The leading manufacturer of APIs today is TAPI (Teva Active Pharmaceutical Ingredients). Specializing in range of API-related fields, TAPI works in areas such as chemical synthesis, fermentation, and chromatography and plant extraction and now has the industry’s largest portfolio of over 300 API products. In 2011 alone they achieved third-party sales of around $750 million.

Dr. Reddy’s is another leading manufacturer with 60 APIs for drug use, diagnostic kits and biotechnology products. Aurobindo and Cipla manufacture 200 APIs each, exporting their products to well over 200 countries worldwide. Other notable manufacturers are Sandoz-Lek-Biochemie, Ranbaxy, Matrix and Sun.

APIs are commonly referred to as ‘bulk pharmaceuticals’ and are in fact usually made in places at quite a distance to where tablets, suspensions and liquids are manufactured. Today, the greatest concentrations of API manufacturers are located around Asia, specifically in India and China.

This has led to more and more companies to outsource API manufacturing to such places, which has the main benefit of eliminating the need to invest in highly expensive equipment and infrastructure – which on top of everything can also be complicated to install and maintain. A good example can be found with AstraZeneca, who manufacture 85% of its APIs but are currently in the process of withdrawing from all API production in favor of outsourcing.

Regardless of where the active pharmaceutical ingredient is made, companies must adhere to strict safety and quality standards set by the country where it will be used. So those APIs manufactured in China or India for use in the United States must still be inspected and licensed by the FDA. Similarly, if the API is intended for use in Europe, they would need to meet regulations set by the European Medicines Agency. Regular inspection outside the country of use however can prove difficult with counterfeiting and contamination being high on the list of various agencies’ concerns. For instance, since 2008, the FDA has considerably increased its overseas staff as a way of attempting to eliminate these problems. As a result, countries such as India have gained their foothold in the global market and now have around 75 FDA-approved manufacturing facilities for API synthesis.

Today there are more and more calls for API manufacturers to go green – that is to say, to reduce the waste they produce. Every year, large pharmaceutical manufacturers can produce anywhere from 3000 to 5000 tons of hazardous waste each. If one were to ask any reputable API manufacturer how they would like to improve the process, they’d likely say to make the reactions faster, or to make them cheaper. Ironically the first steps in reducing waste from API synthesis would be to reduce the number of reactions required to produce a given molecule. Therefore though the goal may be different, the means turn out to be the same as fewer reactions mean less solvent to dispose of. Another step in going green is to find different solvents and catalysts that are not only more efficient, but are also better for the environment.

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID).

Naproxen is a pain medication that relieves inflammation and joint stiffness. Other NSAIDs in the same medication class include acetylsalicylic acid, diclofenac, ibuprofen, and meloxicam.

Naproxen works by blocking the enzyme that produces prostaglandins. Prostaglandins play an essential role in inflammation. The body produces them at the site of injured tissue, and they cause redness, heat, swelling, and pain.

Naproxen is available as naproxen or naproxen sodium. The major difference between naproxen and naproxen sodium is that naproxen sodium is more rapidly absorbed.

The body reaches peak levels of naproxen in 2–4 hours and naproxen sodium in 1–2 hours, meaning that it absorbs naproxen sodium faster than regular naproxen.

Alpha-lipoic acid

Generic name: alpha-lipoic acid (AL fa lye POE ik AS id)

Brand name: Alpha Lipoic Acid, Alpha-Lipoic-Acid-300, Alpha Lipoic

Dosage forms: oral capsule (100 mg; 200 mg; 300 mg; 600 mg); oral tablet (100 mg; 300 mg; 50 mg)

Drug class: Nutraceutical products

Alpha-lipoic acid is an antioxidant also known as Acetate Replacing Factor, ALA, Biletan, Lipoicin, Thioctan, and many other names.

Alpha-lipoic acid is a naturally occurring fatty acid that can be found in many foods such as yeast, spinach, broccoli, potatoes, and organ meats such as liver or kidney.

Alpha-lipoic acid has been used in alternative medicine as a possibly effective aid in weight loss, treating diabetic nerve pain, healing wounds, lowering blood sugar, improving skin discoloration caused by vitiligo, and decreasing complications of coronary artery bypass graft (CABG) surgery. Alpha-lipoic acid may have been combined with other plants or extracts in a specific preparation to treat these conditions.

