Pharmaceutical+Products




 * A pharmaceutical product** is a product that is used to alleviate pain, heal injuries and cure diseases. These products, for all intents and purposes, are drugs and medicines. They are fundamental components of healthcare everywhere, whether it be modern medicine or traditional treatments that stretch back 5,000 years to ancient China. Thus, they can be naturally occuring substances or chemicals such as herbs, or more science-based pills constructed in a laboratory (synthetic).

In most cases, a drug or a medicine is a chemical that does one or more of the following: - Alters the cognitive and physiological state. - Alters incoming sensory sensations ie the nervous system. - Alters emotion/mood

=Where did Pharmaceutical Products Originate?=

It's important to note that pharmaceutical products find their roots with herbs and plants. For example, Morphine, a common pain-killer, comes from the poppy plant, or more specifically, //Papaver somniferum.// Not only that, the precursor to aspirin, salicylic acid, originates from willow bark. Not only that, the primary ingredient in sleeping pills, barbituric acid, occurs naturally in grapes and strawberries.

=How are Various Drugs Administered?=

In order to have any effect or produce any positive results, most drugs must reach the bloodstream. By entering the blood stream the drug can then reach the site where the drug is needed faster. There == are four main methods of reaching the blood stream, each with routes and speed with which the drug enters the blood stream. They are:
 * 1) Taken by mouth (orally)
 * 2) Direct injection into a vein (Intravenously)
 * 3) Direct injection into a muscle (Intramuscularly)
 * 4) Injected directly under the skin (Subcutaneously)

= = =Oral Route=

Most drugs can be administered orally through the use of capsules, liquids, or tablets. They are done this way because they are often the safest, cheapest, and most convenient way to administer drugs. However, there are a few limitations to using t his method. For example, in order to reach the blood stream, most drugs should be absorbed by the stomach or even in the mouth. However, this is often not the case, and sometimes it is absorbed by the intestinal wall or even the liver. When drugs are absorbed by the liver, it can sometimes be chemically altered, which defeats the purpose of the drug. As a result, only a small amount of the drug may actually reach the bloodstream.

In addition, there are some drugs that irritate the digestive tract. Mostly NSAIDs (Non-steroidal Anti-Inflammatory Drugs) are what cause this irratation. A common drug in that category is Aspirin. These drugs can harm the stomach lining and the small intestine, potentially causing or aggravating preexisting ulcers.

=Intravenous Route= When drugs are given intravenously, that means that they are being directly injected into a vein, directly into the blood stream. Most of the time these veins are located in the fore arm. The intravenous route allows drugs to be implemented precisely and rapidly into the bloodstream. In addition, this method is used when the drugs would otherwise irritate the body when used in other methods of administration. One disadvantage to using intravenous methods is that often the effects of the drug wear off faster than other methods. As a result more of the drug may be needed. In addition, it is much more difficult to administer drugs in this manner than other methods because a catheter is required to be injected directly into a vein, which is some cases of obese patients can be very difficult. **Subcutaneous Route**

Using the subcutaneous route, a needle is inserted into the fatty tissue just underneath the skin, from which it uses small blood vessel to transport the drug to the capillaries. It can also reach the bloodstream through lymphatic vessels. This manner of administeration is often used for the delivery of proteins, such as insulin. The reason for this is that the proteins would normally be destroyed in the digestive tract if they were injested orally. =Intramuscular Route=

If it weren't already obvious in the name, the intramuscular route involves injecting a drug into the muscles of a person, beneath the skin and fatty tissues. This form of administration is used whenever large quantities of a drug are needed. The quickness of the drug reaching the bloodstream depends on the overall blood supply to the muscle. The less blood supply to the muscle, the slower the drug is absorbed.

This [|video] from IBM about a Chinese hospital helps to show how these plants, and also treatments, are still used today, often in combination with more 'Western' medicines.

=The Placebo Effect= Pharmaceutical products are (hopefully) taken to improve health or help the body along with a natural process. However, this procedure, the mechanism with which it functions, is still not entirely understood. This leads to something known as 'the placebo effect.' The placebo effect essentially is when a product with no medical value is consumed by a patient and their condition actually changes based on the expected result of the placebo. In other words, the mind makes the medicine. Now, chances are you have heard of the placebo effect before, or have at least witnessed it. A pretty common example is when patients are administered sugar pills in lieu of Aspirin. They pills appear to be identical, and the patients expect the pain-relieving effects of the Aspirin to occur… so they do. But not because the sugar provides a medical miracle, but rather: the brain is convinced that the pill is helping your body. Another example of the placebo effect is in none other than the pop culture phenomenon of Harry Potter. In the 6 th  installment of the series, Ron, who plays the equivalent of goalie in the magical sport Quiditch, is nervous about a big game. Everybody expects him to do badly, so he starts to think he will as well. Harry pretends to spike Ron’s drink with Felix Felicis, a potion that would make Ron lucky. Ron then believes he will be lucky and goes out and is the best player on the field, but out of pure confidence, based on the fact that he //thought //he had consumed the potion. The following video by one “Professor Funk” describes the placebo effect extremely well. In addition to the background and concept of the placebo effect, he also provides factual and trivial information that applies to everyday lives, so it’s worth watching. (Disclaimer: mind the very brief expletive).

