Systems Drug Delivery Devices

These results open the exciting possibility of using degradable, tyrosine-derived polymers as "custom-designed" antigen delivery devices. On the other hand, our results indicate that the immunological properties of tyrosine-derived polymers will have to be carefully evaluated before such polymers can be considered for use as drug delivery systems or medical implants. 

The nanostructured molecular arrangements from DNA developed by Seeman may find applications as biological encapsulation and drug-delivery systems, as artificial multienzymes, or as scaffolds for the self-assembling nanoscale fabrication of technical elements. Moreover, DNA-protein conjugates may be anticipated as versatile building blocks in the fabrication of multifunctional supramolecular devices and also as highly functional-... 

Thus, the side-by-side device, when properly calibrated, is a versatile and useful method to determine diffusion coefficients, to evaluate mass transport mechanisms, and to evaluate up-to-date drug delivery systems. 

For osmotic drug delivery systems, Eq. (2) is of critical importance. This equation demonstrates that the quantity of water that can pass a semipermeable film is directly proportional to the pressure differential across the film as measured by the difference between the hydrostatic and osmotic pressures. Osmotic delivery systems are generally composed of a solid core formulation coated with a semipermeable film. Included in the core formulation is a quantity of material capable of generating an osmotic pressure differential across the film. When placed in an aqueous environment, water is transported across the film. This transported water in turn builds up a hydrostatic pressure within the device which leads to expulsion of the core material through a suitably placed exit port. 

In the gastrointestinal tract, a mucoadhesive drug delivery system provides advantages in prolonging the residence time of devices. The use of pH-sensitive bioadhesive polymers has been proposed [26], An extensive review of pH-sensi-tive hydrogels is given by Brpndsted and Kopecek [27],... 

Recent developments in polymer chemistry have allowed for the synthesis of a remarkable range of well-defined block copolymers with a high degree of molecular, compositional, and structural homogeneity. These developments are mainly due to the improvement of known polymerization techniques and their combination. Parallel advancements in characterization methods have been critical for the identification of optimum conditions for the synthesis of such materials. The availability of these well-defined block copolymers will facilitate studies in many fields of polymer physics and will provide the opportunity to better explore structure-property relationships which are of fundamental importance for hi-tech applications, such as high temperature separation membranes, drug delivery systems, photonics, multifunctional sensors, nanoreactors, nanopatterning, memory devices etc. 

Erdmann et al. (2000) report the fabrication of devices for the localized delivery of salicylic acid from the poly(anhydride-co-ester)s mentioned in Section II.C. A unique feature of this drug delivery system is that the drug compound is part of the polymer backbone. Devices were implanted intraorally and histopathology was reported (Erdmann et al., 2000). Chasin et al. (1990) review fabrication and testing of implantable formulations for other drugs including angiogenesis inhibitors for treatment of carcinomas and bethanechol for the treatment of Alzheimer s disease. 

A device that serves as a container for a drug or a device that is a drug delivery system attached to the drug container where the drug is present in the container is a combination product that will be regulated as a drug by CDER. 

Stimulation of saliva production is under sympathetic and parasympathetic control. Parasympathetic stimulation produces a serous watery secretion, whereas sympathetic stimulation produces much thicker saliva. Drug delivery systems, therefore, should not be placed over a duct or adjacent to a salivary duct, as this may dislodge the retentive system or may result in excessive wash-out of the drug or rapid dissolution/erosion of the delivery system making it difficult to achieve high local drug concentrations. If a retentive system is placed over salivary ducts, the reduced salivary flow rate may produce less or no mucus which is required for the proper attachment of a mucoadhesive delivery device. 

Significant developments have occurred in recent years in the fields of biopolymers and biomaterials. New synthetic materials have been synthesized and tested for a variety of biomedical and related applications from linings for artifical hearts to artifical pancreas devices and from intraocular lenses to drug delivery systems. Of particular interest in the future is the development of intelligent polymers or materials with special functional groups that can be used either for specialty medical applications or as templates or scaffolds for tissue regeneration. 

A great number of researches have so far been carried on the incorporation of poly(IPAAm) and its copolymers in various biomedical devices, utilizing soluble/insoluble or swelling/deswelling processes in the temperature range of LCST. As overviewed by Okano et al. [44] these include drug delivery system (DDS) solute separation concentration of dilute solutions immobilization of enzymes detachment of cultured cells coupling to biomolecules, and other aspects. 

Solid oral dosage forms containing new chemical entities (NCEs) are commonly formulated into tablets or capsules as their first market image formulation. Subsequent drug product line extension development on these NCEs may evaluate more specialized drug delivery systems. Dissolution testing of standard oral tablets or capsules will commonly utilize the paddle or basket apparatus. In this chapter we focus primarily on the development and subsequent validation of dissolution testing methods that use these two devices. 

Intimately related to these factors is the design of the device, formulation, and the interface with the patient. Much of the discussion below will focus on the implications of excipients on formulation challenges for inhaled aerosol products. This chapter summarizes excipients for pulmonary formulations from several perspectives (i) excipient selection based on principles of delivery, (ii) physicochemical requirements for excipients, and (iii) specific challenges for formulations faced with aerosol drug delivery systems, including (a) biological aspects, (b) microbiological aspects, (c) analytical issues, and (d) future prospects. 

These environmentally sensitive gels are being extensively studied and applied to a variety of fields in medical science, engineering, ecology, food science, drug delivery systems, chemo-mechanical and electro-mechanical actuators, switching devices, molecular sieves, chemical re-collecting retainers, and so on. These aspects are not covered in this issue. The reader may consult some of the references [1,8]. 

Novel dendrimers have novel and unique properties that make them promising candidates for use in the development of nanoscale devices and in drug delivery systems. 

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