CycloLab Cyclodextrin Research & Development Ltd.
E: commerce@cyclolab.hu
W: cyclolab.hu
LinkedIn: https://www.linkedin.com/company/10040240

For more than 30 years, Cyclolab Ltd. has been involved in the development, production and distribution of research- and pharma grade cyclodextrin products for pharmaceutical product development purposes.

MAIN PRODUCTS

Dexolve™
Cyclolab’ key product is Dexolve™: a Sulfobutyl-Betadex Sodium Salt manufactured in multiple tons scale quantity under GMP with a patented technology, complying both to USP NP and EP, with valid USFDA, MFDS, NMPA licenses.

SBECD is a versatile and potent excipient that can significantly improve the solubility, bioavailability, and stability of active pharmaceutical ingredients (APIs) in your products.

We’re so confident in the quality and effectiveness of Dexolve^TM that we offer free samples (10g). Reference materials (by-products, starting materials, final product) are also available for qualification. Take your drug formulations to the next level. Try Dexolve^TM and experience the benefits for yourself!

DIMEB
Cyclolab produces in kilogram-scale a methylated derivative of the beta cyclodextrin: Heptakis(2,6-di-O-methyl)-beta-cyclodextrin, (aka DIMEB), a single isomer with exactly 14 methoxy groups at positions C2 and C6, for extraction and solubilization of cholesterol from lipid bilayers with a unique potential applications in various fields of biotechnology.

SUGAMMADEX IMPURITY STANDARDS & CONTRACT SERVICES

CycloLab has vast experience in the production of Per-6-halogeno-gamma-CD intermediates and has developed Sugammadex via various process routes and related compounds, supported by sensitive analytical tools to characterize the products.

Contract Services

• Synthesis
• Process and formulation development
• Contract analysis
• IP/FTO search and evaluation

Standards

• Process intermediates
• Process impurities

OUR SERVICES

Analytical Services

• New CD-derivatives (on demand)
• Target synthesis
• Stability and release testing
• HPLC / HPLC-MS / GC / CE / UV- / IR- / NMR spectroscopy
• Ion mobility – high-resolution mass spectrometry
• Analytical method development
• Impurity isolation and characterization
• Custom method development
• Isomer / enantiomer separation
• Analysis of CD-API complexes
• Instrumental host-guest affinity determination
• Reaction kinetic studies

Formulation Services

Formulation Development

• Customisation of CD enabled formulations
• From proof of concept studies to pre-clinical phase
• For vet, biotech, food, cosmetics and agriculture

Contract Analysis

• Method-development – validation – release-testing
• Characterisation of CD based formulations from biological matrices consultancy

Custom CD-Synthesis

• New derivatives
• Process development, purification, scale-up
• Tailor-made products for clinical trials under cGMP

AS A CDMO, WE OFFER INTERGRATED SERVICES FOR THE POTENTIAL CUSTOMERS:

• Alkylation and acylation reactions
• Solution preparation (including emulsions, suspensions) under cGMP upto 500 liter
• Spray drying up to 20MT/Y in class ’D’ clean area
• Pressure filtration up to 5 bar
• Tempered storage, with delayed stirring (in qualified cooling chambers)
• Purification steps (charcoal, resin treatment)
• In-house in-process controls in-house (HPLC, MS, GC, UV, DLS, IR, CE, etc.)
• Full release tests according to EP, USP, etc.
• Qualified, modularly applicable clean area ’D’
• Syringe-filling
• Autoclave sterilisation
• Evaporation under vacuum
• Filling of porous materials

 WEBSHOP

CycloLab offers the widest variety of cyclodextrins in our webshop (https://cyclolab.hu/products/) for various purposes (research, analytics, cell cultures, formulation studies, etc).

In addition to “regular” cyclodextrin derivatives, we are keen on developing novel and special types, like maltooligomers, polymers or fluorescent-tagged products. Within the product list, several Sugammadex related compounds are included.