Pharmacy, Cosmetic Chemistry and Biotechnology RESEARCH GROUP
Formulation Technology Section
We develop formulations and manufacturing technologies for medicinal products, medical devices, dietary supplements and foodstuffs for special medical purposes.
CONTACT
PhD. Sc. Eng. Jolanta Janiszewska
phone +48 517 883 174
jolanta.janiszewska@ichp.lukasiewicz.gov.pl
Our modern technological facilities (modernised in 2019) ensure the highest manufacturing standards in accordance with EMA and FDA guidelines. The technology park enables the production of solid forms of investigational medicinal products for clinical trials, including:
- Short series for rare, orphan diseases
- Standard batches for common diseases
- Formulations for bioequivalence studies
- Formulations for pre-clinical studies
Research topics:
- solid forms: tablets, coated tablets, mini-tablets, granules (immediate-release and modified-release preparations, orodispersible tablets)
- hard capsules
- liquid and semi-liquid forms
- ointments, creams, gels,
- eye drops.
Research and implementation offer
- Preliminary examination for patent purity
- Selection and evaluation of raw materials
- Development of technology for the manufacture of medicinal products and dietary supplements in the form of tablets, film-coated tablets, hard capsules.
- Research and implementation offer: direct compression, fluidised bed granulation, high-speed mixing on a laboratory scale (up to 1–2 kg), large laboratory scale (up to 5 kg) and pilot scale (up to 10 kg).
- Technology tests, full range of IPC checks
- Modification and upgrading of formulations to reduce manufacturing costs and improve process efficiency, and solving process problems (bonding, perching, incorrect release profile, unstable formulation, etc.).
- Choice of packaging material
- Accelerated, intermediate and long-term stability tests
- Preparation of registration documentation
Technological facilities
- Pharmatech batch mixer (batch size 10 to 50 kg)
- High-speed granulator (input up to 10 l)
- Fluidised bed dryer (pelletising up to 0.5 kg, drying up to 0.7 kg)
- Shelf dryers (loading up to 5 kg/series)
- Rotary tableting machine, EU-B and EU-D standards (capacity from 600 to 60 000 units/hour)
- FlexaLab automatic capsule machine, formats 0, 1, 2 and 3
- dosing of powders
- dosage of mini-pills
- dosage of powders and mini-pills
- Coater with an input of up to 0.5 kg
- Coater with an input of 2 to 10 kg
- Blistering machine – aluminium and polymer films
Control and measuring equipment
- weight-dryer,
- apparatus for testing hardness, diameter and thickness of tablets,
- tablet disintegration time apparatus,
- tablet abrasion test apparatus,
- bulk density test apparatus,
- apparatus for testing mixture parameters (angle of repose, fluidity),
- microscope equipped with a transmitted and reflected light camera.
