Testing Drug Content of Famotidine Core Tablets

Testing Drug Content of Famotidine Core Tablets 6. Formulation development and evaluation 6.1 Preparation of core tablets Core tablets of famotidine were prepared by direct compression and batch size was kept as 100 tablets. Drug , sodium chloride, polymer and MCC were co-sifted through sieve # 30 Now the blend is mixed in polybag for 10 min Citric acid was crushed using mortar and pestle and sifted through sieve # 60 And this is added to above blend and mixed in a polybag for 10 min. Then magnesium stearate talc were passed through sieve #60 and to the above blend and mixing continued for another 2 min Now the blend is compressed to tablets having the average weight of 180 mg using 8 mm round concave punch and at low relative humidity 20 % RH 6.2 Coating of core tablets: 6.2.1. Preparation of coating solution: 5 ml of water was taken in a beaker and to this required amount of PEG 400 was added and dissolved 95 ml of acetone was taken in a beaker and stirred at 150 rpm using electrical stirrer to this above solution was added and stirred for 5 min Now to the above solution 5 gm of cellulose acetate was added slowly and stirring is continued for another 30 min i.e until a clear solution was formed. 6.2.2. Procedure for coating of semi permeable membrane: Coating was done using RD Lab Coater. Core tablets were placed in the coating pan and coated with cellulose acetate solution coating parameters are maintained as below: Inlet temperature : 40 oC  ± 2 oC Bed temperature: 35 oC rpm of pan: 15 -17 Spray rate: 3-7 ml/min Atomizing air pressure: 2.0 psi Coating was done until required weight gain was achieved Drilling of orifice: The orifice was made using needles of different sizes i.e, 24, 22 guage INGREDIENTS F1 F2 F3 F4 F5 F6 Core tablet mg/tablet Famotidine 40 40 40 40 40 40 Citric acid 20 20 20 20 20 20 Sodium chloride 50 50 50 50 50 50 HPMC k100M 9 18 Polyox1105 7.2 Polyox 301 7.2 Polyox303 7.2 Sodium lauryl sulphate 3.6 3.6 3.6 3.6 3.6 3.6 Magnesium stearate 1.8 1.8 1.8 1.8 1.8 1.8 Talc 3.6 3.6 3.6 3.6 3.6 3.6 Avicel PH 102 43 43 53.8 53.8 53.8 53.8 Total wt of tablet 180 180 180 180 180 180 Coating solution Cellulose acetate 5 gm 15 % w/w of total solids (0.669 ml) 4 ml Upto 100 ml 4% PEG 400 Water Acetone Weight gain Coated tablets were left over night for drying Table 6.8 Formulation trails for optimum polymer (using various grades of HPMC and PEO) Table6.9 Formulation trails for optimum polymer concentration and coating weight gain INGREDIENTS F7 F8 F9 Core tablet mg/tablet Famotidine 40 40 40 Citric acid 20 20 20 Sodium chloride 50 50 50 Polyox 301 10.8 10.8 10.8 Avicel PH 102 50.8 50.8 50.8 Sodium lauryl sulphate 3.6 3.6 3.6 Magnesium stearate 1.8 1.8 1.8 Talc 3.6 3.6 3.6 Total wt of tablet 180 180 180 Coating solution Cellulose acetate 5 gm PEG 400 15 % w/w of total solids (0.669 ml) Water 4 ml Acetone Upto 100 ml Weight gain 4 % 3 % 5 % Table 6.10 Formulation trails of optimum plasticizer concentration INGREDIENTS F 10 F 11 F 12 Core tablet mg/tablet Famotidine 40 40 40 Citric acid 20 20 20 Sodium chloride 50 50 50 Polyox 301 10.8 10.8 10.8 Avicel pH 102 50.8 50.8 50.8 Sodium lauryl sulphate 3.6 3.6 3.6 Magnesium stearate 1.8 1.8 1.8 Talc 3.6 3.6 3.6 Total wt of tablet 180 180 180 Coating solution Cellulose acetate 5 gm 5 gm 5 gm PEG 400 (% w/w of total solids) 20% (0.89 ml) 25% (1.25 ml) 35% (1.4 ml) Water 4 ml 4 ml 4 ml Acetone Upto 100 ml Upto 100 ml Upto 100 ml Weight gain 4% 4% 4% 6.3 Evaluation of blend 6.3.1 Angle of repose Angle of repose: Weighed quantity of the drug was passed through a funnel kept at a height 2 cm from the base. The powder is passed till it