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Minodronic acid tablets and preparation method thereof

A technology of minodronic acid tablets and minodronic acid, which is applied in the directions of pill delivery, pharmaceutical formulations, and medical preparations containing active ingredients, can solve problems such as poor patient compliance, uneven content, and gastric acid destruction, and achieve Convenient operation, simple preparation process, and the effect of improving water solubility

Active Publication Date: 2013-03-06
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Minodronic acid is almost insoluble in water, hydrochloric acid solution and phosphate buffered saline (pH6.8), so it is difficult to dissolve it in vitro by conventional techniques
[0005] Patent W09400462A1 discloses the prescription of minodronic acid preparation, which is made into tablets by adding lactose, cornstarch, 10% hyprolose aqueous solution and magnesium stearate, but the dissolution effect in vitro is not ideal;
[0006] Patent CN102114025A discloses a technology to micronize the minodronic acid raw material to increase the dissolution rate of minodronic acid, but after the raw material is micronized, it is easier to aggregate, which increases the difficulty of mixing and easily causes uneven content;
[0007] Patent CN102078323A discloses a technology, adding additives such as sodium carbonate to the minodronic acid preparation to improve the dissolution rate of the drug, but sodium carbonate has a strong alkalinity, which has a destructive effect on gastric acid and poor patient compliance

Method used

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  • Minodronic acid tablets and preparation method thereof
  • Minodronic acid tablets and preparation method thereof
  • Minodronic acid tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1 Preparation of Minodronic Acid Tablets

[0028] 1 minodronic acid tablet prescription

[0029]

[0030] 2 Preparation process

[0031] (1) The prescription quantity takes by weighing mannitol and cross-linked povidone with 100 mesh sieves, mixes them evenly, and sets aside;

[0032] (2) Dissolve the prescribed amount of hydroxypropyl β-cyclodextrin in the aqueous solution, add the prescribed amount of minodronic acid, and stir to dissolve;

[0033] (3) Add all the solution of (2) into (1), granulate, dry, add magnesium stearate, and press into tablets to obtain the product.

Embodiment 2

[0034] Example 2 Preparation of Minodronic Acid Tablets

[0035] 1 minodronic acid tablet prescription

[0036]

[0037] 2 Preparation process

[0038] (1) The prescription quantity is weighed lactose and starch that have passed through a 100-mesh sieve, mixed evenly, and set aside;

[0039] (2) Dissolve the prescribed amount of hydroxypropyl β-cyclodextrin in water, add the prescribed amount of minodronic acid, and stir to dissolve;

[0040] (3) Add all the solution of (2) into (1), granulate, dry, add magnesium stearate, and press into tablets to obtain the product.

Embodiment 3

[0041] Example 3 Preparation of Minodronic Acid Tablets

[0042] 1 minodronic acid tablet prescription

[0043]

[0044] 2 Preparation process

[0045] (1) The recipe quantity takes microcrystalline cellulose and sodium carboxymethyl starch that have been passed through a 100-mesh sieve and mixes them uniformly for subsequent use;

[0046] (2) Dissolve the prescribed amount of hydroxypropyl β-cyclodextrin in water, add the prescribed amount of minodronic acid, and stir to dissolve;

[0047] (3) Add all the solution of (2) into (1), granulate, dry, add talcum powder, and press into tablets to obtain the product.

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PUM

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Abstract

The invention belongs to the field of pharmaceutical preparation, and specifically relates to minodronic acid tablets and a preparation method thereof. With large amounts of experiments, proportions of auxiliary materials and hydroxypropyl beta-cyclodextrin are determined, and tablets containing minodronic acid and hydroxypropyl beta-cyclodextrin are prepared. The tablets are composed of minodronic acid, hydroxypropyl beta-cyclodextrin, a filling material, a disintegrating agent, a lubricant, and other pharmaceutically acceptable auxiliary materials. During a preparation process, hydroxypropyl beta-cyclodextrin and minodronic acid are added in a water solution form into mixed powder of the filling material and the disintegrating agent. The dissolution rate of the tablets provided by the invention is substantially improved, such that rapid dissolution and absorption of minodronic acid in gastrointestinal-tract bodily fluids is facilitated. The preparation process is simple, and operation is convenient, such that the method is suitable for industrialized productions.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a minodronic acid tablet and a preparation method thereof. Background technique [0002] Osteoporosis is a group of bone diseases caused by various reasons. At present, there are about 200 million people suffering from osteoporosis in the world. . [0003] Minodronic acid is the third-generation nitrogen-containing aromatic heterocyclic bisphosphate, which inhibits the activity of farnesyl pyrophosphate synthase in osteoclasts, inhibits bone resorption of osteoclasts, reduces bone turnover, and prevents osteoporosis The effect of this product was jointly developed by Japan Ono Pharmaceutical Co., Ltd. and Japan Astellas Pharmaceutical Co., Ltd., and was approved by the Ministry of Health and Welfare of Japan on January 21, 2009 for listing in Japan. [0004] Minodronic acid is almost insoluble in water, hydrochloric acid solution and phosphate buffered sal...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/675A61K47/40A61P19/10
Inventor 赵志全郝贵周程战立
Owner SHANDONG NEWTIME PHARMA
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