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Pharmaceutical industry is basically, established for production of the drugs and medicines. There are different dosage forms of the drug like, tablets, syrups, suspensions, elixirs, injections, emulsions, transdermal patches, etc. nowadays people has become very aware of their health and they are taking medicines for prevention and cure of the diseases. In last 100 years, there is a big number of inventions can be seen in this field for better service to the patients.
Pfizer is a very well-known pharmaceutical industry in the world. Pfizer was established in 1847, for production of drugs for humans as well as for animals. It is devoted to better health and greater access to health care for lives. Pfizer's purpose is helping people for longer, improved, more contented lives. Everyday Pfizer helps millions of patients, generation, medical researchers, and works in corporation with government, individuals for healthcare to delicacy and prevent illnesses-adding both years to life, and life to years.
This assignment is regarding a new technology introduced at Pfizer which was "IONSYS". IONSYS is the first needle-free, patient controlled transdermal system for acute moderate to severe postoperative pain in the hospital patients. It is patient activated analgesic system. IONSYS is indicated for the short-term management of acute post operative pain in adult patient requiring opiod analgesia during hospitalization. IONSYS is the 1st and only product to incorporate the proprietary E-TRANS iontophoretic transdermal drug delivery system.
This new needle-free technology has brought a lot of benefits to not only Pfizer but also to the patients and employees working in the industry. The most important benefit is when people use injection with needle, there is no dread of insertion of needle to the patient. In many clinical trials and market research studies, this new technology is preferred by patients over unadventurous needle-based systems: in addition, patient can easily use means that less time for doctors and other caregivers to train patients to use the device.
i) The pharmaceutical industry:
"Since the mid-19th century, pharmaceuticals have moved from the margin to the center of health care. Most breakthroughs in the pharmaceutical industry are criticized for the production of drugs with potential side effects, the high prices of medicines, and aggressive marketing practices, and to provide a proposal to set right the situation." (Value of pharmaceuticals: Ensuring the future of Research and development by Serajuddin, Hamida K)
In the world of constant changes, these pharmaceutical industries also have changed to a lsrge extends. The new medicinal chemistry and biochemistry has made a lot of innovations in the field of medicines. Nowadays, it is very common for the people to take medicines for prevention and cure of the diseases. Scientists have claimed that they have invented the drugs for control of the most horrible disease like cancer. During the period of new innovation and new drug testing, firms also face some problems specialy during clinical trials.
ii) About Pfizer:
Pfizer Inc, which was built in 1849, is dedicated to better health and greater access to healthcare for people and their esteemed animals. Pfizer's aim was helping people live longer, healthier, happier lives. Pfizer's route to that purpose is through discovering and mounting breakthrough drugs; providing information on avoidance, wellness, and cure; constant manufacturing of high-quality medicines, consumer products; and universal leadership in business duty. Every day Pfizer helps 38 million patients, employ more than 115,000 social group, uses the skills of more than 12,000 researchers, and work in partnership with governments, individuals, and other payers for healthcare to treat and avert illnesses-adding both years to life, and life to years. (http://www.pfizer.com/about/)
The story of Pfizer's leadership in 19th, 20th and now 21st centuries reflects the enlargement of the company from a consumerist gamble in a young America to a global enterprise now spamming the world. Throughout, its history, Pfizer's hallmarks have been imaginative control and an instruction, innovative labor force. Outstandingly, only twelve people have served Pfizer as chief executives, a record of stability matched only few organization.
iii) The new technology at Pfizer:
This thesis presents research in the field of Microsystems Technology and specifically in the area of micro needle-based drug delivery. The objective of this thesis is to highlight the potential role of iontophoresis and micro needles in achieving painless drug delivery of macromolecular drugs across the skin obstacle. Furthermore, the concept of a micro needle-based transdermal patch is reviewed and discussed. This concept was further realized in form of a fully integrated micro needle system incorporating a drug reservoir as well as an electrically controlled dispensing mechanism.
Triggers for development of needle-less technology for drug administrations: Ø There are problems with syringes when patient have to self-inject. People need a degree of expertise because they have to put it in at right depth and then they need to set out of. Ø For some patients, especially those distress from unceasing diseases requiring injectable products 2-3 times a day, this process is an constant reality of daily life for example diabetics-accepted, but always with the hope that something new will change the uneasiness of needle insertion every day. Ø For problems related to needle based injections, there is a need for development of needle free drug delivery system. Ø The reasons for investment in needle-free technology is there are an increasing number of biotechnology products that can only be given by injection. So it will bring about a lot of benefit to the pharmaceutical industries. Ø There is high risk of blood-born infections with injections, which may spread a wide range of diseases.
PFIZER: ALZA CORPORATION RECEIVED FDA APPROVASL FOR IONSYS (fentanyl iontophoretic transdermal system)
The First Needle-Free, Patient-activated Analgesic System for Acute Postoperative Pain:
"IONSYS is the first needle-free, patient controlled transdermal system for acute moderate to severe postoperative pain in the hospital setting." ( http://digitowl.co.uk/work/ionsys/module3.swf)
IONSYS, basically have 2 mechansims: Iontophoresis and micro needles a) Iontophoresis: Iontophoresis is the first mechanism needle free drug delivery system. The main advantage of this mechanism is that it is that the analgesic system mainly activated by patient himself. It is prescribed for the old hospitalized patients for the quick-fix management of post-operative throbbing, who require opiod analgesics for management of pain during their hospital stay. It is the very 1st and product which has incorporated the proprietary E-TRANS Iontophoresis transdermal drug delivery system.
