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Evaluation of some compression aids in tableting of roller compacted swellable core drug layer.
Int J Pharm. 2013 Sep 10; 453(2):322-8.IJ

Abstract

Swellable core technology (SCT) represents a broadly applicable oral osmotic drug delivery platform for the controlled release of drugs. SCT tablets control drug delivery by using osmosis to regulate the influx of water into the tablet's core. The tablet consists of two layers; drug layer and sweller layer, with a semi-permeable membrane coating and delivery port located in the drug layer side of the tablet. The key component of SCT formulations is polyethylene oxide (PEO), which is typically wet granulated with organic solvents to prevent rapid gel hydration observed during contact with aqueous environments. However, the use of organic solvents has their own environmental and cost considerations which make this form of processing undesirable. To overcome this issue, dry granulation can be employed. However, PEO is a very plastic material and problems may be encountered during the tableting process, when work hardening occurs upon double compression. The addition of compression aids to the drug layer will help to increase the roll force when generating ribbons - reducing fines and segregation potential - while also reducing work hardening effects which impact tablet friability. The five compression aids used in this study were microcrystalline cellulose (MCC), xylitol, di-calcium phosphate (anhydrous), lactose monohydrate and starch. The work undertaken here studies the compression properties of the drug layer blends with different levels of the five compression aids as part of the formulation. Roller compaction properties are also varied to provide granules with differing solid fractions. The results of this study indicate that addition of microcrystalline cellulose in the formulation in levels between 10% and 30% significantly improve the tablet hardness at lower tablet compression forces. Further work is required to investigate the impact on dissolution.

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Authors+Show Affiliations

Golchert D
Pharmaceutical Development, Pfizer Global Research & Development, Sandwich CT13 9NJ, UK. dennis.golchert@novartis.com
Bines E
No affiliation info available
Carmody A
No affiliation info available

MeSH

Calcium PhosphatesCelluloseCompressive StrengthDrug CompoundingExcipientsHardnessHypromellose DerivativesLactoseMethylcelluloseStarchTabletsXylitol

Pub Type(s)

Journal Article

Language

eng

PubMed ID

23796839

Citation

Golchert, D, et al. "Evaluation of some Compression Aids in Tableting of Roller Compacted Swellable Core Drug Layer." International Journal of Pharmaceutics, vol. 453, no. 2, 2013, pp. 322-8.
Golchert D, Bines E, Carmody A. Evaluation of some compression aids in tableting of roller compacted swellable core drug layer. Int J Pharm. 2013;453(2):322-8.
Golchert, D., Bines, E., & Carmody, A. (2013). Evaluation of some compression aids in tableting of roller compacted swellable core drug layer. International Journal of Pharmaceutics, 453(2), 322-8. https://doi.org/10.1016/j.ijpharm.2013.06.025
Golchert D, Bines E, Carmody A. Evaluation of some Compression Aids in Tableting of Roller Compacted Swellable Core Drug Layer. Int J Pharm. 2013 Sep 10;453(2):322-8. PubMed PMID: 23796839.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of some compression aids in tableting of roller compacted swellable core drug layer. AU - Golchert,D, AU - Bines,E, AU - Carmody,A, Y1 - 2013/06/21/ PY - 2013/01/24/received PY - 2013/06/11/revised PY - 2013/06/12/accepted PY - 2013/6/26/entrez PY - 2013/6/26/pubmed PY - 2014/2/12/medline KW - Controlled release KW - Osmotic KW - Roller compaction KW - Swellable core technology SP - 322 EP - 8 JF - International journal of pharmaceutics JO - Int J Pharm VL - 453 IS - 2 N2 - Swellable core technology (SCT) represents a broadly applicable oral osmotic drug delivery platform for the controlled release of drugs. SCT tablets control drug delivery by using osmosis to regulate the influx of water into the tablet's core. The tablet consists of two layers; drug layer and sweller layer, with a semi-permeable membrane coating and delivery port located in the drug layer side of the tablet. The key component of SCT formulations is polyethylene oxide (PEO), which is typically wet granulated with organic solvents to prevent rapid gel hydration observed during contact with aqueous environments. However, the use of organic solvents has their own environmental and cost considerations which make this form of processing undesirable. To overcome this issue, dry granulation can be employed. However, PEO is a very plastic material and problems may be encountered during the tableting process, when work hardening occurs upon double compression. The addition of compression aids to the drug layer will help to increase the roll force when generating ribbons - reducing fines and segregation potential - while also reducing work hardening effects which impact tablet friability. The five compression aids used in this study were microcrystalline cellulose (MCC), xylitol, di-calcium phosphate (anhydrous), lactose monohydrate and starch. The work undertaken here studies the compression properties of the drug layer blends with different levels of the five compression aids as part of the formulation. Roller compaction properties are also varied to provide granules with differing solid fractions. The results of this study indicate that addition of microcrystalline cellulose in the formulation in levels between 10% and 30% significantly improve the tablet hardness at lower tablet compression forces. Further work is required to investigate the impact on dissolution. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/23796839/Evaluation_of_some_compression_aids_in_tableting_of_roller_compacted_swellable_core_drug_layer_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(13)00534-6 DB - PRIME DP - Unbound Medicine ER -