Tablet Direct Compression Methods

Tablet Direct Compression Methods Tablets are solid dosage forms usually prepared with the aid of suitable pharmaceutical excipients. The excipients can include binders, glidants (flow aids) and lubricants to ensure efficient tableting; disintegrants to promote tablet break-up in the digestive tract; sweeteners or flavours to enhance taste; and pigments to make the tablets visually attractive. They may vary in size, shape, weight, hardness, thickness, disintegration, and dissolution characteristics and in other aspects, depending on their intended use and method of manufacture. Most tablets are used in the oral administration of drugs. Many of this are prepared with colorants and coatings of various types. Other tablets, such as those administered sublingually, buccally, or vaginally, are prepared to have features most applicable to their particular route of administration. Tablets are prepared primarily by compression, with a limited number prepared by molding. Compressed tablets are manufactured with tablet machine s capable of exerting great pressure in compacting. Their shape and dimensions are determined by use of various shaped punches and dies. (Allen, Ansel and Popovich (2004)). In the tablet-pressing process, it is important that all ingredients be fairly dry, powdered or granular, somewhat uniform in particle size, and freely flowing. Mixed particle sized powders can segregate during manufacturing operations, which can result in tablets with poor drug or active pharmaceutical ingredient (API) content uniformity. Content uniformity ensures that the same API dose is delivered with each tablet. In early formulation studies, as a promising compound is characterized for biologic activity, it is also evaluated with regard to chemical and physical properties that have a bearing on its ultimate and successful formulation into a stable and effective pharmaceutical product. This is the area of responsibility of pharmaceutical scientists and formulation pharmacists trained in pharmaceutics. When sufficient information is gleaned on the compounds physical and chemical properties, initial formulation of the dosage form are redeveloped for use in human clinical trials. During the course of the clinical trials, the proposed product is developed further, from initial formulation to final formulation and from pilot plant (or small-scale production) to scale-up, in preparation for large-scale manufacturing. The dose of the drug may be described as an amount that is enough but not too much; the idea is to achieve the drugs optimum therapeutic effect with safety but at the lowest possible dose. The effective dose of a drug may be different for different patients. In a normal distribution sample, a drugs dose will provide what might be called an average effect in most individuals. However, in a portion of the population the drug will produce little effect, and in another portion the drug will produce an effect greater than average. The amount of drug that will produce the desired effect in most adult patients is considered the drugs usual adult dose and the likely starting dose for a patient. From this initial dose the physician may, if necessary, increase or decrease subsequent doses to meet the particular requirements of the patient. Certain drugs may produce more than one effect, depending on the dose. Drug doses vary greatly between drug substances; some drugs have small doses, other drugs have relatively large doses. The dose of the drug is based on its biochemical and pharmacologic activity, its physical and chemical properties, the dosage form used, the route of administration, and various patient factors. The dose of a drug for a particular patient may be determined in part on the basis of the patients age, weight, body surface area, general physical health, liver and kidney function (for drug metabolism and elimination), and the severity of the illness being treated. General dosing information for drug substances is provided in the monographs in the British National Formulary (BNF) as well as in the package inserts that accompany manufacturers pharmaceutical products. Again, these sources provide the prescriber and pharmacists with guidelines of usual dosage and usual dosage range. Optimally, appropriate drug dosage should resulting blood serum drug concentrations that are ab ove the MEC and below the MTC for the period of time that drug effects are desired. For certain drugs, a larger than usual initial dose may be required to achieve the desired blood drug level. (Stoklosa and Ansel, 1996) Active ingredients can be separated into two categories: low-dose and high-dose drugs. It should be technically possible to manufacture almost all drugs of low doses (less than 50 mg) by the direct compression process with a proper choice of excipients and tablet equipment. The term direct compression is defined as the process by which tablets are compressed directly from powder mixture of API and suitable excipients. No pretreatment of the powder blend by wet or dry granulation procedure is required. The problems encountered in direct compression of low-dose drugs centre around uniform distribution of the drug (blending) and possible unblending during the compression stage. Steps of Direct Compression Source: http://inferenceforqbd.com/Solutions/Pharmaceutical%20R+D.aspx Some granular chemicals, like potassium chloride, possess free-flowing and cohesive properties that enable them to be compressed directly in a tablet machine without need of granulation. For chemicals lacking this quality, special pharmaceutical excipients may be used to impart the necessary qualities for production of tablets by direct compression. These excipients include fillers, such as spray-dried lactose, microcrystals of alpha-monohydrate lactose, sucrose-invert sugar-corn starch mixtures, microcrystalline cellulose, crystalline maltose, and dicalcium phosphate; disintegrating agents, such as direct compression starch, sodium carboxymethyl starch, cross-linked carboxymethylcellulose fibers, and cross-linked