SVIBOR - Project code: 3-01-154

MINISTRY OF SCIENCE AND TECHNOLOGY

Strossmayerov trg 4, HR - 10000 ZAGREB
tel.: +385 1 459 44 44, fax: +385 1 459 44 69
E-mail: ured@znanost.hr

SVIBOR

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Project code: 3-01-154


Preparation of medical suspensions, pharmacilogical and clinical investigations


Main researcher: IVANDIJA, LIBUŠKA (17203)


Assistants
Type of research: developmental
Duration from: 01/01/90. to 12/15/95.
Papers on project (total): 3
Papers on project quoted in Current Contents: 1
Institution name: Pliva - Istraživački institut, Zagreb (60)
Department/Institute: Veterinary products & agrochemicals
Address: Prilaz baruna Filipovića 89
City: 10000 - Zagreb, Croatia
Communication
Phone: 385 (41)181028
Fax: 385 (41)576690
Summary: By a new technology, product antiparasitic MonilR 10% suspension for veterinary purposes was prepared. The granulometric characteristics of the obtained suspension prove considerably better efficiency compared to the product obtained by previous procedure (90% of particles up to 3,5 mimrometer : 90% particles up to 25 micrometer). Biological trials on cattle has proved good tolerance and no adverse effects of the drug, as well as a higher level of bioavailability. Because of expiring of the Pfizer's patent (in 1994) for oxytetracyclin retard injections (LiquamycinR LA 200) there will be possibility to patent and sell the parallel product produced by PLIVA (GeomycinR retard 20% injections for veterinary purposes). By selecting the adequate technological procedure, we obtained the product with physical, chemical and pharmacodynamic properties identical to LiquamycinR LA 200 (Pfizer). The comparative experiments have showed that the both products have the same local tolerance and very good bioavailability (963 blood samples were examined). Ineffort to replace the import of the foreign product SIMIVET 15% LA suspension, for veterinary use, with ourown formulation and technology, two formulations were prepared applying Dyno-mill technology and were sent on stability testing. In attempt to achieve the greater efficiency, especially antibacterial action of the preparation intended for treatment of the mammary gland infection in cattle (Ampivet K suspension, for veterinary use) the clinical form and concentration of the active substances were changed. As a consequence of introducing the new cemical form of the active substrances is their better dissolving, what together with the increased concentration of the drugs incorporated in a appropriate media produce accomplishment and maintenance of an adequate concentration of the active substances on the site of infection. By using Dyno-mill technology two formulations with different vehicles (vegetative and mineral oil) were prepared and sent on stability testing.

Keywords: suspensions, new technology, pharmacotoxicological properties, clinical efficiency

Research goals: The goal of the project is the preparation of oral, parenteral and intramamary suspension by wet micronization in order to achieve very fine dispersion of uniform particles in liquid phase (particle size up to 10 nicrometer) as well as the comparison of their characteristics to the preparations obtained by standard technology. To achieve more efficient treatment of animals, we have been developing the formulations with prolonged activity. Preparations are based on the gradual release of drug by which the continious and effective blood level of active substances during the day is achieved. The prolonged effect of the formulation is the consequence of controlled release of active substance under the influence of additional substances without tissue damages. The expected goal is on one hand to achieve the preparation of mentioned suspensions of high physical and chemical stability, and on the other hand, the preparation of medical preparations which meet the strict requirement concerning pharmacological properties and clinical activity. The preparations of high quality and obtained in this way are ready to enter the world market.

COOPERATION - INSTITUTIONS


  1. Name of institution: Zavod za ispitivanje i kontrolu lijekova
    Type of institution: International organization
    City: 10000 - Zagreb, Croatia

  2. Name of institution: Veterinarski institut
    Type of institution: University/Faculty
    City: 10000 - Zagreb, Croatia
Other information about the project.
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Last update: 10/09/95
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