Evaluation of Diclofenac Sodium Release from Matrix Pellets Compressed into MUPS Tablets
Abstract
The purpose of the study was to screen the effects of formulation factors on the in vitro release profile of diclofenac sodium from matrix pellets compressed into multiple unit pellet system (MUPS) tablets using design of experiment (DOE). Extended release of diclofenac sodium was accomplished using Carbopol (R) 71G as matrix substance. According to Fractional Factorial Design FFD 2(3-1) four formulations of diclofenac sodium MUPS matrix tablets were prepared. The process of direct pelletization and subsequently compression of the pellets into tablets was applied in order to investigate a different approach in formulation of matrix systems and to achieve a better control of the process factors over the principal response - the release of the drug. The investigated factors were X-1-the percentage of polymer Carbopol (R) 71G, X-2-crushing strength of the tablet and X-3-different batches of the diclofenac sodium. In vitro dissolution time profiles at 6 different sampling times were chosen... as responses. Results of drug release studies indicated that drug release rates vary between different formulations, with a range of 1 to 8 h to complete dissolution. The most important impact on the drug release hart factor X-1-the percentage of polymer Carbopol (R) 71G. The polymer percentage is suggested as release regulator for diclofenac sodium release from MUPS matrix tablets. All other investigated factors had no significant influence on the release profile of diclofenac sodium.
Keywords:
matrix pellet / direct pelletization / diclofenac sodium / Carbopol (R) 71G / multiple unit pellet system (MUPS) / design of experimentsSource:
Zdravstveno varstvo, 2009, 129, 11, 1375-1384Publisher:
- Pharmaceutical Soc Japan, Tokyo
Funding / projects:
DOI: 10.1248/yakushi.129.1375
ISSN: 0031-6903
PubMed: 19881210
WoS: 000271247500014
Scopus: 2-s2.0-70450161335
Collections
Institution/Community
PharmacyTY - JOUR AU - Ivić, Branka AU - Ibrić, Svetlana AU - Betz, Gabriele AU - Đurić, Zorica PY - 2009 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1162 AB - The purpose of the study was to screen the effects of formulation factors on the in vitro release profile of diclofenac sodium from matrix pellets compressed into multiple unit pellet system (MUPS) tablets using design of experiment (DOE). Extended release of diclofenac sodium was accomplished using Carbopol (R) 71G as matrix substance. According to Fractional Factorial Design FFD 2(3-1) four formulations of diclofenac sodium MUPS matrix tablets were prepared. The process of direct pelletization and subsequently compression of the pellets into tablets was applied in order to investigate a different approach in formulation of matrix systems and to achieve a better control of the process factors over the principal response - the release of the drug. The investigated factors were X-1-the percentage of polymer Carbopol (R) 71G, X-2-crushing strength of the tablet and X-3-different batches of the diclofenac sodium. In vitro dissolution time profiles at 6 different sampling times were chosen as responses. Results of drug release studies indicated that drug release rates vary between different formulations, with a range of 1 to 8 h to complete dissolution. The most important impact on the drug release hart factor X-1-the percentage of polymer Carbopol (R) 71G. The polymer percentage is suggested as release regulator for diclofenac sodium release from MUPS matrix tablets. All other investigated factors had no significant influence on the release profile of diclofenac sodium. PB - Pharmaceutical Soc Japan, Tokyo T2 - Zdravstveno varstvo T1 - Evaluation of Diclofenac Sodium Release from Matrix Pellets Compressed into MUPS Tablets VL - 129 IS - 11 SP - 1375 EP - 1384 DO - 10.1248/yakushi.129.1375 ER -
@article{ author = "Ivić, Branka and Ibrić, Svetlana and Betz, Gabriele and Đurić, Zorica", year = "2009", abstract = "The purpose of the study was to screen the effects of formulation factors on the in vitro release profile of diclofenac sodium from matrix pellets compressed into multiple unit pellet system (MUPS) tablets using design of experiment (DOE). Extended release of diclofenac sodium was accomplished using Carbopol (R) 71G as matrix substance. According to Fractional Factorial Design FFD 2(3-1) four formulations of diclofenac sodium MUPS matrix tablets were prepared. The process of direct pelletization and subsequently compression of the pellets into tablets was applied in order to investigate a different approach in formulation of matrix systems and to achieve a better control of the process factors over the principal response - the release of the drug. The investigated factors were X-1-the percentage of polymer Carbopol (R) 71G, X-2-crushing strength of the tablet and X-3-different batches of the diclofenac sodium. In vitro dissolution time profiles at 6 different sampling times were chosen as responses. Results of drug release studies indicated that drug release rates vary between different formulations, with a range of 1 to 8 h to complete dissolution. The most important impact on the drug release hart factor X-1-the percentage of polymer Carbopol (R) 71G. The polymer percentage is suggested as release regulator for diclofenac sodium release from MUPS matrix tablets. All other investigated factors had no significant influence on the release profile of diclofenac sodium.", publisher = "Pharmaceutical Soc Japan, Tokyo", journal = "Zdravstveno varstvo", title = "Evaluation of Diclofenac Sodium Release from Matrix Pellets Compressed into MUPS Tablets", volume = "129", number = "11", pages = "1375-1384", doi = "10.1248/yakushi.129.1375" }
Ivić, B., Ibrić, S., Betz, G.,& Đurić, Z.. (2009). Evaluation of Diclofenac Sodium Release from Matrix Pellets Compressed into MUPS Tablets. in Zdravstveno varstvo Pharmaceutical Soc Japan, Tokyo., 129(11), 1375-1384. https://doi.org/10.1248/yakushi.129.1375
Ivić B, Ibrić S, Betz G, Đurić Z. Evaluation of Diclofenac Sodium Release from Matrix Pellets Compressed into MUPS Tablets. in Zdravstveno varstvo. 2009;129(11):1375-1384. doi:10.1248/yakushi.129.1375 .
Ivić, Branka, Ibrić, Svetlana, Betz, Gabriele, Đurić, Zorica, "Evaluation of Diclofenac Sodium Release from Matrix Pellets Compressed into MUPS Tablets" in Zdravstveno varstvo, 129, no. 11 (2009):1375-1384, https://doi.org/10.1248/yakushi.129.1375 . .