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A number of different bioadhesive formulations are possible: Bioadhesive solutions/suspensions Many viscosity enhancers are also considered to be bioadhesive and putative bioadhesive polymer gels order genuine levitra plus on-line erectile dysfunction at 18, including methylcellulose generic 400 mg levitra plus otc food that causes erectile dysfunction, sodium carboxymethylcellulose order generic levitra plus erectile dysfunction australian doctor, chitosan, Carbopol 934P (one of the carbomers) 241 and Pluronic F127, have been shown to decrease the rate of mucociliary clearance in the rat by 7–57%. By reducing or abolishing ciliary motility, the rate of clearance of the drug from the nasal cavity is reduced. In addition, chitosan has been shown to enhance the nasal absorption of insulin (molecular weight 5. Some bioadhesives, such as carbomers, have also been shown to complex with mucus, increasing the viscoelasticity of the latter and reducing its clearance. In aqueous solution above a certain concentration, such systems are liquid at room temperature and below, but at physiological temperatures (32–37 °C), the viscosity of the solutions increases. Once in the nasal cavity, the viscosity of these solutions will increase, due to the increased temperature, and the contact time between the drug and the absorbing membrane should be extended compared to that of a simple solution. Such systems have also been investigated to enhance vaginal and ocular drug delivery (see Sections 11. Dry powder bioadhesives A slightly different approach is to deliver the active drug in a dry powder carrier system, for example microcrystalline cellulose, hydroxyethyl starch, cross-linked dextran, microcrystalline chitosan, carbomer, pectin, or alginic acid. The polymer absorbs water upon contact with the nasal mucosa and swells to become a viscous gel, often demonstrating bioadhesive properties. For example, the bioavailability in rats of the somatostatin analogue, octreotide, was shown to be enhanced by the co-administration of alginic acid and cross-linked dextran as dry powders. Certain carriers prolong the time during which therapeutic plasma concentrations of drug are maintained, effectively providing sustained release. This is believed to occur due to the rate and extent of water uptake being modified by the formulation, as well as to the type of gel formed by the excipients. As the polymers hydrate by withdrawing water from the secretions of the nasal epithelium, localized changes in mucociliary clearance occur, due to the presence of a hydrating polymer and potentially due to induced alterations in the viscoelasticity of the mucus gel. Colloidal bioadhesives Bioadhesive microspheres composed from a variety of materials such as starch, carbomer, hyaluronan esters, dextrans have been used to prolong the retention time of the drug within the nasal cavity. The clearance half-life of microspheres can be in the order of 3–4 hours, in comparison with 15 minutes for a simple solution. Improved bioavailabilities have been seen for gentamicin, insulin and desmopressin. A temporary widening of the tight junctions of cultured cells, which coincided with an increase in the rate of absorption of the applied drug, insulin, has been observed in the presence of starch microspheres. It is likely that the dry starch microspheres took up water from the cells causing them to dehydrate and “shrink” resulting in a separation of the intercellular junctions. Should this be the case, it provides evidence for the paracellular absorption of insulin. This can be achieved by including an excipient in the formulation with a reversible ciliostatic effect; such agents include certain preservatives. However, it is important that the chosen strategy does not permanently compromise mucociliary clearance, which would adversely affect airway homeostasis and defense. However the long-term effects of even a temporary impediment to the mechanism of nasal clearance is unknown and such an approach should be used with caution. For instance, cytochrome P450-dependent monooxygenase metabolizes nasal decongestants, nicotine, cocaine and progesterone. With respect to the degradation of peptides and proteins, a variety of protease inhibitors have been studied including bestatin, diprotinin A and aprotinin, which inhibit leucine aminopeptidase, dipeptidyl peptidase and trypsin respectively (Table 9. Some inhibitors are active against more than one peptidase, for example leupeptin inhibits both cathepsin and trypsin. The choice of inhibitor depends upon the peptide, for instance inhibitors having a trypsin- inhibitory effect have been shown to enhance the nasal absorption of salmon calcitonin in rats. Interestingly, compounds which have been investigated for their penetration-enhancing effect at the absorbing membrane have also been shown to decrease the metabolism of certain peptides. By denaturing leucine aminopeptidase and preventing enzyme-substrate complex formation, the bile salt sodium glycocholate has been shown to protect insulin from proteolysis in the rat nasal mucosa. In addition to formulation additives, peptides can be chemically modified to improve their stability to proteases, as described in Chapter 1 (Section 1. However, altering the tonicity of the formulation had no effect on the absorption of human granulocyte colony-stimulating factor (molecular weight 19 kDa). In another study, decreasing the pH of the formulation was shown to enhance absorption.


