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Transcript of CycloLab's Dexolve
Research and Development
LOCATION: Illatos út 7, Budapest, Hungary, H-1097
MAIL ADDRESS: Budapest, P.O.Box 435, H-1525 Hungary
PHONE: 0036-1-347-6060 or -6070
The world's only all-round CYCLODEXTRIN company
CycloLab Ltd. started its life over 25 years ago and initially operated as a small R&D company.
Today the company shares its resources between R&D activity and large scale manufacturing of cyclodextrins under GMP circumstances.
CycloLab committed its operations to serve the pharmaceutical industry by participating in early phase drug development studies (feasibility, formulation optimization, bioequivalence, etc.), analysis and GMP manufacturing of various cyclodextrin derivatives to be applied as excipients.
Cyclodextrin-enabled Product Development
Customization of CD-enabled formulations, life-cycle management.
Method development, validation, routine release testing, consultancy.
Custom Cyclodextrin Synthesis
Exclusive manufacture, unique synthetic routes, self-tailored products and characteristics.
GMP Synthesis and Production
GMP manufacture of cyclodextrins, process validation, regulatory documentation.
Betadex Sulfobutyl Ether Sodium (SBECD), the first of its kind.
DMF has been filed to FDA in 2008, to Health Canada in 2009, both maintained ever since.
Cyclolab is registered as the manufacturer of SBECD in EMA’s EUDRAGMDP database since 2014.
Dexolve is prepared via a self-developed
proprietary, patented technology with a process independent from any existing patents (expires in 2031).
36-month stability data
Successful production of over 100 subsequent USP compliant batches (no OOS result)
Dedicated production facility with a capacity of over 6000 kg/year
120 kg batch size
Quality system compliant to ISO 9001 and GMP requirements
Material has been sold to over 40 clients so far, samples have been provided to over 30 further clients. CycloLab is in regular connection with ~150 further companies directly or via agents who show interest in developing drugs with Dexolve.
CycloLab has three Supply Agreements and several Quality Agreements in place for SBECD, seven further Supply Agreements are under discussion.
Cyclolab asks for No down payment, No milestone payment, No royalty payment.
Running an in-depth analysis on SBECD samples from various manufacturers often reveals impurities and degradation products that do not meet the eye for a regular user and suggest cheap and low purity starting materials and inadequate production process and material handling. This will not show in the laboratory or during formulation, yet probably will have an effect when the formulation is commercially applied. This is an extremely high risk for a final product manufacturer.
CycloLab does not ask for any fees from partners besides the price of the material. The price is negotiable based on volumes and commitments set in Supply Agreements.
Available reference materials:
Bis(4-sulfobutyl) Ether Disodium
Why to choose...
APIs formulated with SBECD
Significant solubility enhancement (10 to 100,000 fold)
Improvement of chemical stability
Increased bioavailability, facilitated delivery
Moderate irritation or reduced side-effects
Maximized patient safety, complete renal elimination
Enables formulation of water-insoluble APIs in all dosage forms
Lower API doses can be achieved
We will never charge you with any down payment, milestone-or royalty payment. However, as a compensation for your Dexolve-purchases you can expect CycloLab:
- the full range of services in your formulation development;
- regular info about the relevant IP situation;
- support in drug registration process.
We trust in cooperation and mutual satisfaction with our customers. In case our partners face difficulties during formulation development we gladly offer our 150+ years of cumulative expertise in cyclodextrin science and application for the fastest resolution. Answers to such issues may be trivial to us, yet really difficult to find for someone not skilled enough in CD applications. This is something noone else in the world can provide.
Voriconazole (Vfend, Voriconazole for injection, injection)
Carfilzomib (Kyprolis, injection)
Amiodarone (Nexterone, infusion)
Ziprasidone (Geodon, injection)
Maropitant (Cerenia, injection, veterinary use)
Aripiprazole (Abilify, injection)
Posaconazole (Noxafil, injection)
Carbamazepine (Carnexiv, injection)
Melphalan (Evomela, injection)
The largest inventory of fine chemical, standard and pharma grade cyclodextrins derivatives from mg to kg scale, maltooligormes, fluorescent tagged cyclodextrins, single isomers, polymers and special HPLC columns for their qualification.
... and many more, including cross-linked and fluorescent-tagged derivatives.
among many single isomer derivatives and...
... and many more, including cross-linked derivatives.
... and many more, including cross-linked derivatives.
Improvement of physical and chemical stability
Reduction of undesirable tastes and odors
Increased solubility in water
Stable aqueous solutions of insoluble compounds
can be prepared without the use of organic
co-solvents or surfactants
Enhanced rate of dissolution
Liquids can be transformed into solid form
Extended release of compounds
Alleviation of local irritations (reduced side-effects)
Incompatible compounds can be mixed and
used together in complexed form
Stabilization of emulsions and suspensions