Manufacturing of semi-plastic pharmaceutical dosage units
A process for the manufacture of semi-plastic pharmaceutical unit doses using a rotary moulding machine and semi-plastic pharmaceutical dosage units obtained by this process.
1. A process for the manufacturing of a semi-plastic pharmaceutical dosage unit, wherein the semi-plastic pharmaceutical dosage unit is a soft chewable veterinary pharmaceutical product for oral administration, comprising at least one active pharmaceutical ingredient and a polyethylene glycol forming agent, comprising the steps of:
a) mixing the at least one active pharmaceutical ingredient with a dry and a liquid component to prepare a premix,
b) heating the polyethylene glycol forming agent until melted,
c) mixing the premix and the polyethylene glycol forming agent together to form a dough,
d) feeding the dough into a container connected with a rotary moulding machine; and
e) forming the semi-plastic pharmaceutical dosage unit in the rotary moulding machine,
wherein the liquid component contains an oil; and
wherein the temperature of the dough in step d) is between about 35° C. and about 45° C.
2. The process according to claim 1 wherein the rotary moulding machine comprises forming moulds with concave edges.
3. The process according to claim 1 , wherein all of the ingredients are of a pharmaceutical grade.
4. The process according to claim 1 , wherein the active pharmaceutical ingredient is an antiparasitic.
5. The process according to claim 1 , wherein the active pharmaceutical ingredient is an isoxazoline compound.
6. The process according to claim 5 wherein the active pharmaceutical ingredient is 4-[5-(3,5-Dichlorophenyl)-5-trifluoromethyl-4,5-dihydroisoxazol-3-yl]-2-methyl-N-[(2,2,2-trifluoro-ethylcarbamoyl)-methyl]-benzamide.
7. The process of claim 1 , wherein the dry component is a starch or starch like material.