Pharmaceutical composite formulation comprising proton pump inhibitor and antacid, and method for preparing same
Provided are a pharmaceutical composite formulation and a method of preparing the same, the pharmaceutical composite formulation including: a first layer containing, as an active ingredient, a proton pump inhibitor or a pharmaceutically acceptable salt thereof and a lubricant, and a second layer containing, as an active ingredient, an antacid selected from magnesium hydroxide, magnesium oxide, and a mixture thereof.
1 . A pharmaceutical composite formulation comprising:
a first layer comprising, as an active ingredient, a proton pump inhibitor or a pharmaceutically acceptable salt thereof, a lubricant, and a binder; and
a second layer comprising, as an active ingredient, an antacid that is magnesium hydroxide,
wherein the proton pump inhibitor or a pharmaceutically acceptable salt thereof is esomeprazole or a pharmaceutically acceptable salt thereof,
wherein the lubricant in the first layer is sodium stearyl fumarate, wherein the lubricant is comprised in an amount of 3.7 percent by weight (wt %) to 5.5 wt % based on the total weight of the first layer,
wherein the binder is hydroxypropyl cellulose, wherein the binder is comprised in an amount of 1 wt % to 20 wt % based on the total weight of the first layer,
wherein the first layer comprising the proton pump inhibitor or a pharmaceutically acceptable salt thereof, the lubricant, and the binder is in a form of granules, and
wherein when a total weight of the first layer is 1 part by weight, a total weight of the second layer is 1.58 to 3.2 parts by weight.
2 . The pharmaceutical composite formulation of claim 1 , wherein the composite formulation is a tablet or a capsule.
3 . The pharmaceutical composite formulation of claim 1 , wherein the composite formulation is a double-layer tablet having a length ratio of major axis:minor axis of 1:1 to 2.3:1.
4 . The pharmaceutical composite formulation of claim 1 , wherein the first layer further comprises any one selected from the group consisting of a diluent, a disintegrant, and any mixture thereof.
5 . The pharmaceutical composite formulation of claim 1 , wherein the second layer further comprises any one selected from the group consisting of a diluent, a disintegrant, a fluidizing agent, a lubricant, and any mixture thereof.
6 . The pharmaceutical composite formulation of claim 1 , wherein when a mixed solution of 150 mL of 0.1 N HCl and 450 mL of purified water is tested under conditions of 75 rpm and 37±0.5° C. according to the second paddle method of the US Pharmacopoeia (USP) dissolution test item, a dissolution rate of the proton pump inhibitor for 60 minutes is 55% or higher.
7 . A method of preparing the pharmaceutical composite formulation of claim 1 , the method comprising:
preparing a first layer mixed part comprising, as an active ingredient, a proton pump inhibitor or a pharmaceutically acceptable salt thereof, a lubricant, and a binder; and
preparing a second layer mixed part comprising, as an active ingredient, an antacid that is magnesium hydroxide; and
tableting the first layer mixed part and the second layer mixed part,
wherein the preparing of the first layer mixed part comprises a granulation process,
wherein the proton pump inhibitor or a pharmaceutically acceptable salt thereof is esomeprazole or a pharmaceutically acceptable salt thereof,
wherein the lubricant in the first layer is sodium stearyl fumarate, wherein the lubricant is comprised in an amount of 3.7 percent by weight (wt %) to 5.5 wt % based on the total weight of the first layer,
wherein the binder is hydroxypropyl cellulose, wherein the binder is comprised in an amount of 1 wt % to 20 wt % based on the total weight of the first layer,
wherein the first layer comprising the proton pump inhibitor or a pharmaceutically acceptable salt thereof, the lubricant, and the binder is in a form of granules, and
wherein when a total weight of the first layer is 1 part by weight, a total weight of the second layer is 1.58 to 3.2 parts by weight.