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Development of innovative formulations based on doxycycline for a rationale use of antibiotherapy in animal health

Development of different dosage forms containing doxycycline alone or associated with paracetamol or others, for improving the extrinsic and intrinsic characteristics for a safe and rationale use of this antibiotic in animal health.

Doxycycline is an antibiotic of the tetracycline family and used in veterinary therapy. As regards the use of antibiotics in food producing animals, the authorities are concerned with the effects of this use in the creation of new resistant bacteria strains to these antibiotics, and especially to the ability of the resistant bacteria to exchange their information to human flora or pathogen bacteria. Health authorities are promoting a rational use of antibiotics on food producing animals in order to avoid loss of efficacy in human anti-biotherapy. Doxycycline is an antibiotic with a relatively limited use in human medicine, however, it is very useful in animal health for its efficiency, something that makes doxycycline a good candidate to be used in veterinary anti-biotherapy, also taking into account that tetracyclines have little application in human medicine since several resistant strains have been described as a result of tetracycline abuse in the past. Doxycycline formulations have some particularities that make it difficult to attain acceptable products with regards to their performance and stability. Doxycycline is unstable in solution; therefore few formulations are available in the European market under this dosage form, either for oral and parenteral route, both ways being very useful in veterinary work, since the handling costs involved are less than other dosage forms that require a previous preparation of the product. A well-characterised product is also important for quality, safety and efficacy assurance, especially in all those items concerning food safety. The aim of this project is to develop different formulations of doxycycline, well characterised and documented in the frame of European requirements for marketing authorisation in the entire European area. The formulations will have improved stability and improved tolerance when administered parenterally, under different galenic strategies. In addition, associations of doxycycline and paracetamol in solution will be developed. This dosage form is not at present available in the market and it would be advantageous, since antipyretic and anti-biotherapy are commonly associated using different products. Solutions are easily administered and it allows for establishing a more accurate application than other dosage forms. Other possible associations could be considered in order to improve the qualities of the product and its efficiency, always as a last resort, for a better and rational use of the product. Keywords: pharmaceutical development, animal health, veterinary.
Acronym: 
PARADOX
Project ID: 
3 419
Start date: 
01-01-2004
Project Duration: 
66months
Project costs: 
4 800 000.00€
Technological Area: 
Virus, Virology, Vaccines/ Antiobiotics / Bacteriology
Market Area: 
Animal Husbandry

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