Gateway for:

Member Countries

Acetylsalicylic acid as soluble tablets

#3165


Realization of Pharmacological Tests, Development of the Specifications and Technical Documentation and Registration in the Russian Federation of Medical Products as Soluble Tablets of Acetylsalicylic Acid/Calcium Carbonate in Two Dosages Intended for use

Tech Area / Field

  • MED-OTH/Other/Medicine

Status
3 Approved without Funding

Registration date
30.11.2004

Leading Institute
Siberian Branch of RAS / Institute of Solid State Chemistry and Mechanochemistry, Russia, Novosibirsk reg., Novosibirsk

Supporting institutes

  • JSC Biochimmash, Russia, Moscow

Collaborators

  • Groton Laboratories / Pfizer Inc., USA, CT, Groton\nBoram Pharm. Co., Ltd, Korea, Ansan-si

Project summary

The project purpose: 1) Realization of pharmacological tests, development of the specifications and technical documentation and registration in the Russian Federation of medical products as soluble tablets of acetylsalicylic acid / calcium carbonate in two dosages intended for use as medical products pain-allaying, febrifugal and antiaggregation action, 2) development of tabletting technology of the above-stated preparations.

The overview: Soluble acetylsalicylic acid medicinal forms are known to have greater efficiency and safety in application. However their essential lack is high cost of manufacture, surplus of auxiliary substances, in case of "effervescent" tablets reaching 3-3,5 g, plentiful gas evolution at dissolution and impossibility of tablets reception by direct swallowing without preliminary dissolution.

The Institute of Solid State Chemistry of the Siberian Branch of the Russian Academy of Science developed the original technology of producing fast soluble solid disperse systems (as powders) of acetylsalicylic acid and metals carbonates. The spectrum of laboratory samples of soluble tablets, granules and powders different in combination of carbonates, additives and in a dosage, practically providing all possible applications of acetylsalicylic acid preparations and free from the above-stated lacks was received.

Contents of work: Within the framework of the present project we plan the development of two types of the soluble tablets varying in their dosage, the realization of all necessary pharmacological tests and the registration of the preparations in the Russian Federation. Especially we shall note, that in order to speed up the preparations manufacturing at pharmaceutical factories, there will be developed the trial technology of soluble tablets manufacturing.

The final result of the project is the preparation for the manufacturing of the preparation possessing pain-allaying, anti-inflammatory, febrifugal and antiaggregation preventive effect and its application in clinics.

Expected results: the most important results expected from carrying out of the project can be:

- Development and registration in the Russian Federation of a new soluble acetylsalicylic acid preparation;

- Development of trial-industrial tabletting technology;

- Preparation of the medicine manufacturing in the form of substance and tablets;

- Development of "development - tests - manufacturing " base for a series of the further preparations on the base of mechanochemically produced fast soluble solid disperse systems of medicinal substances;

- Preparation of the developed medical products patenting.

The carrying out of the project will allow to reorient research activity of the employees working before in military area, will expand the researchers’ international contacts, and will provide the further development of research work in the field of pharmaceutical applications, what meets the ISTS goals.

Scope of activity: Within 2 years it is supposed to carry out the following research work:

- To develop specifications and technical documentation for fast soluble substance and tablets (in two dosages)

- To develop trial technology of manufacturing of fast soluble powder and tablets in two dosages - 0,1 and 0,5 g of acetylsalicylic acid. To produce pre-production samples for laboratory and clinical tests;

- To carry out comparative laboratory tests for toxicity and bioavailability on laboratory animals, to develop the project of application instructions of the medicinal;

- To carry out clinical tests;

- To prepare the application for patenting of medical products;

- To approve the application instructions of medical products, specifications and technical documentation in Health Ministry of the Russian Federation;

- To carry out the registration of the developed medical products in the Russian Federation.


Back