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,
Dexolve^TM) 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.

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.

Dexolve^TM 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!

CycloLab is the manufacturer and supplier of USP NF grade Dexolve^TM, (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 Dexolve^TM please see:

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Dexolve™ (SBECD)

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