forms a heap and touches the tip of the funnel. The radius the base of the conical pile, and the height of pile were measured and the angle of repose was calculated using the formula: (h/r) h = height of the pile r = radius of the base of the conical pile Table 6.4 Flow property and corresponding angle of repose Flow property Angle of repose (ÆÅ ¸) Excellent 25 – 30 Good 31 – 35 Fair-no need of aid 36 – 40 Passable –hang up chances 41 – 45 Poor – must vibrate, agitate 46 – 55 Very poor 56 – 65 Very, very poor >66 Formulation code Angle of repose F1 25.45 F2 22.92 F3 23.13 F4 19.20 F5 18.62 F6 17.20 F7 20.09 Table no. : Data for angle of repose of all formulations 6.3.2 Bulk density An accurately weighed quantity of powder carefully poured into graduated cylinder. Then after pouring the powder into the graduated cylinder the powder bed was made uniform without disturbing. Then the volume was measured directly from the graduation marks on the cylinder as ml. The volume measure was called as the bulk volume and the bulk density is calculated by following formula: Bulk density = Weight of powder / Bulk volume Tapped Density: After measuring the bulk volume the same measuring cylinder was set into tap density apparatus. The tap density apparatus was set to 300 taps drop per minute and operated for 500 taps. Volume was noted as (Va) and again tapped for 750 times and volume was noted as (Vb). If the difference between Va and Vb not greater than 2% then Vb is consider as final tapped volume. The tapped density is calculated by the following formula: Tapped density = Weight of powder / Tapped volume Compressibility Index: It gives the flow property of the granules. More is the compressibility; less will be the flow property. It was calculated by the following formula using previously obtained bulk and tapped densities. Carrs index = Tapped density Bulk density X 100 Tapped Density Hausner Ratio: It is used for flow property of the granules. It was also calculated from bulk and tapped densities using following formula: Hausners ratio = Tapped density / Bulk density Table 6.3 Flow property and corresponding Carrs index Hausner ratio Flow property C.I ( % ) Hausner ratio Excellent ≠¤10 1.00 – 1.11 Good 11 – 15 1.12 – 1.18 Fair 16 – 20 1.19 – 1.25 Passable 21 – 25 1.26 – 1.34 Poor 26 – 31 1.35 – 1.45 Very poor 32 – 37 1.46 – 1.59 Very, very poor >38 >1.60 Formulation code Bulk density (gm/cm3) Tapped density (gm/cm3) Carr’s index (%) Haussners ratio Angle of repose F1 0.486 0.631 22.9 1.25 25.45 F2 0.410 0.513 20.08 1.25 22.92 F3 0.438 0.601 18.259 1.18 23.13 F4 0.436 0.583 16.39 1.196 19.20 F5 0.430 0.520 17.31 1.21 18.62 F6 0.462 0.535 13.64 1.16 17.20 F7 0.446 0.523 14.72 1.17 20.09 Table no. : Data for Bulk density, Tapped density, Compressibility index and Hausner’s ratio of all formulations 6.4 Post compression studies 6.4.1 Weight variation The average weight of core tablets and coated tablets were determined using a digital weighing balance. 20 tablets were selected randomly from each batch and weighed individually, calculating the average weight and comparing the individual tablet weight to the average. From this, percentage weight difference was calculated. Table 6.11 Limits of weight variation IP/BP Limit USP 80 mg or less 10% 130mg or less More than 80mg or Less than 250mg 7.5% 130mg to 324mg 250mg or more 5% More than 324mg Table no. : Data for weight variation test of all formulations Formulation Code Avg weight (mean ±%deviation) Before Coating After Coating F1 178.42 ± 1.02 185.72 ±1.12 F2 181.31 ± 0.91 188.79 ±1.45 F3 179.21 ±1.34 187.89 ±1.09 F4 181.39 ±0.98 189.01 ±0.98 F5 179.76 ±1.32 186.96 ±1.42 F6 183.12 ±2.24 190.32 ±1.08 