IP Library › Patent Application 17884045
Patent Application
App. No. 17/884,045

FORMULATIONS OF MAZINDOL

Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US None
App. No.
17/884,045
Abstract

Formulations of mazindol having superior stability and methods of administering same are provided. The formulations may be immediate, enhanced, or otherwise delayed release formulations of mazindol.

Claims (16)

1 .- 23 . (canceled)

24 . A pharmaceutical formulation, comprising:

(a) an immediate release (IR) component comprising:

(1) an immediate release core comprising mazindol intermixed with an acidifying agent; and

(2) a seal coat surrounding the immediate release core;

(b) a delayed-release (DR) component comprising:

(1) an immediate release or extended release core comprising mazindol intermixed with an acidifying agent;

(2) a seal coat surrounding the immediate release or extended core; and

(3) a delayed release coating surrounding the seal coat comprising 5% to 99% by weight of a pH dependent polymer selected from the group consisting of poly(methyl acrylate-co-methyl methacrylate-co-methacrylic acid), poly(methacrylic acid-co-methyl methacrylate), hydroxypropyl methylcellulose acetate succinate, hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, shellac, zein, and combinations thereof;

wherein the IR component comprises a plurality of immediate release tablets and the DR component comprises a plurality of delayed release tablets, and

wherein the formulation exhibits a predicted maximum plasma concentration (C max ) of mazindol between 3.5 and 6.5 hours after administration.

25 . The formulation of claim 24 , wherein the formulation comprises from 0.1 mg to 10 mg of mazindol.

26 . The formulation of claim 24 , wherein the formulation exhibits a predicted maximum plasma concentration (C max ) of mazindol at about 5.0+/−30% hours after administration.

27 . The formulation of claim 24 , wherein the formulation exhibits a predicted maximum plasma concentration (C max ) of mazindol between 5 and 6 hours after administration.

28 . The formulation of claim 24 , wherein the seal coat is a hypromellose polymer containing natural wax.

29 . The formulation of claim 24 , wherein the predicted maximum plasma concentration is based on in silico modeling.