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Innovative Technologies for the Development and Production of Solid Dosage Forms.

ProCell: Process Characteristics

Process Technology for the manufacture of very high concentrated spherical particles

• Modified fluid bed granulation process
  – in particular performed as melt granulation
  – no inert starting beads required
  – „controlled“ particle movement
• Controlled material circulation through special air flow design
• Special processing chamber design, no bottom sieve

ProCell: Spray Granulation - Mechanism

ProCell: Product Characteristics

• Very high material concentration (up to 100%)
• Particle size range from 50 – 1500 µm
• High density, low porosity
• Particularly suitable for processing of products with inherent stickiness
• Processing of excipients and drug substances

Propels: Ibuprofen 100%

• Mean particle size 300 µm
• High density, low porosity
• Specific surface area ProCell-Ibuprofen:
  d= 300 µm > specific surface = 66,7 mm²/mm³
• Specific surface area commercial reference API:
  d = 30 µm > specific surface = 6666,7 mm²/mm³

ProCell: Case Studies - Ibuprofen 100%

Case Study 1: IR tablet with high drug loading by direct compression

Case Study 2: Modified release film coated Ibuprofen 100% pellets

Case Study 3: Modified release matrix tablets with high drug loading by direct
Case Study 3: compression

Case Study 1A

Objective:
High drug load immediate release tablets manufactured by direct compression, i.e. 90% ProCell-Ibuprofen

• Tablet characteristics
  - Diameter 10 mm
  - Weight 444 mg corresponding to 400 mg API
• Tabletting conditions
  - Fette P1200, 24 stations
  - Output 90’000 units/hour
  - Run time 3 hours

Case Study 1A: Results

• ProCell-Pellets consisting of 100% API may serve as DC grade with good compression properties
• ProCell-Pellets consisting of 100% API permit extraordinary high drug load in the drug product, i.e. reduced tablet weight / tablet size

Case Study 1B

Objective:
Immediate release tablets manufactured by direct compression, i.e. 78%
ProCell-Ibuprofen in a marketed reference formulation (200 mg)

• Tablet characteristics
  - Diameter 8 mm
  - Weight 256 mg corresponding to 200 mg API
• Tabletting conditions
  - Fette P 1200, 24 stations
  - Output 90’000 units/hour
  - Run time 3 hours

Case Study 1B: Results

• ProCell-Ibuprofen consisting of 100% API may serve as valuable API alternative
• An additional granulation step may be omitted

Case Study 2

Objective:
Modified release ProCell-Ibuprofen consisting of 100% API coated with release controlling polymer membrane

• Pellet characteristics
  - Core diameter 200 – 400 µm
• Coating conditions
  - Glatt GPCG 1
  - Wurster processing
  - Coating level: 15, 20 and 25% weight gain

Case Study 2: Results

• Drug release from ProCell-Ibuprofen consisting of 100% API can be controlled with suitable coatings, i.e. modified release, taste masking etc.

Case Study 3

Objective:
High drug load modified release matrix tablets manufactured by direct compression, i.e. ≥ 90% ProCell-Ibuprofen.

• Targeted tablet characteristics

Dosage strengths 600 / 800 mg
Sustained release 12 – 24 hours
Maximum drug load / minimum size

Case Study 3: Results

High drug load modified release matrix tablets manufactured by direct compression, i.e. 96% ProCell-Ibuprofen vs. marketed reference product (66% API).

Case Study 3: Results

• Results demonstrate promising potential of ProCell-Ibuprofen for the development of sustained release products with an extraordinary high drug substance load

Case Study 3: Results

• Results indicate that release profiles can be modified by using
  ProCell-Ibuprofen in combination with suitable excipents (matrix former, disintegrant, solubilizer) maintaining a high drug load in the tablet

Summary / Conclusion

• Results of case studies
  - Good tabletting properties => DC (direct compression) grade 100%
  - Technology enables potential for modified release products
  - Cost efficient manufacturing process of dosage forms
  - Improved product attractiveness due to significant reduction of tablet size
• ProCell Technology offers promising possibilities for drug product development for a wide range of drug substance candidates