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Effect of carbamazepine on viscoelastic properties and hot melt extrudability of Soluplus ®.
Int J Pharm. 2015 Jan 15; 478(1):232-239.IJ

Abstract

The purpose of this study was to apply viscoelastic properties of polymer and drug-polymer mixtures to determine processing conditions for the preparation of amorphous solid dispersion by melt extrusion. A poorly water-soluble drug, carbamazepine (CBZ), was mixed with Soluplus(®) as the carrier. Torque analysis using a melt extruder was performed at 10, 20 and 30% w/w drug concentrations and the effect of barrel temperature was studied. Viscosity of the mixtures either at fixed temperatures with different angular frequencies or as a function of temperature with the same frequency was studied using a rheometer. The viscosity of Soluplus(®) and the torque exerted on the twin screws decreased with the increase in CBZ concentration. The viscosity versus temperature plots for different CBZ concentrations were parallel to each other, without the drug melting transition, indicating complete drug-polymer miscibility. Thus, the drug-polymer mixtures could be extruded at temperature as low as 140°C with 10% w/w drug load, 135°C with 20% w/w drug and 125°C with 30% w/w drug, which were, respectively, ∼ 50°C, 55°C and 65°C below the melting point of 191°C for CBZ. The differential scanning calorimetry (DSC) and powder X-ray diffraction (XRD) analyses of the binary mixtures extruded at 125-150°C showed absence of crystalline drug. A systematic study of miscibility and extrudability of drug-polymer mixtures by rheological and torque analysis as a function of temperature will help formulators select optimal melt extrusion processing conditions to develop solid dispersions.

Authors+Show Affiliations

College of Pharmacy and Health Sciences, St. John's University, 8000 Utopia Parkway, Queens, NY 11439, USA.College of Pharmacy and Health Sciences, St. John's University, 8000 Utopia Parkway, Queens, NY 11439, USA.College of Pharmacy and Health Sciences, St. John's University, 8000 Utopia Parkway, Queens, NY 11439, USA.Catalent Pharma Solutions, 14 Schoolhouse Road, Somerset, NJ 08873, USA.Catalent Pharma Solutions, 14 Schoolhouse Road, Somerset, NJ 08873, USA.College of Pharmacy and Health Sciences, St. John's University, 8000 Utopia Parkway, Queens, NY 11439, USA. Electronic address: serajuda@stjohns.edu.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25448585

Citation

Gupta, Simerdeep Singh, et al. "Effect of Carbamazepine On Viscoelastic Properties and Hot Melt Extrudability of Soluplus ®." International Journal of Pharmaceutics, vol. 478, no. 1, 2015, pp. 232-239.
Gupta SS, Parikh T, Meena AK, et al. Effect of carbamazepine on viscoelastic properties and hot melt extrudability of Soluplus ®. Int J Pharm. 2015;478(1):232-239.
Gupta, S. S., Parikh, T., Meena, A. K., Mahajan, N., Vitez, I., & Serajuddin, A. T. M. (2015). Effect of carbamazepine on viscoelastic properties and hot melt extrudability of Soluplus ®. International Journal of Pharmaceutics, 478(1), 232-239. https://doi.org/10.1016/j.ijpharm.2014.11.025
Gupta SS, et al. Effect of Carbamazepine On Viscoelastic Properties and Hot Melt Extrudability of Soluplus ®. Int J Pharm. 2015 Jan 15;478(1):232-239. PubMed PMID: 25448585.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of carbamazepine on viscoelastic properties and hot melt extrudability of Soluplus ®. AU - Gupta,Simerdeep Singh, AU - Parikh,Tapan, AU - Meena,Anuprabha K, AU - Mahajan,Nidhi, AU - Vitez,Imre, AU - Serajuddin,Abu T M, Y1 - 2014/11/13/ PY - 2014/07/24/received PY - 2014/10/02/revised PY - 2014/11/12/accepted PY - 2014/12/3/entrez PY - 2014/12/3/pubmed PY - 2016/8/31/medline KW - Drug-polymer miscibility KW - Hot melt extrusion KW - Polymer KW - Rheology KW - Soluplus(®) KW - Torque analysis KW - Viscosity SP - 232 EP - 239 JF - International journal of pharmaceutics JO - Int J Pharm VL - 478 IS - 1 N2 - The purpose of this study was to apply viscoelastic properties of polymer and drug-polymer mixtures to determine processing conditions for the preparation of amorphous solid dispersion by melt extrusion. A poorly water-soluble drug, carbamazepine (CBZ), was mixed with Soluplus(®) as the carrier. Torque analysis using a melt extruder was performed at 10, 20 and 30% w/w drug concentrations and the effect of barrel temperature was studied. Viscosity of the mixtures either at fixed temperatures with different angular frequencies or as a function of temperature with the same frequency was studied using a rheometer. The viscosity of Soluplus(®) and the torque exerted on the twin screws decreased with the increase in CBZ concentration. The viscosity versus temperature plots for different CBZ concentrations were parallel to each other, without the drug melting transition, indicating complete drug-polymer miscibility. Thus, the drug-polymer mixtures could be extruded at temperature as low as 140°C with 10% w/w drug load, 135°C with 20% w/w drug and 125°C with 30% w/w drug, which were, respectively, ∼ 50°C, 55°C and 65°C below the melting point of 191°C for CBZ. The differential scanning calorimetry (DSC) and powder X-ray diffraction (XRD) analyses of the binary mixtures extruded at 125-150°C showed absence of crystalline drug. A systematic study of miscibility and extrudability of drug-polymer mixtures by rheological and torque analysis as a function of temperature will help formulators select optimal melt extrusion processing conditions to develop solid dispersions. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/25448585/Effect_of_carbamazepine_on_viscoelastic_properties_and_hot_melt_extrudability_of_Soluplus_®_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(14)00828-X DB - PRIME DP - Unbound Medicine ER -