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Owing to the selective nature of the skin barrier, only a small pool of drugs can be delivered systemically at therapeutically relevant rates. Approximately 1. 5 drugs constitute the whole segment of the transdermal drug market (Table 1). Besides great potency, the physicochemical drug characteristics often evoked as favorable for percutaneous delivery include moderate lipophilicity and low- molecular- weight . However, a large number of pharmaceutical agents do not fulfill these criteria. This is especially true for macromolecules, such as insulin, human growth hormone or cyclosporine, which are very challenging from the drug delivery point of view. Overcoming low skin permeability to xenobiotics can be achieved by a variety of approaches, and is an active field of research. Their effectiveness and applicability will vary from drug to drug depending on the physicochemical nature of the compound. Here, a brief overview of the enhancement methods including chemical methods, physical methods and a prodrug approach will be provided with special emphasis on the recent developments. Chemical methods. Chemical permeation enhancers facilitate drug permeation across the skin by increasing drug partitioning into the barrier domain of the stratum corneum, increasing drug diffusivity in the barrier domain of the stratum corneum or the combination of both . The heterogeneous stratum corneum is composed of keratin . Depending on the nature of the drug either of these two environments may be the rate- limiting milieu (barrier domain) for the percutaneous transport. As a consequence it is anticipated that the magnitude of permeation improvement obtained with a given permeation enhancer will vary between lipophilic and hydrophilic drugs. Several mechanisms of action are known: increasing fluidity of stratum corneum lipid bilayers, extraction of intercellular lipids, increase of drug’s thermodynamic activity, increase in stratum corneum hydration, alteration of proteinaceous corneocyte components and others. More detailed discussion of the modes of action has been reported elsewhere . Permeation enhancers are conventionally divided into several groups based on their chemical structure rather than the mechanism of action. This is partially due to the difficulty determining a primary or mixed mode of action for many of them. Furthermore, compounds from the same group can exert their effect through different mechanisms. More than 3. 00 substances have been shown to have skin permeabilization potential and this number is still growing. Most known enhancers fall into the following categories: alcohols (ethanol, pentanol, benzyl alcohol, lauryl alcohol, propylene glycols and glycerol), fatty acids (oleic acid, linoleic acid, valeric acid and lauric acid), amines (diethanolamine and triethanolamine), esters (isopropyl palmitate, isopropyl myristate and ethyl acetate), amides (1- dodecylazacycloheptane- 2- one . The importance of water, or hydration of the stratum corneum, is not to be underestimated. A fully hydrated stratum corneum (under occlusion) presents lesser diffusional resistance to xenobiotics than its dehydrated counterpart. However, a common drawback of permeation enhancers is that their efficacy is often closely mimicked by skin irritation. In general, the same mechanisms that are responsible for enhanced drug transport such as disrupting ordered stratum corneum lipid bilayers or corneocyte structural organization are also responsible for skin irritation . One possibility to address this concern is to identify mixtures of permeation enhancers that exhibit synergistic effects . The details are described in the next section of this article. Most of the products on the transdermal market use the effect of occlusion, which can be classified as an enhancement technique acting through the hydration of the stratum corneum. Additionally, drugs such as nitroglycerin (Nitro- Dur. Traditionally, chemical enhancers have been used to increase the delivery of small molecules and showed only limited success in permeation enhancement of macromolecules. Overall, chemical methods, although effective, cannot compete with physical enhancement methods that provide a greater magnitude of skin permeabilization. Physical methods. The oldest and by far the most popular way of overcoming the skin barrier physically is the use of hypodermic needles. In many cases it is the only viable method of delivery for poorly absorbable and highly unstable compounds. Typically, drug solution is forced under piston pressure directly into the bloodstream or tissue (skin and muscle). Such drug administration results in quick delivery of large amounts of drug. If controlled drug delivery over longer periods of time is desired, indwelling catheters are used. However, both require mechanical perforation of skin with a needle, which causes pain and trauma. According to Hamilton, needle phobia is a medical condition that