F7 180.09 ±1.08 187.34 ±1.12 F8 178.12 ±1.24 184.52 ±1.33 F9 179.35 ±1.02 187.01 ±1.14 F10 180.45 ±0.98 188.00 ±1.11 F11 181.32 ±1.23 188.67 ±1.28 F12 182.45 ±1.11 189.79 ±1.20 Hardness Hardness indicates the ability of a tablet to withstand mechanical shocks while handling. Hardness of both core and coated tablets were determined using a Monsanto hardness tester. It is expressed in kg/cm2. Three tablets were randomly picked from each batch and analyzed for hardness. The mean and standard deviation were also calculated. Table no. : Data for hardness of all formulations Formulation Code Hardness (kg/cm2)(n=3) (mean ±SD) Before Coating After Coating F1 5.06 ±0.19 6.18 ±0.22 F2 5.21 ±0.26 6.29 ±0.42 F3 4.96 ±0.32 6.03 ±0.15 F4 5.02 ±0.22 6.41 ±0.32 F5 5.28 ±0.18 6.17 ±0.18 F6 5.11 ±0.33 6.25 ±0.28 F7 4.89 ±0.25 6.00 ±0.33 F8 4.99 ±0.14 6.32 ±0.36 F9 5.08 ±0.18 6.75 ±0.25 F10 4.99 ±0.25 5.98 ±0.12 F11 5.12 ±0.33 5.90 ±0.21 F12 4.97 ±0.10 5.96 ±0.19 Friability (F) It is the phenomenon whereby tablet surfaces are damaged and/or show evidence of lamination or breakage when subjected to mechanical shock or attrition. The  friability of core tablets was determined using Roche Friabilator. It is expressed in percentage (%). Twenty core tablets were initially weighed (Winitial) and transferred into friabilator. The friabilator was operated at 25 rpm for 4 minutes or run up to 100 revolutions. The tablets were weighed again (Wfinal). The % friability was then calculated % Friability = ((A-B)/A) Ãâ€" 100 Where, Formulation Code Friability (%) (n=10) F1 0.010 F2 0.015 F3 0.017 F4 0.012 F5 0.009 F6 0.016 F7 0.014 F8 0.013 F9 0.012 F10 0.015 F11 0.014 F12 0.012 A = Initial weight of tablets B = Final weight of tablets after 100 revolutions Friability of tablets less than 1% are considered acceptable. Drug content The famotidine core tablets were tested for their drug content. Five tablets were finely powdered; quantities of the powder equivalent to 100 mg of famotidine were accurately weighed and transferred to a 100 ml of volumetric flask. Made up to 100ml with 4.5 phosphate buffer. From the above solution 1ml was taken and made up to100 ml with phosphate buffer (pH 4.5) From the above solution 10 ml was taken and made up to100 ml with phosphate buffer (pH 4.5) i.e.,10 µg/ml solution and measure the absorbance of the resulting solution at 265 nm using a Shimadzu UV-visible spectrophotometer. The linearity equation obtained from calibration curve was used for estimation of famotidine in the tablet formulations. Formulation Code Assay (%) F1 99.25 ±0.042 F2 98.32 ±0.052 F3 99.15 ±0.016 F4 99.52 ±0.019 F5 101.95 ±0.021 F6 99.25 ±0.034 F7 99.98 ±0.028 F8 98.74 ±0.052 F9 98.23 ±0.061 F10 100.12 ±0.011 F11 99.52 ±0.021 F12 99.56 ±0.023 Table no. : Data for drug content of all formulations In-Vitro Dissolution Studies The developed formulations of were subjected in vitro dissolution studies using USP Type II dissolution apparatus (Electrolab, India) with a speed of 50 rpm. The dissolution study was carried out in 900 ml dissolution media maintained at 37 ±0.5 oC. At suitable time interval, 10 ml samples were withdrawn and replaced with equivalent amount of fresh medium to maintain sink conditions. Samples withdrawn were filtered and analyzed at 265 nm using a UV spectrophotometer. After analyzing the drug content in the dissolution samples, cumulative percentage of drug release versus time was plotted. The general conditions for in vitro dissolution studies are as summarized below. Dissolution conditions: Medium : 4.5 phosphate buffer Volume: 900 ml Temperature: 37  °C  ± 0.5  °C Apparatus: USP Type-II (paddle) Rpm: 50 Time intervals : 