Alpha-lipoic acid has also been used to treat rheumatoid arthritis, Alzheimer's disease, alcoholic liver problems, altitude sickness, heart-related nerve problems, HIV-related brain problems, or eye problems caused by diabetes. However, research has shown that alpha-lipoic acid may not be effective in treating these conditions.

Azithromycin

Generic name: azithromycin (a ZITH roe MYE sin)

Brand name: Azasite, Azithromycin 3 Day Dose Pack, Azithromycin 5 Day Dose Pack, Zithromax, Zithromax TRI-PAK, Zithromax Z-Pak, Zmax

Drug class: Macrolides

Azithromycin is an antibiotic that fights bacteria.

Azithromycin is used to treat many different types of infections caused by bacteria, such as respiratory infections, skin infections, ear infections, eye infections, and sexually transmitted diseases.

Azithromycin may also be used for purposes not listed in this medication guide.

Ketoprofen

Generic name: ketoprofen (kee toe PROE fen)

Brand name: Orudis, Oruvail, Actron, Orudis KT

Dosage forms: oral capsule (25 mg; 50 mg; 75 mg); oral capsule, extended release (200 mg)

Drug class: Nonsteroidal anti-inflammatory drugs

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat pain or inflammation caused by arthritis.

The ketoprofen regular capsule is also used to treat mild to moderate pain, or menstrual pain.

Only ketoprofen extended-release capsules are used for treating arthritis. This form of ketoprofen will not work fast enough to treat acute (immediate) pain.

Pregabalin

Generic name: pregabalin (pre GAB a lin)

Brand name: Lyrica, Lyrica CR

Dosage forms: oral capsule (100 mg; 150 mg; 200 mg; 225 mg; 25 mg; 300 mg; 50 mg; 75 mg); oral solution (20 mg/mL); oral tablet, extended release (165 mg; 330 mg; 82.5 mg)

Drug class: Gamma-aminobutyric acid analogs

Pregabalin is an anti-epileptic drug, also called an anticonvulsant. It works by slowing down impulses in the brain that cause seizures. Pregabalin also affects chemicals in the brain that send pain signals across the nervous system.

Pregabalin is used to treat pain caused by fibromyalgia, or nerve pain in people with diabetes (diabetic neuropathy), herpes zoster (post-herpetic neuralgia), or spinal cord injury.

Pregabalin is also used with other medications to treat partial onset seizures in adults and children who are at least 1 month old.

The post ACTIVE PHARMA INGREDIENTS (API) [AZITHROMYCIN, ALPHA LIPOIC ACID, PREGABLIN, NAPROXEN, KETOPROFEN] appeared first on EIRI - eBooks and Project Reports.

The leading manufacturer of APIs today is TAPI (Teva Active Pharmaceutical Ingredients). Specializing in range of API-related fields, TAPI works in areas such as chemical synthesis, fermentation, and chromatography and plant extraction and now has the industry’s largest portfolio of over 300 API products. In 2011 alone they achieved third-party sales of around $750 million.

Dr. Reddy’s is another leading manufacturer with 60 APIs for drug use, diagnostic kits and biotechnology products. Aurobindo and Cipla manufacture 200 APIs each, exporting their products to well over 200 countries worldwide. Other notable manufacturers are Sandoz-Lek-Biochemie, Ranbaxy, Matrix and Sun.

APIs are commonly referred to as ‘bulk pharmaceuticals’ and are in fact usually made in places at quite a distance to where tablets, suspensions and liquids are manufactured. Today, the greatest concentrations of API manufacturers are located around Asia, specifically in India and China. This has led to more and more companies to outsource API manufacturing to such places, which has the main benefit of eliminating the need to invest in highly expensive equipment and infrastructure – which on top of everything can also be complicated to install and maintain. A good example can be found with AstraZeneca, who manufacture 85% of its APIs but are currently in the process of withdrawing from all API production in favor of outsourcing.

Regardless of where the active pharmaceutical ingredient is made, companies must adhere to strict safety and quality standards set by the country where it will be used. So those APIs manufactured in China or India for use in the United States must still be inspected and licensed by the FDA. Similarly, if the API is intended for use in Europe, they would need to meet regulations set by the European Medicines Agency. Regular inspection outside the country of use however can prove difficult with counterfeiting and contamination being high on the list of various agencies’ concerns. For instance, since 2008, the FDA has considerably increased its overseas staff as a way of attempting to eliminate these problems. As a result, countries such as India have gained their foothold in the global market and now have around 75 FDA-approved manufacturing facilities for API synthesis.

