Pharmaceutical development

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

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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

Your one-stop-shop for hands-on experience, state-of-the-art equipment and the ability to combine and interpret complex results