CycloLab's Dexolve

Fine chemicals

portfolio

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.

Octakis(6-deoxy-6-iodo)-gamma-cyclodextrin

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.

For example:

Heptakis(6-deoxy-6-amino)-beta-cyclodextrin heptahydrochloride

among many single isomer derivatives and...

(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.

The world's only all-round CYCLODEXTRIN company

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

R&D

Services

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.

Today the company shares its resources between R&D activity and large scale manufacturing of cyclodextrins under GMP circumstances.

GMP Synthesis and Production

GMP manufacture of cyclodextrins, process validation, regulatory documentation.

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.

Dexolve is

CycloLab's

generic USP-conform

Betadex Sulfobutyl Ether Sodium (SBECD), the first of its kind.

Why to choose...

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?

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

Dexolve?

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.

APIs formulated with SBECD

• 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)

DMF has been filed to FDA in 2008, to Health Canada in 2009, both maintained ever since.

Under development

• Busulfan
• Acetaminophen
• Sertraline
• Cetirizine
• Silymarin
• Prexasertib

• Omeprazole
• Mebendazole
• Allopregnanolone
• Trametinib
• Propofol
• Lamotrigine
• Altiratinib

• Delafloxacin
• Fosphenytoin
• Topiramate
• Budesonide
• Clopidogrel
• Docetaxel
• Meloxicam

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

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 is registered as the manufacturer of SBECD in EMA’s EUDRAGMDP database since 2014.

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.

Available reference materials:

Betadex

SBECD

4-Hydroxybutane-1-sulfonic Acid

Bis(4-sulfobutyl) Ether Disodium

1,4-Butane Sultone

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.

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.