Vétoquinol

MICROENCAPSULATED PRODUCTS OF ASCOR CHIMICI
GRANULATED PRODUCTS OF ASCOR CHIMICI
Veterinary medicines for livestock and disinfectants
Products: 58
Supplementary feedingstuffs, vitamin-mineral-aminoacid premixes, oral solutions and water soluble powders
Products: 46
 
 
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PHARMACOLOGICAL TREATMENTS THROUGH THE FEED>>
PRODUCTIVE EVOLUTIONS>>
PHYSICAL-TECHNOLOGICAL CHARACTERISTICS OF ASCOR CHIMICI's GRANULATED PREMIXES>>
A) Apparent volume
B) Particle-size
C) Theoretical evaluation of particles number
D) Determination of flowability: Flowing angle, Flowing time
E) Determination of electrostaticity-adhesiveness (Ascor Chimici) or "Tube - Active - Residue" (TAR), determination of dustiness as per Stauber and Bentel with the Heubach pulverimeter
F) Presence of residues of active principles after mixing in industrial mixers


PHARMACOLOGICAL TREATMENTS THROUGH THE FEED:
TECHNOLOGICAL PROGRESSES


A modern approach to problems related to mass pharmacological treatments (with auxinic, prophylactic or therapeutic ingredients) requires particular attention for what concerns safety and technological releability of the products.

The traditional use of pharmacological active substances in the feed (growth promoters, anticoccidials, antibiotics) has shown risks related to the use of products with low technological profile.

Especially powders are often involved as one of the most serious risk factors for the entire zootechnical sector.
1. Contamination of the work sourroundings during handling and of the mixers (cross contamination) brings risks to workers and may cause resistance and hypersensitiveness in target species.
2. The non-homogeneous distribution of the active ingredient in the feed can cause a lack of therapeutic response (hypodosage) and, at the same time, the occurrence of toxic effects (hyperdosage).

In consideration of these data it is clear that the traditional approach (which evaluates the identity, the purity and titre of active ingredients), should be modified showing more and more attention to the physical and technological parameters of the products.







PRODUCTIVE EVOLUTIONS:
FROM POWDERS TO GRANULATED PRODUCTS


In powder premixes, pharmacologically active ingredients (PAI) and excipients are powders with higher or lower tendency to dustiness.

Picture 1. Magnification with optical microscope of a powder medicated premix.

The so called "anti-dust technique" has represented the first effort to the solution of the problem. This technique is based on the use of liquid substances (oil, surfactants, etc.) in order to "wet" powders: the particles stick one to the other, getting heavier, so limiting the possibility of suspension in the atmosphere. Nevertheless, in "anti-dust" products the adhesion is weak and can cause problems very hard to control like (unmixing, poor flowability, or adhesiveness of particles to mixer's walls).

Picture 2 & 3. Magnification with optical microscope of anti-dust medicated premixes.

The GRANULATION is an important technological progress in the prevention of the problems related to the dustiness of powder products.

This technology is widely used in human pharmaceutical products, and consists in producing the "granulate", that is a pharmaceutical form in which active principles and excipients are closely linked, in this way, every granulometric fraction is marked by the same concentration of the active principle. The particle-size of granules, even if variable, is included within a short range (see chapter 3 par. B - "Particle-size").

As it can easily be understood, the "congealing" of the active principle and of the excipients in new homogeneous units, allows to solve the problems of powder products and, at same time, can guarantee an optimal technological effectiveness of the products.

Picture 4 & 5. Different magnification with optical microscope of granulated premixes. .

PHYSICAL-TECHNOLOGICAL CHARACTERISTICS OF ASCOR CHIMICI's GRANULATED PREMIXES

The physical-technological characteristics of a premix can determine the mechanical behaviour of the finished product. For this reason, when deciding the characteristics of Ascor Chimici's granulated products particular attention has been paid for the parameters indicating the premixes technological efficiency.

A) Apparent volume (European Pharmacopoeia, 3rd ed.; Italian Pharmacopoeia, IX ed.)

The apparent volume (Va) of the solid substance (reciprocal of its apparent density - Da) gives an important index of its tendency to mixability with the various carriers.

Product
Va x 100 g
Da g/ml
Chlortetracycline 20%
162 ml
0.617
Oxytetracycline 20%
140 ml
0.714
Robenidine 6,6%
74 ml
1.35
Nicarbazine 25%
140 ml
0.714
Colistine 12%
140 ml
0.714
Sulfadimethoxine 20%
152 ml
0.657
Carbadox 10%
148 ml
0.676

B) Particle-size (Italian Pharmacopoeia, IX ed., French P.)
Ascor Chimici granulated products' particle-size is included (at 90%) between 400 and 800 microns.

