objectives improved tablet focus on stability focus on low costs high-end tablet maximum…
DESCRIPTION
Improved Tablet Improved Tablet Film coated tablets (FCT) vs Dragees 25°C / 60% r.h.TRANSCRIPT
Objectives
Improved Tablet focus on stability focus on low
costs
High-End Tablet maximum dose controlled release
G&H Meeting 1-2 October, 2002G&H Meeting 1-2 October, 2002Montpellier, FranceMontpellier, FranceWP 7 Pharmaceutics (Lichtwer Pharma)WP 7 Pharmaceutics (Lichtwer Pharma)
Improved TabletImproved Tablet
A Comparison
Dragee (Market Standard) 300 mg Garlic powder 15 – 20 Excipients Production time: 24 h
Film coated tablet 300 mg Garlic powder 7-8 Excipients (pre dried) Production time: 8 h
Improved TabletImproved Tablet
50
60
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110
0 3 6 9 12 15 18 21 24
FCT - blisterFCT freeze dried garlic - blisterFCT - HDPE bottleFCT freeze dried garlic - HDPE bottle Dragee - HDPE bottle
[%]
Months
Stability of 100 mg film coated tablets
Film coated tablets (FCT) vs Dragees25°C / 60% r.h.
Improved TabletImproved Tablet Film coated tablets (FCT) vs Dragees
30
40
50
60
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100
110
0 3 6 9 12 15 18 21 24
Film coated tablet
Film coated tablet freeze dried garlic
Dragee (market standard)
Alli
cin
Rel
ease
%
Months
Stability of 100 mg film coated tablets (HDPE Bottles)
30°C / 70% r.h.
Improved TabletImproved Tablet
Dragees produced by a water based sugar-coating process are a non suitable galenic formulation when pharmaceutical stability demands must be met
100% water vapour resistant packaging is necessary (HDPE/Glas bottles)
No kind of transparent polymer blister quality provide sufficient protection
Significant improvement in stability for film coated tablets – meeting international pharmaceutical standards!
Conclusions
High-End TabletHigh-End Tablet
Laboratory experiments to gain a alliin enriched extract were successful
4-5 fold enrichment of alliin (up to 7%) without transformation to allicin by a economic single-step extraction procedure
Extract seems to be suitable for direct use for production (“crystalline like” – not sticky)
Technical production – open
Garlic powder combined with a alliin rich extract
High-End TabletHigh-End Tablet
Development of a slow release matrix tablet – open Additional development time of 9-15 months
necessary (only with orientation stability data) – End of the project in Jan 2004!
Garlic powder combined with a alliin rich extract
Discussion/SuggestionsDiscussion/Suggestions
Use of film coated tablets for clinical trials Should the film provide a gastric acid protection?
Guarantee of allicin release in the duodenum High-End tablets as a possible target of Lichtwer’s
project activities?! – not for the human intervention study (HIS) of the project
Appointment in Leiden – discussing details of HIS?