Transdermal delivery systems devices

Approved packaging is normally selected after completing package performance qualification testing as well as product compatibility and stability studies. Since in most cases (exceptions transdermal delivery systems, diagnostic tests, and medical devices) packaging is not intimately involved in the manufacturing process of the product itself, it differs from other factors, such as raw materials. 

Scopolamine, a semisynthetic derivative of atropine, is marketed as a transdermal delivery system (Transderm Sc5p) to prevent motion sickness. The device, which is... 

Since the introduction of transdermal scopolamine,f" many transdermal delivery systems have been developed for systemic activity. Major advantages claimed for this drug delivery route include continuous release of drug over a specified period, low presystemic clearance, facile drug withdrawal by simply removing the device, and good patient convenience and compliance. 

There are several variants to this apparatus, which is based on a sample holder that oscillates up and down in the medium vessel. The sample holder may take the form of a disk, cylinder, or a spring on the end of a stainless steel or acrylic rod, or it may simply be the rod alone. The sample is attached to the outside of the sample holder either by virtue of being self-adhesive (e.g., transdermal delivery system) or is glued in place using a suitable adhesive. This apparatus may be used for transdermal products, coated drug delivery systems, or other suitable products (e.g., osmotic pump devices). It is prescribed for the drug-release testing of Psuedoephedrine hydrochloride extended-release tablets USP where the tablets are enclosed in a 5x5 cm of nylon, which is then attached to the rod. 

Figure 9.2 Reservoir delivery systems based on rate-limiting polymer membranes. Rate-limiting polymer membranes can be used to produce several different types of drug delivery devices including (a) transdermal delivery systems, (b) planar con-trolled-release systems, and (c) cylindrical controlled-release systems.

Other delivery systems are transdermal patches, metered dose inhalers, nasal sprays, implantable devices, and needle-free injections. A description of needleless injection is given in Exhibit 5.16. 

Transdermal delivery is a noninvasive intravenous infusion of drug to maintain efficacious drug levels in the body for predictable and extended duration of activity. Diffusion-controlled transdermal systems are designed to deliver the therapeutic agent at a controlled rate from the device to and through the skin into the systemic circulation. This route of administration avoids unwanted presystemic metabolism (first-pass effect) in the GI tract and the liver. Patient satisfaction has been realized through decreased... 

Good, W. Transdermal drug delivery systems. Medical Device Diagnostic Industry. 2 35-42, 1986. 

Membrane-reservoir systems based on solution-diffusion mechanism have been utilized in different forms for the controlled delivery of therapeutic agents. These systems including membrane devices, microcapsules, liposomes, and hollow fibres have been applied to a number of areas ranging from birth control, transdermal delivery, to cancer therapy. Various polymeric materials including silicone rubber, ethylene vinylacetate copolymers, polyurethanes, and hydrogels have been employed in the fabrication of such membrane-reservoir systems (13). 

This section focuses on adhesives that are used for the assembly of medical devices. In medical device assembly, the primary substrates are plastics, elastomers, and metals. The total medical adhesive market is much larger since it encompasses a broader definition of products. For example, medical adhesives can be used for bonding human tissue, transdermal drug delivery systems, dental restoration, and wound care in addition to medical device assembly. 

Figure 8.34 Examples of drug-delivery systems employing polymeric membranes, (o) Ocusert system for the eye with two rote-controlling membranes, (b) Tronsiderm system for transdermal medication with one rote-controlling layer, (c) The Progestasert device for intrauterine insertion in which the body of the device serves as the rote-controlling barrier, (d) The oral Oros device in which the membrane is o semipermeable membrane which forbids drug transport, allowing water ingress only.

Nicotine bioavailability also varies with the delivery system. The reported bioavailability from the nasal spray and transdermal patch is 53% and 82%, respectively (93,184). In nicotine polacrilex gum, nicotine is bound to an ion exchange resin and is released only by chewing. Nicotine bioavailability, therefore, is dependent on the vigor, rapidity, and duration of chewing. Of the 10 mg in each cartridge of a nicotine inhaler, only 4 mg is actually delivered from the device to the oral mucosa and is available for absorption. 

Transdermal Drug Delivery Systems Skin Perturbation Devices... 

Yuzhakov et al. [93] describe the production of an intracutaneous microneedle array and provide an account of its use (microfabrication technology). Various embodiments of this invention can include a microneedle array as part of a closed loop system smart patch to control drug delivery based on feedback information from analysis of body fluids. Dual purpose hollow microneedle systems for transdermal delivery and extraction which can be coupled with electrotransport methods are also described by Trautman et al. [91] and Allen et al. [100]. These mechanical microdevices which interface with electronics in order to achieve a programmed or controlled drug release are referred to as microelectromechanical systems (MEMS) devices. 

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