Support of pharmaceutical development and production
Do you need hands-on experts with state-of-the art equipment to support your pharma development and production?
API solid form
You need
Deal with IP restrictions
Improved bioavailability
Stable amorphous form
Stable “metastable” form
Targeted API properties (PSD, …)
Crystallisation scale-up
…
We offer
Solid form screening (polymorphs, salts,
co-crystals, solvates)
Polymorph investigation
Solubilisation of poorly soluble APIs
Amorph stabilisation by polymers, small molecules, particle loading
Chemical engineering approach to crystallisation development
…
API characterization
You need
Fully characterise the API
Select API solid form
Understand stability issues
Understand in vitro behaviour
Solve agglomeration, sticking, …
API suppliers in-depth comparison
API batch-to-batch variability
Understand out-of-specs results
…
We offer
Molecular structure and properties
API solid state form properties
Powder properties
Standard and advanced in vitro testing
Impurity identification and degradation mechanisms
API form selection based on physicochemical properties
…
Intermediates
You need
Understand granule inner structure
Investigate flowability, elasticity, plasticity, sticking, ...
Investigate surface energy and composition
Understand process parameters
critical for in vitro release
Understand sensitivity to humidity
Solve transfer and scale-up issues
…
We offer
Intermediate characterisation
Hygroscopicity testing
Surface properties
Creation of 2D/3D models of inner structure
Disintegration behaviour study
Stress testing
Advanced in vitro testing
…
Drug products
You need
Minimise in vivo testing risks
Solve out-of-specs results
Understand disintegration
Understand effect of packaging
Drug product troubleshooting
Understand degradation
Understand original or competitor product for Gx or LCM development
…
We offer
Drug product reverse engineering
Standard and advanced characterisation
Drug product hygroscopicity
Standard and advanced in vitro testing
Disintegration mechanism study
Stress testing and impurity identification
Critical quality attributes identification
…
Solid dosage form preformulation
Method development
Troubleshooting
Root-cause analysis
Prof. František Štěpánek
University of Chemical Technology
Scientific Director of The Parc
Owner of Chobotix
Prague
Pavel Calta is a true professional who combines technical expertise with a clear focus on strategic goals and the ability to energise people by a friendly, no-nonsense approach. It has been an honour to work together with Pavel on the creation of The Parc, a unique industry–academia partnership for applied pharmaceutical research