Importance

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Abstract

A multiphasic sustained release injectable delivery system is provided, as well as a method for treating humans and other mammals with that multiphasic sustained release system. The multiphasic sustained release system comprises prolonged, controlled delivery of microencapsulated macromolecular bioactive agent of biological origin comprising the bioactive agent encapsulated in microcapsules of bioerodible encapsulating polymer, which permits a sustained, multiphasic release of said bioactive agent, including (i) a first portion of said bioactive agent that upon injection is capable of being released from said microcapsules of bioerodible encapsulating polymer in a manner whereby only a relatively small amount of said bioactive agent is released during said first phase, whereby initial biological reaction is minimized due to said first portion producing a mild reaction similar to that normally observed with low doses of conventional administration; and (ii) secondary portions of said bioactive agent that provide a substantially higher level of bioactive agent in doses which could provoke a serious reaction in the patient, but for the prior release of said first portion.

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First Claim