affects at least 1. This condition is a serious problem in the healthcare system in the sense that people with needle phobia tend to avoid medical care. To address these drawbacks, several alternative physical skin enhancement methods such as jet injections, dermabrasion, thermal ablation, laser, microneedles, iontophoresis, electroporation, ultrasound and combinations of the above have been investigated. These methods aim at developing more user- friendly and flexible delivery systems, and are able to produce bolus type as well as sustained drug delivery profiles. Jet injections involve the delivery of liquid or solid particles driven by high- pressure accelerators across the stratum corneum . The concept of drug delivering jets is not new as first reports date back to the 1. Technology advances in the later decades enabled the construction of more reliable and effective devices based on compressed helium . It proved its potential in the delivery of insulin to diabetic patients . This method is similar to the hypodermic injection in that it enables rapid delivery of large amounts of drug, but it has resulted in improved patient compliance . Shortcomings of jet injections include inability to deliver drugs over longer periods of time; however, they seem to be well suited for vaccination delivery . Recently, the potential of this technique for transdermal drug delivery has been recognized. Mechanistically, crystal microdermabrasion uses microcrystals blown onto the skin surface to perform the exfoliating process. Several- fold improvement in flux for low- molecular- weight drugs was shown by various researchers with the use of this technique . A recent study by Gill et al. The effectiveness of the skin barrier removal correlated with the number of passes of the mobile dermabrasion device and selective removal without damage to the viable epidermis was possible . Heating of the skin surface to hundreds of degrees for a very short period of time allows the thermal damage to be limited to the stratum corneum alone without further heat propagation to live epidermal layers. An interesting publication by Park et al. The authors pointed out skin permeability changes to a model hydrophilic compound at different temperature ranges. While an intermittent increase in the skin temperature to 1. Different mechanisms were postulated to be responsible for such change at each temperature range. Altea Therapeutics developed a Pass. Port. Phase I and II clinical trials have been completed for the delivery of insulin via this enhancement system. A laser can also be used to thermally ablate parts of the stratum corneum creating pores. These pores allow drug molecules applied to the surface of the skin to bypass the diffusional barrier and gain easy access to the vascularized deeper layers of the skin. This method has been able to extract interstitial fluid to measure glucose levels in diabetic patients as well as being effective in augmenting transdermal flux of hydrophilic and hydrophobic molecules . A transdermal laser system P. L. E. A. S. E. Furthermore, laser- assisted drug delivery (Norwood Abbey) was developed and the device has been cleared for marketing by the FDA for the delivery of a topically applied local anesthetic. The pitfall of the laser approach is that it is a relatively complicated technology associated with high costs. Microneedles became one of the major enhancement techniques in the transdermal drug delivery field after advancements in microfabrication techniques were made in recent years. Long enough to perforate the topmost layers of the epidermis but short enough not to excite nerve endings in the skin, microneedles offer painless and powerful dermal permeabilization . A variety of different microneedle designs have been used in in vitro testing. Solid microneedles are used to pierce microchannels through the skin followed by application of a transdermal patch, and microneedles themselves can be coated with a drug or contain a drug dissolved in their matrix. Yet another option involves hollow microneedles through which a convective flux of drug is delivered into deeper skin layers. A multitude of other studies proved that microneedles effectively permeabilize skin to drugs . A first- inhuman microneedle study showed that therapeutically relevant plasma levels of naltrexone, an opioid antagonist, were achieved after skin pretreatment with microneedles and subsequent application of transdermal patches . Currently, several systems based on microneedles are being investigated, such as Microstructured Transdermal Systems (3. M), Macroflux. Iontophoresis relies on the continuous electric current to drive charged drug molecules across the skin via electrophoresis and electroosmosis . It is commonly stated that iontophoresis mainly provides additional electrochemical driving force for drug transport across skin, rather than increasing the permeability of the skin. |
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