# US 2019/0167592 A1 · Process for directly compressible co-processed excipient for modified release application

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- Number: US 2019/0167592 A1
- Document ID: US20190167592A1
- Status: Published application
- Kind: A1
- Application number: 16/317,463
- Filed: 2017-07-05
- Published: 2019-06-06
- Earliest claimed: 2016-07-13
- Applicants: Gangwal Chemicals Private Limited
- Inventors: Anil K. Jain; Rajan KALE
- Web page: https://patentgrep.com/patent/US20190167592A1

## CPC

- A61K 9/1694: {resulting in granules or microspheres of the matrix type containing more than 5% of excipient}
- A61K 9/1611: {Inorganic compounds}
- A61K 9/1617: {Organic compounds, e.g. phospholipids, fats}
- A61K 9/1635: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates}
- A61K 9/1652: {Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin (homeopathic globules A61K9/1623)}
- A61K 9/20: Pills, tablets, {discs, rods (A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095)}
- A61K 31/135: having aromatic rings {, e.g. ketamine, nortriptyline (methadone A61K31/137)}
- A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone}
- A61K 31/155: Amidines ([IMAGE cpc-sch-A61K-1029.gif]), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
- A61K 31/196: the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
- A61K 31/4178: not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
- A61K 47/02: Inorganic compounds
- A61K 47/06: Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61K 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone}
- A61K 47/38: Cellulose; Derivatives thereof
- 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

The present invention provides a process for manufacturing a co-processed directly compressible excipient for sustained/extended release formulation based on pharmaceutically acceptable inert diluent, hydrophilic swellable polymer and a binder.

## Claims

### Claim 1

A process of producing a co-processed directly compressible excipient comprising an inert diluent, a hydrophilic swellable polymer and a binder, wherein the said compressible excipient controls the rate of drug release.

### Claim 2 (depends on 1)

The process of producing a co-processed directly compressible excipient of claim 1, wherein the binder is selected from water, organic solvent, starch paste, hydrophilic polymer or a combination thereof.

### Claim 3 (depends on 1)

The process of producing a co-processed directly compressible excipient of claim 1, wherein the diluent is carbohydrate or microcrystalline cellulose.

### Claim 4 (depends on 1)

The process of producing a co-processed directly compressible excipient of claim 1, wherein the hydrophilic swellable polymer is a neutral polymer selected from the group consisting of synthetic polymers, cellulose based polymers, hydrocolloids and a combination thereof.

### Claim 5 (depends on 4)

The process of producing a co-processed directly compressible excipient of claim 4, wherein the synthetic polymer is selected from the group consisting of poly acrylic acid derivatives, poly vinyl alcohol derivatives and a combination thereof.

### Claim 6 (depends on 4)

The process of producing a co-processed directly compressible excipient of claim 4, wherein the cellulose based polymer is nonionic or substituted.

### Claim 7 (depends on 4)

The process of producing a co-processed directly compressible excipient of claim 4, wherein the cellulose based polymer is selected from the group consisting of hypromellose, hypromellosepthalate, hydroxypropyl cellulose, hydroxyethyl cellulose, carboxymethylcellulose, carboxyethyl cellulose, ethyl cellulose, methyl cellulose, their salts and a combination thereof.

### Claim 8 (depends on 4)

The process of producing a co-processed directly compressible excipient of claim 4, wherein the hydrocolloids is selected from the group consisting of gum arabic, guar gum, xanthan gum, alginic acid derivatives, carrageenan, chitosan and a combination thereof.

### Claim 9

A process for producing a co-processed directly compressible excipient comprising the steps of:
a) mixing water insoluble diluent and water to form wet mass of diluent;
b) unloading wet mass of step (a) and collect in a collector;
c) performing dry blending by loading pre-sifted hydrophilic swellable polymer in high shear mixer granulator having impeller-chopper combination and dry mix;
d) slow addition of wet mass of diluent of step (a) to the dry powder blend of step (c) to granulate dry blend and addition of binder during granulation;
e) discharging wet granulated mass and drying it in fluidized bed dryer; and
f) addition of glidant and/or lubricants to the dried and sized granules.

### Claim 10 (depends on 9)

The process of producing a co-processed directly compressible excipient of claim 9, wherein the said diluent is microcrystalline cellulose and the said binder is water.

### Claim 11 (depends on 9)

The process of producing a co-processed directly compressible excipient of claim 9, wherein the said of glidant and/or lubricants is selected from the group consisting of stearic acid, magnesium stearate, calcium stearate, sodium stearate, boric acid, sodium lauryl sulfate, magnesium lauryl sulfate, corn starch, talcum, flow regulator and hardness enhancing agent