In the Pharmaceutical and Fine Chemicals industries the choice of the right solid form can have a dramatic influence on the successful development of an active pharmaceutical ingredient (API). Until a few years ago, salts and polymorphic solid forms have been the classical targets. Recently, however, co-crystals have emerged as a new alternative that has stirred the interest in APIs development and manufacturing areas, due to the unique applications and interesting advantages when compared to other solid forms. Briefly, in co-crystals, the API crystallizes with one or more neutral “coformer” components, being the interactions between the counterparts weak, non covalent, non ionic intermolecular forces. Cocrystallisation chemistry can be used to improve the physico-chemical properties of APIs (solubility, stability, hygroscopicity, flowability…) and, in the manufacturing processes, it can represent a valuable tool to solve issues related to purification, resolution and stabilization of products. Any new co-crystal (or process involving co-crystals in the API manufacturing process) may be patented. Last but not the least, a recent FDA Guideline, related to co-crystals Regulatory classifications, is opening interesting perspectives and opportunities for the generic industry in USA and Europe. PHARMACEUTICAL CO-CRYSTALS A not to miss opportunity for the API generics industry 29 MAGGIO 2014 9.30 Registrazione partecipanti 10:00 Welcome and introductions 10:15 Value creation through new solid forms development. What is a co-crystal? 10:45 FDA Regulatory Classification of Pharmaceutical co-crystals, April-2013. Opportunities and limitations for the generic industry in USA and Europe. 11.45 Coffee break 12:00 Co-crystallization technology. Beyond pharmaceutical cocrystals 13.00 Lunch 14:15 Real case stories & Open discussion Question & Answer 16.00 Concluding remarks Speakers from Enantia (Italian language): Joan Feixas - Llorenç Rafecas – Enrico Grassi Enantia is a privately held company devoted to chemical research and development, custom synthesis and crystal engineering, with a strong focus on asymmetric chemistry and co-crystallization technologies Sede workshop: CPA c/o Istituto Piero Pirelli Viale Fulvio testi, 223 – 20162 Milano 29 MAGGIO 2014 PHARMACEUTICAL CO-CRYSTALS A not to miss opportunity for the API generics industry SCHEDA iscrizione La presente scheda dovrà essere compilata ed inviata : via email : [email protected] O via fax : 02 6692373 Azienda_____________________________________________________________________ Via_________________________________________________________________________ CAP___________Città ________________________________________Prov. ____________ Cognome___________________________________Nome____________________________ Funzione Aziendale____________________________________________________________ Tel ______________________________ email_____________________________________ Partita IVA aziendale___________________________________________________________ Quota di partecipazione: - € 350,00 + IVA per il 1° partecipante non associato CPA - € 270,00 + IVA per il 2° partecipante della stessa società non associata CPA - € 250,00 + IVA per il 1° partecipante Associato CPA / Partner Enantia - € 200,00 + IVA per il 2° partecipante stessa società Associato CPA / Partner Enantia - € 320,00 + IVA per il 1° partecipante cliente 2014 eventi CPA - € 240,00 + IVA per il 2° partecipante stessa società cliente 2014 eventi CPA La quota comprende - documentazione ed attestato di partecipazione; - coffee break e colazione di lavoro. Sede workshop : CPA c/o Istituto Pirelli (Viale Fulvio Testi, 223 —Milano) Il pagamento dovrà essere effettuato tramite BONIFICO BANCARIO su c/c presso della Banca Popolare di Sondrio - Agenzia 20 Milano intestato a CPA (Viale Fulvio Testi, 223 – 20162 Milano - Partita IVA — Cod Fisc 04357310962) IBAN : IT 81 Z056 9601 6190 0000 2697X87 Fattura quietanziata verrà emessa a riscontro dell’avvenuto pagamento Per ogni informazione: Tel. 02 67380474 - [email protected]
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