Impact of the chemical and physical stability of ketoprofen compounded in various pharmaceutical bases on its topical and transdermal delivery

Increasing demands for individualized drug treatment has led to an increase in the practice of compounded medications. In this study, we determined the impact of the chemical and physical stability of ketoprofen (10%w/w) cream on its topical/transdermal delivery over a 6-month period. The shelf life of ketoprofen at 25 °C in the pharmaceutical bases LipoDerm and LipoBase (109.94 and 85.9 days) was significantly longer than that in Pluronic Lecithin Organogel (PLO; 44.81 days), justifying extending its beyond use date (BUD) from 30 (USP37/NF32) to at least 60 days in LipoDerm and LipoBase. All the creams evaluated exhibited shear-thinning flow behavior with moderate thixotropy, while the flow properties for LipoBase and PLO creams were altered at storage times greater than 90 days. The percentage of ketoprofen permeated through porcine ear skin was 13.7, 19.1 and 12.7% of the dose from LipoDerm, LipoBase and PLO, respectively and decreased 2- to 3-fold after 28 days of storage. Flux ranging from 85.3 to 446.7 µg/cm(2)/h and topical delivery, on the other hand, were not influenced by storage duration past 28 days. In conclusion, this study justifies extending the BUD of ketoprofen in LipoDerm and LipoBase to 60 days if used for topical delivery only.

Medienart:

E-Artikel

Erscheinungsjahr:

2016

Erschienen:

2016

Enthalten in:

Zur Gesamtaufnahme - volume:21

Enthalten in:

Pharmaceutical development and technology - 21(2016), 2 vom: 19. März, Seite 204-13

Sprache:

Englisch

Beteiligte Personen:

Nornoo, Adwoa O [VerfasserIn]
Wulz, Jordan [VerfasserIn]
Yoon, Haena [VerfasserIn]
Nan, Yu [VerfasserIn]
Lese, Michele [VerfasserIn]

Links:

Volltext

Themen:

90Y4QC304K
Gels
Journal Article
Ketoprofen
Lecithins
LipoBase
LipoDerm
PLO
Research Support, Non-U.S. Gov't

Anmerkungen:

Date Completed 18.10.2016

Date Revised 30.12.2016

published: Print-Electronic

Citation Status MEDLINE

doi:

10.3109/10837450.2014.986684

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM243872127