Claims for Patent: 11,654,106

Summary for Patent: 11,654,106

Title:	Aqueous suspension suitable for oral administration
Abstract:	The present invention provides liquid oral dosage form of lipid lowering agent suitable for oral administration to human or animals.
Inventor(s):	Sandip P. Mehta, Henil Alpeshbhai PATEL, Jayanta Kumar Mandal
Assignee:	Liqmeds Worldwide Ltd , FTF Pharma Pvt Ltd
Application Number:	US17/824,993
Patent Claims:	1. An aqueous suspension for oral administration, consisting of: atorvastatin in an amount of about 0.4% w/w; a suspending agent in an amount of about 2% w/w comprising carboxymethyl cellulose sodium in an amount of about 0.7% w/w and magnesium aluminum silicate in an amount of about 1.3% w/w; a preservative in an amount of from 0.01% w/w to 0.5% w/w; a sweetener in an amount of about 0.1% w/w to 2% w/w; a flavoring agent in an amount of from 0.01 to 2.0% w/w; and a water vehicle; wherein the atorvastatin has a d90 particle size of from 1 μm to 15 μm. 2. The aqueous suspension of claim 1, wherein the atorvastatin has a d90 particle size of from 1 μm to 10 μm. 3. The aqueous suspension of claim 1, wherein the preservative is selected from the group consisting of alcohol, benzyl alcohol, chlorobutol, chlorocresol, an alkyl ester of paraben, phenol, phenyl ethanol, sodium benzoate, propylene glycol, chloroform, and a combination thereof. 4. The aqueous suspension of claim 1, wherein the preservative comprises an alkyl ester of paraben. 5. The aqueous suspension of claim 1, wherein the pH of the aqueous suspension ranges from 5 to 10. 6. The aqueous suspension of claim 1, wherein the pH of the aqueous suspension ranges from 6 to 9. 7. The aqueous suspension of claim 1, wherein an amount of total atorvastatin-related impurities is about 0.4% w/w after storage for 3-months at a temperature of about 25° C. and a relative humidity of about 40%. 8. The aqueous suspension of claim 1, wherein the atorvastatin has a d90 particle size of about 6 μm and wherein a dose of the aqueous suspension comprising 40 mg of atorvastatin has a T/R ratio of from 90% to 110%, wherein T is a ln-transformed Cmax-value of the dose after administration to a human, and wherein R is a ln-transformed Cmax-value of a tablet comprising 40 mg atorvastatin after administration to the human. 9. The aqueous suspension of claim 1, wherein the atorvastatin has a d90 particle size of about 6 μm and wherein a dose of the aqueous suspension comprising 40 mg of atorvastatin has a T/R ratio of from 90% to 110%, wherein T is a ln-transformed AUC0-t-value of the dose after administration to a human, and wherein R is a ln-transformed AUC0-t-value of a tablet comprising 40 mg atorvastatin after administration to the human. 10. A method for lowering a cholesterol level in a human, comprising administering a therapeutically effective amount of the aqueous suspension of claim 1 to a human in need thereof. 11. The method of claim 10, wherein the therapeutically effective amount of the aqueous suspension of comprises 40 mg atorvastatin.