1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 12 hr Samples were suitably diluted and absorbance was measured. Cumulative percentage drug released was calculated for each batch. The study was performed in triplicate and the average was reported. Table no. : In-Vitro data drug release data for formulation F-1 S.no Time Cumulative % drug release 1 0 0 2 1 2.81 ±2.75 3 2 4.00 ±1.64 4 3 6.67 ±2.56 5 4 10.61 ±1.98 6 5 13.07 ±2.84 7 6 16.31 ±1.27 8 7 18.56 ±1.32 9 8 21.86 ±0.99 10 10 27.07 ±1.46 11 12 32.76 ±1.21 Figure no. : In-Vitro drug release of formulation F-1 Table no. : In-Vitro data drug release data for formulation F-2 S.no Time Cumulative % drug release 1 0 0 2 1 2.10 ±2.84 3 2 4.21 ±1.95 4 3 7.52 ±2.95 5 4 10.61 ±2.09 6 5 13.07 ±1.95 7 6 16.31 ±2.75 8 7 18.56 ±2.94 9 8 21.86 ±1.24 10 10 32.16 ±1.89 11 12 40.79 ±1.11 Figure no. : In-Vitro drug release of formulation F-2 Table no. : In-Vitro data drug release data for formulation F-3 S.no Time Cumulative % drug release 1 0 0 2 1 4.02 ±3.72 3 2 8.04 ±1.34 4 3 13.34 ±2.83 5 4 18.63 ±1.52 6 5 22.90 ±1.32 7 6

A Corporate Code of Ethics is Not Enough Essay -- Sarbanes-Oxley Act o

After news of the scandal of Enron, one of the hottest items on e-Bay was a 64-page copy of Enron’s corporate code of ethics. One seller/former employee proclaimed it had â€Å"never been opened.† In the forward Kenneth L. Lay, CEO of Enron stated, â€Å"We want to be proud of Enron and to know that it enjoys a reputation for fairness and honesty and that it is respected (Enron 2).† For a company with such an extensive code of ethics and a CEO who seemed to want the company to be respected for that, there are still so many unanswered questions of what exactly went wrong. I believe that simply having a solid and thorough code of ethics alone does not prevent a company from acting unethically when given the right opportunity. Investors and the media once considered Enron to be the company of the future. The company had detailed code of ethics and powerful front men like Kenneth Lay, who is the son of a Baptist minister and whose own son was studying to enter the ministry (Flynt 1). Unfortunately the Enron board waived the company’s own ethic code requirements to allow the company’s Chief Financial Officer to serve as a general partner for the partnership that Enron was using as a conduit for much of its business. They also allowed discrepancies of millions of dollars. It was not until whistleblower Sherron S. Watkins stepped forward that the deceit began to unravel. Enron finally declared bankruptcy on December 2, 2001, leaving employees with out jobs or money. For a company to be successful ethically, it must go beyond the notion of simple legal compliance and adopt a values-based organizational culture. A corporate code of ethics can be a very valuable and integral part of a company’s culture but I believe that it is not strong enough to stand alone. Thought and care must go into constructing the code of ethics and the implementation of it. Companies need to infuse ethics and integrity throughout their corporate culture as well as into their definition of success. To be successfully ethical, companies must go beyond the notion of simple legal compliance and adopt a values-based organizational culture. Creating a Solid Code of Ethics What a Code of Ethics Should Entail The importance of having a code of ethics is to define acceptable behaviors and promote higher standards of practice within a company. The code should provide a benchmark for... ...y’s code but to our own code. We must make the choice of what is right and wrong and if put in a situation that is against our code we must stand up for what is right. A corporate code of ethics is a necessity in today’s society, but the company cannot simply rely on just a code. For the code to be successful, the company must prove to their employees that they have the desire and drive to back the words of their code. Bibliography Enron. Code of Ethics. Jul. 2000. 