Today there are more and more calls for API manufacturers to go green – that is to say, to reduce the waste they produce. Every year, large pharmaceutical manufacturers can produce anywhere from 3000 to 5000 tons of hazardous waste each. If one were to ask any reputable API manufacturer how they would like to improve the process, they’d likely say to make the reactions faster, or to make them cheaper. Ironically the first steps in reducing waste from API synthesis would be to reduce the number of reactions required to produce a given molecule. Therefore though the goal may be different, the means turn out to be the same as fewer reactions mean less solvent to dispose of. Another step in going green is to find different solvents and catalysts that are not only more efficient, but are also better for the environment.

The post ACTIVE PHARMA INGREDIENTS (API) appeared first on EIRI - eBooks and Project Reports.

IV fluid therapy is an efficient and effective way of supplying fluids directly into the intravascular fluid compartment, in replacing electrolyte losses, and in administering medications and blood products.

STANDARD IVF & ELECTROLITES

- NaCl 0.18 – 2.7%
- Glucose 2.5 - 50%
- Sodium Lactate (Hartmanns’s) Solution
- Ringer Lactate
- Water For injection
- Sterile Water for Irrigation
- Sodium Chloride 0.9% for irrigation
- Sodium Chloride 0.18 – 0.45% and Glucose 4 – 10 %
- Potassium Chloride 0.15 – 0.3% in Sodium Chloride 0.9%
- Potassium Chloride 0.15 – 0.3% in Glucose 5%

The aims of IV fluid administration should be to

• Avoid dehydration

• Maintain an effective circulating volume

• Prevent inadequate tissue perfusion during a period when the patient is unable to achieve these goals through normal oral fluid intake

“Intravenous fluids have a range of physiologic effects and should be considered to be drugs with indications, dose ranges, cautions, and side effects.”

The intravenous route is the fastest way to deliver medications and fluid replacement throughout the body, because they are introduced directly into the circulation.

Intravenous therapy may be used for fluid volume replacement, to correct electrolyte imbalances, to deliver medications, and for blood transfusions.

Basic IV Setup

Let's take a look at the most basic possible setup for an IV:

The drip chamber is located just below the IV bag; inside this chamber we can see the fluid drip down from the bag into the IV tubing. This is where we measure the speed of a manual IV setup; we look at this chamber and count the number of drops we see per minute. So, for example, if we count 25 drops over the period of 60 seconds, we would say that the IV is infusing at a rate of 25 drops per minute, or 25 gtt/min. (In reality, we may not count the number of drops in a full minute; we can, for example, count the number of drops we see over a period of 15 seconds, and then multiply that number by 4 to get the number of drops in a full minute.)

The drip chamber must always be half full. If the drip chamber is too full, we will not be able to see the drops to count them, and so we will be unable to determine the rate at which the IV is infusing. If the drip chamber is not full enough, then this will allow air to get into the IV tubing, which means that air would get into the patient's circulatory system, which could be very dangerous, blocking a blood vessel or stopping the heart.

The roller clamp is what we use to control the rate at which the IV fluid infuses. If we roll it one way, it squeezes the IV tubing more tightly, making it more narrow and therefore making the fluid flow through the tubing more slowly; if we roll it the other way, it loosens its pinching of the IV tubing, making the tubing less narrow, and allowing the IV fluid to flow through at a faster rate. So, if for example, we observe (by looking at the drip chamber and counting drops) that an IV is infusing at a rate of 50 gtt/min, but it was ordered to infuse at a rate of 30 gtt/min, we would tighten the roller clamp to slow the drip rate down until we could count only 30 drops going through the drip chamber each minute.

All roller clamps on a set of IV tubing should be closed before we attach a bag of IV fluid to the top of the tubing; this ensures that no air gets into the tubing.

Every IV medication will be ordered to infuse at a specific rate, and one of the major tasks of hosptial nurses is to set up the IV so that it infuses at this rate and to adjust the IV periodically if the rate has changed so that it remmains at the ordered rate. The rate at which an IV fluid infuses is referred to as the IV infusion rate or flow rate.
The slide clamp is used when we want to completely stop the IV from flowing, without having to adjust the roller clamp. This is handy if we want to stop the IV for a moment, but we don't want to have to reset the flow rate by readjusting the roller clamp all over again once we start the IV up again. This works by pinching the tubing completely shut when we slide the tubing into the narrowest part of the clamp.

