# US 10,117,831 B2 · Soft chew pharmaceutical formulations

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- Number: US 10,117,831 B2
- Document ID: US10117831B2
- Status: Granted
- Kind: B2
- Application number: 15/629,354
- Filed: 2017-06-21
- Published: 2018-06-21
- Granted: 2018-11-06
- Earliest claimed: 2016-12-19
- Assignees: First Time US Generics LLC
- Applicants: First Time US Generics LLC
- Inventors: Manesh A. Dixit; Vaibhav L. Pawar; Rushi R. Patel; Mineshkumar D. Patel; Amol Somwanshi
- Web page: https://patentgrep.com/patent/US10117831B2

## CPC

- A61K 9/0056: {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}
- A61K 9/2013: {Organic compounds, e.g. phospholipids, fats}
- A61K 9/2018: {Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates}
- A61K 9/2031: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers}
- A61K 9/2054: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose}
- A61K 9/2059: {Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin}
- A61K 9/2095: {Tabletting processes}
- A61K 31/405: Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
- A61K 31/496: Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
- A61K 31/501: not condensed and containing further heterocyclic rings
- A61K 31/546: containing further heterocyclic rings, e.g. cephalothin
- A61K 31/635: having a heterocyclic ring, e.g. sulfadiazine
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

A product and process of manufacturing an edible soft-chewable dosage form for the delivery of pharmaceutically active ingredients or nutritional agents orally to an animal or human subject, by forming a granulated soft-chew mass by appropriate mixing and sifting steps, and forming tablets with a compression press. Such soft-chew dosage forms have hardness of less than about 2 kilopond and friability of less than about 1% at 300 rotations (per USP). The process for manufacturing such compressed soft-chew tablets employs compression (tablet) pressing equipment to produce soft-chew tablets of consistent weight and texture.

## Claims

### Claim 1

A process for the manufacture of a compressed soft-chew semi-plastic unit dosage form, manufactured without molding or extrusion, for the oral administration of active pharmaceutical agents or nutritional agents comprising the steps of:
a. forming a fluid premix comprising 5% to 20% w/w vegetable oil of the total weight of the dosage form and 5% to 20% w/w glycerin of the total weight of the dosage form;
b. blending granulation ingredients comprising 3.0% to 25% w/w of microcrystalline cellulose, or silicified microcrystalline cellulose and at least one other excipient to form a granulation ingredient mixture;
c. wherein at least one active pharmaceutical agent or nutritional agent is added to the fluid premix or granulation ingredient mixture;
d. blending the fluid premix and the granulation ingredient mixture to form a soft-chew mass;
e. a sifting the soft-chew mass to form granules of the soft-chew mass;
f. adding a lubricant or anti-sticking agent to the granules of the soft-chew mass and compressing the resulting mixture on a tablet press to form a soft-chew semi-plastic unit dosage form, wherein the resulting dosage forms have a hardness of less than 2 kp when tested with a conventional tablet hardness tester and a friability of less than 1.0% at 100 rotations.

### Claim 2 (depends on 1)

The process of claim 1, wherein the compressed soft-chew semi-plastic unit dosage form disintegrates in less than 60 minutes according to the USP disintegration test <701> using water as the medium.