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Pharmaceutical composition comprising risedronic acid or a salt thereof and vitamin D

A technology of risedronic acid and its composition, which is applied in the field of pharmaceutical compositions containing risedronic acid or its salt and vitamin D, and can solve problems such as difficulty in ensuring content balance, lack of specific disclosure, and low stability of dosage forms , to achieve excellent stability, enhance homeostasis, and inhibit bone resorption

Inactive Publication Date: 2011-08-10
HANLIM PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Although the above existing literature discloses the mixed composition of alendronate and vitamin D compound, there is no specific disclosure whether it can be applied to other bisphosphonates (such as risedronic acid or its salts)
In addition, when preparing oral preparations including vitamin D and bisphosphonates, the content of vitamin D is relatively small compared to the content of bisphosphonates, so not only is it difficult to ensure the balance of the content during the preparation process, but there are also Difficulty in formulating and low stability of the obtained dosage form caused by oily vitamin D

Method used

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  • Pharmaceutical composition comprising risedronic acid or a salt thereof and vitamin D
  • Pharmaceutical composition comprising risedronic acid or a salt thereof and vitamin D
  • Pharmaceutical composition comprising risedronic acid or a salt thereof and vitamin D

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1 to 5

[0031] Tablets containing risedronate sodium and cholecalciferol were prepared according to the ingredient contents in Table 1 below.

[0032] In a double cone mixer (ERWEKA Gmbh, Germany), risedronate sodium (contents in Table 1 are expressed as anhydrous content), cholecalciferol, lactose monohydrate (lactose monohydrate), microcrystalline cellulose Mix for about 10 minutes. After the crospovidone was added to the above mixture and mixed for about 5 minutes, the magnesium stearate was added and mixed for about 5 minutes. The resulting mixture was compressed at 217 mg / tablet using a tablet machine (FETTA Perfecta 1, Germany). The coating solution was prepared by using hypromellose, polyethylene glycol 6000, titanium dioxide, talcum powder, iron oxide yellow, and iron oxide red. Coating the above-prepared non-coated tablet with the above-prepared coating solution in a coating machine and then drying to obtain a tablet with a coating layer formed. The resulting tablets had a...

Embodiment 6 to 9

[0037] Soft capsules comprising risedronate sodium and cholecalciferol were prepared according to the ingredients and contents in Table 2 below.

[0038] Mix risedronate sodium (the content in Table 1 indicates the content as anhydrous), cholecalciferol, soybean oil, hydrogenated coconut oil, yellow wax, and lecithin, and then use a homogenizer (Homogenizer) to make the mixture uniform, A content solution was obtained. Gelatin or succinylated gelatin, mixed concentrated glycerin, 70% sorbitol solution, purified water, yellow No. 5, yellow No. 203, and titanium dioxide are prepared to obtain the soft capsule capsule material solution. In a continuous soft capsule filling machine, the above-prepared soft capsule material solution is used to fill the content solution obtained above, and dry to prepare soft capsules. The average amount of internal solution contained in each capsule of the prepared soft capsule is about 135 mg.

[0039] Table 2

[0040]

[0041]

experiment example 1

[0042] Experimental example 1 Disintegration test

[0043] Under the following conditions, disintegration experiments were carried out on the tablets and capsules prepared in Examples 1 to 9.

[0044] (1) Disintegration test conditions

[0045] Specimen: 6 tablets or 6 capsules

[0046] Disintegration fluid: water

[0047] Temperature: 37.0±0.5℃

[0048] (2) Disintegration test results

[0049] Disintegration test results in water: all the tablets of Examples 1 to 5 were disintegrated within 5 minutes, and all the soft capsules of Examples 6 to 9 were disintegrated within about 30 minutes.

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Abstract

The present invention provides a pharmaceutical composition for preventing or treating osteoporosis, comprising risedronic acid or a salt thereof and vitamin D. Further, the present invention provides an oral tablet obtained by tableting a mixture of risedronic acid or a salt thereof and granular vitamin D; and an oral capsule obtained by uniformly distributing risedronic acid or a salt thereof and vitamin D among the mixed solvent of soybean oil and hydrogenated coconut palm oil and filling a capsule with the resultant material.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing risedronic acid or its salt and vitamin D, which is used for preventing or treating osteoporosis. The invention also relates to an oral tablet and a capsule capable of maintaining the balance and stability of the contents of risdronic acid or its salt and vitamin D. Background technique [0002] The chemical name of risedronic acid is 2-(3-pyridyl)-1-hydroxyethane-1,1-bisphosphonic acid, which is used for the treatment and prevention of postmenopausal osteoporosis and Drugs used to maintain or enhance bone density in male and female patients receiving long-term corticosteroid treatment (systemic corticosteroid treatment). It is known that risedronic acid has salts in various forms including risedronate sodium, and risedronate sodium can exist in various forms such as anhydrate, monohydrate, and 2.5 hydrate, and has multiple A polymorph (International Patent Publication No. WO2003 / 086355...

Claims

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Application Information

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IPC IPC(8): A61K31/663
CPCA61K45/06A61K31/593A61K9/00A61K31/663A61P19/10A61K2300/00A61K9/48A61K31/59
Inventor 金真善李槿赫柳宗铉金载臣
Owner HANLIM PHARMA CO LTD
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