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Improved Tablet  Focus on stability  Focus on reasonable production

G&H Meeting 18-20 February, 2003 Liverpool, UK WP 7 Pharmaceutics (Lichtwer Pharma). Objectives…. Improved Tablet  Focus on stability  Focus on reasonable production  Focus on packaging material High-End Tablet  Vision?! Study Medication  Focus on time line

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Improved Tablet  Focus on stability  Focus on reasonable production

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  1. G&H Meeting 18-20 February, 2003 Liverpool, UK WP 7 Pharmaceutics (Lichtwer Pharma) • Objectives… Improved Tablet Focus on stability  Focus on reasonable production  Focus on packaging material High-End Tablet  Vision?! Study Medication  Focus on time line  Focus on GCP compliance

  2. Improved Tablet • Comparing… • Dragee (Market Standard) • 300 mg Garlic powder • Higher amounts of excipients • Coating time: up to 15 h • Total process time: up to 24 h • Novel film coated tablet • 300 mg Garlic powder • Less amounts of excipients (pre dried) • Coating time:  up to 5 h • Total process time: up to 14 h • Advantages of a film tablet… • Size (Compliance) • Costs for Excipients • Costs for Production (time)

  3. Improved stabile Tablet • Details on Stability Study • Full ICH-guideline compliance • Tests under GMP conditions with validated methods • Three production batches providing a minimum of 100.000 tablets per batch • Three different controlled climatic zones • Up to seven different packaging materials • PVC-, PVDC, COC-Aluminium blister • Two different kinds of Alu-Alu blisters • PE-, and glass bottles • Two different dosage forms • 100 mg and 300 mg Tablets • Estimated full costs for the study: 160 k€

  4. Improved Tablet Dragees (Commercial Products) 25°C/60% and 40°C/75% Commercial products are insufficient !!!

  5. Improved Tablet Comparison Powder/Dragees 25 °C / 60% r.h. Proof that commercial tablet formulations are sub optimal

  6. Improved Tablet • Comparing… Commercial Dragee vs. Novel Film Tablet • Dragee • 300 mg Garlic powder • 117 mg Lactose monohydrate • 9 mg Cellulose • 5 mg Silicium dioxide • 3 mg Mg Stearate • 224 mg Saccharose • 46 mg Talcum • 22 mg HPMC (mod. Cellulose) • 9 mg Castor oil, native • 5 mg Polyethylenglycol • 5 mg Polyvinylpyrrolidon • 2 mg Silicium dioxide • 2 mg Gelatine • 1 mg Montan glycol wax • 750 mg Total Weight • Novel film coated tablet • 300 mg Garlic powder • 117 mg microcristalline Cellulose • 24 mg Lactose, anhydrous • 10 mg Cellulose • 5 mg Silicium dioxide • 6 mg Soy polysaccharides • 3 mg Triglycerides • 25 mg HPMC (mod. Cellulose) • 5 mg Talcum • 4 mg Titan dioxide • 1 mg Carnauba wax • 500 mg Total Weight

  7. Improved Tablet Comparison Tablets with lyophilisised/non lyophilisised Powder/Dragees 25 °C / 60% r.h. Improvement of Stability of at least >100%

  8. Improved Tablet Comparison Packaging Material 25 °C / 60% r.h.

  9. Improved Tablet Comparison Packaging Material 30 °C / 70% r.h.

  10. Improved Tablet Comparison Packaging Material 40 °C / 75% r.h. • Conclusion • at least 24 months stability available • countries with difficult climatic conditions included!

  11. Improved Tablet Comparison Packaging Material 25 °C / 75% r.h. – 300 mg Tablets

  12. Improved Tablet Comparison Packaging Material 30 °C / 70% r.h. – 300 mg Tablets

  13. Improved Tablet Comparison Packaging Material 40 °C / 75% r.h. – 300 mg Tablets

  14. Improved Tablet Comparison Blister Material 25 °C / 60% r.h. – 300 mg Tablets

  15. Improved Tablet • Conclusion • Sugar coated tablets are not suitable to meet the high international standards of pharmaceutical stability • No kind of transparent polymer blister quality provide sufficient protection • A strict dry formulation (ingredients and process) combined with… • a 100% water vapour resistant packaging …are indispensable

  16. 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%in total) without transformation to allicin by an economic single-step extraction procedure • Extract seems to be suitable for direct use for production (“crystalline like” – not sticky) • Scale up experiments – still open

  17. High-End Tablet • Garlic powder combined with an alliin rich extract • Development of a slow release matrix tablet – open • Additional development time of 9-15 months is necessary (only with orientating stability data) • Realisation: not really realistic – see end of the project in Jan 2004!

  18. Study medication Human Intervention Study • Three arm study – double blind performing a double dummy design • Verum: Garlic powder tabletsReference: Statin medication (Cholesterol- Synthesis-InhibitorPlacebo: for Garlic tablets and for statin medication • 30 Volunteers in each group; 2100 mg garlic powder a day; Treatment over 100 days • Medication produced and packed under GMP

  19. Tablet core Gastric resistant film Sugar coating Improved Tablet • Formulation – Study medication • “Film-Dragee” • 300 mg Garlic powder • 187 mg Lactose anhydrous • 25 mg Cellulose • 4 mg Silicium dioxide • 4 mg Mg Stearate • ca. 40 mg Methacrylic acid copolymer • ca. 10 mg Citric acid • ca. 5 mg Talcum • 224 mg Saccharose • 46 mg Talcum • 5 mg Polyethylenglycol • 5 mg Polyvinylpyrrolidon • 2 mg Silicium dioxide • 2 mg Gelatine • 1 mg Montan glycol wax • Ca. 800 mg Total weight

  20. Study medication Human Intervention Study • Verum: Tablet design Gastric Fluid Resistant Coating Sugar Coating Tablet Core „Dragee“

  21. Study medication Time schedule • 7th-8th Week Production Verum & Placebo • 7th-8th Week Writing & Authorisation production protocol • 9th-10th Week Writing Randomisation Plan • 9th-10th Week Quality Control Verum & Placebo • 10th-11th Week Writing & Authorisation packaging/ labelling • 12th Week Packaging & Labelling • 13th-14th Week Final Release & Delivery

  22. Anybody who fell asleep? Thanks for listening!!! Fine!

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