Dispersible tablets of abiraterone acetate

Patent metadata

Field	Value
Publication number	US-12403149-B2
Application number	US-202017624842-A
Country	US
Kind code	B2
Filing date	Jul 2, 2020
Priority date	Jul 15, 2019
Publication date	Sep 2, 2025
Grant date	Sep 2, 2025

Abstract

The present invention relates to a dispersible tablet comprising at least 70% w/w of abiraterone acetate based on the total weight of the tablet and at least one pharmaceutically excipient selected from group consisting of diluents, binders, surfactants, glidants, disintegrants, lubricants, sweeteners and flavorants and further relates to the process for the preparation thereof.

First claim

We claim:

1. A dispersible tablet comprising at least 70% w/w of abiraterone acetate and pharmaceutically acceptable excipients, wherein the dispersible tablet is free of binder.

2. The dispersible tablet as claimed in claim 1 comprising about 70% w/w to about 90% w/w of abiraterone acetate based on the total weight of the dispersible tablet.

3. The dispersible tablet as claimed in claim 1 comprising the pharmaceutically acceptable excipients selected from the group consisting of diluents, surfactants, glidants, disintegrants, lubricants, sweeteners and flavorants.

4. The dispersible tablet as claimed in claim 1 , wherein diluents are selected from group consisting of lactose, microcrystalline cellulose, saccharose, sorbitol, mannitol, dextrates, dextrins, dextrose and maltodextrin.

5. The dispersible tablet as claimed in claim 1 , wherein surfactants are selected from the group consisting of sodium lauryl sulfate, polysorbate 80, and docusate sodium.

6. The dispersible tablet as claimed in claim 1 , wherein glidants are selected from group consisting of colloidal silicon dioxide and talc.

7. The dispersible tablet as claimed in claim 1 , wherein disintegrants are selected from group consisting of crospovidone, pre-gelatinized starch and croscarmellose sodium.

8. The dispersible tablet as claimed in claim 1 , wherein lubricants are selected from group consisting of magnesium stearate and sodium stearyl fumarate.

9. A dispersible tablet as claimed in claim 1 comprising
a) about 70% w/w to about 90% w/w of abiraterone acetate,
b) about 15% w/w to about 25% w/w of diluent,
c) about 0.2% w/w to about 2% w/w of surfactant,
d) about 0.2% w/w to about 2% w/w of glidant,
e) about 1% w/w to about 5% w/w of disintegrant
f) about 0.2% w/w to about 1% w/w of lubricant and
g) at least one excipient selected from group consisting of flavorants and sweeteners.

10. A dispersible tablet consisting of
a) about 70% w/w to about 90% w/w of abiraterone acetate,
b) about 15% w/w to about 25% w/w of microcrystalline cellulose,
c) about 0.2% w/w to about 2% w/w of sodium lauryl sulfate,
d) about 0.2% w/w to about 2% w/w of colloidal silicon dioxide,
e) about 1% w/w to about 5% w/w of crospovidone,
f) about 0.2% w/w to about 1% w/w of magnesium stearate and
g) at least one excipient selected from group consisting of flavorants and sweeteners,
wherein the dispersible tablet is free of binder.

Assignees

• Shilpa Medicare Ltd

Inventors

• Math Nijaguni Revansiddayya Rudraswamy
• Reddy Sreenivasa
• Peri Ravi Vamsi
• Pradeep Shivakumar

Classifications

• 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

• A61K9/2054

  Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose · CPC title

• A61K9/0095

  Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches (A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006) · CPC title

• A61K31/58 Primary

  containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin (digitoxin {A61K31/7048}) · CPC title