In the mechanism of Iontophoresis, there is a low intensity electric field. Generally, the patients cannot detect that field. It immediately transport fentanyl across the skin and into the circulatory system of the body. IONSYS strongly sticks to the upper outer upper limb or chest, and provides patients an on-demand dose of opioids. IONSYS is indicated for the short-term management of severe post-operative pain in adult patients requiring opioid analgesics during hospital stay.
When patient feels pain, he double clicks on the dosing machine button. So the machine delivers 40 mcg dose of fentanyl through the skin. Over every 10 minute time duration, it delivers a single dose of the drug. But the patient must have access to supplemental analgesia.
In recent years, attention has been drawn to a new type of delivery manner where arrays of miniaturized needles are used to penetrate the skin layer. Since the needles are short, they do not reach the nerve-rich regions of the lower parts of the skin. As an outcome, the stimulus caused by micro needle insertion into the skin is weak and perceived as painless. By combining micro needles with a patch-like structure, a system can be realized which essentially has all the favorable properties of a traditional transdermal patch, i.e. continuous release, ease-of-use, unobtrusiveness and painlessness. Such a patch would not only offer a tactful and patient-friendly drug administration system, but also an efficient and possibly safe way to administer drugs with minimum participation from health-care professionals. A number of Fortune 500 companies, as well as start-ups, are actively developing micro needle technology for transdermal drug delivery. Most of them work with solid, non-hollow, needles. (http://www.ee.kth.se/php/modules/publications/reports/2007/TRITA-EE_2007_046.pdf)
Benefits because of new technology: As needle-free drug delivery system has a lot of benefits, it will become a preferred set on the house option patients and physicians for many injected medicines. These benefits include:
In many clinical trials, this new technology has been shown to be preferred by patients over unadventurous needle-based systems. In addition, there is ease of use for patients means that less time for physicians and other caregivers to train patients to use the same device. In market research studies, it is concluded that physicians also prefer the needle free drug delivery system rather than traditional needle based systems. (http://www.floegel.info/MUNDIPHARMA/mundipharma/TD%20drug%20delivery%20optimizing.pdf)
Evaluation of the new technology:
Thomson Pharma's SWOT analysis suggests that Duragesic's patent expiry will help sales of the new formulation, as Johnson & Johnson promotes Ionsys as a potential replacement.
The initial launch is for the management of acute moderate-to-severe post-operative pain in adults during hospitalization. Abuse, a high possibility with patch formulations, is minimized by the Ionsys technology, which can be programmed for a variety of drug delivery patterns to achieve customized dosing schedules for optimal therapy. The drug, which acts as a high affinity ligand trap, is designed to attach to and neutralize IL-1 in the bloodstream before it can attach to cell-surface receptors and generate signals that can trigger disease activity in body tissue. Once attached to the trap, IL-1 cannot bind to the cell surface receptors and is flushed from the body together with the trap. Data from a 6-month double-blind, placebo-controlled CAPS registration study showed patients taking rilonacept had an 85% reduction in symptoms, compared with a 13% reduction from placebo.
(journal- pharma matters, the ones to watch)
Innovation because of the new technology in Pfizer: The new technology has so many advantages to both patients and physicians. The new technology showed a lot of specific innovations in its ability to deliver different kind of therapeutic components to the patients. These drug molecules may be larger or smaller. It is also useful for inserting biological products which has dose volume less than o.5 ml or less than that. While needle-less technology has already shown the good results in insertion of drugs with saline. Scientists conducted the tests called "human pilot study", which has good and positive results with different protein and pharmaceutical drugs.
The studies for this needle free technology include bioequivalence studies. It had better results for injecting growth hormone and erythropoietin, and pharmacodynamic equivalence study using granulocyte colony-stimulating factor, or GCSF.
Pre-clinical work with monoclonal antibodies which evaluates bioavailability which is the concentration of the drug which reaches to the local area also had been done using this new technology. Generally highly viscous drug are difficult to inject into the body specialy with needle based system, which was made very easy ion case of needle free drug delivery.As a result of the versatility of needle-free injections to deliver various typesproducts in humans and animals, this technology may have important market latent across a broad range of therapeutic areas, including those typically treated with small volume injectable products, such as rheumatoid arthritis.
Role of a manager at Pfizer:
In any industry, the role of a manager in any industry is very important. The manager have associated the organization into curative area teams finding thought the branches of the Pfizer in the world. The manager have made the staff of global expertise. They have standardized the system-wide processes and stopped duplicating in any processes. They have created their own unique procedures. They have created patient-centric plans and they have increased the time and capital spent on creating value. Simultaneously, they give attention at the department of R & D.
In manufacturing, they have announced important plant explanation and will rely more on outsourcing partners. Similarly, many back-office corporate functions are being outsourced. Given the speed at which the outsourcing market is increasing, they regularly evaluate strategy in this area.
The head of Pfizer Inc's emerging markets unit said that the drug maker's plans for a big push into high-growth underdeveloped countries is still very much a work in progress, but one that will eventually yield rock-hard profits. (http://pfizer.com/responsibility/protecting_environment/ehs_external_supply.jsp)
Thus, in pharmaceutical industry there is lot of innovations and technologies, which has changed the world of pharmacy. Pfizer is such a big and well-known industry of pharmaceuticals. It has developed a needle-free technology for injecting the drugs into the body. The basic mechanism for that includes mainly iontophorosis and micro-needles. Needle-free technology offers the very noticeable benefit of reducing patient concern about the use of needle. Other benefits include very fast injection compared with traditional needles and no need to worry about needle disposal issues. Not only it can profit the pharmaceutical industry in increasing product sales, it has the added potential to increase compliance with dosage regimens and improved outcomes. In the developing world, there are major challenges of disease communication through re-use of needles. Thus this needle-free technology has brought a lot of change in the pharmaceutical industry, which is beneficial to both patients and the industry.