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Drugs oral administration system

Country of Origin: Russia
Reference Number: TORU20180828001
Publication Date: 28 August 2018

Summary

A university from Russia represents the manufacturing technology oral administration system of drugs into the blood. The system is designed for use in combination with drugs that have otherwise low oral bioavailability, meaning almost none of the consumed drug reach bloodstream (e.g. insulin). Industrial pharmaceutical companies are sought as potential partners under the commercial agreement with technical assistance and research cooperation agreements.

Description

The developer of technology is a research institute, which is part of a multidisciplinary university from Russia.
There are a number of drugs with extremely low oral bioavailability. Only insignificant portion of a drug reaches bloodstream when administrated orally. This requires more complex ways of taking the medicine: subcutaneous and intravenous injections. The basis of the developed technology is a unique multicomponent oral administration system of drugs into blood. The chemical composition based on modified chitosan is a nanostructured multi-layered matrix that implements transport and protective functions simultaneously. The composition in gel form inhibits destruction of the medicine it transfers under the influence of proteolytic enzymes of the gastrointestinal tract while absorbing into blood where it gradually decomposes and releases the drug without damaging the liver.
The chemical composition (the drug transport matrix) has been developed at the present moment. The structure obtained has been studied and the possibility of transferring various drugs has been determined. The primary tests on bioavailability of insulin were carried out. Based on the results of preliminary tests of the new drug on small lab animals, bioavailability of insulin with oral administration of the new drug is 20-25%.
First of all, an independent test on bioavailability of the transferred medicines (on large lab animals in particular) and development of the reproducibility of substances are necessary for the further development of the project, after which it is possible to conduct preclinical trials of the drug.
Developers consider joint research and development. In this case, developers take on the task of developing the technology of the required drug. The tasks of conducting bioavailability tests by GMP standards and further preclinical trials remain for the partners.

Under the commercial agreement with technical assistance the developers consider the sale of rights on technology, as there are no sufficient capacities at their disposal to do further research and for develop the product to its final form. Developers are ready to provide any necessary assistance – installation and setup of technology, personnel training etc.
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Advantages and Innovations

The developed system allows partial or complete replacement of injections with an oral pill, which is more convenient and not painful way to administer a drug. The unique chitosan-based multilayered complex protects carried drug from the destructive effect of the acidic environment of the gastric tract and allows it to stick to and penetrate through intestinal walls. Bioavailability of the drug reaches 20% even without the use of capsules that protect against gastric acids.
One of the innovations is the alternation of drug-containing layers and protective layers around the core in the matrix. Innovations concerning the core of the matrix, which allows a complex to be absorbed in the intestine, are currently know-how secrets and cannot be disclosed. The technology of production has the ability to control release time of carried drugs, giving the opportunity for the individual approach to treatment.

Stage Of Development

Under development/lab tested

Stage Of Development Comment

Oral administration system in combination with insulin, as well as biodegradation and biocompatibility of developed system were tested on small lab animals. Studies have shown that product is not toxic and significantly increases oral bioavailability of insulin. The gel containing insulin for oral administration is available for demonstration. Studies are underway to verify compatibility of the system with other drugs and with human blood coagulation factors in particular (factor VIII, factor IX, von Willebrand factor).

Requested partner

Pharmaceutical companies are sought for buying of technology rights under the commercial agreement with technical assistance.
Joint research and development with pharmaceutical companies and research centers are considered as well, need the independent tests under EU standards.

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