Abstract
Controlled-drug-delivery oral devices are implanted or inserted into an oral cavity, built onto a prosthetic tooth crown, a denture plate, braces, a dental implant, or the like. The devices are refilled or replaced as needed. The controlled drug delivery may be passive, based on a dosage form, or electro-mechanically controlled, for a high-precision, intelligent, drug delivery. Additionally, the controlled delivery may be any one of the following: delivery in accordance with a preprogrammed regimen, delivery at a controlled rate, delayed delivery, pulsatile delivery, chronotherapeutic delivery, closed-loop delivery, responsive to a sensor's input, delivery on demand from a personal extracorporeal system, delivery regimen specified by a personal extracorporeal system, delivery on demand from a monitoring center, via a personal extracorporeal system, and delivery regimen specified by a monitoring center, via a personal extracorporeal system. Drug absorption in the oral cavity may be assisted or induced by a transport mechanism, such as any one of, or a combination of iontophoresis, electroosmosis, electrophoresis, electroporation, sonophoresis, and ablation. The oral devices require refilling or replacement at relatively long intervals of weeks or months, maintain a desired dosage level in the oral cavity, hence in the gastrointestinal tract, for extended periods, address situations of narrow drug therapeutic indices, and by being automatic, ensure adherence to a prescribed medication regimen. The oral devices and methods for controlled drug delivery apply to humans and animals.
Description
technical field
[0001] The present invention relates to controlled drug delivery and monitoring, and more particularly, to oral devices and methods that provide multiple drug delivery protocols and clinical sampling methods. Background technique
[0002] Oral administration is the most common route of drug delivery, and more than half of the drugs on the market are administered for this route. Drug delivery from the gastrointestinal tract at a controlled rate is desired to maintain controlled levels of the drug in the bloodstream and tissues through the patient, and to control diurnal variations resulting from oral intake at specific times of the day. However, the bioavailability of oral administration, the extent to which the drug reaches the target tissue, is affected by drug dissolution, drug degradation, and drug absorption in the gastrointestinal tract, and is generally not constant over time. Certain drugs have high bioavailability, which may dissolve and absorb so qu...
