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Orodispersible tablets containing taste-masked solid lipid pellets with metformin hydrochloride: Influence of process parameters on tablet properties.
Eur J Pharm Biopharm. 2018 Jan; 122:137-145.EJ

Abstract

Compaction of multiparticulates into tablets, particularly into orodispersible tablets (ODTs), is challenging. The compression of pellets, made by solid lipid extrusion/spheronization processes, presents peculiar difficulties since solid lipids usually soften or melt at relatively low temperature ranges and due to applied mechanical forces. Until now, there are no reports in literature about the development of ODTs based on solid lipid pellets. To investigate the feasibility of producing such tablets, a design of experiment (DoE) approach was performed to elucidate the influence of compression force and amount of two co-processed excipients (Ludiflash® and Parteck® ODT) on properties of the tablets (friability, tensile strength, and disintegration time). ODTs (15 mm, flat-faced) with solid lipid pellets (250-1000 µm in diameter) containing 500 mg of metformin HCl, presenting immediate drug release profile and taste-masked properties, were targeted. During compression, a strong lamination of the tablets containing Parteck® ODT was observed. This phenomenon was prominently observed when high compression forces (≥5 kN) and high excipient amounts (≥40%; w/w) were used. On the other hand, the DoE focused on tablets with Ludiflash® showed better results regarding the production of ODTs. A positive influence of the compression force on the tensile strength and disintegration time of the tablets, regarding specifications of the Ph. Eur., was observed. The increase in the amount of this excipient resulted in fast disintegrating tablets, however, a negative influence on the tensile strength was noticed. After optimization of the parameters and formulation, based on the DoE results and considering the Ph. Eur. specifications for tablets, ODTs based on lipid pellets containing metformin HCl presenting immediate release profile (85% drug release in less than 30 min) and taste-masked properties (determined by an electronic tongue) were successfully obtained.

Authors+Show Affiliations

Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University, Universitaetsstrasse 1, 40225 Duesseldorf, Germany. Electronic address: gustavo.petrovick@uni-duesseldorf.de.Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University, Universitaetsstrasse 1, 40225 Duesseldorf, Germany.Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University, Universitaetsstrasse 1, 40225 Duesseldorf, Germany. Electronic address: joerg.breitkreutz@uni-duesseldorf.de.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

29106946

Citation

Petrovick, Gustavo Freire, et al. "Orodispersible Tablets Containing Taste-masked Solid Lipid Pellets With Metformin Hydrochloride: Influence of Process Parameters On Tablet Properties." European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, vol. 122, 2018, pp. 137-145.
Petrovick GF, Kleinebudde P, Breitkreutz J. Orodispersible tablets containing taste-masked solid lipid pellets with metformin hydrochloride: Influence of process parameters on tablet properties. Eur J Pharm Biopharm. 2018;122:137-145.
Petrovick, G. F., Kleinebudde, P., & Breitkreutz, J. (2018). Orodispersible tablets containing taste-masked solid lipid pellets with metformin hydrochloride: Influence of process parameters on tablet properties. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, 122, 137-145. https://doi.org/10.1016/j.ejpb.2017.10.018
Petrovick GF, Kleinebudde P, Breitkreutz J. Orodispersible Tablets Containing Taste-masked Solid Lipid Pellets With Metformin Hydrochloride: Influence of Process Parameters On Tablet Properties. Eur J Pharm Biopharm. 2018;122:137-145. PubMed PMID: 29106946.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Orodispersible tablets containing taste-masked solid lipid pellets with metformin hydrochloride: Influence of process parameters on tablet properties. AU - Petrovick,Gustavo Freire, AU - Kleinebudde,Peter, AU - Breitkreutz,Jörg, Y1 - 2017/10/26/ PY - 2017/04/24/received PY - 2017/10/18/revised PY - 2017/10/25/accepted PY - 2017/11/7/pubmed PY - 2018/8/3/medline PY - 2017/11/7/entrez KW - Compression force KW - DoE KW - Lipid pellets KW - Metformin hydrochloride KW - Orodispersible tablets KW - Taste-masking SP - 137 EP - 145 JF - European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V JO - Eur J Pharm Biopharm VL - 122 N2 - Compaction of multiparticulates into tablets, particularly into orodispersible tablets (ODTs), is challenging. The compression of pellets, made by solid lipid extrusion/spheronization processes, presents peculiar difficulties since solid lipids usually soften or melt at relatively low temperature ranges and due to applied mechanical forces. Until now, there are no reports in literature about the development of ODTs based on solid lipid pellets. To investigate the feasibility of producing such tablets, a design of experiment (DoE) approach was performed to elucidate the influence of compression force and amount of two co-processed excipients (Ludiflash® and Parteck® ODT) on properties of the tablets (friability, tensile strength, and disintegration time). ODTs (15 mm, flat-faced) with solid lipid pellets (250-1000 µm in diameter) containing 500 mg of metformin HCl, presenting immediate drug release profile and taste-masked properties, were targeted. During compression, a strong lamination of the tablets containing Parteck® ODT was observed. This phenomenon was prominently observed when high compression forces (≥5 kN) and high excipient amounts (≥40%; w/w) were used. On the other hand, the DoE focused on tablets with Ludiflash® showed better results regarding the production of ODTs. A positive influence of the compression force on the tensile strength and disintegration time of the tablets, regarding specifications of the Ph. Eur., was observed. The increase in the amount of this excipient resulted in fast disintegrating tablets, however, a negative influence on the tensile strength was noticed. After optimization of the parameters and formulation, based on the DoE results and considering the Ph. Eur. specifications for tablets, ODTs based on lipid pellets containing metformin HCl presenting immediate release profile (85% drug release in less than 30 min) and taste-masked properties (determined by an electronic tongue) were successfully obtained. SN - 1873-3441 UR - https://www.unboundmedicine.com/medline/citation/29106946/Orodispersible_tablets_containing_taste_masked_solid_lipid_pellets_with_metformin_hydrochloride:_Influence_of_process_parameters_on_tablet_properties_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0939-6411(17)30523-4 DB - PRIME DP - Unbound Medicine ER -