20 Feb. 2005. . Flynt, Sean. â€Å"Enron Whistleblower Tells Chilling Tale of Corporate Ruin.† Samford University. Ed. Donna Fitch. 19 Feb. 2004. 3 Mar. 2005. . Hawkins, John. â€Å"The Path to Ethical Internalization: Moving the Code from the Wall to Daily Life.† Leadership Lifestyle. May. 2003 Johnson & Johnson. Our Credo. 18 August 2004. 3 Mar. 2005. . Wee, Heesun. â€Å"Corporate Ethics: Right Makes Might.† Business Week Online. Ed. Douglas Harbrecht. 11 Apr. 2002. 3 Mar. 2005. United States of America. One Hundred Seventh Congress. Sarbanes-Oxley Act of 2002. Sec 406. Brooks, Leonard J. Business & Professional Ethics for Directors, Executives, & Accountants. Mason: Thompson South-Western, 2004. p227.

Love Themes in the Great Gatsby

The Great Gatsby Many people dream of being rich and famous because they want to be honored and idolized by people. This is the goal of Jay Gatsby, the protagonist in The Great Gatsby, a novel written by F. Scott Fitzgerald which was considered his masterpiece in the year 1925. Jay Gatsby only wished to be with Daisy, the girl that he truly loved. In this essay, one will notice that the high amount of love in the story isn’t usually the kind of love that saves people’s lives and brings them their true happiness.Nick Carraway is a young man from Minnesota who moves to New York to learn about the bond business. He rents a house in West Egg, Long Island, a place where newly rich people live. He lives next to Jay Gatsby, the mysterious owner of the grand mansion who throws lavish parties every Saturday night. Nick’s cousin is Daisy, the wife of Tom Buchanan and the woman that Gatsby loves. Tom Buchanan has an affair with Myrtle Wilson.Because of Jordan Baker, a compe titive golfer with whom Nick met and fell in love but didn’t work out with, he found out that Gatsby’s been in love with Daisy for a long time, and the reason why he lives like a young rajah is to impress Daisy with how successful he is. Through a favor that Gatsby’s asks, Nick sets a meeting for Gatsby and Daisy for them to reunite and find out the love they had. After a short time, Tom suspects the extraordinary relationship of his wife with Gatsby.Though Tom is involved in an affair, he is deeply insulted by the idea that his wife could also cheat on him. One day, Tom forced the group to go to New York to have lunch in Plaza Hotel, where he confronts Gatsby about his relationship with Daisy. Tom announced that Gatsby is a bootlegger and his involved on other illegal activities, and Daisy demanded to go home. Gatsby and Daisy drive back home together in Gatsby’s car, while Tom, Nick and Jordan are in Tom’s car. On the way home, Myrtle was hit and killed by the car of Gatsby.Later Nick discovered that Daisy is the one who’s driving when the accident happened. Tom told Wilson, the husband of Myrtle, that the car who hit his wife is owned by Gatsby. While Gatsby is relaxing in his pool, Wilson shoots and kills Gatsby and himself. After the small funeral Nick arranged for Gatsby, he ended his relationship with Jordan, and moves back to Midwest. In the novel it was quite obvious how Gatsby longed for Daisy; watching the green light from Daisy’s house every night, reaching out to it. He did get Daisy back through Nick in the story, ut during the time that he wished very hard that Daisy would be his, he was unable to spend much time with the woman at