polyvinylpyrrolidone; lubricants, such as magnesium stearate and talc; and glidants, such as fumed silicon dioxide. The capping, splitting, or laminating of tablets is sometimes related to air entrapment during direct compression. When air is trapped, the resulting tablets expand when the pressure of tableting is released, resulting in splits or layers in the tablets. Forced or induced feeders can reduce air entrapment, making the fill powder more dense and amenable to compaction. Capping also may be caused by punches that are not immaculately clean and perfectly smooth or by a granulation with too much fines, or fine powder. Fine powder, which results when a dried granulation is sized, is generally 10 to 20% of the weight of the granulation. Some fine powder is desired to fill the die cavity properly. However, an excess can lead to tablet softness and capping. Tablets that have aged or been stored improperly also may exhibit splitting or other physical deformations. In low dose formulation, advances in pharmaceutical research have resulted in the development of high potency active ingredients, which can be difficult to formulate into capsules or tablets. The use of Starch 1500HYPERLINK http://www.colorcon.com/products/core-excipients/immediate-release/starch-1500 ®HYPERLINK http://www.colorcon.com/products/core-excipients/immediate-release/starch-1500 partially pregelatinized maize starch as an active-premix in low dose formulations can provide consistent drug uniformity, which allows manufacturing by a direct compression process. Since many low dose medications are manufactured by a wet granulation method to assure each tablet contains the proper amount of active, switching to a direct compression process can result in substantial savings in total process time and cost. Comparison of wet granulation and direct compression methods Source: http://www.atacamalabs.com/technology_specialty Spray-dried lactose is the earliest and is still one of the most widely-used direct compression fillers. It is one of the few such excipients available from more than a single supplier. In spite of many early problems, this material revolutionized tableting technology. Coarse and regular grade sieved crystalline fractions of a-lactose monohydrate have very good flow properties but lack compressibility. However spray drying produces an agglomerated product that is more fluid and compressible than regular lactose. In the production of spray-dried lactose, lactose is first placed in an aqueous solution which is treated to remove impurities. Partial crystallization is then allowed to occur before spray-drying the slurry. As a result the final product contains a mixture of large a-monohydrate crystals and spherical aggregates of smaller crystals held together by glass or amorphous material. The fluidity of spray-dried lactose results from the large particle size and intermixing of spheric al aggregates. The compressibility is due to the nature of the aggregates and the percentage of amorphous material present and the resulting plastic flow, which occurs under compaction pressure. The problem of compressibility of spray-dried lactose is still real and troublesome. The compressibility of spray-dried lactose is borderline, and furthermore, it has relatively poor dilution potential. Spray-dried lactose is an effective direct compression filler when it makes up the major portion of the tablet (more than 80%), but it is not effective in diluting high-dose drugs whose crystalline nature is, in and of itself, not compressible. Furthermore, spray-dried lactose does not lend itself to reworking because it loses compressibility upon initial compaction. (Lieberman, Lachman and Schwartz). For the binders, there are many excipients that can be used. these include hydroxypropylcellulose (HPC), methylcellulose (MC), povidone (PVP), hydroxypropylmethylcellulose (HPMC), and starches and their derivatives, such as pregelatinized and granulated starches. These polymers differ in their physico-chemical, mechanical and morphological characteristics. For direct compression, studies suggest highly compactable, plastic, fine particle size binders facilitate compression of drugs at relatively low filler-to-drug ratios, therefore representing ideal properties for tablet binders (Drug Dev Ind Pharm. 1999;25:1129-35) (Drug Dev Ind Pharm. 2001;27:181-924). Tablet manufacturing by direct compression has increased steadily over the years. It offers advantages over the other manufacturing processes for tablets, such as wet granulation and provides high efficiency (Zhang et al., 2003). As direct compression is more economic, reducing the cycle time and straight forward in terms of good manufacturing practice requirements. Amongst the techniques used to prepare tablets, direct compression is the most advanced technology. It involves only blending and compression. Thus offering advantage particularly in terms of speedy production. Because it requires fewer unit operations, less machinery, reduced number of personnel and considerably less processing time along with increased product stability. Drugs characterized by high-dose, high bulk volume, poor compactibility, and poor fluidity (flow properties) do not lend themselves to direct compression. A typical sample would be paracetamol, an analgesic. The API of which is not easily compressed, then it require usually restricted to about 30% of direct compression formula hence tablet will costly and difficult to swallow. While it is possible to densify some drugs or formulations by preprocessing, there is some question as to whether the final tableting process could then be called direct compression. Paracetamol is high dose at 500 mg, is highly elastic and requires tastemasking. The taste-masking system to use is important for the active ingredient. If a finished dosage form has great taste, the consumer may prefer your tablet to another tablet solely based upon taste. If the product has an unpleasant taste, the consumer may discount speed of delivery and prefer better tasting slower tablets. The taste-masked API needs to survive the tabletting operation. It is inherently a poor compressible drug and high dose formulation can show capping and lamination. This can be attributed to the elastic recovery and brittle nature of the drug. Good tablet hardness (17kP), friability (30%) and elimination of capping and lamination were achieved with 7% HPC EXF binder level in the IR granulation and employing a pre-compression force of 3kN in addition to a main compression force of 25kN.