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Development and Optimization of a Wet Granulation Process at Elevated Temperature for a Poorly Compactible Drug Using Twin Screw Extruder for Continuous Manufacturing.
J Pharm Sci. 2017 02; 106(2):589-600.JP

Abstract

The objective of this study was to enhance tabletability of a poorly compactible drug, acetaminophen, by wet granulation using twin screw extruder at high temperature. It was desired that there would be minimum amounts of excipients used and the granules obtained after extrusion would be dry and fall within a size range suitable for tableting without any further processing. Mixtures of acetaminophen (95%) with binders (5% povidone or partially pregelatinized starch) were wet granulated through twin screw extruder at 70°C by adding 7% w/w water. The process had a short granulation time (<1 min), and, on account of the elevated processing temperature used, no drying after extrusion was needed. By optimizing formulation and processing parameters, >90% granules in the size range of 125 to 1000 μm (<3% above 1000 μm and <7% below 125 μm) were obtained without any milling. When the granules were compressed by adding 1% disintegrant and 0.5% lubricant extragranularly, tablets produced (93.6% drug load) had good mechanical strength having hardness >1.7 MPa, which was superior to that of tablets prepared by conventional high shear wet granulation. As the granules could be extruded continuously and did not require drying and milling, the method was amenable to continuous processing.

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Publisher Full Text (DOI)

Authors+Show Affiliations

Meena AK
Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, St. John's University, Queens, New York 11439.
Desai D
Drug Product Science and Technology, Bristol-Myers Squibb Company, One Squibb Drive, New Brunswick, New Jersey 08903.
Serajuddin AT
Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, St. John's University, Queens, New York 11439. Electronic address: serajuda@stjohns.edu.

MeSH

AcetaminophenAnalgesics, Non-NarcoticDesiccationDrug CompoundingEquipment DesignExcipientsHardnessHot TemperatureParticle SizePovidoneStarchTabletsTensile StrengthWater

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27890244

Citation

Meena, Anuprabha K., et al. "Development and Optimization of a Wet Granulation Process at Elevated Temperature for a Poorly Compactible Drug Using Twin Screw Extruder for Continuous Manufacturing." Journal of Pharmaceutical Sciences, vol. 106, no. 2, 2017, pp. 589-600.
Meena AK, Desai D, Serajuddin AT. Development and Optimization of a Wet Granulation Process at Elevated Temperature for a Poorly Compactible Drug Using Twin Screw Extruder for Continuous Manufacturing. J Pharm Sci. 2017;106(2):589-600.
Meena, A. K., Desai, D., & Serajuddin, A. T. (2017). Development and Optimization of a Wet Granulation Process at Elevated Temperature for a Poorly Compactible Drug Using Twin Screw Extruder for Continuous Manufacturing. Journal of Pharmaceutical Sciences, 106(2), 589-600. https://doi.org/10.1016/j.xphs.2016.10.020
Meena AK, Desai D, Serajuddin AT. Development and Optimization of a Wet Granulation Process at Elevated Temperature for a Poorly Compactible Drug Using Twin Screw Extruder for Continuous Manufacturing. J Pharm Sci. 2017;106(2):589-600. PubMed PMID: 27890244.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and Optimization of a Wet Granulation Process at Elevated Temperature for a Poorly Compactible Drug Using Twin Screw Extruder for Continuous Manufacturing. AU - Meena,Anuprabha K, AU - Desai,Divyakant, AU - Serajuddin,Abu T M, Y1 - 2016/11/24/ PY - 2016/08/19/received PY - 2016/10/17/revised PY - 2016/10/20/accepted PY - 2016/11/29/pubmed PY - 2017/12/13/medline PY - 2016/11/29/entrez KW - compactibility KW - continuous manufacturing KW - hardness KW - powder technology KW - tablet KW - twin-screw extruder KW - wet granulation SP - 589 EP - 600 JF - Journal of pharmaceutical sciences JO - J Pharm Sci VL - 106 IS - 2 N2 - The objective of this study was to enhance tabletability of a poorly compactible drug, acetaminophen, by wet granulation using twin screw extruder at high temperature. It was desired that there would be minimum amounts of excipients used and the granules obtained after extrusion would be dry and fall within a size range suitable for tableting without any further processing. Mixtures of acetaminophen (95%) with binders (5% povidone or partially pregelatinized starch) were wet granulated through twin screw extruder at 70°C by adding 7% w/w water. The process had a short granulation time (<1 min), and, on account of the elevated processing temperature used, no drying after extrusion was needed. By optimizing formulation and processing parameters, >90% granules in the size range of 125 to 1000 μm (<3% above 1000 μm and <7% below 125 μm) were obtained without any milling. When the granules were compressed by adding 1% disintegrant and 0.5% lubricant extragranularly, tablets produced (93.6% drug load) had good mechanical strength having hardness >1.7 MPa, which was superior to that of tablets prepared by conventional high shear wet granulation. As the granules could be extruded continuously and did not require drying and milling, the method was amenable to continuous processing. SN - 1520-6017 UR - https://www.unboundmedicine.com/medline/citation/27890244/Development_and_Optimization_of_a_Wet_Granulation_Process_at_Elevated_Temperature_for_a_Poorly_Compactible_Drug_Using_Twin_Screw_Extruder_for_Continuous_Manufacturing_ DB - PRIME DP - Unbound Medicine ER -