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CycloLab's Dexolve

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Mihaly Balint

on 22 May 2017

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Transcript of CycloLab's Dexolve

Fine chemicals
portfolio
Contact
information
CycloLab Cyclodextrin
Research and Development
Laboratory Ltd.

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
FAX: 0036-1-347-6068
E-MAIL: cyclolab@cyclolab.hu
The world's only all-round CYCLODEXTRIN company
25
R&D
GMP
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.
GMP
R&D
Services
Cyclodextrin-enabled Product Development
Customization of CD-enabled formulations, life-cycle management.
Analytical Services
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.
Dexolve is
CycloLab's
generic USP-conform
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:

Betadex

SBECD

4-Hydroxybutane-1-sulfonic Acid



Bis(4-sulfobutyl) Ether Disodium



1,4-Butane Sultone

Why to choose...
APIs formulated with SBECD
Significant solubility enhancement (10 to 100,000 fold)

Improvement of chemical stability

Increased bioavailability, facilitated delivery

Reduced aggregation

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)
Omeprazole
Mebendazole
Allopregnanolone
Trametinib
Propofol
Lamotrigine
Altiratinib
Delafloxacin
Fosphenytoin
Topiramate
Budesonide
Clopidogrel
Docetaxel
Meloxicam
Busulfan
Acetaminophen
Sertraline
Cetirizine
Silymarin
Prexasertib
Under development
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.
(2-hydroxypropyl)-beta-cyclodextrin
Methylated-beta-cyclodextrin
Heptakis(2,3,6-tri-
O
-methyl)-beta-cyclodextrin
Acetyl-beta-cyclodextrin
Carboxymethyl-beta-cyclodextrin
Beta-cyclodextrin phosphate
(2-Hydroxy-3-N,N,N-trimethylamino)propyl-beta-cyclodextrin chloride
... and many more, including cross-linked and fluorescent-tagged derivatives.
For example:
Heptakis(6-deoxy-6-amino)-beta-cyclodextrin heptahydrochloride
among many single isomer derivatives and...
(2-hydroxypropyl)-alpha-cyclodextrin
Methylated-alpha-cyclodextrin
Carboxymethyl-alpha-cyclodextrin
Alpha-cyclodextrin phosphate
... and many more, including cross-linked derivatives.
(2-hydroxypropyl)-gamma-cyclodextrin
Methylated-gamma-cyclodextrin
Gamma-cyclodextrin phosphate
... and many more, including cross-linked derivatives.
Octakis(6-deoxy-6-iodo)-gamma-cyclodextrin
and...
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

Improved wettability

Liquids can be transformed into solid form

Extended release of compounds

Alleviation of local irritations (reduced side-effects)

Enhanced absorption

Incompatible compounds can be mixed and
used together in complexed form

Stabilization of emulsions and suspensions
Cyclodextrins?
Dexolve?
Full transcript