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...
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MDPI AG
2020-10-01
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| Series: | Pharmaceuticals |
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| Online Access: | https://www.mdpi.com/1424-8247/13/10/311 |
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| author | Eman M. Mohamed Tahir Khuroo Hamideh Afrooz Sathish Dharani Khaldia Sediri Phillip Cook Rajendran Arunagiri Mansoor A. Khan Ziyaur Rahman |
| author_facet | Eman M. Mohamed Tahir Khuroo Hamideh Afrooz Sathish Dharani Khaldia Sediri Phillip Cook Rajendran Arunagiri Mansoor A. Khan Ziyaur Rahman |
| author_sort | Eman M. Mohamed |
| collection | DOAJ |
| description | 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 (X<sub>1</sub>, 5, 7.5 and 10%) and CAB 171-15 percentage (X<sub>2</sub>, 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 (Y<sub>1</sub>), 8 (Y<sub>2</sub>), and 24 (Y<sub>3</sub>) h. Statistically significant (<i>p</i> < 0.05) effects of X<sub>1</sub> on Y<sub>1</sub> and X<sub>2</sub> on Y<sub>1</sub>, Y<sub>2,</sub> and Y<sub>3</sub> 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 Y<sub>1</sub>, Y<sub>2,</sub> and Y<sub>3</sub>, 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 Y<sub>1</sub>, Y<sub>2</sub>, and Y<sub>3</sub>, respectively. Y<sub>1</sub>, Y<sub>2,</sub> and Y<sub>3</sub> 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. |
| first_indexed | 2024-03-10T15:36:23Z |
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| institution | Directory Open Access Journal |
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| language | English |
| last_indexed | 2024-03-10T15:36:23Z |
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| spelling | doaj.art-5515c70dd14842ecb305354a9d40122d2023-11-20T17:09:35ZengMDPI AGPharmaceuticals1424-82472020-10-01131031110.3390/ph13100311Development of a Multivariate Predictive Dissolution Model for Tablets Coated with Cellulose Ester BlendsEman M. Mohamed0Tahir Khuroo1Hamideh Afrooz2Sathish Dharani3Khaldia Sediri4Phillip Cook5Rajendran Arunagiri6Mansoor A. Khan7Ziyaur Rahman8Irma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, Texas A&M University, College Station, TX 77843, USAIrma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, Texas A&M University, College Station, TX 77843, USAIrma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, Texas A&M University, College Station, TX 77843, USAIrma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, Texas A&M University, College Station, TX 77843, USAIrma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, Texas A&M University, College Station, TX 77843, USAEastman Chemical Company, Kingsport, TN 37662, USAEastman Chemical Company, Kingsport, TN 37662, USAIrma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, Texas A&M University, College Station, TX 77843, USAIrma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, Texas A&M University, College Station, TX 77843, USAThe 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 (X<sub>1</sub>, 5, 7.5 and 10%) and CAB 171-15 percentage (X<sub>2</sub>, 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 (Y<sub>1</sub>), 8 (Y<sub>2</sub>), and 24 (Y<sub>3</sub>) h. Statistically significant (<i>p</i> < 0.05) effects of X<sub>1</sub> on Y<sub>1</sub> and X<sub>2</sub> on Y<sub>1</sub>, Y<sub>2,</sub> and Y<sub>3</sub> 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 Y<sub>1</sub>, Y<sub>2,</sub> and Y<sub>3</sub>, 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 Y<sub>1</sub>, Y<sub>2</sub>, and Y<sub>3</sub>, respectively. Y<sub>1</sub>, Y<sub>2,</sub> and Y<sub>3</sub> 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.https://www.mdpi.com/1424-8247/13/10/311cellulose acetate butyratecellaburatediclofenacdissolutionhyperspectroscopymultivariate |
| spellingShingle | Eman M. Mohamed Tahir Khuroo Hamideh Afrooz Sathish Dharani Khaldia Sediri Phillip Cook Rajendran Arunagiri Mansoor A. Khan Ziyaur Rahman Development of a Multivariate Predictive Dissolution Model for Tablets Coated with Cellulose Ester Blends Pharmaceuticals cellulose acetate butyrate cellaburate diclofenac dissolution hyperspectroscopy multivariate |
| title | Development of a Multivariate Predictive Dissolution Model for Tablets Coated with Cellulose Ester Blends |
| title_full | Development of a Multivariate Predictive Dissolution Model for Tablets Coated with Cellulose Ester Blends |
| title_fullStr | Development of a Multivariate Predictive Dissolution Model for Tablets Coated with Cellulose Ester Blends |
| title_full_unstemmed | Development of a Multivariate Predictive Dissolution Model for Tablets Coated with Cellulose Ester Blends |
| title_short | Development of a Multivariate Predictive Dissolution Model for Tablets Coated with Cellulose Ester Blends |
| title_sort | development of a multivariate predictive dissolution model for tablets coated with cellulose ester blends |
| topic | cellulose acetate butyrate cellaburate diclofenac dissolution hyperspectroscopy multivariate |
| url | https://www.mdpi.com/1424-8247/13/10/311 |
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