The injection port is a place where medicine or fluids other than those in the current IV bag can be injected so that they will infuse into the patient's vein through the IV tubing. On the photo above we can see two ports: one on the IV bag itself and one below the drip chamber. There is also usually an injection port close to where the needle goes into the patient's vein; we'll see this below. The injection port on the actual IV bag is used if we want to mix some kind of medication with the fluid that is in the IV bag; if we inject the medication into this port and then roll the bag a little to mix the medication into the fluid in the bag, then the patient will recieve both the medication and the IV fluid at the same time. However, this can only be done when the IV fluid and the medication are allowed to be mixed. If we want to inject medication or a second kind of IV fluid directly so that it does not mix with the IV fluid that we've already attached, then we will use one of the ports that are located below the drip chamber.

The post FFS I.V. FLUID UNIT appeared first on EIRI - eBooks and Project Reports.

IV fluid therapy is an efficient and effective way of supplying fluids directly into the intravascular fluid compartment, in replacing electrolyte losses, and in administering medications and blood products.

STANDARD IVF & ELECTROLITES

- NaCl 0.18 – 2.7%
- Glucose 2.5 - 50%
- Sodium Lactate (Hartmanns’s) Solution
- Ringer Lactate
- Water For injection
- Sterile Water for Irrigation
- Sodium Chloride 0.9% for irrigation
- Sodium Chloride 0.18 – 0.45% and Glucose 4 – 10 %
- Potassium Chloride 0.15 – 0.3% in Sodium Chloride 0.9%
- Potassium Chloride 0.15 – 0.3% in Glucose 5%

The aims of IV fluid administration should be to

• Avoid dehydration

• Maintain an effective circulating volume

• Prevent inadequate tissue perfusion during a period when the patient is unable to achieve these goals through normal oral fluid intake

“Intravenous fluids have a range of physiologic effects and should be considered to be drugs with indications, dose ranges, cautions, and side effects.”

The intravenous route is the fastest way to deliver medications and fluid replacement throughout the body, because they are introduced directly into the circulation.

Intravenous therapy may be used for fluid volume replacement, to correct electrolyte imbalances, to deliver medications, and for blood transfusions.

Basic IV Setup

Let's take a look at the most basic possible setup for an IV:

The drip chamber is located just below the IV bag; inside this chamber we can see the fluid drip down from the bag into the IV tubing. This is where we measure the speed of a manual IV setup; we look at this chamber and count the number of drops we see per minute. So, for example, if we count 25 drops over the period of 60 seconds, we would say that the IV is infusing at a rate of 25 drops per minute, or 25 gtt/min. (In reality, we may not count the number of drops in a full minute; we can, for example, count the number of drops we see over a period of 15 seconds, and then multiply that number by 4 to get the number of drops in a full minute.)

The drip chamber must always be half full. If the drip chamber is too full, we will not be able to see the drops to count them, and so we will be unable to determine the rate at which the IV is infusing. If the drip chamber is not full enough, then this will allow air to get into the IV tubing, which means that air would get into the patient's circulatory system, which could be very dangerous, blocking a blood vessel or stopping the heart.

The roller clamp is what we use to control the rate at which the IV fluid infuses. If we roll it one way, it squeezes the IV tubing more tightly, making it more narrow and therefore making the fluid flow through the tubing more slowly; if we roll it the other way, it loosens its pinching of the IV tubing, making the tubing less narrow, and allowing the IV fluid to flow through at a faster rate. So, if for example, we observe (by looking at the drip chamber and counting drops) that an IV is infusing at a rate of 50 gtt/min, but it was ordered to infuse at a rate of 30 gtt/min, we would tighten the roller clamp to slow the drip rate down until we could count only 30 drops going through the drip chamber each minute.

All roller clamps on a set of IV tubing should be closed before we attach a bag of IV fluid to the top of the tubing; this ensures that no air gets into the tubing.

Every IV medication will be ordered to infuse at a specific rate, and one of the major tasks of hosptial nurses is to set up the IV so that it infuses at this rate and to adjust the IV periodically if the rate has changed so that it remmains at the ordered rate. The rate at which an IV fluid infuses is referred to as the IV infusion rate or flow rate.

The slide clamp is used when we want to completely stop the IV from flowing, without having to adjust the roller clamp. This is handy if we want to stop the IV for a moment, but we don't want to have to reset the flow rate by readjusting the roller clamp all over again once we start the IV up again. This works by pinching the tubing completely shut when we slide the tubing into the narrowest part of the clamp.

