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Investigation of Thermal and Viscoelastic Properties of Polymers Relevant to Hot Melt Extrusion, IV: Affinisol™ HPMC HME Polymers.
AAPS PharmSciTech. 2016 Feb; 17(1):148-57.AP

Abstract

Most cellulosic polymers cannot be used as carriers for preparing solid dispersion of drugs by hot melt extrusion (HME) due to their high melt viscosity and thermal degradation at high processing temperatures. Three HME-grade hydroxypropyl methylcelluloses, namely Affinisol™ HPMC HME 15 cP, Affinisol™ HPMC HME 100 cP, and Affinisol™ HPMC HME 4 M, have recently been introduced by The Dow Chemical Co. to enable the preparation of solid dispersion at lower and more acceptable processing temperatures. In the present investigation, physicochemical properties of the new polymers relevant to HME were determined and compared with that of Kollidon(®) VA 64. Powder X-ray diffraction (PXRD), modulated differential scanning calorimetry (mDSC), thermogravimetric analysis (TGA), moisture sorption, rheology, and torque analysis by melt extrusion were applied. PXRD and mDSC showed that the Affinisol™ polymers were amorphous in nature. According to TGA, the onset of degradation for all polymers was >220°C. The Affinisol™ polymers exhibited less hygroscopicity than Kollidon(®) VA 64 and another HPMC polymer, Methocel™ K100LV. The complex viscosity profiles of the Affinisol™ polymers as a function of temperature were similar. The viscosity of the Affinisol™ polymers was highly sensitive to the shear rate applied, and unlike Kollidon(®) VA 64, the viscosity decreased drastically when the angular frequency was increased. Because of the very high shear rate encountered during melt extrusion, Affinisol™ polymers showed capability of being extruded at larger windows of processing temperatures as compared to that of Kollidon(®) VA 64.

Authors+Show Affiliations

Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, St. John's University, 8000 Utopia Parkway, Queens, New York, 11439, USA. Present Address Teva Pharmaceuticals Inc., 223 Quaker Rd, Pomona, New York, 10970, USA.Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, St. John's University, 8000 Utopia Parkway, Queens, New York, 11439, USA.Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, St. John's University, 8000 Utopia Parkway, Queens, New York, 11439, USA. serajuda@stjohns.edu.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

26511936

Citation

Gupta, Simerdeep Singh, et al. "Investigation of Thermal and Viscoelastic Properties of Polymers Relevant to Hot Melt Extrusion, IV: Affinisol™ HPMC HME Polymers." AAPS PharmSciTech, vol. 17, no. 1, 2016, pp. 148-57.
Gupta SS, Solanki N, Serajuddin AT. Investigation of Thermal and Viscoelastic Properties of Polymers Relevant to Hot Melt Extrusion, IV: Affinisol™ HPMC HME Polymers. AAPS PharmSciTech. 2016;17(1):148-57.
Gupta, S. S., Solanki, N., & Serajuddin, A. T. (2016). Investigation of Thermal and Viscoelastic Properties of Polymers Relevant to Hot Melt Extrusion, IV: Affinisol™ HPMC HME Polymers. AAPS PharmSciTech, 17(1), 148-57. https://doi.org/10.1208/s12249-015-0426-6
Gupta SS, Solanki N, Serajuddin AT. Investigation of Thermal and Viscoelastic Properties of Polymers Relevant to Hot Melt Extrusion, IV: Affinisol™ HPMC HME Polymers. AAPS PharmSciTech. 2016;17(1):148-57. PubMed PMID: 26511936.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Investigation of Thermal and Viscoelastic Properties of Polymers Relevant to Hot Melt Extrusion, IV: Affinisol™ HPMC HME Polymers. AU - Gupta,Simerdeep Singh, AU - Solanki,Nayan, AU - Serajuddin,Abu T M, Y1 - 2015/10/28/ PY - 2015/07/28/received PY - 2015/09/28/accepted PY - 2015/10/30/entrez PY - 2015/10/30/pubmed PY - 2016/12/15/medline KW - Affinisol™ HPMC HME KW - hot melt extrusion KW - hydroxypropyl methylcellulose KW - solid dispersion KW - thermal analysis KW - viscosity SP - 148 EP - 57 JF - AAPS PharmSciTech JO - AAPS PharmSciTech VL - 17 IS - 1 N2 - Most cellulosic polymers cannot be used as carriers for preparing solid dispersion of drugs by hot melt extrusion (HME) due to their high melt viscosity and thermal degradation at high processing temperatures. Three HME-grade hydroxypropyl methylcelluloses, namely Affinisol™ HPMC HME 15 cP, Affinisol™ HPMC HME 100 cP, and Affinisol™ HPMC HME 4 M, have recently been introduced by The Dow Chemical Co. to enable the preparation of solid dispersion at lower and more acceptable processing temperatures. In the present investigation, physicochemical properties of the new polymers relevant to HME were determined and compared with that of Kollidon(®) VA 64. Powder X-ray diffraction (PXRD), modulated differential scanning calorimetry (mDSC), thermogravimetric analysis (TGA), moisture sorption, rheology, and torque analysis by melt extrusion were applied. PXRD and mDSC showed that the Affinisol™ polymers were amorphous in nature. According to TGA, the onset of degradation for all polymers was >220°C. The Affinisol™ polymers exhibited less hygroscopicity than Kollidon(®) VA 64 and another HPMC polymer, Methocel™ K100LV. The complex viscosity profiles of the Affinisol™ polymers as a function of temperature were similar. The viscosity of the Affinisol™ polymers was highly sensitive to the shear rate applied, and unlike Kollidon(®) VA 64, the viscosity decreased drastically when the angular frequency was increased. Because of the very high shear rate encountered during melt extrusion, Affinisol™ polymers showed capability of being extruded at larger windows of processing temperatures as compared to that of Kollidon(®) VA 64. SN - 1530-9932 UR - https://www.unboundmedicine.com/medline/citation/26511936/Investigation_of_Thermal_and_Viscoelastic_Properties_of_Polymers_Relevant_to_Hot_Melt_Extrusion_IV:_Affinisol™_HPMC_HME_Polymers_ L2 - https://dx.doi.org/10.1208/s12249-015-0426-6 DB - PRIME DP - Unbound Medicine ER -