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

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

  C 303419 vedená u Městského soudu v Praze | IČO 076 19 332|DIČ CZ07619332

*) Důležitá informace: Dovolujeme si sdělit, že naše společnost neposkytuje služby, k jejichž výkonu je třeba zvláštní povolení podle právních předpisů, a to zejména, nikoli však výlučně, poskytování právních služeb, služeb patentových zástupců apod. V případě potřeby jsme připraveni ke spolupráci se subjekty, které příslušnými oprávněními disponují.

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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?

Definice

We help you precisely home in on the problem which requires our expertise

Proposal

We prepare a proposal of the solution including definition of our inputs and expected outputs

Analyses and interpretation

We analyse and interpret the analytical results and discuss our conclusions with you. We mutually agree on the final report and perhaps define next steps

Verification

We verify whether the problem has been successfully solved

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

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