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, to Health Canada (DMF
No. 2009-080) in 2009 and to China
CDE in 2019 (No.
F20190000489),
all 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 350 kg/batch). Our proprietary technology
is extremely robust, no OOS results
have been obtained after 150
manufactured batches. The
production is carried out according
to cGMP (
OGYÉI-57792-7/2018) and
ISO 9001 and the product meets all requirements of the USP-NF and EP.

DexolveTM is used in commercial
and development phases for over
50 APIs by over 100 client.
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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CycloLab is the manufacturer and supplier of USP NF grade DexolveTM,  (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: Links on the page:
 

Dexolve free sample form

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