| 摘要 |
<p>New controlled-release formulations containing tryptophan and/or its metabolites are described, as well as the process to obtain them in tablet forms suitable for oral administration in the treatment of pathologies or conditions related to serotonin deficiency in the Central Nervous System. The formulations are comprised in a two-layer tablet, of which one example is a first layer containing 5-hydroxytryptophan to be released rapidly ("fast" phase) and the second layer containing tryptophan or 5-hydroxytryptophan to be released progressively ("retard" phase). The finished product is characterized by optimal release profiles under physiological conditions. In all cases the release kinetics of the active ingredients obtained is accurately time- and concentration-controlled, which avoids undesirable excess release of the active ingredients and in controlled clinical trial conditions has been shown to be free of undesirable side effects.</p> |
