Development of a Multivariate Predictive Dissolution Model for Tablets Coated with Cellulose Ester Blends

The focus of the present investigation was to develop a predictive dissolution model for tablets coated with blends of cellulose acetate butyrate (CAB) 171-15 and cellulose acetate phthalate (C-A-P) using the design of experiment and chemometric approaches. Diclofenac sodium was used as a model drug. Coating weight gain (X₁, 5, 7.5 and 10%) and CAB 171-15 percentage (X₂, 33.3, 50 and 66.7%) in the coating composition relative to C-A-P and were selected as independent variables by full factorial experimental design. The responses monitored were dissolution at 1 (Y₁), 8 (Y₂), and 24 (Y₃) h. Statistically significant (p < 0.05) effects of X₁ on Y₁ and X₂ on Y₁, Y_2, and Y₃ were observed. The models showed a good correlation between actual and predicted values as indicated by the correlation coefficients of 0.964, 0.914, and 0.932 for Y₁, Y_2, and Y₃, respectively. For the chemometric model development, the near infrared spectra of the coated tablets were collected, and partial least square regression (PLSR) was performed. PLSR also showed a good correlation between actual and model predicted values as indicated by correlation coefficients of 0.916, 0.964, and 0.974 for Y₁, Y₂, and Y₃, respectively. Y₁, Y_2, and Y₃ predicted values of the independent sample by both approaches were close to the actual values. In conclusion, it is possible to predict the dissolution of tablets coated with blends of cellulose esters by both approaches.

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or continue reading here: Mohamed, E.M.; Khuroo, T.; Afrooz, H.; Dharani, S.; Sediri, K.; Cook, P.; Arunagiri, R.; Khan, M.A.; Rahman, Z. Development of a Multivariate Predictive Dissolution Model for Tablets Coated with Cellulose Ester Blends. Pharmaceuticals 2020, 13, 311.

Keywords: cellulose acetate butyrate; cellaburate; diclofenac; dissolution; hyperspectroscopy; multivariate, CAB 171-15 and C-A-P polymers, Acetone, acetonitrile (ACN), monobasic potassium phosphate, croscarmellose sodium (CCS), magnesium stearate (MGS), polyethylene glycol 400, hydroxypropyl cellulose (HPC, MW 100,000), lactose monohydrate (LMH, Supertab 145D), and microcrystalline cellulose (MCC, Vivapur^® 102).