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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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Presentation Transcript
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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

slide2
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)

slide3
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
slide4
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!

slide5
Improved Tablet Formulation

Stability of Commercial Products (Dragees)

slide6
Improved Tablet Formulation

Commercial Products (Dragees)

slide7
Improved Tablet Formulation

Organic Film Tablets (100 mg)

slide8
Improved Tablet Formulation

Organic Film Tablets (100 mg)

slide9
Improved Tablet Formulation

Organic Film Tablets (100 mg)

slide10
Improved Tablet Formulation

Organic Film Tablets (300 mg)

slide11
Improved Tablet Formulation

Organic Film Tablets (300 mg)

slide12
Improved Tablet Formulation

Organic Film Tablets (300 mg)

slide13
Improved Tablet Formulation

Organic Film Tablets (300 mg)

slide14
Improved Tablet Formulation

Organic Film Tablets (300 mg)

slide15
Improved Tablet Formulation

Organic Film Tablets (300 mg)

slide16
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
slide17
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)

slide18
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

slide19
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
slide20
Production Scheme

Weighing and Mixing

Tabletting

Coating suspension

Coating

In-Process Controls

Packaging

slide27
The Team you can trust…

Silvia Striegl

Wolfgang Lüdeke

José Galan-Sousa

Anke Wermann

&

Anja Müller

slide28
Bianca Beutke

Stability Coordination

The Team you can trust… part II

You can‘t get enough stability!

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