| abstract |
The present invention relates in certain embodiments to a controlled release formulation, especially a sachet, comprising a unit dosage of a dry powder of tamsulosin or a pharmaceutically acceptable salt thereof in a controlled release matrix and to methods of making and using such formulation. The controlled release formulation is beneficial in the treatment of benign prostatic hyperplasia (BPH), particularly in those patients suffering from dysphagia. The controlled release formulation is easily dispersed in water or other suitable liquid, and so solves the problem of dysphagia, thereby improving patient compliance in that targeted patient population, yet the controlled release formulation has a release profile in a patient on an empty stomach similar to FLOMAX® ((R)-5-(2-{[2-(2-Ethoxyphenoxy)ethyl]amino}propyl)-2-methoxybenzene-1-sulfonamide hydrochloride) taken 30 minutes after a meal, but does not exhibit the FLOMAX® tablet food effect, thereby improving dosage form administration flexibility. |