Tablets & Capsules

TC0116

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stored for 6 months at 25°C/60% RH and 40°C/75% RH were similar and stable under stressed conditions. Conclusions On the basis of the results pro- vided above, extruding AquaSolve HMPCAS does not cause physico- chemical degradation within the pro- cessing temperature ranges studied. However, the processing tempera- tures should be optimized based on the miscibility of the API with the polymer and should take into account the plasticizing effect (if any) of the API on the polymer. T&C References 1. Timpe, C. and Forschung, L. (2007). Strategies for formulation development of poorly water-soluble drug candidates—A recent perspec- tive. American Pharmaceutical Review, 10(2), 104-109. 2. Sarode, A.L., Obara, S., Tanno, F.K., Sandhu, H., Iyer, R., and Shah, N. (2014). Stability assessment of hypromellose acetate succinate NF for application in hot melt extrusion (HME). Carbohydrate Polymers, 101, 146-153. 3. Scwhing, Q., Davis, M., Tewari, D., Dürig, T. (2015). Redesigning the hypromellose acetate succinate (HPMCAS) molecule for enhanced extrudability: Evaluation in solid dis- persion formulations. Poster presen- tation at American Association of Pharmaceutical Scientists Annual Meeting in Orlando, FL, October 2015. Quyen Schwing is a senior staff scientist, Marvin Davis is a scientist, Divya Tewari is the technical directior of global pharmaceutical R&D, and Thomas Dürig is the senior technical director of pharmaceutical and nutrition specialties at Ashland Specialty Ingredients, 500 Hercules Road, Wilmington, DE 19808. Website: www.ashland.com. 48 January 2016 Tablets & Capsules Figure 8 DSC of felodipine-HPMCAS after 6 months at 40°C/75% RH 0.05 0.02 -0.01 -0.04 -0.07 -0.10 Reversing heat flow (W/g) -100 -50 0 50 100 150 200 Temperature (°C) XA1300-147-6MO Fel-LG XA1300-147B-6MO Fel-LG XA1300-148-6MO Fel-MG XA1300-148B-6MO Fel-MG Figure 9 Dissolution (FASSIF pH 6.5) of felodipine-HPMCAS after 6 months at 25°C/60% RH and 40°C/75% RH Felodipine-HPMCAS LG, initial Felodipine-HPMCAS LG @ 25°C/60% Felodipine-HPMCAS LG @ 40°C/75% Felodipine-HPMCAS MG, initial Felodipine-HPMCAS MG @ 25°C/60% Felodipine-HPMCAS MG @ 40°C/75% Felodipine only 0 50 100 150 200 250 300 100 90 80 70 60 50 40 30 20 10 0 Felodipine release (%) Time (min)

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