Analysis of available surface area can predict the long-term dissolution profile of tablets using short-term stability studies.
Available surface area
Dissolution model
Long-term stability
Solid dosage form
Journal
International journal of pharmaceutics
ISSN: 1873-3476
Titre abrégé: Int J Pharm
Pays: Netherlands
ID NLM: 7804127
Informations de publication
Date de publication:
30 Aug 2020
30 Aug 2020
Historique:
received:
27
02
2020
revised:
24
05
2020
accepted:
01
06
2020
pubmed:
9
6
2020
medline:
4
3
2021
entrez:
8
6
2020
Statut:
ppublish
Résumé
Generally, since at least 6 months are usually needed for accelerated testing of tablet at 40 °C/75% relative humidity (RH), it would be crucial important to predict the dissolution profiles during long-term storage period by using samples stored with shorter periods such as 3 months. In this study, we developed a new method for predicting changes in dissolution from tablets during long-term storage-based changes in the available surface area [S (t)]. In addition, we discussed the dissolution behavior and mechanisms using S (t). The results revealed drastic delays in dissolution in samples stored at 40 °C/75% RH for 7 weeks. Considering changes of S (t) patterns, this delay was derived from changes of the tablet surface. New parameters, namely T
Identifiants
pubmed: 32505576
pii: S0378-5173(20)30488-9
doi: 10.1016/j.ijpharm.2020.119504
pii:
doi:
Substances chimiques
Butyrophenones
0
Piperidines
0
Tablets
0
ebastine
TQD7Q784P1
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
119504Informations 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.