(www.aqualon.com). Magnesium stearate dihydrate (MgSt-D) is a more effective lubricant for a high dose product containing 90+% COMPAPà ¢Ã¢â‚¬Å¾Ã‚ ¢ L at a high tableting speed. CONCLUSION As shown, there is a big difference in the formulation of low dose and high dose tablet. For the low dose tablet, an example is digoxin which is a cardiotonic, it is manufactured under direct compression since the powder mixture of the active pharmaceutical ingredient (API) is compressed directly with its excipients. Low dose means having a small amount of API, since there is a small amount of it, direct compression is the best possible way because when compounding a tablet, it is unavoidable that there will have some residue or some particles that can be left in the containers or when triturating. For the high dose tablet, an example is paracetamol, direct compression cant be use since high dose API are not easily compressed.

Intellectual Capitalism (Swot and Industry Analysis of General Motors)

Q2) : What information is provided and how can this be useful in understanding your chosen company’s strategic situation? The profile covers many different areas that pertain to the strategy of the General Motors ranging from history to a swot anaylsis. History- the history of the firm will allow us to study how General Motors has acted to fulfill its mission in the past and thus give us clues to their future decisions. The history section of the profile basically lists all of the investments and divestment of GM since its inception in 1909.The list is too long to put into this case, but the lists shows that GM is not by any means strictly a car company. The list also shows that General Motors has been an international company for over 90 years. So strategically speaking GM is mildly protected from some shocks, but as we saw in 2009, they are not protected from very large global shocks to the automobile industry. Products and Services- The report also lists the car types of ca rs (12) and brands (11) they produce.Along with the finished automobiles they are actively involved in the inputs that are necessary for the production of the automobiles. They also provide a financial service for the automobiles. Revenue analysis- The revenue analysis section states the revenue figures for the company from the last two years also showing the percent increase. The section also breaks down these figures into different business segments such as GM North American and GM Asia.These more detailed figures can be used in conjunction with market share and growth of entire market to form a strategy plan for the company. For example if South America’s market is largely made up of local brands and growing at a very fast rate, it would be more beneficial for GM to concentrate their production and capital there instead of a saturated market like that of the United States. SWOT- This section included the most information from a strategic stand point. It includes strengths and weaknesses as well as opportunities and threats.An example of the firms strengths would be â€Å"strong market position and brand portfolio†. A weakness would be â€Å"underfunded pension funds†. Strengths and weaknesses are characteristics of the firm as opposed to opportunities and threats which are characteristics of the firm’s environment. One of GM’s opportunities is â€Å"increased demand for cars in BRIC nations†, and one of their threats is â€Å"intense competition†. The SWOT framework is used ideally to strategically take advantage of a firms opportunity with their strengths.For example, GM should use their strong brand image and profits from strong market positions around the world to fund a stronger entrance into Brazil, Russia, India, and China. Also the converse of that strategy would be to avoid weaknesses and threats to the firm. Q3): Based on the information provided, what are the three most important things you can say about your company’s industry? 1) The effect of the financial crisis on the American Automobile market. Obviously the crisis had a major effect on the automotive market, but the effect is underestimated in the news.According to the industry report in the business source complete database the amount of passenger vehicle decreased by six million units from 2006 to 2009, so even if the saturation level of the market is at the 2006 level which is very unlikely since the population has grown since then, the U. S. market has not reached the pre-crisis levels saturation. These levels paired with renewed customer confidence and the ease of attaining credit will fuel an increase in the U. S. utomobile market. Although the increase may be gradual, it is still a realistic goal for an established brand such as GM. 2) The emergence of China as the largest automobile market in the world. As a result of increasing incomes paired with sales incentive and decreased tariffs caused by China joi ning the WTO has resulted in a booming automotive industry in China. Even though the year-to-year growth of car ownership in the nation is over 30% the market has very low saturation levels.Only 35 people per 1000 own cars in China which compared to the United States, 600 per 1000, shows there is ample room for growth in the market. Most major car manufacture has a presence in the market, but political forces limit the penetration of these companies. According to report in Business source complete, the Chinese government is even pressuring domestic companies to grow and force out foreign competition. But this goal of the Chinese government cannot be realized until the smaller local manufactures can somehow combine so they may compete