HYDROFORMED MICROSPHERES AS NEW INJECTABLE DRUG VEHICLE

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BIOTEK has developed a new hydroforming process for making sustained release injectable biodegradable microsphere and microcapsule well suited for delivery of water soluble drugs such as peptides and proteins. The process incorporates drug into hydroformed microspheres made of sparingly soluble calcium minerals, such s calcium sulfate, which can then be overcoated with a polymer, mineral or lipid shell. The technique can produce microsphere from calcium compounds involving sulfate, phosphate or silicate anions. Calcium sulfate cement, better known as plaster of Paris, is used as a temporary bone filler, and calcium phosphate cements based on a natural bone mineral, hydroxyapatite, are under investigation for tooth an drone repairs. Unlike thermoformed ceramics, which may persist indefinitely in the body, hydroformed calcium minerals have been found to bioresorb harmlessly. Although they offer many advantages as injectable microsphere, they have not previously been investigated for that purpose. Using an opiate antagonist, methadone HCL, as a prototype water-soluble drug. Phase I will prepare and characterize hydroformed microcapsule and examine their erosion and delivery in vitro. Phase II will then conduct in vivo animal tests, submit an IND to the FDA,and initiate human clinical studies on the use of such injectable microcapsule as part of opiate abuse therapy.