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Study Medication  Time schedule  Résumé Development of an improved tablet formulation

G&H Meeting Sep 29 - Oct 2, 2003 Munich, Germany WP 7 Pharmaceutics (Lichtwer Pharma). Objectives…. Study Medication  Time schedule  Résumé Development of an improved tablet formulation  Long term stability  Reasonable production conditions  Focus on packaging material.

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Study Medication  Time schedule  Résumé Development of an improved tablet formulation

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  1. G&H Meeting Sep 29 - Oct 2, 2003 Munich, Germany WP 7 Pharmaceutics (Lichtwer Pharma) • Objectives… Study Medication  Time schedule  Résumé Development of an improved tablet formulation  Long term stability  Reasonable production conditions  Focus on packaging material

  2. Study Medication Time schedule • 7th-8th Week Production Verum & Placebo 7th-8th Week • 7th-8th Week Writing & Authorisation production protocol 9th-10th Week • 9th-10th Week Writing Randomisation Plan 12th Week • 9th-10th Week Quality Control Verum & Placebo 13th Week • 10th-11th Week Writing & Authorisation(!) packaging/labelling 12th Week • 12th Week Packaging & Labelling 16th Week • 14th Week Final Release & Delivery 22th Week Final Release & Delivery (first part) 33th Week Final Release & Delivery (second part)

  3. Study Medication • Résumé… • Tabletting: Difficulties with the flowability and compressibility of the EU garlic powder • Coating: Everything went fine… • Sugar Coating: Everything went fine… • Release: Full compliance with specifications! • GCP: Minor deviations

  4. Improved Tablet Formulation Details on Stability Studies Ongoing Studies Organic film based • Full compliance to ICH-guidelines • Up to seven different packaging materials • Two different dosage forms Aqueous film based • Reformulation of tablet core • Formulation of coating • Establishing aqueous coating procedure New Studies!

  5. Improved Tablet Formulation Stability of Commercial Products (Dragees)

  6. Improved Tablet Formulation Commercial Products (Dragees)

  7. Improved Tablet Formulation Organic Film Tablets (100 mg)

  8. Improved Tablet Formulation Organic Film Tablets (100 mg)

  9. Improved Tablet Formulation Organic Film Tablets (100 mg)

  10. Improved Tablet Formulation Organic Film Tablets (300 mg)

  11. Improved Tablet Formulation Organic Film Tablets (300 mg)

  12. Improved Tablet Formulation Organic Film Tablets (300 mg)

  13. Improved Tablet Formulation Organic Film Tablets (300 mg)

  14. Improved Tablet Formulation Organic Film Tablets (300 mg)

  15. Improved Tablet Formulation Organic Film Tablets (300 mg)

  16. Improved Tablet Formulation • Conclusion Organic Coated Film Tablet I • It is possible to prolong shelf life up to 4 times when… • the residual humidity of the tablets is limited to 3,5 – 4 % • a strictly humidity controlled coating procedure is applied • a packaging material providing a 100% humidity barrier is used • It is possible to produce the improved tablets in an economic way (e.g. no freeze drying necessary!) • Concerning the high demands on the water barrier there is no sufficient polymer blister material available

  17. Improved Tablet Formulation • Conclusion Organic Coated Film Tablet II • Further optimisation is possible to solve… … the poor disintegration time of the 300 mg tablets from up to 45 min to < 30 min … poor robustness of the formulation concerning high speed tabletting … residual organic solvent problem (film coating)

  18. Improved Tablet Formulation • Transforming… an organic film coated tablet into… an aqueous film coated tablet! • Why? More flexible production process No organic solvents necessary Adaptable at Lichtwer’s Facilities

  19. Improved Tablet Formulation • Overview Status Aqueous Coated Tablets • Three production scale batches according ICH-Guidelines have been manufactured successfully in Aug 2003 • The residual water content of the tablets are 2.6 to 2.8% (limit: 3.5%) • The batches have been packed in PE bottles and COC300 Blister (Alu/Alu blister coming up next) • The batches are stored under 25°C/60%, 30°C/65%, and 40°C/75% conditions

  20. Production Scheme Weighing and Mixing Tabletting Coating suspension Coating In-Process Controls Packaging

  21. Weighting/Mixing

  22. Tabletting

  23. Coating Suspension

  24. Coating

  25. In-Process Control

  26. Packaging (Blister)

  27. The Team you can trust… Silvia Striegl Wolfgang Lüdeke José Galan-Sousa Anke Wermann & Anja Müller

  28. Bianca Beutke Stability Coordination The Team you can trust… part II You can‘t get enough stability!

  29. Thank you very much for… !!!

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