Influence of granulation temperature on particle size distribution of granules in twin-screw granulation (TSG).


Journal

Pharmaceutical development and technology
ISSN: 1097-9867
Titre abrégé: Pharm Dev Technol
Pays: England
ID NLM: 9610932

Informations de publication

Date de publication:
Sep 2019
Historique:
pubmed: 7 6 2019
medline: 4 12 2019
entrez: 7 6 2019
Statut: ppublish

Résumé

This study investigated an influence of granulation temperature during twin-screw granulation (TSG) on particle size distributions (PSDs). The influence of the granulation temperature on granule size distributions varied, depending on the liquid to solid (L/S) ratio, the kind of binders, the method of binder addition, and the filler material. The PSD of granules was broad and bimodal at a barrel temperature of 30 °C. Granules size distributions became narrow and second height decreased at high barrel temperature. While the L/S ratio had an effect on the sharpness of granule size distributions, this effect was minor compared to the granulation temperature. Granule size distributions were influenced by binder addition methods. When the binder was added as solution, PSD became broad. In formulations using lactose as filler, PSD became broad and bimodal at 90 °C. Much lactose was dissolved in granulation solution at high temperature, because the solubility of lactose rises significantly with the solution temperature leading to higher effective L/S ratio in the granulator. Hence, granulation was proceeded and large granules were formed. From these results, the granulation temperature is one of important parameters to obtain mono-modal PSD in TSG.

Identifiants

pubmed: 31169439
doi: 10.1080/10837450.2019.1615089
doi:

Substances chimiques

Excipients 0
Tablets 0
Acetaminophen 362O9ITL9D

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

874-882

Auteurs

Akihiko Ito (A)

a Nihongi Factory , Nippon soda Co., Ltd ., Niigata , Japan.

Peter Kleinebudde (P)

b Institute of Pharmaceutics and Biopharmaceutics , Heinrich Heine University , Dusseldorf , Germany.

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Classifications MeSH