ENGINEERING DRUG DELIVERY-SUMMARY

ENGINEERING DRUG DELIVERY-SUMMARY - Engineering Drug...

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Engineering Drug Delivery By: Aron Deen, Michael Matlock, Brian Copeland, Brett Covey, Jenny Oberlag Capstone Design Project- University of Oklahoma - Spring 2003 Introduction Based on extensive research of all aspects of the process and economic analysis, the Controlled Release Osmotic Drug delivery of is a feasible, and profitable venture. The type of delivery system to be used will be a capsule taken orally, consisting of a semi-permeable membrane, and making use of osmotic pressure to slowly release the drug over a predetermined time frame. The drug can be designed and produced in Norman, Oklahoma and distributed to the national market from that location. Tamsulosin hydrochloride, commonly known as Flomax® is the active ingredient of the drug and is marketed towards men past middle age. Flomax® is used to treat the symptoms of an enlarged prostate--a condition technically known as benign prostatic hyperplasia or BPH. The major symptom associated with BPH is trouble urinating. BPH is obviously only experienced by men and rarely causes symptoms before age 40. However, more than half of men in their sixties and as many as 90 percent in their seventies and eighties have some symptoms of BPH. Controlled Release Drug Delivery Systems Three main categories exist for controlled release (CR) oral drug delivery systems: matrix, reservoir and osmotic. In matrix systems, the drug is embedded in a polymer matrix and the release takes place by partitioning of the drug into the polymer matrix and the release medium. In contrast, reservoir systems have a drug core surrounded/coated by a rate controlling membrane. However, factors like pH, presence of food, and other physiological factors may affect drug release from conventional CR systems. Osmotic systems utilize the principles of osmotic pressure for the delivery of drugs. A major advantage of drug release from these systems is that it is largely independent of pH and other physiological parameters, and it is possible to modulate the release characteristics by optimizing the properties of the drug and system. For these reasons, osmotic release systems will be the focus of this design. There are several osmotic design possibilities that were considered by CORRN Consulting. They all fall under the category of osmotically controlled oral drug delivery systems. The two main tablet systems researched were: Elementary osmotic pumps (EOP) and Push-pull osmotic pumps (PPOP). CORRN Consulting recommends using the push-pull osmotic pump system due to the low solubility of tamsulosin hydrochloride which can be better handled by a PPOP system. Drugs having extremes of water solubility can be delivered via the push-pull osmotic pump. As shown in Figure 1, it is a tablet consisting of two layers coated with a semipermeable membrane that allows water to pass into the concentrated drug without allowing the drug to exit anywhere but the delivery orifice. The drug along with osmagents is present in the upper compartment whereas the lower compartment consists of polymeric osmotic agents.
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