Formulation and Preformulation
2014-07-21 23:11:53 Author:admin
 
   Formulation R&D is one of the core departments in our company which takes charge of pre-formulation, formulation development, process design and optimization, and manufacture. The scientists are highly skilled in a wide range of analytical approaches and have extensive experience and strong technical force in formulating immediate and controlled release oral dosage forms such as tablet, capsule, suspension, solid dispersion and lipid based formulation, providing improved bioavailability and stability suitable for the pre-clinical and clinical studies.
     Pre-formulation research includes the physico-chemical profiling of new chemical entities: pH-solubility, dissociation constant (pKa),  partition coefficient (logP, logD) and hygroscopicity; evaluating the stability of NCE: solution stability, solid state stability and light stability; solid state characterization: DSC, TGA, PXRD,  particle size and water content; screening and selection of salt form and polymorph form; investigating the drug excipient compatibility; evaluating of micromeritic properties; and screening formulations by stability and dissolution test. Pre-formulation work plays an important role in supporting clinical lead selection, and the formulation research and development.
     Formulation group covers the wide spectrum of the responsibility from early in vivo PK, PD and toxicology evaluation; prototype formulation screening and late stage formulation development, to scale up process design and optimization; clinical trial manufacture, and packaging, storage and shipping conditions evaluation and selection. The integration of these capabilities ensures a quick and seamless development of our drug candidates from preclinical to regulatory filings. 
     The state-of-the-art instrument and equipment in the department include: Glatt high shear granulator, Vector roller compactor, automated rotary tablet press, Vector coating system, Freund fluid bed, ProCepT spray dryer, Turbula shaker-mixer, freeze-drying machine, automatic blister packaging machine, Jet mill, ball mill, sieve shaker, powder tester, tablet hardness tester, tablet friability tester, tablet disintegration tester, fast halogen moisture meter, Malvern mastersizer 2000, dissolution stations, powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC), thermal gravimetric analysis (TGA), and high performance liquid chromatography (HPLC).
 

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