Product

Product % at differents particle-size

<125
(µm)

240
(µm)

427
(µm)

677
(µm)

1015
(µm)

>1180
(µm)

Chlortetracycline 20%

0.2

2.4

9.3

58.3

25.6

4.2

Oxytetracycline 20%

0.1

0.3

6.8

74.9

17.4

0.5

Robenidine 6,6%

0.3

0.7

1.6

82.5

2.9

0.0

Nicarbazine 25%

1.8

2.6

15.1

77.5

2.8

0.2

Colistine 12%

0.4

3.6

20.8

68.8

5.9

0.5

Sulfadimethoxine 20%

0.2

1.8

15.8

64.5

16.8

0.9

Carbadox 10%

0.1

1.8

17.6

61.9

18.4

0.2




          

        



C) Theoretical evaluation of particles number
(M. Amorosa - Tecnica Farmaceutica, 3rd ed. 1989)

This datum, obtained on the basis of the particle-size and of the apparent density of granules (assuming that the particles are spherical), gives a direct indication on the probability of the distribution efficiency of the granulated premix in the finished product.

Product

Average
diameter (µm)

Average N° of particles x 100 g

Chlortetracycline 20%

749.8

743,000

Oxytetracycline 20%

719.5

718,000

Robenidine 6,6%

648.1

519,000

Nicarbazine 25%

628.4

1,078,000

Colistine 12%

629.5

1,072,000

Sulfadimethoxine 20%

689.8

886,000

Carbadox 10%

687.8

868,000

PHYSIC-TECHNOLOGICAL CHARACTERISTICS OF ASCOR CHIMICI's GRANULATED PREMIXES

D) Determination of flowability: Flowing angle (M. Amorosa - Tecnica Farmaceutica, 3rd ed. 1989; Italian Pharmacopoeia, IX ed.), Flowing time (European Pharmacopoeia, 3rd ed.)

The flowability parameters evaluate the weak adhesion strengths existing among the particles; also comparative data with products made with the anti-dust technology have been given. Increasing the cohesion among the particles, trough the use of "wetting" agents, this can increase the adhesion strengths with the structures which the particles themselves get in contact with.

Product

alpha*

Chlortetracycline 20%

37.5°

Oxytetracycline 20%

33.7°

Robenidine 6,6%

34.2°

Nicarbazine 25%

33.9°

Colistine 12%

35.7°

Sulfadimethoxine 20%

36.8°

Carbadox 10%

34.4°


Product

Time in sec. x 200 g

Chlortetracycline 20%

22".85

Oxytetracycline 20%

18".09

Robenidine 6,6%

8".85

Nicarbazine 25%

16".25

Colistine 12%

16".51

Sulfadimethoxine 20%

22".19

Carbadox 10%

17".12

A granulated product the more is flowable the less is the a value. Generally products with a minimum value of alpha (~ 25°) flow easily, on the contrary values higher than 50° flowability is faulty (Amorosa M., 1959).

Product

Flowing time

Flowing angle

Oxytetracycline 20%

18".8

33°.7

Oxytetracycline X

30".1*

40°.1

* with shaking

Comparison of flowability parameters on Ascor Chimici's oxitetracycline 20% with "anti-dust" premix.

Product

Flowing time

Flowing angle

Colistine 12%

16".5

35°.7

Colistine X

28".5*

41°.8

* with shaking

Comparison of flowability parameters on Ascor Chimici's colistin 12% with "anti-dust" premix.


E) Determination of electrostaticity-adhesiveness (Ascor Chimici) or "Tube - Active - Residue" (TAR), determination of dustiness as per Stauber and Bentel with the Heubach pulverimeter (Fresenius Z. An. Chem. 1984)
The parameters obtained with the above mentioned methods are particularly important for the evaluation both of the cross-contamination and the tendency of the premix to free dusts.

Granulated premix

Tube residues mg/500g

Chlortetracycline 20%

1.00

Oxytetracycline 20%

3.07

Robenidine 6,6%

1.57

Nicarbazine 25%

1.80

Colistine 12%

< 10.0*

Sulfadimethoxine 20%

2.60

Carbadox 10%

1.83

* Microbiological determination

Granulated premix

Tube residues mg/500g

Chlortetracycline 20%

1.00

Oxytetracycline 20%

3.07

Robenidine 6,6%

1.57

Nicarbazine 25%

1.80

Colistine 12%

< 10.0*

Sulfadimethoxine 20%

2.60

Carbadox 10%

1.83

* Microbiological determination

Product

Powders on Heubach filter (mg)

Chlortetracycline 20%

0.0 ± 0.1

Oxytetracycline 20%

1.8 ± 0.1

Colistine 12%

0.8 ± 0.1

Sulfadimethoxine 20%

0.2 ± 0.1

 
Determination of dustiness of some Ascor Chimici's granulated products with the Heubach pulvimeter.


F) Presence of residues of active principles after mixing in industrial mixers
Trials lately ordered (March 1998) by some Ascor Chimici's customers to outer Analysis Laboratories, have shown lack of the detectable residues, in samples of finished feeds mixed after the use of granulated colistin and oxitetracycline (at normal therapeutic dosage).
Also the first mixed feed produced after the use of granulated antibiotics (on a total of 5 subsequent mixings) has resulted negative.
The detailed results of these trials are available on request.


The reported data are not products’ specifications, and are referred to average experimental values.


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Via Piana,265 - 47032 Bertinoro (FC) Italy
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