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Even if the drug is sufficiently potent buy levitra plus cheap erectile dysfunction doctors naples fl, it must yet satisfy other criteria to be considered a viable candidate for transdermal delivery levitra plus 400mg line erectile dysfunction medication ratings. First generic 400 mg levitra plus mastercard prostate cancer erectile dysfunction statistics, its physicochemical properties must allow it to be absorbed percutaneously. This means that its molecular weight should be reasonable (see above), and that it should have adequate solubility in both lipophilic and aqueous environments since, to reach the dermal microcirculation and gain access to the systemic circulation, the molecule must cross the stratum corneum (a lipoidal barrier) and then transfer through the much-more-aqueous-in-nature viable epidermis and upper dermis. Absence of either oil or water solubility will preclude permeation at a useful rate. Second, the pharmacokinetic and pharmacodynamic characteristics of the drug must be such that the relatively sustained and slow input provided by transdermal delivery makes sense. Tolerance-inducing compounds, for example, are not an intelligent choice for this mode of administration unless an appropriate “wash-out” period is programmed into the dosing regimen (see the discussion of nitroglycerin below). Drugs with short biological half-lives, that are subject to large first-pass metabolism, necessitating inconvenient and frequent oral or parenteral dosing (with the concomitant problems of side-effects and poor compliance), are good candidates. On the other hand, drugs that can be given orally once a day, with reproducible bioavailability, and which are well tolerated by the patient, do not really need a patch formulation. Third, the drug must not be locally irritating or sensitizing, since provocation of significant skin reactions beneath a transdermal delivery system will most likely prevent its regulatory approval. Although of demonstrated efficacy, these vehicles are often inelegant and result in poor reproducibility of the delivered dose (and hence of the provoked pharmacological effect). This variability, of course, originates in the 199 application procedure: the amount of formulation applied, the area to which it is applied, the amount of inunction used, and the potential for subsequent depletion to clothing, etc. There is a concern, furthermore, about the inadvertent transfer of material from the treated individual to another person via bodily contact. On the other hand, these conventional delivery systems are relatively simple and inexpensive to manufacture. All of these drugs are extremely potent, none requiring more than about 20 mg per day (and some, much less) for effective therapy. These patches are diversely referred to as “reservoir”, “monolithic”, “membrane-controlled”, “adhesive”, “matrix”, and so on. Unfortunately, these terms are not always used consistently and, worse, they are sometimes used inaccurately. In all cases, however, the idea is that the system offers a means to hold a “payload” of the drug and a configuration (or “platform”) to ensure presentation of the active agent to the skin surface at a rate sufficient to ensure a systemic pharmacological effect after the drug has crossed the skin’s barrier. Most simplistically, one can divide the transdermal formulations presently available into three categories (Figure 8. Upon removal from their package, all these devices present common exterior surfaces. On one side, they have an impermeable backing layer across which neither the drug nor any other component can diffuse. On the other face which will contact the skin, there is a peel strip which is removed prior to application. In between these two layers, however, the composition and design of the device varies considerably. Adhesive patches The adhesive patches are simplest in concept, consisting only of a layer of drug-containing adhesive polymer which serves, therefore, as a reservoir of the compound and the means by which the device is held to the skin. These systems can hold substantial amounts of the active agent, often in considerable excess of that delivered during the designated application of the patch (e. Not infrequently, the degree of control offered by these systems is relatively small (see below), and it is the stratum corneum that ultimately regulates the absorption rate of the drug into the body. It should be noted that these representations of the patches greatly exaggerate their real thicknesses, which are in fact similar to that of a normal Band-Aid The layered devices are a little more complex than the simple adhesive systems in that they use different polymer compositions or different polymers to provide the functions of drug-containing matrix and adhesive. It should also be noted that some layered systems have been developed in which the drug-containing matrix contacts the skin directly and the patch is held to the skin by a peripheral adhesive. While effective, these devices suffer from the drawback that the area of contact between patch and skin is significantly greater than the “active” area, i. These devices are characterized by two particular features: first, an enclosed reservoir of the drug, which may be liquid in nature; and, second, a polymeric membrane separating the reservoir from the adhesive layer, itself made from a different polymer. The idea, naturally, behind this design is that the membrane acts as a rate-controlling element for drug delivery to and across the skin (i. There are, in fact, situations for which this claim is true; however, it must also be noted that there are others where the control lies, at least in part, elsewhere (see below).


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