Development of low dose micro-tablets by high shear wet granulation process.

Content uniformity Dose flexibility Drug particle size High shear wet granulation Ibuprofen (PubChem CID: 3672) Micro-dose Micro-tablets

Journal

International journal of pharmaceutics
ISSN: 1873-3476
Titre abrégé: Int J Pharm
Pays: Netherlands
ID NLM: 7804127

Informations de publication

Date de publication:
25 Sep 2020
Historique:
received: 02 05 2020
revised: 17 06 2020
accepted: 20 06 2020
pubmed: 12 7 2020
medline: 22 6 2021
entrez: 12 7 2020
Statut: ppublish

Résumé

Low dose micro-tablets with acceptable quality attributes, specifically content uniformity (CU), would not only enhance the dose flexibility in the clinic, but also decrease excipient burden in pediatric population. Considering the CU challenges associated with directly compressed low dose micro-tablets, in this study, high shear wet granulation (HSWG) process was evaluated to manufacture micro-tablets with reduced CU variability. The impact of active pharmaceutical ingredient (API) particle size (D

Identifiants

pubmed: 32652180
pii: S0378-5173(20)30555-X
doi: 10.1016/j.ijpharm.2020.119571
pii:
doi:

Substances chimiques

Excipients 0
Tablets 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

119571

Informations de copyright

Copyright © 2020 Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Auteurs

Shashwat Gupta (S)

Chemical and Biochemical Engineering, Rutgers University, 98 Brett Road, Piscataway NJ 08854, USA.

Prajwal Thool (P)

Drug Product Development, Bristol Myers Squibb, 181 Passaic Avenue, Summit NJ 07901, USA.

Saikishore Meruva (S)

College of Pharmacy, The University of Iowa, 115 S. Grand Avenue, Iowa City IA 52242, USA.

Jianmin Li (J)

Drug Product Development, Bristol Myers Squibb, 181 Passaic Avenue, Summit NJ 07901, USA.

Jhalak Patel (J)

Drug Product Development, Bristol Myers Squibb, 181 Passaic Avenue, Summit NJ 07901, USA.

Anjali Agrawal (A)

Drug Product Development, Bristol Myers Squibb, 181 Passaic Avenue, Summit NJ 07901, USA.

Shyam Karki (S)

Drug Product Development, Bristol Myers Squibb, 181 Passaic Avenue, Summit NJ 07901, USA.

William Bowen (W)

Drug Product Development, Bristol Myers Squibb, 181 Passaic Avenue, Summit NJ 07901, USA.

Biplob Mitra (B)

Drug Product Development, Bristol Myers Squibb, 181 Passaic Avenue, Summit NJ 07901, USA. Electronic address: biplob.mitra@bms.com.

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Classifications MeSH