with larger foreign firms. ) Environmental issues are also a main concern within the industry. This issues stems from two areas Gasoline and CO2 emissions. Gasoline a major factor pertaining not only to the consumption of cars but also the type of car t hat is demanded by consumers. While the United States gasoline prices are relatively lower than other nations, car producers world-wide are still producing different cars in the wake of high gas prices. The low emission car is the new fad in the industry and has jointly led to the production of the alternative resources cars.The combination of high gas prices and threat of damaging the environment from combustible engines has increased the consumer’s demands for automobiles to run off of alternative resources. This new development plays well into the strengths of GM because General Motors is already heavily devoted to R&D. Q4): Based on the information provided, how would you characterize the company’s competitive situation? Well I think the best way to answer this question will be to separate each answer due to the three questions. ) The financial crisis almost crippled the entire U. S. automobile industry with the both GM and Ford receiving bailout money for the Unit ed States government, but the crisis could have a created an opportunity for GM. As I stated earlier, car registration is down six million since 2006 but population has not decreased so there must be a portion of the car market that wants a car but did not have the means during the financial down turn. GM may use this period of time to gain the re-emergence of this demographic to gain market share in a semi-saturated market. ) Although China has become the largest automobile market in the world, I do not think that GM has a strategic position in the market. However, GM may be able to be very profitable in because the market is growing so fast, but the fasted growing segments are luxury cars and SUV which do not create a strategic advantage for General Motors. Also, the Chinese government will heavily regulate the growth of the market as well as give every possible advantage to the domestic manufactures. 3. ) The change in demand due to environmental pressure is an interesting factor in the automotive industry.Toyota has been the market leader in electric and alternative fuels but that doesn’t necessarily give them strategic leverage in the market. The environmental pressures will just create another segment of products for the industry much like SUV or Sedans so having experience with the technologies will not necessarily create a boost in Market Share. GM’s commitment to R&D will enable them to compete, and the use of their strong brand and supply chain management will help GM gain market share. Q5) :What useful information is provided to help you understand the competitive situation of your company?The market research report listed in Business source complete was written by Marketwatch which is also the same company that produced the company profile used in the second question. Instead of a stagnant overview of the companies past this report deals with recent moves within the industry by all of the major companies within the industry. The repor t starts off with an industry update which is the details of new investments and operations of major automotive manufactures around the world. General Motors announced to invest $450 mil in additions to one of its plants in Argentina. MarketWatch: Automotive) The investment seems like a good choice for the company since the region is growing so fast. However, the article also reports BMW’s $200 mil investment into the same region so competition will be fierce in the future especially in South America. (MarketWatch: Automotive) Along with the potentially bad news from BMW, the report also includes a recall from Toyota involving over 7 mil cars globally. The recall could signal to General Motors to act quickly, so they may be able to capture market share from Toyota’s unsatisfied customers.After the industry overview, the next section is a comment on movement within the industry away from Navigation systems. The introduction of free Google Maps paired with the popularity of the cell has severely decreased the demand from in dash and even after-market navigational systems. General Motors may be able to use this information and decrease the models in production with navigational systems, so sales are not affected by unwanted accessories. The next section is simply a report featuring some of the companies’ performances.General Motors’ metrics were not reported in this issue. The report mainly included foreign companies mostly in Europe. For example, Audi’s sales increase 14%, BMW sales increase 12%, and Renault sales decrease 29%. (MarketWatch: Automotive) These figures are very useful in understanding the competitive situation of General Motors because they allow the company to benchmark it’s success against it’s competitors. Q6) What three items did you find that are most interesting to you? Why? 1) Who may be responsible for the growth of the Chinese Automotive industry?Article from Manufacturing Engineer about Ch inese manufacturing was wrong, China’s growth in production and consumption has grown faster than estimates and this could be fueled by western investment. Companies all over the world including GM wanting to capture market share in what is now the largest market for automobile in the. According GM China’s president, GM’s plan to penetrate the market is to use Chinese researchers in China. (Nick Santhanam) I found this interesting because a side effect of the penetration into the market could be the training and development of domestic researchers within China.The two problems restricting China’s automotive manufacturing industry growth are lack of graduate level researchers and a highly fractioned industry. Both of these problems may be solved by foreign joint ventures with Chinese companies. 