media type="youtube" key="yfRVCaA5o18" height="315" width="560"

=Developmental Research, and Testing of New Products.=

The process of what makes a drug a drug is extremely complicated, long-term and can rack up some pretty exorbitant costs. However, the procedure can be narrowed down to several vague steps.

In the grand scope of things, a product is usually synthesized from an already-existing substance. But doing this may not be as easy as it sounds. After the product is isolated from the original species, it is subject to multiple primary studies that are conducted in labs by clinical pharmacologists. Before humans can participate in these studies, it is important to find what is called a “lethal dose.” LD50 is what is required to kill half of the animal population being tested on. Then, the effective does (ED50) required to bring out a noticeable change in 50% of a population is also obtained.

But all of this takes place after several other steps, so let’s back track.

1.) A relationship is noticed in between the compounds and elements of a substance.

2.) The compounds are separated in to lead compounds, which are shown to have organic/biological activity and to non-lead compounds.

3.) A certain compound is isolated from the rest of the substance to see the effect of just that compound. Note: A compound can also be chemically synthesized which would skip steps 1 and 2.

4.) Under very strict rules, this compound is tested on animals to look for correlations between a compound and a change in behaviorisms and/or health in the animal.

5.) Next, it is important to find what is called a “lethal dose.” LD50 is what is required to kill half of the animal population being tested on. Then, the effective dose (ED50) required to bring out a noticeable change in 50% of a population is also obtained. These are plugged into a simple formula:

Therapeutic index= LD50 / ED50 (this can also be called a therapeutic window)

<span style="font-family: Arial,sans-serif; font-size: 10pt;"> What this does is it helps pharmacologists to see the danger and risk of the drug. They need to find a safe therapeutic index that can be tested on humans.

<span style="font-family: Arial,sans-serif; font-size: 10pt;">6.) Human testing begins in initial clinical trials. Small groups composed of 20 to 200 healthy individuals take samples of the product. Usually, half of all test groups are given placeboes as a control, to see if the drug has any actual effect. It is tested for safety, dosage and possible side effects.

<span style="font-family: Arial,sans-serif; font-size: 10pt;">7.) Providing no fatal or otherwise terrible setbacks occur, human testing moves to larger and larger groups, still using placeboes. This time, the drug is modified so that all variables are controlled, and scientists ensure that benifits > risk.

<span style="font-family: Arial,sans-serif; font-size: 10pt;">8.) A system is put in place to track long-term effects.

<span style="font-family: Arial,sans-serif; font-size: 10pt;">9.) The product is released to the public after being licensed.

<span style="font-family: Arial,sans-serif; font-size: 10pt;">10.) Marketing of the product begins, but this marks the end of how a compound becomes a drug in a 10-step process.

<span style="font-family: Arial,sans-serif; font-size: 10pt;">Please refer to the above flowchart for a slightly different, but more technical approach to the topic.

<span style="font-family: Arial,sans-serif; font-size: 10pt;">As far as how expensive drugs costs, one study estimates that developing an innovative new drug from scraps costs $800 million. This includes estimates for failed projects and unexpected financial problems. This is why, in 2005, the United States government spent $25 billion on medical innovation and pharmaceutical development.

=Side-effects and Tolerance=

Some times, drugs can have unwanted side effects. In some cases, aspirin can cause bleeding in the stomach. In addition, morphine, the pain killer, is known to cause constipation. For drugs, the severity of side effects is often relative to the benefit of the drug. For people with heart attacks, doctors often tell people to take aspirin, because it is known to have anti-clotting properties. As a result, a risk-to-benefit ratio is used. So, this means that if a drug can be used to treat and cure a life-threatening disease, then a high risk for side effects is more acceptable.

