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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 machines 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 compound’s 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 drug’s 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 drug’s 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 drug’s 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 patient’s 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 above 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: R 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 “″®HYPERLINK “” 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: 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 spherical 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.( Magnesium stearate dihydrate (MgSt-D) is a more effective lubricant for a high dose product containing 90 % COMPAPâ„¢ 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 can’t be use since high dose API are not easily compressed. Tablet Direct Compression Methods
Architecture of the 20th Century. While discussing the subject of architecture of the 20th century, the discussion is incomplete without a special mention of Robert Venturi. The man started his life in Philadelphia on 25th June, 1925 he went on to become one of the most prevalent names in American architecture. The information on Venturi includes a special mention of his wife Denise Scott Brown. 1960 was the year they first meet , got married in 1967 they have always been together ever since . This husband and wife team did remarkable work in the region of architecture, launching themselves with their joint venture better recognized as Venturi, Scott BrownArchitecture of the 20th Century
Samuel Merritt Globalization and the Legal Environment for Possible Expansion Report.

Instructions XYZ Company sells clothing and other apparel and it has decided to expand its operations globally, meaning it will examine options to manufacture and sell its products in other countries besides the United States. As the project manager in charge of overseeing global initiatives, you have been asked to research three possible countries in which to start operations for this company: Analyze and compare each country in terms of possible barriers to entry, laws that could affect the move, international law that may play a role in the move, and e-commerce considerations.Choose one of the three countries that are most appropriate to conduct this expansion. Discuss a globalization strategy, global competitive dynamics, and the process recommended for entering into the foreign market. This will be a professional report that is presented to the executive management team and the Board of Directors. Length: 3-5 pages, not including title page and references References: 5 Reference…….. Your presentation should demonstrate thoughtful consideration of the ideas and concepts presented in the course and provide new thoughts and insights relating directly to this topic. Your response should reflect scholarly writing and current APA standards.
Samuel Merritt Globalization and the Legal Environment for Possible Expansion Report

TC Customer Service at Independent Retail Food Chains Presentation.

Part 2: Select an article located in the Expert Journal of Marketing (an Open Access Journal) located at: and find an article that interests you. Create a 7-10 slide narrated presentation that takes the research data in the article and presents it in a usable format to the Board of Directors at a business that could use the research from the article.You will need to identify the industry and any company you think would benefit from the research. Briefly explain why you think this research applies to this company. This information should not take more than one slide.Outcome 5. Identify and focus on the perspectives of stakeholders (the marketing research firm, the client, respondents and the general public) using data analysis techniques.Outcome 7. Understand how professional marketing firms conduct data research.
TC Customer Service at Independent Retail Food Chains Presentation

Negligent Tort

Negligent Tort.

Visit the United States Consumer Product Safety Commission (Links to an external site.)Links to an external site. website. Click on “Recalls.” Choose one product that has been recalled.Describe the product subject to recall, including the recall date, recall number, and the reason for the recall.Analyze whether the manufacturer would be liable for negligence if the product had not been recalled and had caused harm to a consumer.Discusses the following in relation to the product recall:Duty of CareStandard of CareBreach of the Duty of CareActual CausationProximate CausationActual InjuryDefenses to NegligenceAnalyze and apply a relevant consumer protection statute identified under “Consumer Protection” in Chapter 8 of your text in conjunction with the product recall that you have identified. Must address the topic with critical thought.Submit a four- to five-page paper (not including title and reference pages). Your paper must be formatted according to APA style as outlined in the approved APA style guide and must cite at least three scholarly sources in addition to the textbook
Negligent Tort

Rasmussen College Professional Development Reflection Paper

python assignment help Rasmussen College Professional Development Reflection Paper.

Core Clinical Objective Develop professional nursing identity and clinical judgement. Activity Statements Apply principles of professionalism when engaging in community-based activities. Consult and/or collaborate with preceptor and other community health providers as appropriate. Analyze internal and external cues based on community assessment to generate hypotheses. Prioritize hypotheses and nursing actions based on needs and resources of the community. Generate potential solutions based on community needs assessment. Design strategies to evaluate community outcomes based on the generated hypotheses. Reflective Questions Given the population of interest served by your practicum agency, what types of needs assessment data is available? What additional data would you need to prioritize health needs? How would you use this data to develop health program goals, actions, and measures of evaluation? How did the practicum agency utilize outcome data to improve their programs? Describe how you engaged in community-based activities to promote critical thinking, clinical reasoning and clinical judgment during your practicum experience. Describe how your preceptor and other community providers influenced your thinking about a population and their specific needs? The Community is Bradenton FL, 34205. Manatee County Practicum site: LTAC/SNF Suggested Resource Websites: Community Health Assessments & Health Improvement Plans
Rasmussen College Professional Development Reflection Paper

Statistics unit 9 Discussion

Statistics unit 9 Discussion. Need help with my Statistics question – I’m studying for my class.

