CN-121971487-A - Pharmaceutical composition containing iron-acacia complex and preparation method thereof

Abstract

The application discloses a pharmaceutical composition taking an iron-acacia compound as an active ingredient, a dosage form (especially a tablet) and a preparation method thereof.

Inventors

• ZHAO HAIXIA
• LIU DONGYING
• TIAN BIN
• LI JIALIANG
• SHU CHUTIAN
• LI FANG
• WANG FENG

Assignees

• 礼邦医药(江苏)股份有限公司

Dates

Publication Date

20260505

Application Date

20260209

Claims (10)

1. 1. A pharmaceutical composition comprising an iron-acacia complex and a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carrier is selected from one or more of the group consisting of excipients, binders, disintegrants and lubricants.
2. 2. A pharmaceutical composition comprising at least 50% (w/w) acacia-iron oxyhydroxide and 10% to 35% (w/w) microcrystalline cellulose.
3. 3. A method of preparing the pharmaceutical composition of any one of the preceding claims, the method comprising: (a) Weighing acacia-ferric hydroxide, excipient, binder and disintegrating agent, mixing, and sieving; (b) Adding a lubricant to the mixture obtained in step (a) and then continuing mixing; (c) Tabletting the mixture obtained in step (b).
4. 4. A tablet prepared according to the method of claim 3.
5. 5. Use of a pharmaceutical composition according to any one of claims 1-2 or a tablet according to claim 4 for the manufacture of a medicament for the treatment of excess liquid and salts.
6. 6. Use of a pharmaceutical composition according to any one of claims 1-2 or a tablet according to claim 4 for the manufacture of a medicament for adsorbing excess calcium, cholesterol, phosphate, potassium, sodium or toxins from infectious agents.
7. 7. Use of a pharmaceutical composition according to any one of claims 1-2 or a tablet according to claim 4 for the preparation of a elemental medical food for the treatment of abnormal mineral balance with elevated blood calcium, blood phosphate, blood potassium, blood sodium outside the normal range, hyperphosphatemia, hyperkalemia, hypercalcemia, hyperlipidemia or for adsorbing toxins from infectious agents in the gastrointestinal tract or for the treatment of abnormal metabolic parameters selected from glucose, insulin, GLP-1, glucagon, glycerol, triglycerides, cholesterol, NEFA and leptin levels.
8. 8. Use of the pharmaceutical composition of any one of claims 1-2 or the tablet of claim 4 in the preparation of a food supplement for mammals, wherein the food supplement is for treating abnormal mineral balance with elevated blood calcium, blood phosphate, blood potassium, blood sodium outside of normal ranges and for maintaining bone health, or for maintaining normal lipid profile and cardiovascular health, or for maintaining normal metabolic parameters selected from glucose, insulin, GLP-1, glucagon, glycerol, triglycerides, cholesterol, NEFA and leptin levels.
9. 9. Use of a pharmaceutical composition according to any one of claims 1-2 or a tablet according to claim 4 in the manufacture of a medicament for reducing blood phosphorus levels in a subject.
10. 10. Use of a pharmaceutical composition according to any one of claims 1-2 or a tablet according to claim 4 for the manufacture of a medicament for the treatment or prevention of a subject suffering from hyperphosphatemia.

Description

Pharmaceutical composition containing iron-acacia complex and preparation method thereof Technical Field The invention belongs to the field of pharmaceutical preparations, and in particular relates to a pharmaceutical composition taking an iron-acacia complex as an active ingredient, a pharmaceutical dosage form and a preparation method thereof. Background Iron-acacia complex (also called "complex"), such as acacia-iron oxyhydroxide, is a new generation of iron-phosphorus-containing binder, and by combining phosphate in gastrointestinal tract to reduce absorption of phosphate, thereby reducing phosphate level in circulatory system, and has the characteristics of high phosphorus binding force, no foreign odor, small expansion volume of digestive tract, and high patient compliance. The iron-acacia compound has the advantages of high particle density, high hardness, good fluidity, no caking property and poor compression forming property, so that the difficulty in tabletting is high, the daily dosage of the active ingredient is large, the weight of the medicinal preparation is increased after the iron-acacia compound is mixed with a large amount of auxiliary materials, and the medicine taking burden of patients can be increased. Therefore, most of the pharmaceutical preparations containing the active ingredient acacia-iron oxyhydroxide which are clinically applied at present are capsules. Compared with capsules, the tablet can be prepared by adopting various preparation technologies, and the preparation method can help manufacturers flexibly optimize the performance of the tablet through the selection of tablet components and the preparation process design. Meanwhile, the appearance of the tablet can be improved through coating, active ingredients are protected from external factors such as light, oxidation and moisture, and the stability of the preparation is improved. Accordingly, there is a need to invent an alternative tablet pharmaceutical composition for dose titration or to meet the needs of different patient populations for different dosages or dosage forms. Disclosure of Invention The present invention provides a novel pharmaceutical composition comprising an iron-acacia complex and a pharmaceutically acceptable carrier. The pharmaceutical composition can be prepared into tablets containing active ingredients with high drug loading, low production cost and high efficiency of manufacturing process. The tablets prepared based on the pharmaceutical composition of the present invention have excellent mechanical strength, disintegration properties and storage stability. Moreover, the tablet provided by the invention has physicochemical properties required for further amplified production, can be further combined with other pharmacologically active medicaments to form a medicinal composition, and can be effectively used in the medical field. The tablet provided by the invention has the advantages that the active substance ratio is high, so that the tablet is smaller in volume, convenient for patients to take, and improves the taking compliance of the patients. In addition, the preparation method adopts a powder direct tabletting process, has high efficiency in manufacturing process, good tablet strength and disintegration property, good tablet strength, stable and efficient production process and easy mass production, and can select a coating/non-coating mode. In one aspect, the invention provides a pharmaceutical composition comprising an iron-acacia complex and a pharmaceutically acceptable carrier. In some embodiments, wherein the pharmaceutically acceptable carrier is selected from one or more of the group consisting of excipients, binders, disintegrants, and lubricants. In another aspect, the invention provides a pharmaceutical composition comprising at least 50% (w/w) acacia-iron oxyhydroxide and 10% to 35% (w/w) microcrystalline cellulose. In another aspect, the invention provides a method of preparing a pharmaceutical composition according to the invention, the method comprising: (a) Weighing acacia-ferric hydroxide, excipient, binder and disintegrating agent, mixing, and sieving; (b) Adding a lubricant to the mixture obtained in step (a) and then continuing mixing; (c) Tabletting the mixture obtained in step (b). In another aspect, the invention provides a tablet prepared based on the process according to the invention. In another aspect, the invention provides the use of a pharmaceutical composition or tablet according to the invention for the manufacture of a medicament for the treatment of excess liquid and salt. In another aspect, the invention provides the use of a pharmaceutical composition or tablet according to the invention in the manufacture of a medicament for adsorbing excess calcium, cholesterol, phosphate, potassium, sodium or toxins from infectious agents. In another aspect, the invention provides the use of a pharmaceutical composition or tablet according to the invention for the pre