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Impact of non-binder ingredients and molecular weight of polymer binders on heat assisted twin screw dry granulation.
Int J Pharm. 2018 Jan 30; 536(1):336-344.IJ

Abstract

Two grades of commercial AFFINISOL™ HPMC HME were used as polymer binders to explore the influence of polymer viscosity and concentration on a novel heat assisted dry granulation process with a twin screw extruder. Contributions of other non-binder ingredients in the formulations were also studied for lactose, microcrystalline cellulose and an active pharmaceutical ingredient of caffeine. As sensitive indicators of processing conditions that expose the drug to high internally generated heat, dehydration of α-lactose monohydrate and polymorphic transformation of caffeine were monitored by differential scanning calorimetry (DSC) and powder X-ray diffraction (XRD). Additionally, any decomposition of caffeine was determined by high-performance liquid chromatography (HPLC). Granular samples were characterized by particle size, circularity, fracture strength and their temperature on the exit of extruder. Higher screw speed and lower feed rate were found to help particles agglomerate by allowing feed particles a greater opportunity to increase in temperature. Lower binder molecular weight and higher binder concentration enable granules to build stronger strength and thereby lead to higher particle size. This new twin screw dry granulation was demonstrated as offering advantages over conventional hot melt granulation by minimizing thermal degradation of the tested ingredients.

Authors+Show Affiliations

MMRI/ CAPPA-D, Department of Chemical Engineering, McMaster University, Hamilton, Ontario, L8S 4L7 Canada.MMRI/ CAPPA-D, Department of Chemical Engineering, McMaster University, Hamilton, Ontario, L8S 4L7 Canada. Electronic address: mthomps@mcmaster.ca.Larkin Laboratory, The Dow Chemical Company, Midland, MI, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

29191485

Citation

Liu, Y, et al. "Impact of Non-binder Ingredients and Molecular Weight of Polymer Binders On Heat Assisted Twin Screw Dry Granulation." International Journal of Pharmaceutics, vol. 536, no. 1, 2018, pp. 336-344.
Liu Y, Thompson MR, O'Donnell KP. Impact of non-binder ingredients and molecular weight of polymer binders on heat assisted twin screw dry granulation. Int J Pharm. 2018;536(1):336-344.
Liu, Y., Thompson, M. R., & O'Donnell, K. P. (2018). Impact of non-binder ingredients and molecular weight of polymer binders on heat assisted twin screw dry granulation. International Journal of Pharmaceutics, 536(1), 336-344. https://doi.org/10.1016/j.ijpharm.2017.11.061
Liu Y, Thompson MR, O'Donnell KP. Impact of Non-binder Ingredients and Molecular Weight of Polymer Binders On Heat Assisted Twin Screw Dry Granulation. Int J Pharm. 2018 Jan 30;536(1):336-344. PubMed PMID: 29191485.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Impact of non-binder ingredients and molecular weight of polymer binders on heat assisted twin screw dry granulation. AU - Liu,Y, AU - Thompson,M R, AU - O'Donnell,K P, Y1 - 2017/11/28/ PY - 2017/09/07/received PY - 2017/11/19/revised PY - 2017/11/26/accepted PY - 2017/12/2/pubmed PY - 2018/8/14/medline PY - 2017/12/2/entrez KW - Dry granulation KW - Hot melt granulation ™Trademark of Dow chemical company KW - Polymorphic transformation KW - Viscosity SP - 336 EP - 344 JF - International journal of pharmaceutics JO - Int J Pharm VL - 536 IS - 1 N2 - Two grades of commercial AFFINISOL™ HPMC HME were used as polymer binders to explore the influence of polymer viscosity and concentration on a novel heat assisted dry granulation process with a twin screw extruder. Contributions of other non-binder ingredients in the formulations were also studied for lactose, microcrystalline cellulose and an active pharmaceutical ingredient of caffeine. As sensitive indicators of processing conditions that expose the drug to high internally generated heat, dehydration of α-lactose monohydrate and polymorphic transformation of caffeine were monitored by differential scanning calorimetry (DSC) and powder X-ray diffraction (XRD). Additionally, any decomposition of caffeine was determined by high-performance liquid chromatography (HPLC). Granular samples were characterized by particle size, circularity, fracture strength and their temperature on the exit of extruder. Higher screw speed and lower feed rate were found to help particles agglomerate by allowing feed particles a greater opportunity to increase in temperature. Lower binder molecular weight and higher binder concentration enable granules to build stronger strength and thereby lead to higher particle size. This new twin screw dry granulation was demonstrated as offering advantages over conventional hot melt granulation by minimizing thermal degradation of the tested ingredients. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/29191485/Impact_of_non_binder_ingredients_and_molecular_weight_of_polymer_binders_on_heat_assisted_twin_screw_dry_granulation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(17)31116-X DB - PRIME DP - Unbound Medicine ER -