Dexolve™ (SBECD)

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After a precise development work
CycloLab established and validated
the production of pharma grade
Betadex Sulfobutyl Ether Sodium
formulation excipient (SBECD,

DexolveTM) in 2008. This cyclodextrin
is the main component of several commercial formulations worldwide
acting as a solubility and stability
enhancer. A non-comprehensive
list of target APIs are included
in this
Tutorial.
DMF documentations were
filed to the FDA (DMF No.
21922) in 2008 and to
Health Canada (DMF No.
2009-080) in 2009, both
have been maintained
ever since.
In addition, CycloLab is a
registered manufacturer of
the Betadex Sulfobutyl
Ether Sodium in the

EudraGMDP database.

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The facility is dedicated to the
production of SBECD with multiple
tons annual capacity (over 100 kg/batch). Our proprietary technology
is extremely robust, no OOS results
have been obtained after 100
manufactured batches. The
production is carried out according
to cGMP and ISO 9001 and the
product meets all requirements of
the USP-NF.

DexolveTM is used in commercial
and development phases for over
20 APIs by dozens of clients.
CycloLab's business model is free
from license, milestone- and
royalty payments:
inquire today!*
Free sample, reference materials
(by-products, starting materials,
final product) for qualification and
research grade SBECD at a
reduced price are also available!

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* Davos Chemical Company is the exclusive disributor of DexolveTM in North- and South-America, Africa and Australia.

CycloLab is the manufacturer and supplier of USP NF grade DexolveTM, a „generic” Captisol (Betadex Sulfobutyl Ether Sodium, Sulfobutyl ether beta cyclodextrin sodium, SBECD, SBEBCD, SBE), developed and manufactured by CycloLab with a proprietary process under cGMP conditions. This pharma grade cyclodextrin excipient is a general solubility and stability enhancer (via inclusion complex formation) applied in numerous commercial formulations and products under development. Beta-cyclodextrin derivative excipients such as Dexolve are frequently used in pharma and medical formulations with common issues for increasing solubility, stability, bioavailability and preventing aggregation of the APIs, reducing side-effects, taste masking, etc. 


For more information about DexolveTM please see:
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