Because the sample is typically a relatively small portion of the entire population, errors will have to be considered. Using a sample to create a range or interval of values that estimates a population value is called a “confidence interval.”

Why is it often impossible to know the actual value of any population parameter? Explain and offer at least two examples of a population parameter that you cannot calculate, but that you can estimate.
A sample can be used to estimate a population parameter. How does the sample size affect the estimate?
To estimate a population parameter (such as the population mean or population proportion) using a confidence interval first requires one to calculate the margin of error, E. Why will there always be errors when using a sample to estimate a population? It is possible to use a sample to estimate a population parameter with 100% accuracy? Explain.
The value of the margin of error, E, can be calculated using the appropriate formula. The formula depends on whether one is estimating a mean or estimating a proportion. The formulas for E are the following (for 95% confidence):

The Margin of Error, E, for means is: E = 1.96*s/sqrt(n), where s is the sample standard deviation and n is the sample size. The “sqrt” stands for square root.
The Margin of Error, E, for proportions is: E = 1.96*sqrt[p*(1-p)/n], where s is the sample standard deviation and n is the sample size.
Invent a variable, such as Age, Weight, Exam Score, etc. Next, invent a small set of data (20 data values) to describe that variable. Use Excel to calculate the sample mean of your data and the sample standard deviation. If you create 20 values, the sample size is 20.
Use your data and calculations to determine the error E for your dataset. Use the formula for means. Show and include all your work and Excel results in your post. Include your dataset in your post and attach your Excel document.
Please create personalized and substantive responses to at least two other student main posts. In your response, include the following:
Choose any two classmates and review their main posts.

Review the student’s response to numbers 1 and 2 above. Compare these answers to your answers. Create a paragraph that offers this comparison and better explains why samples can estimate population parameters, but will never be 100% accurate.
Review the student’s responses to numbers 3 and 4. Evaluate their work and answer. What variable did they choose? What were their sample mean, sample standard deviation, and sample sizes? Is their margin of error E correct? If yes, what is their margin of error and what does it tell you? If not, correct it and show all the work and steps.

Reading and Resources

Read the assigned chapters from the following textbooks:

Bennett, J., Briggs, W.L. & Triola, M.F. (2013) Statistical Reasoning for Everyday Life (4th ed.). Upper Saddle, NJ: Pearson.

Chapter 8 “From Samples to Populations”

Reading the textbook and reviewing the textbook examples are excellent methods for starting each unit. Reading the textbook offers context and explanations for new concepts and methods. Completing the textbook examples on paper (and with Excel) is a great way to practice and learn the new methods and concepts introduced. Student feedback has suggested that reading the textbook and practicing the textbook examples has been particularly helpful if completed before the unit Seminar. Some students have reported that keeping a notebook handy, and recording new definitions or concepts encountered while reading is helpful, more organized, and stress reducing.
This chapter includes a section that offers examples using technologies such as Excel. In addition, at the end of each chapter section, or at the end of the chapter, are review exercises that are very helpful for practicing and preparing.
In this course, students may use Excel for any statistical calculations. Excel can be used to evaluate data in many ways. Excel can be used to calculate numerical measures, such as measures of center (such as mean and median) and measures of variation (variance, standard deviation, and range), as well as many other measures such as min, max, and correlation (r-value). Excel can also be used to create visualizations, such as histograms, bar graphs, pie graphs, scatterplots, and others. Excel may also be used to create linear regression equations. Because Excel is a very common tool, the Internet and YouTube both contain considerable support resources and tutorials.

Bennett, J., Briggs, W.L. & Triola, M.F. (2013) Statistical Reasoning for Everyday Life (4th ed.). Upper Saddle, NJ: Pearson.

Statistics unit 9 Discussion

Two questions

Read CH 11: Stevenson( textbook access below)Throughout this episode we hear about police officers acting in a way that makes them seem more like the criminals than what they are supposed to be protecting their city from. The city kept piling their debt with their own wrongdoings yet can still continue to do what they do. Instead of looking at temporary fixes, what would make actual change to disabling and reforming corrupt policing styles?

In Stevenson, Chapter 11 we hear about the impact that the media has had on a case and how the defense used 60 minutes to their advantage. What are some recent examples of ways the media has played a role in national events? Have you noticed any examples in your own life of the media being coercive or playing a role in your opinionsor beliefs?