Enteric Hard Capsules for Targeting the Small Intestine: Positive Correlation between In Vitro Disintegration and Dissolution Times
In this study, the potential for correlation between disintegration and dissolution performance of enteric-coated (EC) dosage forms was investigated. Different enteric hard shell capsule formulations containing caffeine as model drug were tested for disintegration (in a compendial disintegration tester) and for dissolution in both USP type I (basket) and type II (paddle) apparatuses using different media. Overall, good correlations were obtained. This was observed for both the basket and the paddle apparatus, indicating that the use of disintegration testing as a surrogate for dissolution testing (allowed by International Conference on Harmonization (ICH) for immediate release dosage forms in case, in addition to other conditions, a correlation between disintegration and dissolution is proven) could be extended to include delayed release dosage forms.
Download the full publication here: Enteric Hard Capsules for Targeting the Small Intestine- Positive Correlation between In Vitro Disintegration and Dissolution Times
or continue reading here: Fu, M.; Al-Gousous, J.; Blechar, J.A.; Langguth, P. Enteric Hard Capsules for Targeting the Small Intestine: Positive Correlation between In Vitro Disintegration and Dissolution Times. Pharmaceutics 2020, 12, 123.
Keywords: disintegration; dissolution; enteric-coated; ICH; quality control
Materials: Hydroxypropyl methylcellulose size 0 capsules (ACG Nature Caps Plus) were received form ACG Associated Capsules Pvt Ltd (Mumbai, India). DRcaps® (nutraceutical capsules with inherent enteric properties of the capsule shell) were obtained from Neue Lebensqualität (Badendorf, Germany). Caffeine (median particle size 48 µm) and magnesium stearate were purchased from Caesar & Loretz GmbH (Hilden, Germany). Fumed silica was purchased from Fagron GmbH & CO.KG (Glinde, Germany). Hypromellose phthalate (HP-50), hypromellose acetate succinate (HPMCAS-HG, AQOAT) and low substituted hydroxypropyl cellulose (L-HPC) were received as a gift from Shin-Etsu (Wiesbaden, Germany). Lactose (FlowLac® 90) was received from Molkerei Meggle (Wasserburg, Germany). Triethyl citrate (TEC) was purchased from Sigma-Aldrich (Overijse, Belgium). Talc was purchased from Imerys (Luzenac, France). All other materials were of analytical grade.