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Roller compaction of hydrophilic extended release tablets-combined effects of processing variables and drug/matrix former particle size.
AAPS PharmSciTech. 2015 Apr; 16(2):267-77.AP

Abstract

The present study shows that roller compaction (RC) can successfully be used as a granulation method to prepare hydroxypropyl methylcellulose (HPMC)-based extended release matrix tablets containing a high drug load, both for materials deforming mainly by fragmentation (paracetamol) as for those having mainly plastic deformation (ibuprofen). The combined effect of RC process variables and composition on the manufacturability of HPMC tablets was investigated. Standard wet granulation grade HPMC was compared with a larger particle size direct compressible HPMC grade. Higher roll pressure was found to result in larger paracetamol granules and narrower granule particle size distributions, especially for formulations containing smaller size HPMC. However, for ibuprofen, no clear effect of roll pressure was observed. High roll pressure also resulted in denser ribbon and less bypass fines during RC. Loss of compactibility was observed for granules compared to powder blends, which was found to be related to differences in granule porosity and morphology. Using the large-sized HPMC grade did in some cases result in lower tensile strength tablets but had the advantage to improve the powder flow into the roller compactor. This work also indicates that when the HPMC level lies near the percolation threshold, significant changes can occur in the drug release rate due to changes in other factors (raw material characteristics and processing).

Authors+Show Affiliations

Faculty of Pharmacy, Industrial Pharmacy, University of Helsinki, Helsinki, Finland.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

25273028

Citation

Heiman, Johanna, et al. "Roller Compaction of Hydrophilic Extended Release Tablets-combined Effects of Processing Variables and Drug/matrix Former Particle Size." AAPS PharmSciTech, vol. 16, no. 2, 2015, pp. 267-77.
Heiman J, Tajarobi F, Gururajan B, et al. Roller compaction of hydrophilic extended release tablets-combined effects of processing variables and drug/matrix former particle size. AAPS PharmSciTech. 2015;16(2):267-77.
Heiman, J., Tajarobi, F., Gururajan, B., Juppo, A., & Abrahmsén-Alami, S. (2015). Roller compaction of hydrophilic extended release tablets-combined effects of processing variables and drug/matrix former particle size. AAPS PharmSciTech, 16(2), 267-77. https://doi.org/10.1208/s12249-014-0219-3
Heiman J, et al. Roller Compaction of Hydrophilic Extended Release Tablets-combined Effects of Processing Variables and Drug/matrix Former Particle Size. AAPS PharmSciTech. 2015;16(2):267-77. PubMed PMID: 25273028.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Roller compaction of hydrophilic extended release tablets-combined effects of processing variables and drug/matrix former particle size. AU - Heiman,Johanna, AU - Tajarobi,Farhad, AU - Gururajan,Bindhumadhavan, AU - Juppo,Anne, AU - Abrahmsén-Alami,Susanna, Y1 - 2014/10/02/ PY - 2014/04/18/received PY - 2014/09/10/accepted PY - 2014/10/3/entrez PY - 2014/10/3/pubmed PY - 2015/12/15/medline SP - 267 EP - 77 JF - AAPS PharmSciTech JO - AAPS PharmSciTech VL - 16 IS - 2 N2 - The present study shows that roller compaction (RC) can successfully be used as a granulation method to prepare hydroxypropyl methylcellulose (HPMC)-based extended release matrix tablets containing a high drug load, both for materials deforming mainly by fragmentation (paracetamol) as for those having mainly plastic deformation (ibuprofen). The combined effect of RC process variables and composition on the manufacturability of HPMC tablets was investigated. Standard wet granulation grade HPMC was compared with a larger particle size direct compressible HPMC grade. Higher roll pressure was found to result in larger paracetamol granules and narrower granule particle size distributions, especially for formulations containing smaller size HPMC. However, for ibuprofen, no clear effect of roll pressure was observed. High roll pressure also resulted in denser ribbon and less bypass fines during RC. Loss of compactibility was observed for granules compared to powder blends, which was found to be related to differences in granule porosity and morphology. Using the large-sized HPMC grade did in some cases result in lower tensile strength tablets but had the advantage to improve the powder flow into the roller compactor. This work also indicates that when the HPMC level lies near the percolation threshold, significant changes can occur in the drug release rate due to changes in other factors (raw material characteristics and processing). SN - 1530-9932 UR - https://www.unboundmedicine.com/medline/citation/25273028/Roller_compaction_of_hydrophilic_extended_release_tablets_combined_effects_of_processing_variables_and_drug/matrix_former_particle_size_ L2 - https://dx.doi.org/10.1208/s12249-014-0219-3 DB - PRIME DP - Unbound Medicine ER -