2) I also found it strange how the market leader in this industry is the slowest to change. The companies specialize themselves to the point where there products la ck demand in the market, and their brand and market share lose value. Ford Motor Co. was the first company to mass produce the automobile and through this innovation captured the majority of the U.S. ’s market share. However, the overemphasis on mass production sacrificed choices for the consumer which allowed General Motors to penetrate the market. General Motors then gained almost 50% of the U. S. market share by the 1960’s. But the entrance of the Asian manufactures decreased their market share slightly at first. General Motors first case was about the bankruptcy of general motors and the companies revival through a government buyout and an ipo which lead to a decrease in 40b in costs at the same levels of revenue.The case asks are these profit margins and growth figure robust or are they just because the market is recovering and the company is on a short leash. Another thing that is very interesting is how slow the companies respond to market changes especially whe n they are the market leader. The article was an interview with GM China’s president. He describes how GM will penetrate the market by taking advantage of the â€Å"talent† from local universities. He believes that the best way to innovate in China is to use younger local researcher to develop products for the Chinese market. General Motors: Leading US Car Maker Emerges From Bankruptcy. (Cover Story). †Ã‚  General Motors: Leading US Car Maker Emerges From Bankruptcy(2012): 1-16. Business Source Complete. Web. 9 Apr. 2013. â€Å"SPECIAL REPORT: Automotive Manufacturing. (Cover Story). â€Å"Manufacturing Engineer  84. 6 (2005): 26-27. Business Source Complete. Web. 9 Apr. 2013. Nick Santhanam, et al. â€Å"Automotive Innovation In China: The View From General Motors. †Ã‚  Mckinsey Quarterly  1 (2012): 85-92. Business Source Complete. Web. 9 Apr. 2013.

What Does A Sample of Research Paper Mean?

What Does A Sample of Research Paper Mean? By using APA research paper, you will understand how to compose a great essay or paper. Before you start writing your research paper, you should get familiar with the fundamentals and essentials of APA format, so you find it possible to make the APA format template seamlessly by yourself. When you would like to use the right section of paper, utilize the proper APA format paper. The MLA research paper outline template is just one of the popular formats to be utilized in academic writing. a Sample of Research Paper - Dead or Alive? Correct all errors you could spot and enhance the total grade of the paper to the best of your ability. Otherwise, you can estimate it yourself. Be certain that every citation you use is related to your purpose and don't neglect to cite it correctly using your necessary citation style. 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Understanding the U.S. Electoral College

The number of electors in the Electoral College is established in the United States Constitution. First, within the context of the Constitution, the meaning of  college, as in the Electoral College, does not mean a school, but of a group of people organized toward a common goal. The Electoral College was set up in the Constitution as a compromise between election of the President by a vote in Congress and election of the President by a popular vote of citizens who are eligible to vote. The  12th Amendment expanded voting rights. The result was that the use of the popular vote in the States as the vehicle for selecting electors changed radically. According to the Constitution, the Founding Fathers determined that every state should be given votes equal to the number of senators and representatives in its U.S. Congressional delegation. This gives two votes for its senators in the U.S. Senate plus a number of votes equal to the number of its members in the U. S. House of Representatives. Therefore, every state has at least three electoral votes because even the smallest states have one representative and two senators. The number of any additional electoral votes per state is determined by the United States Census which is completed every ten years. After the Census, the number of representatives is reapportioned to reflect any changes in population. That can mean the number of electors each state can vary in different presidential elections. Because of the 23 Amendment, the District of Columbia is treated as a state and allocated three electors for purposes of the Electoral College. In total, there are 538 electors in the Electoral College. A majority of 270 electoral votes is required to elect the President.   There is no law that requires the Electors in the Electoral College to vote according to the results of the popular vote in their states. These decisions are made by each state where restrictions fall into two categories—Electors that are bound by state law and those that are bound by pledges to political parties. The U.S. National Archives and Records Administration  maintains a website dedicated to information regarding the Electoral College. The website lists the number of votes per state, the records of the Electoral College elections, and links to the Electoral College process in each state. There is also contact information for each Secretary of State on the National Association of Secretaries of State:  http://www.nass.org.   The Secretary of State of each state can provide information as to the voting procedure and whether or not the voting is open to the public. Currently, the state with the largest number of electoral votes is California with 55. The U.S. National Archives and Records Administration also offers a frequently asked question page with links such as the ones below: Why did the Founding Fathers create electors?How many total electoral votes are there?How many electoral votes does a candidate need to win?What happens if there is a tie in the electoral college?Why dont the candidates get a proportion of the electoral vote?If the states winner chooses electors, wont the person with the most votes win?Why have elections when the states winner receives all the electoral votes?