Manufacturing of semi-plastic pharmaceutical dosage units

Patent metadata

Field	Value
Publication number	US-11911503-B2
Application number	US-202117225634-A
Country	US
Kind code	B2
Filing date	Apr 8, 2021
Priority date	Nov 20, 2012
Publication date	Feb 27, 2024
Grant date	Feb 27, 2024

Abstract

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.

First claim

What is claimed is:

1. A soft chewable veterinary pharmaceutical product for oral administration,
wherein the soft chewable veterinary pharmaceutical product is obtainable by a process wherein the soft chewable veterinary pharmaceutical product is formed with a rotary moulding machine, comprising the steps of:
a) mixing at least one active pharmaceutical ingredient with one or more components wherein the components are dry components and liquid components to prepare a premix,
b) heating a polyethylene glycol forming agent until melting,
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 a soft chewable veterinary pharmaceutical product for oral administration in a rotary moulding machine,

wherein the liquid component comprises one or more oils and the polyethylene glycol forming agent is solid at room temperature and has a melting point between 45° C. and 100° C.;
wherein the temperature of the dough in step d) is between 35° C. and 45° C.; and
wherein the rotary moulding machine does not have a knockoff mechanism or a punch mechanism;
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; and
wherein the soft chewable veterinary pharmaceutical product has concave edges and has a weight of about 2 g or less or has a weight of more than about 10 g.

2. The soft chewable veterinary pharmaceutical product for oral administration according to claim 1 , wherein soft chewable veterinary pharmaceutical product is of cylindrical form.

3. A method of controlling a parasitic insect, acarid or nematode infestation of an animal comprising administering to the animal an effective amount of the soft chewable veterinary pharmaceutical product for oral administration of claim 1 .

Assignees

• Intervet Inc

Inventors

• Kluger Dominique
• Hauler Albin
• Schmidt Carsten
• Schroeckenfuchs David
• Waldron Niki

Classifications

• A61K31/4439

  containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole (nicotine A61K31/465) · CPC title

• A61P33/00

  Antiparasitic agents · CPC title

• A61K31/42

  Oxazoles · CPC title

• A61K9/0056 Primary

  Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals · CPC title

• A61K47/10

  Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers · CPC title