Methods, compositions and kits for treating autophagy mediated diseases and disorders are disclosed as well as methods of treating a subject suffering from chronic granulomatous disease (CGD) by administering an effective amount of a thymosin polypeptide or variant thereof to the subject.

Methods, compositions and kits for treating autophagy mediated diseases and disorders are disclosed as well as methods of treating a subject suffering from chronic granulomatous disease (CGD) by administering an effective amount of a thymosin polypeptide or variant thereof to the subject.

Compositions of a cyclooxygenase inhibitor and a calcium channel antagonist in a liquid carrier. The composition may be administered the the urinary tract during urological diagnostic, interventional, surgical and other medical procedures. One disclosed composition comprises ketoprofen and nifedipine in a liquid irrigation carrier, and includes a solubilizing agent, stabilizing agents and a buffering agent.

Compositions of a cyclooxygenase inhibitor and a calcium channel antagonist in a liquid carrier. The composition may be administered the urinary tract during urological diagnostic, interventional, surgical and other medical procedures. One disclosed composition comprises ketoprofen and nifedipine in a liquid irrigation carrier, and includes a solubilizing agent, stabilizing agents and a buffering agent.

Embodiments of the present invention are directed to a plurality of substantially spherical microspheres comprising at least one API substantially dispersed in at least one polymer and a lyoprotectant on an outside surface of the plurality of substantially spherical microspheres, wherein the plurality of substantially spherical microspheres have a D99[num] particle diameter of less than about 10 μm; a D90[num] circularity value of from about 0.8 to about 1.0; and comprise API in a weight of about 20 to about 40 wt. % of the polymer. Other embodiments relate to injectable compositions comprising such microspheres and methods of treating a number of conditions by administering such injectable compositions to a subject.

The present invention provides methods, compositions, and kits for treating bladder disorders or conditions, in which botulinum toxin is topically administered to the mucosal inner lining or urothelium of the bladder, of a subject in need thereof, for transmucosal delivery across the urothelium to surrounding bladder wall musculature and/or neuronal tissue. Rather than requiring injection, the toxin instead may be administered by instillation in solution via the urethra. In particular, the botulinum toxin is administered in conjunction with a positively charged or lipophilic carrier comprising a positively charged polymeric backbone or a hydrophobic backbone with covalently attached groups that enhance transmucosal transport across the urothelium and may also stabilize the botulinum toxin in aqueous formulations.

The present invention provides methods, compositions, and kits for treating bladder disorders or conditions, in which botulinum toxin is topically administered to the mucosal inner lining or urothelium of the bladder, of a subject in need thereof, for transmucosal delivery across the urothelium to surrounding bladder wall musculature and/or neuronal tissue. Rather than requiring injection, the toxin instead may be administered by instillation in solution via the urethra. In particular, the botulinum toxin is administered in conjunction with a positively charged or lipophilic carrier comprising a positively charged polymeric backbone or a hydrophobic backbone with covalently attached groups that enhance transmucosal transport across the urothelium and may also stabilize the botulinum toxin in aqueous formulations.

The present invention provides novel compounds with improved solubility and altered pharmacokinetic properties. The compounds of the present invention may be represented by Formula I as below:

##STR00001##

Embodiments of the present invention are directed to a plurality of substantially spherical microspheres comprising at least one API substantially dispersed in at least one polymer and a lyoprotectant on an outside surface of the plurality of substantially spherical microspheres, wherein the plurality of substantially spherical microspheres have a D99[num] particle diameter of less than about 10 m; a D90[num] circularity value of from about 0.8 to about 1.0; and comprise API in a weight of about 20 to about 40 wt. % of the polymer. Other embodiments relate to injectable compositions comprising such microspheres and methods of treating a number of conditions by administering such injectable compositions to a subject.

Compounds and methods for treating diseases mediated by a P2X.sub.3 and/or a P2X.sub.2/3 receptor antagonist, the methods comprising administering to a subject in need thereof an effective amount of a compound of formula (I):

##STR00001##

or a pharmaceutically acceptable salt, solvate or prodrug thereof, wherein X is O, D, Y, R.sup.1, R.sup.2, R.sup.3, R.sup.4, R.sup.5, R.sup.6, R.sup.7 and R.sup.8 are as defined herein.