University of Malta
 

Co-Crystal Drugs
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Co-Crystal Drugs
Project Number: KD01LVZ

 

The Invention 

Beclomethasone is a corticosteroid which prevents the release of substances in the body that cause inflammation. It is primarily used to prevent and control symptoms (wheezing and shortness of breath) caused by asthma by inhalation. It can also be used as a cream or ointment for inflammatory skin disorders. The invention relates to the introduction of a guest molecule into the Beclomethasone crystal structure, which alters its physical properties without interacting with or altering the active pharmaceutical ingredient (API).



Novelty 

Creating co-crystal forms of drugs is relatively new and does not change the application or the chemical properties of the API. However, it enables pharmaceutical companies to create new and improved formulations for products, because:

  • The API becomes soluble in water, which is safer for human consumption (reduces irritation and side effects) and the environment 
  • The API has increased solubility in media other than water
  • Increased solubility leads to increased bioavailability, improving the effectiveness of the API
  • Increased bioavailability of the API means less API is required to manufacture end product
 

Applications / Industries

The licensee can gain an edge over competing products by introducing new formulations for existing products which are safer and more effective.

If the licensee can show equivalence in the lab, additional FDA testing is not required to create new formulations and market new products. The University of Malta can provide data showing the difference in solubility between the pure API and the co-crystallised form. In addition, guest molecules are taken from list of chemicals ‘generally regarded as safe for use in the body’.

Such new forms may also extend patent lifetime for a drug.

 

Development Status

A method for synthesizing the co-crystal form of the API beclomethasone has been developed and can be applied directly in industrial processes.

Additional drugs are in the development pipeline. 

 

Intellectual Property Status 

A patent application (no. GB 1604125.3) was filed in UK by the University of Malta in March 2016. The application relates specifically to the beclomethasone co-crystal form. 

 

Commercial Interest

We are looking for potential licencees to license the rights to using the beclomethasone co-crystal form. We are also interested in hearing from companies and researchers who would like to develop new crystal forms of drugs and other materials.

 

Lead Originator & Relevant Publications


Baisch, U. & Vella-Zarb, L. 2014, "Towards understanding P-gp resistance: a case study of the antitumour drug cabazitaxel", CrystEngComm, vol. 16, no. 44 (Cover Page Illustration), pp. 10151-10322.

Harriss, B.I., Vella-Zarb, L., Wilson, C. & Evans, I.R. 2014, "Furosemide Cocrystals: Structures, Hydrogen Bonding and Implications for Properties", Crystal Growth & Design, vol. 14, pp. 783-791.

Vella-zarb, L., Baisch, U. & Dinnebier, R.E. 2013, "Small molecule, big difference: The role of water in the crystallization of paclitaxel", Journal of pharmaceutical sciences, vol. 102, no. 2, pp. 674-683.

Vella-Zarb, L., Dinnebier, R.E. & Baisch, U. 2013, "The Devil is in the Detail: A Rare H-Bonding Motif in New Forms of Docetaxel", Crystal Growth & Design, vol. 13, no. 10, pp. 4402-4410.

Vella-Zarb, L. & Dinnebier, R.E. 2012, "Form, function and functionality of two dimeric toluene-2, 4-diisocyanate polymorphs", Acta Crystallographica Section B: Structural Science, vol. 68, no. 2, pp. 204-208.


 

Download summary [PDF]

 

Interested? Contact Michelle Cortis or the Knowledge Transfer Office.
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Last Updated: 6 July 2017

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