While testing a drug, another aspect tested is the tolerance towards the drug. Tolerance occurs when the body adapts to the effects of the drug, and over time the drug loses overall effectiveness. So, in order to achieve the same effect as originally, the user must consume more of the drug or larger doses. When tolerance occurs, the effects can be slightly dangerous as when larger doses are consumed, the chanc es of reaching lethal doses are much greater. = = = =

= =

=Thalidomide: A pharmaceutical company's nightmare.= <span style="font-family: Arial,sans-serif;">Drug research and //testing// is so crucial to any medicine, a lesson learnt after what transpired due to Thalidomide in the late 50s, often called. A German-based company thought they had discovered a new drug that combated morning sickness and nausea in pregnant women. It did do exactly that, but studies and tests during developmental stages were not very longitudinal. Thus, after the company publicized it like crazy (it spread to plenty of other countries as well), a large amount of pregnant women had already administered the drug. Unfortunately there were fatal side effects for the unborn children. Many were born without limbs, and for every child who was partially or totally limbless, 10 children didn't survive. This is an example of the fatal side effects of pharmaceuticals that do not experience thorough testing.

=Pop Quiz (10 Non-IB and 6 IB)= <span style="font-family: Arial,sans-serif;">1. What is, in your own words, a placebo? <span style="font-family: Arial,sans-serif;">2. True or false: Pharmaceutical products are always in pill-form. <span style="font-family: Arial,sans-serif;">3. When drugs have entered the initial human trial phase, what do half of the patients recieve in lieu of actual drugs? <span style="font-family: Arial,sans-serif;">4. If LD50 is 60, and the therapeutic index is 2, what is ED50? <span style="font-family: Arial,sans-serif;">5. Why do pharmacologists look for a therapeutic index? <span style="font-family: Arial,sans-serif;">6. What is often the cheapest form of administering a drug? <span style="font-family: Arial,sans-serif;">7. From where do pharmaceutical products get their roots? <span style="font-family: Arial,sans-serif;">8. What can cause a drug to lose it's effectiveness over multiple uses? <span style="font-family: Arial,sans-serif;">9. What is a common side effect of Aspirin? <span style="font-family: Arial,sans-serif;">10. Which form of injection is best used for larger quantities of a drug?

<span style="font-family: Arial,sans-serif;">IB <span style="font-family: Arial,sans-serif;">1. Many drugs are taken orally. State three other ways in which drugs may be taken by a patient. (2 points) 2. State what is meant by the term //side effect//. 3. Outline the stages involved in the research, development, and testing of new pharmaceutical products. 4. Outline the benefits and limitations to the four manners of administering a drug. 5. Explain why is it alright for a drug that cures HIV to have a high rick for a side effect like a heart attack. 6. State the three uses for pharmaceutical products.

=Sources and References= http://www.youtube.com/watch?feature=player_embedded&v=yfRVCaA5o18 http://www.cbo.gov/sites/default/files/cbofiles/ftpdocs/76xx/doc7615/10-02-drugr-d.pdf http://www.dailymail.co.uk/news/article-2211626/Thalidomide-victim-Tom-Yendell-world-renowned-artist-painting-mouth-feet.html http://chemistry-helper.blogspot.com/2011/05/medicines-and-drugs.html http://25.media.tumblr.com/tumblr_md2la22txq1qghwxto1_500.gif http://gifsoup.com/webroot/animatedgifs1/3684260_o.gif http://www.merckmanuals.com/home/drugs/administration_and_kinetics_of_drugs/drug_administration.html http://www.healthytransplant.com/the_basics/after_transplant.aspx http://www.pharmainfo.net/files/images/stories/article_images/Stages%20involved%20in%20%20%20development%20of%20pharmaceutical%20formulation.jpg http://en.wikipedia.org/wiki/File:ICU_IV_1.jpg

<span style="background-color: #ffffff; color: #4d4d4d; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 11px;">Neuss, Geoff. //<span style="background-color: #ffffff; color: #4d4d4d; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 11px;">IB Study Guide //<span style="background-color: #ffffff; color: #4d4d4d; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 11px;">. 2nd ed. Oxford: Oxford University Press, 2007. Print.

<span style="background-color: #ffffff; color: #4d4d4d; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 11px;">Neuss, Geoffrey. //<span style="background-color: #ffffff; color: #4d4d4d; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 11px;">Chemistry: IB diploma course companion //<span style="background-color: #ffffff; color: #4d4d4d; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 11px;">. 2nd ed. Oxford: Oxford University Press, 2010. Print.

<span style="background-color: #ffffff; color: #4d4d4d; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 11px;">Crane, John, and Jette Hannibal. //<span style="background-color: #ffffff; color: #4d4d4d; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 11px;">IB diploma programme: psychology course companion //<span style="background-color: #ffffff; color: #4d4d4d; font-family: Verdana,Arial,Helvetica,sans-serif; font-size: 11px;">. Oxford: Oxford University Press, 2009. Print.