Dexolve

Dexolve
Product Description

Dexolve is the first generic USP and EP-conform Betadex Sulfobutyl Ether Sodium for:• solubility enhancement (10 to 100,000 fold) • Improvement of chemical stability • Increased bioavailability, facilitated delivery • Reduced aggregation • Moderate irritationor reduced side-effects • Maximized safety, complete renal elimination • Enables formulation of water-insoluble APIs in all dosage forms • Lower API doses to be achieved • Maintained DMF TypeIV in US, Canada, China • Prepared via a self-developed proprietary, patented technology with a process independent from any existing patents • 48-month stability data • Successful production of over 150 subsequent USP compl. batches •  No down payment, No milestone payment, No royalty payment • Over 60 APIs in development using Dexolve

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CYCLOLAB Ltd.

  • Country/Region:
    Hungary
  • On CPHI since:
    2019
  • Certificates:
    4
  • Employees:
    50 - 99
Company types
Drug delivery device Supplier/Manufacturer
Primary activities
Contract Research Organisation
Excipients Manufacturer
View company profile
Categories
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Specifications
  • CAS Registry Number
    1824-10-0
  • Supplied from
    Hungary
More specifications Fewer specifications

CYCLOLAB Ltd.

  • Country/Region:
    Hungary
  • On CPHI since:
    2019
  • Certificates:
    4
  • Employees:
    50 - 99
Company types
Drug delivery device Supplier/Manufacturer
Primary activities
Contract Research Organisation
Excipients Manufacturer
View company profile

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CYCLOLAB Ltd. resources (1)

  • Cyclolab Dexolve Presentation

    Brochure Cyclolab Dexolve Presentation

    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.
    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 produ...