and heated in a boiling water bath with 41. continuous stirring until a translucent paste is formed. 42. It has been observed that during paste formation, not 43. all of the starch is hydrolyzed. 44. Preparation of Gelatin solution: 45. Gelatin solution should be freshly prepared and used 46. while hot. 4 gms of gelatin was taken in a beaker and 47. 16ml of boiling water was added and stirred well to 48. form a solution by heating in a boiling water bath. 49. Finally the gelatin solution was poured into the starch 50. solution and mixed well and the mixture is heated in 51. boiling water bath with continuous stirring until a 52. translucent paste forms. 53. Wet Granulation: 54. The steps involved in wet granulation were, Weighing, Mixing, Granulation, Screening the damp mass, Drying, Dry screening, Lubrication and Compression. The active ingredients of Paracetamol, diluents and disintegrants were mixed. For small batches the ingredients may be mixed in stainless steel bowls or mortars. A solution of the binding agents was added to the mixed powders with stirring. The powder mass is wetted with the binding solution until the mass has the consistency of damp snow. If the granulation is over wetted the granules will be hard, requiring considerable pressure to form the tablets. If the powder mixture is not wetted sufficiently the resulting granules will be too soft, breaking down during lubrication and causing difficulty during compression. The wet granulation is forced through a 6 or 8 mesh screen. The moist materials was placed on large sheets of paper on shallow wire trays and placed in drying cabinets with a circulating air current and thermostatic heat control. Particle size distribution can be controlled by varying the speed of rotation and drying temperature. After drying, the granulation is reduced in particle size by passing it through a smaller mesh screen. After dry granulation the lubricants such as M.C.C.P and Magnesium stearate was added. Then the lubricated granules were compressed by using Single punch Machine16. Preparation of Paracetamol Tablets by Using Maize Starch: The ingredients were weighed as Starch, Sodium benzoate, Gelatin, Paracetamol, Starch (Maize starch), M.C.C.P, Magnesium stearate in the required quantities. Paracetamol Tablets by Using Maize Starch was prepared by same Procedure as Previously Mentioned. Evaluation of Paracetamol Tablets Prepared by Using Above Mentioned Binders: Tablet Hardness: The resistance of the tablet to chipping, abrasion or breakage under conditions of storage, transportation and handling before usage depends on its hardness. Different types of Hardness tester were used as Strong Cobb, Monsanto, Pfizer and Scheluniger. Friability: Measurement is made by use of the Roche friabilator. This instrument is designed to evaluate the ability of the tablet to withstand abrasion in packaging, handling and shipping. A number of tablets were weighed and placed in the tumbling apparatus. After a given number of rotations of tablets were weighed and the loss in weight indicates the ability of the tablets to withstand this type of wear. Tablet Thickness: Tablet thickness was determined with a Caliper or thickness gauge which measured the thickness in millimeters. +5% or -5% may be allowed depends on the size of the tablet. Tablet Weight: The volumetric fill of the die cavity determines the weight of the compressed tablet. The weight of the tablet is the quantity of the granulation which contains the labeled amount of the therapeutic ingredient. Twenty tablets were weighed individually and average weight was calculated. The variation from the average weight in the weights of not more than two tablets must not differ by more than the percentage. Tablet Disintegration: The apparatus consists of a basket rack holding six plastic tubes open at the top and bottom. The bottom of the tube is covered with 10 mesh screen. The basket rack is immersed in a bath of suitable liquid held at 37°C preferably in 1 litre beaker. The rack moves up and down in the fluid at specific rate. The end point of the test is indicated when any residue remaining in a soft mass having no probably soft core. Results and Discussion In this present study, paracetamol tablet were formulated using Manihot esculenta starch and industrial starch as a binder. The tablets were evaluated for, Physical Characteristics, Weight variation, Friability, Hardness, Disintegration test and Dissolution Studies. Physical Characterists: The Paracetamol tablets manufactured by using both Manihot esculenta a starch & industrial starch was found to be white, smooth and circular in appearance. They had sufficient hardness to withstand the wear & tear during the handling of the tablets for the various evaluation studies. The physical appearance of the tablets was same for both formulated as well as industrial starch. Weight Variation: The percentage weight variation of the tablet formulated from the Manihot esculenta starch was found to be 2.431 and that of industrial starch was 3.06% are given in table-1. Batch 1 (Paracetamol Tablets By Using Industrial Starch as Binder). Batch 2(Paracetamol Tablets by Using Manihot Esculanta.L Starch as Binder). Friability: The friability for tablets formulated using Manihot esculenta starch was found to be 0.1% which is 0.2% lesser than that of tablet formulated from industrial starch (0.3%) are given in table-2. Hardness: The hardness of the tablet formulated from Manihot esculenta starch was found to be 4—5 kg/cm2 and that of