Abstract: The present invention relates to a new, enhanced process for the manufacture of Cysteamine Bitartrate (I) and of its key intermediate thiazolidine (II). Furthermore, it relates to a new processes for the manufacture of crystalline anhydrous Cysteamine Bitartrate (polymorph L2) and monohydrate Cysteamine Bitartrate (polymorph L1). The crystalline anhydrous Cysteamine Bitartrate (polymorph L2) so obtained is characterized by particularly fine particle size and good appearance.

Abstract: Disclosed are triazole, imidazole and pyrrole condensed piperazine derivatives and their use as allosteric modulators of mGlus receptor activity, pharmaceutical compositions comprising such compounds, and methods of treatment therewith. Compounds of the invention can be used for the treatment and/or prevention of neurological and psychiatric disorders associated with glutamate dysfunction such as schizophrenia or cognitive decline, dementia or cognitive impairment, or other pathologies that can be related either directly or indirectly to glutamate dysfunction, i.e., disorders treatable by positive allosteric modulation (PAM) or by negative allosteric modulation (NAM) of mGluR5.

Abstract: A prolonged release multiple unit dosage form, preferably pellets, of cysteamine, cystamine or a pharmaceutically acceptable salt thereof, preferably cysteamine bitartrate, with a non gastro-resistant coating is described. The dosage form is particularly indicated for the administration to patients once or twice a day and it can be used also for pediatric administration.

Abstract: The present invention relates to a pharmaceutical formulation suitable for parenteral administration containing carglumic acid and a buffering agent having a pKa from 5.5 to 9.0 at 25° C.; according to an embodiment, the buffering agent may have a pKa from 7.5 to 8.5, preferably a pKa of about 8.07, such as trometamol. The formulation may also contain at least one bulking agent, such as mannitol. The invention also includes a method for manufacturing a lyophilised sterile formulation by freeze-drying a water solution containing carglumic acid, a buffering agent having a pKa from 5.5 to 9.0 at 25° C., preferably from 7.5 to 8.5, and optionally a bulking agent to obtain a freeze-dried powder.

Abstract: The present invention relates to a pharmaceutical formulation suitable for parenteral administration containing carglumic acid and a buffering agent having a pKa from 5.5 to 9.0 at 25° C.; according to an embodiment, the buffering agent may have a pKa from 7.5 to 8.5, preferably a pKa of about 8.07, such as trometamol. The formulation may also contain at least one bulking agent, such as mannitol. The invention also includes a method for manufacturing a lyophilised sterile formulation by freeze-drying a water solution containing carglumic acid, a buffering agent having a pKa from 5.5 to 9.0 at 25° C., preferably from 7.5 to 8.5, and optionally a bulking agent to obtain a freeze-dried powder.

Abstract: A process for the resolution of racemic tetrahydropapaverine with optically active arylpropionic acids is described.

Abstract: A process for the resolution of racemic tetrahydropapaverine with optically active arylpropionic acids is described.

Abstract: This invention relates to crystalline polymorphs of sertraline hydrocloride, i.e. (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphtalenamine hydrochloride, denominated form I, II and V, and methods for their preparation.

Abstract: This invention relates to a method for the preparation of sertraline hydrochloride, (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphtalenamine hydrochloride, in its crystalline form II.