Innovative Continuous Manufacturing: Wet Granulation of High-Dose Drug Formulations Without Subsequent Drying

See the presentation of Lukas Ries from BASF at the 6th APV Continuous Manufacturing Conference 2025:

Conventional wet granulation requires the addition and removal of a granulation liquid. The process has several disadvantages.

Conceptual idea:

Making use of in-situ released crystal water from potassium sodium tartrate (PST) as granulation liquid

Kollitab® PST

Potassium sodium tartrate tetrahydrate
Salt of tartaric acid

Regulatory status

Food (E 337): 240 mg/kg/day
Pharma: 20 to 30 g/day
Monographs: PhEur, BP, USP, …

Chemical structure

Appearance

Whitish crystals
Odourless
Solubility: 630 g/L (H2O, 25°C)
Melting temperature: 70 to 80°C

Differential Scanning Calorimentry (DSC)

Prove of concept:

Case study on Paracetamol (APAP) & Metformin HCl (MET)

Case study formulation (internal phase)

API (APAP/ MET) incl. fumed silica 0.8 % / 0.4%) 80%
Kollitab® PST 15% (Potassium sodium tartrate tetrahydrate)
Kollidon® 305% (Poly(vinyl pyrrolidone) K 30)

Equipment & process parameters

ThermoFisherPharma 11(Twin-screw extruder)
Feed rate600, 800g/h
Screw speed100rpm
Barrel temperature100°C

➢ Sucessful granulation with the Kollitab® PST-granulation method for both APIs

Tableting formulation

Equipment

STYL’One Evolution (Compaction simulator)

Compression

Force 7 to 28 kN
Pressure 60 to 250 MPa

Tablet

Round-shaped, flat
Diametes 12 mm
Mass 500 mg API

Summary

Benefits of a continuous wet granulation process, not requiring a drying step

Enabling excipient: Kollitab® PST

Potassium sodium tartrate tetrahydrate
Monographed excipient (high daily intake)

Formulation benefits

Vegan, bio-based, derived from renewable resources
Substitution of regular fillers
Excellent tabletting characteristics
Low moisture exposure (process, drug product)

Intellectual property

Process and application patent filed

Processing benefits

Energy consumption (sustainability: reduced CO2footprint)
Equipment footprint (investment, depletion, maintenance)
Losses of active ingredient (carryover, fluid bed processing)
Quality Assurance expenses (batch size advantages)
Risk of failure (development and manufacturing)

See the presentation slides on Innovative Continuous Manufacturing here

(click the picture to download the brochure)

Source: BASF speech Innovative Continuous Manufacturing at 6th APV Continuous Manufacturing Conference 2025

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Innovative Continuous Manufacturing: Wet Granulation of High-Dose Drug Formulations Without Subsequent Drying

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