Testosterone microspheres

Drugs can be incorporated into biodegradable microspheres. When injected intramuscularly, such drug-loaded microspheres provide controlled release of the substance for several weeks or even months. As an example, microencapsulated GnRH agonists have become a valuable modality in the treatment of prostatic carcinoma. Testosterone has been incorporated into poly(DL-lactide-co-glycolide) micro-spheres. When first tested in castrated monkeys single injections resulted in an elevation of serum levels above the lower limit of normal for several months (Asch etal. 1986). When similar microsphere injections containing 315 mg of testosterone were given to eight hypogonadal men, serum testosterone levels slowly increased to peak levels at about eight weeks and fell thereafter to reach pathological levels again by 11 weeks (Burris etal. 1988). In a later study the size-range and the testosterone loading of the microspheres were adjusted so that in hypogonadal men single intramuscular injections resulted in relatively constant serum levels within the normal range for about 70 days (Bhasin etal. 1992). These two clinical studies demonstrated that the microspheres can be adapted to the required needs and the results were encouraging. However, this formulation of microspheres is technically difficult to manufacture consistently and requires two painful, large-volume intramuscular injections that limits its appeal for long-term therapy.

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