Publication Alert March 2021

Bioavailability & Solubility Special Edition: Replacing Outdated Inactives With Cyclodextrins in Parenteral Formulations

CycloLab Cyclodextrin Research & Development Ltd.
W: https://cyclolab.hu/ or https://cyclodextrinnews.com/
E: info@cyclolab.hu
LinkedIn: https://www.linkedin.com/company/10040240

The World’s Only All-Round Cyclodextrin Company

CycloLab Cyclodextrin Research and Development Ltd. is a private SME with the focus on cyclodextrin research and development for over 30 years. CycloLab has four main activities:

1. Cyclolab Ltd. manufactures Dexolve^TM (Sulfobutylether Beta-Cyclodextrin: SBECD, https://cyclolab.hu/dexolve/) in multiple ton scale under cGMP conditions based on an FDA-approved Drug Master File. Dexolve is a potent general solubilizer and stabilizer excipient, compatible with any kinds of administration routes and dosage forms. Cyclolab offers free feasibility study (https://cyclolab.hu/feasibility/) with molecules to support cyclodextrin-based formulation development and free samples. Benefits of the application of Dexolve^TM:

• Significant chemical stability and solubility enhancement (10 to 100,000 fold)
• Increased bioavailability, facilitated delivery
• Reduced aggregation
• Maximized patient safety, complete renal elimination

2. As an R&D company, we develop next generation proprietary cyclodextrins and explore potential applications as well. These are focused in several areas such as evaluating cyclodextrins:

• as excipients in new areas like protein stabilization and non-viral gene delivery, fermentation and enzymatic processes, serum free culture media
• creating selective and targeted drug delivery systems (targeted cancer treatment, BBB permeation, controlled release)
• evaluation of cyclodextrins as API candidates for CNS diseases, infections, antidotes and other conditions
• develop innovative and added-value (505b2) formulations with small molecules

For these activities we seek collaboration, contractual and licensing partners.

3. CycloLab operates as a CRO for cyclodextrin related services including:

• development of products (pharma, veterinary, cosmetic, food, agricultural industries) – formulation development, optimization, characterization, in vitro bioequivalence studies
• offering custom synthesis of cyclodextrins, fine-tailored for certain guest molecules or purposes. Cyclolab also has a Grant to support creating cyclodextrin-based NCE development (https://cyclolab.hu/grant/ )
• performing cGMP compliant manufacturing of cyclodextrins to be used as APIs or excipients in clinical studies or cyclodextrin enabled formulations for the same purpose that are not available in suitable grades globally
• all analytical tasks related to the above, under GMP (method development, validation, stability studies for formulation ingredients (APIs, cyclodextrins) and final products) as well.

4. CycloLab offers the widest variety of cyclodextrins in various grades (pharma, standard, fine chemical) in our webshop (https://cyclolab.hu/products/) for various purposes (research, analytics, cell cultures, formulation studies, etc). Besides “regular” cyclodextrin derivatives, we are keen on developing novel and special types, like maltooligomers, polymers or fluorescent-tagged products. Within the product list, several Sugammadex related compounds are included.