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

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

karel@kapaji.eu, pavel@kapaji.eu, jiri@kapaji.eu, or kapaji@kapaji.eu

Kapaji s.r.o. | Litevská 1174/8 | 100 00 Prague 10 – Vršovice

  C 303419 registerd in Municipal Court in Prague | VAT CZ07619332

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