Lupron Depot drug products

Appendix C contains a list of the NDAs within the scope of the study. The drug products included in the study represent some of the largest dmg products as measured by annual sales, including so-called blockbuster drugs such as Capoten, Cardizem CD, Cipro, Claritin, Lupron Depot, Neurontin, Paxil, Pepcid, Pravachol,... 

Polymeric micropsheres, particularly those prepared from the biodegradable polylactide/ polyglycolide polymers, have been widely investigated as a means to achieve sustained parenteral drug delivery. The advantage of formulating the polymeric matrix as microspheres is the ability to administer them via a conventional needle and syringe as a suspension formulation, rather than as an implant (see below). Lupron depot formulations are available which can provide therapeutic blood levels of leuprolide acetate for up to four months. These products are presented as lyophilized polylactic acid microspheres which are reconstituted to form a suspension prior to administration. 

Okada and co-workers (1988,1989,1991) and Ogawa etal. (1988) have also described a 75 25 PLGA microencapsulated 30-day release system for the delivery of another LHRH analog leuproUde acetate [(D-Leu , Pro NEt)-LHRH Lupron Depot , Takeda-Abbott], Their results indicate that a single injection of microcapsules maintains constant and effective serum levels of the analog for one month. Sufficient therapeutic efficacy in the treatment of advanced prostatic cancer has also been shown for leuprolide acetate, and the product has recently been approved for use by the U.S. Food and Drug Administration (Lupron Depot , 7.5mg PDR, 1994). This treatment has also shown to cause a dramatic regression of... 

---