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Effect of different excipients on the physical characteristics of granules and tablets with carbamazepine prepared with polyethylene glycol 6000 by fluidized hot-melt granulation (FHMG).
AAPS PharmSciTech. 2011 Dec; 12(4):1241-7.AP

Abstract

The objective of this study was to investigate the properties of granules and tablets with carbamazepine which were prepared employing a fluidized hot-melt granulation (FHMG) technique. The FHMG process was carried out at 65°C. Macrogol 6000 (PEG 6000) was used as a binder at the content 10% (w/w) of the granulated mass. Granules containing up to 70% (w/w) of the drug and 20-90% (w/w) of a filler (lactose, mannitol, calcium hydrogen phosphate (Di-Cafos), pregelatinized starch, and microcrystalline cellulose (MCC)) were produced. When the drug content was 30% (w/w), the yield of the process was satisfying (>95%) and flowability of the granules was better than placebo granules or drug-loaded granules prepared by wet granulation. Type of a filler had strong impact on physical properties of granules, and size distribution of the particles was the most homogenous when lactose or Di-Cafos were used. The FHMG technique enabled preparation of granules with better compressability compared with the wet-granulated product or with non-granulated powders. Tablets with shorter disintegration time than 10 min were obtained with 2.0% crospovidone added as a disintegrant. In comparison to tablets prepared from the wet-granulated mass, employment of the FHMG method resulted in tablets with faster dissolution of carbamazepine (more than 80% of the drug released within 15 min). This was achieved with mannitol or lactose/MCC, as fillers.

Authors+Show Affiliations

Pharmaceutical Works Polpharma SA, Starogard Gdański, Poland. radoslaw.kraciuk@polpharma.comNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

21948307

Citation

Kraciuk, Radosław, and Malgorzata Sznitowska. "Effect of Different Excipients On the Physical Characteristics of Granules and Tablets With Carbamazepine Prepared With Polyethylene Glycol 6000 By Fluidized Hot-melt Granulation (FHMG)." AAPS PharmSciTech, vol. 12, no. 4, 2011, pp. 1241-7.
Kraciuk R, Sznitowska M. Effect of different excipients on the physical characteristics of granules and tablets with carbamazepine prepared with polyethylene glycol 6000 by fluidized hot-melt granulation (FHMG). AAPS PharmSciTech. 2011;12(4):1241-7.
Kraciuk, R., & Sznitowska, M. (2011). Effect of different excipients on the physical characteristics of granules and tablets with carbamazepine prepared with polyethylene glycol 6000 by fluidized hot-melt granulation (FHMG). AAPS PharmSciTech, 12(4), 1241-7. https://doi.org/10.1208/s12249-011-9698-7
Kraciuk R, Sznitowska M. Effect of Different Excipients On the Physical Characteristics of Granules and Tablets With Carbamazepine Prepared With Polyethylene Glycol 6000 By Fluidized Hot-melt Granulation (FHMG). AAPS PharmSciTech. 2011;12(4):1241-7. PubMed PMID: 21948307.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of different excipients on the physical characteristics of granules and tablets with carbamazepine prepared with polyethylene glycol 6000 by fluidized hot-melt granulation (FHMG). AU - Kraciuk,Radosław, AU - Sznitowska,Malgorzata, Y1 - 2011/09/23/ PY - 2011/02/23/received PY - 2011/09/13/accepted PY - 2011/9/28/entrez PY - 2011/9/29/pubmed PY - 2012/3/27/medline SP - 1241 EP - 7 JF - AAPS PharmSciTech JO - AAPS PharmSciTech VL - 12 IS - 4 N2 - The objective of this study was to investigate the properties of granules and tablets with carbamazepine which were prepared employing a fluidized hot-melt granulation (FHMG) technique. The FHMG process was carried out at 65°C. Macrogol 6000 (PEG 6000) was used as a binder at the content 10% (w/w) of the granulated mass. Granules containing up to 70% (w/w) of the drug and 20-90% (w/w) of a filler (lactose, mannitol, calcium hydrogen phosphate (Di-Cafos), pregelatinized starch, and microcrystalline cellulose (MCC)) were produced. When the drug content was 30% (w/w), the yield of the process was satisfying (>95%) and flowability of the granules was better than placebo granules or drug-loaded granules prepared by wet granulation. Type of a filler had strong impact on physical properties of granules, and size distribution of the particles was the most homogenous when lactose or Di-Cafos were used. The FHMG technique enabled preparation of granules with better compressability compared with the wet-granulated product or with non-granulated powders. Tablets with shorter disintegration time than 10 min were obtained with 2.0% crospovidone added as a disintegrant. In comparison to tablets prepared from the wet-granulated mass, employment of the FHMG method resulted in tablets with faster dissolution of carbamazepine (more than 80% of the drug released within 15 min). This was achieved with mannitol or lactose/MCC, as fillers. SN - 1530-9932 UR - https://www.unboundmedicine.com/medline/citation/21948307/Effect_of_different_excipients_on_the_physical_characteristics_of_granules_and_tablets_with_carbamazepine_prepared_with_polyethylene_glycol_6000_by_fluidized_hot_melt_granulation__FHMG__ L2 - https://dx.doi.org/10.1208/s12249-011-9698-7 DB - PRIME DP - Unbound Medicine ER -