all, and so, if truly thought about, he didn’t love Daisy for what she currently is because he didn’t know that anymore. Gatsby loved the Daisy he once knew, or how he remembers her to be. In turn, Daisy thought she was in love with Gatsby also, but shown t hrough how she still didn’t try to get out of her marriage with Tom, she really wasn’t. She thought her appreciation of Gatsby’s attention was love.Tom cheated on Daisy with Myrtle and thought that was fine as long as he loved his wife, but then how come he was furious when he found out about his Daisy’s love affair? Was it really only because he was insulted that Daisy would cheat on him too? Finally, the main character Nick claimed he loved Jordan Baker, but found it necessary to separate from her at the end of the book. There seems to be a lot of love going around in the story, but somehow love became something that ruined their lives, because somehow, it never became what the characters or what the readers knew it was supposed to be.In chapter 3 Nick speaks of how he feels about Jordan towards the end of the story, talking about he thought he and Jordan had to go their separate ways, â€Å"†¦she had deliberately shifted our relations, and for a moment I thought I loved her†¦I’d been writing letters once a week and signing them: ‘Love, Nick,’ and all I could think of was how, when that certain girl played tennis, a faint mustache of perspiration appeared on her upper lip. Nevertheless there was a vague understanding that had to be tactfully broken off before I was free. † (3. 169) Nick says that he only thought he loved Jordan out right.He probably thought to mention the sweat on her upper lip while playing tennis because that’s not something that you call to mind right away about the person you love, at least not something as shallow as sweat. You don’t do things you should only be doing with the person you love with someone else, as Tom did with Myrtle. Oddly he cheated on Daisy, but he loved her. â€Å"I love Daisy too,† he says during their group confrontation at the Plaza Hotel, â€Å"Once in a while I go off on a spree and make a fool of myself, but I always come ba ck, and in my heart I love her all the time. (7. 251) If you could love someone but go behind his or her back to have an affair, and everybody in the world believed this, no one would be happy in love. In the same chapter Daisy also proves the love she feels is also twisted, â€Å"‘Oh, you want too much! ’ she cried to Gatsby. ‘I love you now – isn’t that enough? I can’t help what’s past. ’ She began to sob helplessly. ‘I did love him once – but I loved you too. ’† (7. 266) If at one point Daisy suddenly said she loved everybody she knew, it wouldn’t be hard to believe.With a lot of skill, Fitzgerald was able to sum up all that love was in the story in the first chapter. Gatsby was only reaching out to something, and the whole time he loved he Daisy, he was in love with a green light—the thought of her. In the first chapter, Nick notices an odd gesture of Gatsby’s which told about w hat he felt about Daisy. â€Å"†¦he stretched out his arms toward the dark water in a curious way, and, far as I was from him, I could have sworn he was trembling.Involuntarily I glanced seaward—and distinguished nothing except a single green light, minute and far away†¦Ã¢â‚¬  (1. 152) The book showed how love can take a hold and take full control of people’s lives, but in a scary way, not be real love at all. Though most people know that love is beautiful, that there can be times that love is all we need, there’s a need to be careful. You need to be sure that it’s truly love, or else, love will be something you’d rather not have at all.