G&H Meeting Sep 29 - Oct 2, 2003
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Study Medication  Time schedule  Résumé Development of an improved tablet formulation PowerPoint PPT Presentation


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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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Study medication time schedule r sum 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


Study medication time schedule r sum development of an improved tablet formulation

Study Medication

Time schedule

  • 7th-8th WeekProduction Verum & Placebo

    7th-8th Week

  • 7th-8th WeekWriting & Authorisation production protocol

    9th-10th Week

  • 9th-10th WeekWriting Randomisation Plan

    12th Week

  • 9th-10th WeekQuality Control Verum & Placebo

    13th Week

  • 10th-11th WeekWriting & Authorisation(!) packaging/labelling

    12th Week

  • 12th WeekPackaging & Labelling

    16th Week

  • 14th WeekFinal Release & Delivery

    22th Week Final Release & Delivery (first part)

    33th Week Final Release & Delivery (second part)


Study medication time schedule r sum development of an improved tablet formulation

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


Study medication time schedule r sum development of an improved tablet formulation

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!


Study medication time schedule r sum development of an improved tablet formulation

Improved Tablet Formulation

Stability of Commercial Products (Dragees)


Study medication time schedule r sum development of an improved tablet formulation

Improved Tablet Formulation

Commercial Products (Dragees)


Study medication time schedule r sum development of an improved tablet formulation

Improved Tablet Formulation

Organic Film Tablets (100 mg)


Study medication time schedule r sum development of an improved tablet formulation

Improved Tablet Formulation

Organic Film Tablets (100 mg)


Study medication time schedule r sum development of an improved tablet formulation

Improved Tablet Formulation

Organic Film Tablets (100 mg)


Study medication time schedule r sum development of an improved tablet formulation

Improved Tablet Formulation

Organic Film Tablets (300 mg)


Study medication time schedule r sum development of an improved tablet formulation

Improved Tablet Formulation

Organic Film Tablets (300 mg)


Study medication time schedule r sum development of an improved tablet formulation

Improved Tablet Formulation

Organic Film Tablets (300 mg)


Study medication time schedule r sum development of an improved tablet formulation

Improved Tablet Formulation

Organic Film Tablets (300 mg)


Study medication time schedule r sum development of an improved tablet formulation

Improved Tablet Formulation

Organic Film Tablets (300 mg)


Study medication time schedule r sum development of an improved tablet formulation

Improved Tablet Formulation

Organic Film Tablets (300 mg)


Study medication time schedule r sum development of an improved tablet formulation

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


Study medication time schedule r sum development of an improved tablet formulation

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)


Study medication time schedule r sum development of an improved tablet formulation

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


Study medication time schedule r sum development of an improved tablet formulation

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


Study medication time schedule r sum development of an improved tablet formulation

Production Scheme

Weighing and Mixing

Tabletting

Coating suspension

Coating

In-Process Controls

Packaging


Study medication time schedule r sum development of an improved tablet formulation

Weighting/Mixing


Study medication time schedule r sum development of an improved tablet formulation

Tabletting


Study medication time schedule r sum development of an improved tablet formulation

Coating Suspension


Study medication time schedule r sum development of an improved tablet formulation

Coating


Study medication time schedule r sum development of an improved tablet formulation

In-Process Control


Study medication time schedule r sum development of an improved tablet formulation

Packaging (Blister)


Study medication time schedule r sum development of an improved tablet formulation

The Team you can trust…

Silvia Striegl

Wolfgang Lüdeke

José Galan-Sousa

Anke Wermann

&

Anja Müller


Study medication time schedule r sum development of an improved tablet formulation

Bianca Beutke

Stability Coordination

The Team you can trust… part II

You can‘t get enough stability!


Study medication time schedule r sum development of an improved tablet formulation

Thank you very much for…

!!!


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