industrial starch was 3-4kg/cm2 are given in table-3. Disintegration: The disintegration time of the tablet formulated from the Manihot esculenta starch was found to be 20 mins and the disintegration time of the tablet formulated from the industrial starch was 22 secs are given in table-4. weight of the compressed tablet. The weight of the tablet is the quantity of the granulation which contains the labeled amount of the therapeutic ingredient. Twenty tablets were weighed individually and average weight was calculated. The variation from the average weight in the weights of not more than two tablets must not differ by more than the percentage. Tablet Disintegration: The apparatus consists of a basket rack holding six plastic tubes open at the top and bottom. The bottom of the tube is covered with 10 mesh screen. The basket rack is immersed in a bath of suitable liquid held at 37°C preferably in 1 litre beaker. The rack moves up and down in the fluid at specific rate. The end point of the test is indicated when any residue remaining in a soft mass having no probably soft core. Results and Discussion In this present study, paracetamol tablet were formulated using Manihot esculenta starch and industrial starch as a binder. The tablets were evaluated for, Physical Characteristics, Weight variation, Friability, Hardness, Disintegration test and Dissolution Studies. Physical Characterists: The Paracetamol tablets manufactured by using both Manihot esculenta a starch & industrial starch was found to be white, smooth and circular in appearance. They had sufficient hardness to withstand the wear & tear during the handling of the tablets for the various evaluation studies. The physical appearance of the tablets was same for both formulated as well as industrial starch. Weight Variation: The percentage weight variation of the tablet formulated from the Manihot esculenta starch was found to be 2.431 and that of industrial starch was 3.06% are given in table-1. Batch 1 (Paracetamol Tablets By Using Industrial Starch as Binder). Batch 2(Paracetamol Tablets by Using Manihot Esculanta.L Starch as Binder). Friability: The friability for tablets formulated using Manihot esculenta starch was found to be 0.1% which is 0.2% lesser than that of tablet formulated from industrial starch (0.3%) are given in table-2. Hardness: The hardness of the tablet formulated from Manihot esculenta starch was found to be 4—5 kg/cm2 and that of industrial starch was 3-4kg/cm2 are given in table-3. Disintegration: The disintegration time of the tablet formulated from the Manihot esculenta starch was found to be 20 mins and the disintegration time of the tablet formulated from the industrial starch was 22 secs are given in table-4. V.CHALAPATHI et al /Int.J. ChemTech Res.2010,2(1) 409 Table-1. Weight Variations of Batch 1 and 2. Table-2. Friability of Batch 1 and 2. Table-3.Hardness test of Batch 1 and 2. Table-4.Disintegration time of Batch 1 and 2. Batch 1 (time in seconds) Batch 2 (Time in minutes) I II III I II III 22 23 22 20 22 20 Dissolution Study: The characteristics of paracetamol tablet formulated from the Manihot esculenta starch and the tablet formulated from industrial starch were investigated adopting the USP XXII rotating basket apparatus at stirring rates of 100 rpm and a temperature of 37°C, 900 ml of distilled water utilized. The samples of 10 ml were withdrawn and measured spectro photometrically at 257nm by UV Spectrometer (Shimadzu). Dissolution Study of Batch 1 and 2 are given in table-5. Conclusion From the above result it is learn that the paracetamol tablet manufactured by using Manihot esculenta starch is better in friability and hardness than that of tablets made up of industrial starch (Maize). As the disintegration time for paracetamol tablets formulated by using Manihot esculenta starch has increased 60 times than that of industrial starch. It is concluded that the binding capacity of Manihot esculenta starch would be many times greater than that of industrial starch. So if the concentration of Manihot esculenta starch is decreased then the same effect may be Batch 1 (weights in mg) Batch 2 Sl.No. (weights in mg) I II III I II III 1 252 264 270 262 252 265 2 260 256 263 264 260 260 3 270 248 265 270 270 250 4 263 250 252 265 263 263 5 265 255 260 267 265 268 6 255 250 268 250 255 270 7 268 252 270 255 268 250 8 270 260 248 248 270 248 9 270 265 250 250 270 255 10 265 270 255 263 265 270 11 264 252 260 260 255 273 12 256 260 265 265 250 270 13 248 270 263 258 248 260 14 250 263 264 255 256 260 15 255 265 270 260 264 255 16 250 255 262 265 250 261 17 252 268 260 263 252 263 18 260 270 265 250 260 265 19 265 270 250 255 265 260 20 270 265 255 260 270 255 Batch 1(Friability in %) Batch 2 (Friability in %) I II III I II III 0.30 0.32 0.30 0.15 0.10 0.10 Batch 1 (In kg/cm2 ) Batch 2 (In kg/cm2 ) I II III I II III 3.5 3.5 4.0 4.5 5.0 4.5 V.CHALAPATHI et al /Int.J. ChemTech Res.2010,2(1) 410 obtained. From dissolution study paracetamol tablets formulated by using Manihot esculenta starch has increased release of 21% than that of industrial starch. If this could be proved, then it is very much beneficial to the tablet manufacturing industry as it is cheap and abundantly available. Further study on this starch as a binder at different concentrations and with different drugs would give further information which is needed to establish the usefulness of this starch, as an effective binder in the field of tablet manufacturing.

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