The injection port is a place where medicine or fluids other than those in the current IV bag can be injected so that they will infuse into the patient's vein through the IV tubing. On the photo above we can see two ports: one on the IV bag itself and one below the drip chamber. There is also usually an injection port close to where the needle goes into the patient's vein; we'll see this below. The injection port on the actual IV bag is used if we want to mix some kind of medication with the fluid that is in the IV bag; if we inject the medication into this port and then roll the bag a little to mix the medication into the fluid in the bag, then the patient will recieve both the medication and the IV fluid at the same time. However, this can only be done when the IV fluid and the medication are allowed to be mixed. If we want to inject medication or a second kind of IV fluid directly so that it does not mix with the IV fluid that we've already attached, then we will use one of the ports that are located below the drip chamber.

The post I.V. FLUID MANUFACTURING UNIT appeared first on EIRI - eBooks and Project Reports.

Many dynamic scientific, social and economic factors affect the pharmaceutical industry. Some pharmaceutical companies operate in both national and multinational markets. Therefore, their activities are subject to legislation, regulation and policies relating to drug development and approval, manufacturing and quality control, marketing and sales (Spilker 1994). Academic, government and industry scientists, practising physicians and pharmacists, as well as the public, influence the pharmaceutical industry. Health care providers (e.g., physicians, dentists, nurses, pharmacists and veterinarians) in hospitals, clinics, pharmacies and private practice may prescribe drugs or recommend how they should be dispensed. Government regulations and health care policies on pharmaceuticals are influenced by the public, advocacy groups and private interests. These complex factors interact to influence the discovery and development, manufacturing, marketing and sales of drugs.

The pharmaceutical industry is largely driven by scientific discovery and development, in conjunction with toxicological and clinical experience (see figure below). Major differences exist between large organizations which engage in a broad range of drug discovery and development, manufacturing and quality control, marketing and sales and smaller organizations which focus on a specific aspect. Most multinational pharmaceutical companies are involved in all these activities; however, they may specialize in one aspect based upon local market factors. Academic, public and private organizations perform scientific research to discover and develop new drugs. The biotechnology industry is becoming a major contributor to innovative pharmaceutical research. Often, collaborative agreements between research organizations and large pharmaceutical companies are formed to explore the potential of new drug substances.

Drug development in the pharmaceutical industry

Collectively, the top 20 pharmaceutical companies spend approximately $60 billion on drug development each year, and the estimated average cost of bringing a drug to market (including drug failures) is now $2.6 billion—a 140 percent increase in the past ten years.

The post PHARMACEUTICAL UNIT (TABLET, CAPSULES, SYRUPS, OINTMENTS, LOTION) appeared first on EIRI - eBooks and Project Reports.

Academic, government and industry scientists, practising physicians and pharmacists, as well as the public, influence the pharmaceutical industry. Health care providers (e.g., physicians, dentists, nurses, pharmacists and veterinarians) in hospitals, clinics, pharmacies and private practice may prescribe drugs or recommend how they should be dispensed. Government regulations and health care policies on pharmaceuticals are influenced by the public, advocacy groups and private interests. These complex factors interact to influence the discovery and development, manufacturing, marketing and sales of drugs.
The pharmaceutical industry is largely driven by scientific discovery and development, in conjunction with toxicological and clinical experience (see figure below). Major differences exist between large organizations which engage in a broad range of drug discovery and development, manufacturing and quality control, marketing and sales and smaller organizations which focus on a specific aspect. Most multinational pharmaceutical companies are involved in all these activities; however, they may specialize in one aspect based upon local market factors. Academic, public and private organizations perform scientific research to discover and develop new drugs. The biotechnology industry is becoming a major contributor to innovative pharmaceutical research. Often, collaborative agreements between research organizations and large pharmaceutical companies are formed to explore the potential of new drug substances.

Drug development in the pharmaceutical industry

The post PHARMACEUTICAL UNIT (TABLET, CAPSULES, SYRUPS, OINTMENTS, LOTION, NEBULIZER) appeared first on EIRI - eBooks and Project Reports.

Ferrous Sulphate is also obtained as a bye product in the manufacture of titanium pigment and copper sulphate. For medicinal use, it is prepared by the action of dilute sulphuric acid on iron. Exsiccated Ferrous Sulphate used in therapy is a grayish white powder prepared by drying Ferrous Sulphate crystals at 40oC when a part of the water of crystallization is removed. It is slowly but almost completely soluble in freshly boiled cooled water.

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