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As per available reports about 43 Relevant Journals, 43 Conferences, 2 National Symposiums are presently dedicated exclusively to breathing disorder and about 223 articles are being published on thin film drug delivery.
Insulin Drug Delivery is the use of insulin and similar proteins as a medication to treat disease. Insulin comes in a number of different types including short acting (such as regular insulin) and long acting (such as NPH insulin). The initial sources of insulin for clinical use in humans were cow, horse, pig or fish pancreases. Insulin from these sources is effective in humans as it is nearly identical to human insulin (three amino acid difference in bovine insulin, one amino acid difference in porcine). Differences in suitability of beef-, pork-, or fish-derived insulin for individual patients have historically been due to lower preparation purity resulting in allergic reactions to the presence of non-insulin substances.
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Scope and Importance:
The global market for emerging insulin drug and delivery technologies is very dynamic and is developing at a fast pace. The industry has progressed steadily during the past decade and will continue to sustain growth in the coming four to five years. Modern industries and research institutes have begun to explore newer method for diabetes control in adults and juveniles, leading to a steady market for these technologies. New advancements, new product launches, along with increased awareness and early detection of the disease are expected to influence the market growth in the foreseeable future.
Insulin delivery systems that are currently available for the administration of insulin include syringes, insulin infusion pumps, jet injectors and pens. A concise review of these delivery devices has been described as under:
Insulin syringes that were introduced initially were large and heavy with reusable glass plungers and barrels with a long, large bore needle. These syringes underwent significant changes over the years. Today, many insulin injection syringes are available in the marketplaces that are derived from plastics being light in weight, disposable and versatile in use of variety of microfine needles. These syringes increase patient comfort and offer convenience, thus better patient compliance.
Insulin syringes are characterized by three factors, i.e. needle gauge, needle length and syringe capacity. The manufacturers of the syringes offer a wide array of sizes and styles. Almost all syringes available today are disposable and come with microfine needles. The proper selection of an appropriate syringe is based on many considerations, like chemical composition of the material from which syringes are made, syringe capacity, ease with which air bubbles are removed, clarity of the markings on the syringe barrel and convenience of syringe disposal. In addition, one must consider the condition of the patient with respect to his/her ability to operate the syringe safely and effectively.
While conventional syringes offer a wide choice of products that are easy to read and operate, the disadvantages include their bulky construction and the requirement of time and practice to learn optimal syringe technique. Furthermore, the required syringe manipulations in the social setting (such as workplace, classroom and public places including department stores, playgrounds and restaurants) may be considered as drawbacks. In some cases, patients need to mix different types of insulin preparations in one syringe to meet their individual needs, which can be cumbersome and complicated. In patients with less dexterity, this may result in inaccurate doses, compromising their glycaemics control.
Insulin infusion pumps:
Continuous subcutaneous insulin infusion (CSII) is a way to simulate the physiology of daily insulin secretion24. The first CSII pump was introduced in the market in 1974. By design, an insulin pump typically consists of a reservoir filled with insulin (e.g., Velosulin®BR), a small battery operated pump and a computer chip that allows the patient to control the insulin delivery. The pump is designed to provide a continuous supply of insulin infusion around the clock and can be adjusted as per the specific needs of the patient. Appropriate amounts of insulin are delivered into the body by the pump through a thin plastic tube known as an infusion set. Most of the factors that affect the variability of subcutaneous injections such as depth of injection and change of injection sites are avoided with pump systems. In these pumps, the insulin reservoir is connected to a subcutaneous catheter, which is changed every two to three days. Thus, advantageous for people who do not like injections as it is only necessary to insert a needle once every three to four days. Patient education by a healthcare team is a crucial component of successful insulin pump therapy.
Although the size of the initial designs was prohibitive, the technological advances in the pump designs of CSII led to the development of newer systems that are much smaller in size (approximately the size of a pager, i.e., 5×7.5 cm). These are relatively easier to operate than the earlier ones and can be carried conveniently in a shirt pocket. However, some patients may not like the idea of wearing a pump constantly or disconnecting the catheter before bathing or swimming.
Insulin pumps provide accuracy and greater flexibility in insulin delivery for patients according to their individual requirements, especially during travel. Some of the available infusion pumps have the ability to accurately deliver microdoses (0.1 units) of insulin. The newer devices are easy to use and carry and provide a small subcutaneous depot of unabsorbed insulin. The pump devices allow a patient to achieve a very tight control of plasma glucose levels and enhance the overall quality of life. However, if and when insulin delivery is interrupted by infusion set malfunction, needle displacement, pump dysfunction or lack of insulin in the reservoir, circulating insulin concentration drops rapidly causing problems. This may be a great concern for some patients. However, patients who experience many hypoglycemic episodes may benefit from infusion pumps. When compared with optimized multiple daily insulin injections, CSII resulted in a modest but worthwhile improvement in blood sugar in adults with type 1 diabetes.
