Title : Crystallization Process of API ( Active Pharmaceutical Ingredients) for Dosage form Design
Abstract:
Crystallization is a widely used purification and a unit operation in pharma and chemical industries. Ibuprofen will be used as a model API in this presentation which is an analgesic. However commercial ibuprofen particles are irregular shape and size with rough surfaces. And show poor mechanical properties such as flowability, compaction etc. To overcome these problems desirable size shape of ibuprofen particle is needed which could offer direct compression with fewer operational steps but still having good product stability and therapeutic efficacy. So design a crystallization operation for producing desire size ibuprofen particle, the following information (data) is needed:
- Solubility diagram
- Metstable zone width
- Crystal growth rate
- Nucleation rates
The methods used, the results achieved and the data to design an industrial crystallizer will be presented