SOFT CHEWABLE FORMED BODY FOR THE ADMINISTRATION TO ANIMALS
The invention relates to a formed body for the administration to animals and to a process for the production of the formed body for the administration to animals. The formed body serves in particular for the oral administration of pharmaceutically active substances to animals. The formed body for the administration to animals comprises one or more pharmaceutically active substance, one or more flavouring agents, one or more binding agents, one or more gel-forming agents, one or more fillers, water and glycerol.
1 . A formed body for administration to an animal comprising:
a. one or more pharmaceutically active substances,
b. one or more flavouring agents,
c. one or more binding agents,
d. one or more gel-forming agents,
e. one or more fillers,
f. water, and
g. glycerol.
2 . The formed body according to claim 1 , wherein the content by weight of gel-forming agent d) in the formed body is in a range of from 0.5 to 30 wt. %, optionally from 1 to 25 wt. %, from 2 to 20 wt. %, from 3 to 17 wt. % or from 5 to 15 wt. %, based on the total weight of the formed body.
3 . The formed body according to claim 1 , wherein the weight ratio of gel-forming agent d) to the combined weight of water f) and glycerol g) in the formed body is in a range of from 1:2 to 1:20, optionally from 1:3 to 1:15, from 1:5 to 1:10 or from 1:6 to 1:8.
4 . The formed body according to claim 1 , wherein the weight ratio of water f) to glycerol g) in the formed body is from 5:95 to 35:65, optionally from 10:90 to 30:70 or from 15:85 to 25:75.
5 . The formed body according to claim 1 , wherein the one or more gel-forming agents d) are selected from the group of croscarmellose, low substituted carboxymethylcellulose, low substituted hydroxypropylcellulose, crospovidone and cross-linked sodium carboxymethylstarch.
6 . The formed body according to claim 1 , wherein
a. water content of the formed body is in a range of 0.5 to 20 wt. %, optionally 0.75 to 18 wt. %, 1.0 to 15 wt. %, 1.5 to 13 wt. % or 1.75 to 11.5 wt. %, based on the total weight of the formed body, and/or
b. a value of water activity a w is below or equal to 0.60, optionally in a range from 0.10 to 0.60, in a range from 0.20 to 0.58, in a range from 0.30 to 0.55.
7 . The formed body according to claim 1 , wherein the one or more binding agents c) are selected from the group of polyvinylpyrrolidone, croscarmellose, hydroxypropylcellulose, hydroxypropylmethyl cellulose, hydroxyethylcellulose, pectin, pullulan, carrageenan, xanthan gum, alginate and agar agar.
8 . The formed body according to claim 1 , wherein the gel-forming agents d) comprise or consist of croscarmellose and the binding agents c) comprise or consist of polyvinylpyrrolidone.
9 . The formed body according to claim 1 , wherein at least one of the one or more pharmaceutically active substances a) is selected from the group of orally administrable systemically active veterinary pharmaceuticals.
10 . The formed body according to claim 1 , wherein the one or more flavouring agents b) are selected from the group of natural or artificial meat, poultry, fish and sea food flavours, optionally dried meat, poultry and fish powders, optionally pig liver powder.
11 . The formed body according to claim 1 , wherein the one or more fillers e) are selected from the group of lactose, cellulose, poorly soluble inorganic salts, optionally dicalcium phosphate, solid sugar alcohols, optionally mannitol, xylitol or sorbitol and inorganic calcium, magnesium, sodium or potassium salts.
12 . The formed body according to claim 1 , comprising
0.1 to 25 wt. % of one or more pharmaceutically active substances a),
1 to 25 wt. % of one or more flavouring agents b),
1 to 20 wt. % of one or more binding agents c),
0.5 to 30 wt. % of one or more gel-forming agents d),
0 to 50 wt. % of one or more fillers e),
2 to 30 wt. % water f),
5 to 65 wt. % glycerol g),
0 to 20 wt. % of one or more auxiliary additives, optionally one or more of formulation adjuvants, lubricants, disintegrants, surfactants, humectants and/or preservatives, wherein percentages add up to the sum of 100 wt. %.
13 . The formed body according to claim 1 for control of one or more parasites in one or more non-human animals, optionally one or more dogs and/or cats.
14 . A process for production of a formed body according to claim 1 , comprising:
a) providing at least the following components:
c. one or more pharmaceutically active substances,
d. one or more flavouring agents,
e. one or more binding agents,
f. one or more gel-forming agents,
g. one or more fillers,
h. optionally one or more auxiliary additives, as for instance formulation adjuvants, lubricants, disintegrants, surfactants, humectants and preservatives,
b) preparing a swollen mixture by mixing components of a), glycerol and water,
c) forming a formed body by extrusion of the swollen mixture prepared in b).
15 . The process according to claim 14 , wherein the step(s) b) and/or c) is/are performed in an extruder.