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Objectives Improved Tablet  focus on stability  focus on low costs

G&H Meeting 1-2 October, 2002 Montpellier, France WP 7 Pharmaceutics (Lichtwer Pharma). Objectives Improved Tablet  focus on stability  focus on low costs High-End Tablet  maximum dose  controlled release. Improved Tablet. A Comparison . Dragee (Market Standard)

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Objectives Improved Tablet  focus on stability  focus on low costs

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  1. G&H Meeting 1-2 October, 2002 Montpellier, France WP 7 Pharmaceutics (Lichtwer Pharma) • Objectives Improved Tablet focus on stability  focus on low costs High-End Tablet  maximum dose  controlled release

  2. Improved Tablet • AComparison • 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

  3. Improved Tablet Film coated tablets (FCT) vs Dragees 25°C / 60% r.h.

  4. Improved Tablet • Film coated tablets (FCT)vs Dragees 30°C / 70% r.h.

  5. Improved Tablet • Conclusions • 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!

  6. High-End Tablet • Garlic powder combined with a alliin rich extract • 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

  7. High-End Tablet • Garlic powder combined with a alliin rich extract • 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!

  8. Discussion/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?

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