The therapy with insulin pump is very expensive as compared to the use of traditional syringes and vials. In a clinical study, the cost/benefit ratio was found to be favourable only in those patients who were prone to frequent hypoglycaemia. This is because of the lower hospitalization rate of such patient population. Also the health and management benefits of the use of the insulin pump outweighed that of multi dose injections as it provides more freedom, flexibility, and spontaneity in the person's daily life.
Insulin jet injectors:
Jet injectors, (introduced in the 1980s), are designed to deliver a fine stream of insulin transcutaneously at high speed and high pressure to penetrate the skin without a needle. The use of force on a fluid under considerable pressure through a very small opening allows such systems to deliver insulin without using a needle to pierce the skin. The dose is controlled by a dial-a-dose operation through a single component design in comparison to the conventional multicomponent syringe and vial method. The available jet injectors allow a dose range of two to 50 units of insulin and can deliver insulin in half-unit increments. Insulin that is administered by the jet injector method is absorbed rapidly without the risk of subcutaneous infection. In gestational diabetes, jet injection therapy is associated with less antiinsulin antibody (AIA) production and better postprandial glycemia.
The size and the cost of these jet injectors are considered unfavourably and often limit their routine use in patients with diabetes. The potential for a decreased amount of absorbed insulin over repeated administration with jet injectors is a disadvantage. Additional concerns with jet injectors include pain or bruising at the administration site and the noise the injector makes upon delivery. Pressure may be difficult to adjust and the frequency of side effects seems to be significantly higher for young children. However, jet injectors may be considered for patients suffering from needle phobia and for patients who suffer from severe lipomas.
Pen devices are novel in that they combine the insulin container and the syringe into a single modular unit. Insulin pens eliminate the inconvenience of carrying insulin and syringes. The first insulin pen (NovoPen®) was introduced by Novo Nordisk in 1987. Many pens are available since then in a variety of types and shapes. There are two main types of pens, one that is reusable and the other a prefilled device. In the former case, the patient must load an insulin cartridge prior to use. Regardless of the type, both pens hold cartridges containing from 1.5 ml to 3 ml of U100/ml insulin. The number of steps required to change an insulin cartridge with reusable pens varies between the different pen device manufacturers. Prefilled devices are well accepted in a bedtime insulin regimen for type 2 patients.
Reusable insulin pens offer a wide range of advantages such as their durability, eliminating the need of cartridge refrigeration and flexibility in carrying three to five day supply. The pens also offer discreetness by resembling fountain pen. The refilled insulin pens are smaller in size and lighter in weight. They cause minimal pain due to the finest and shortest disposable insulin needles. In addition, they are quick and easy to use as they resemble the fountain pen; they are considered to be discreet.
In using insulin pens, the patient must attach a needle, prime the pen, set the dose by a dial and depress the plunger to administer the selected dose. There are several brands from which the patient with neuromuscular weakness and impaired manual coordination can select to employ the overall lowest force throughout delivery. The manufacturers of the pen devices recommend keeping the needle separate and attaching only when ready to use. A study has shown that reusing insulin pen needles could help in reducing the economic burden of diabetes without leading to needle tip deformity and increased pain. The needles for pens are available in varying lengths (from 8 mm to 12.7 mm) and varying gauges (from 29- to 31-gauge; the larger the gauge number, the smaller the diameter of the needle bore). The needles have a bevel on each end; one is intended to be inserted into skin and the other is to pierce the septum of the insulin cartridge.
The devices can add lifestyle flexibility and may result in better glycaemic control. The precision of insulin doses varies between different pens but remains better than that obtained in studies where traditional syringes were used. Many newer generation pens are able to deliver 60 U at a time for type 2 patients. Insulin pens have become very popular in some countries such as France where over 50 percent of insulin-treated patients are using insulin pens. Some studies indicated wider acceptability in elderly and adolescent patients with respect to easier and faster injection and greater comfort.
While pens offer convenience, comfort, accuracy, discretion, durability and ease of storage, patient education is essential in order to avoid operational errors, particularly when changing the cartridge in reusable pens. The proper use of insulin pens has been shown to enhance patient compliance during multiple injection regimen management.
Evaluation of emerging technologies in the insulin drug and delivery field that have potential in the diabetes market, with improved glucose control, along with improved and well-accepted newer delivery methods. The global market for insulin drug and delivery devices totalled $24 billion in 2012. The overall insulin drug and device market is projected to be worth $25.7 billion by 2013 and $40.2 billion by 2018, a five-year compound annual growth rate (CAGR) for of 9.3% from 2013 to 2018.
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This page was last updated on 11th Sep, 2015
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