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Composite capsules comprising raloxifene, and vitamin D or its derivatives

A technology of compound capsules and vitamins, applied in the directions of capsule delivery, microcapsules, drug combination, etc., can solve the problems of poor biochemical stability and inability to guarantee stability.

Active Publication Date: 2017-09-26
HANMI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Cholecalciferol (vitamin D 3 ) also have poor biochemical stability and may not guarantee stability over time

Method used

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  • Composite capsules comprising raloxifene, and vitamin D or its derivatives
  • Composite capsules comprising raloxifene, and vitamin D or its derivatives
  • Composite capsules comprising raloxifene, and vitamin D or its derivatives

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] Embodiment 1: Preparation I of compound preparation

[0068] Povidone K30 (Povidone K30) and polysorbate 80 (Polysorbate80) shown in Table 1 were dissolved in ethanol and distilled water to obtain a binder solution. The other ingredients of Table 1 were mixed, then wet granulated with a binder solution, then sieved through a sieve with a mesh size of 30, and dried to obtain dry granules. The resulting dried raloxifene granules were compressed with a round punch having a diameter of about 5.5 mm to prepare raloxifene tablets. Next, Opadry White was dissolved in distilled water and ethanol to prepare a coating solution, and then the raloxifene tablet was coated with the coating solution.

[0069] The ingredients of the cholecalciferol-containing layer of Table 2 were mixed together and then compressed to obtain cholecalciferol tablets. Opadry White and Blue No. 2 colorants were dissolved in distilled water and ethanol to obtain a coating solution, and then cholecalcif...

Embodiment 2

[0076] Embodiment 2: the preparation II of compound preparation

[0077] A composite capsule comprising 60 mg of raloxifene and 800 IU of cholecalciferol was prepared in the same manner as in Example 1, except that a hard capsule comprising hypromellose as a main material was used.

Embodiment 3

[0078] Embodiment 3: the preparation III of compound preparation

[0079] A composite capsule comprising 60 mg of raloxifene and 800 IU of cholecalciferol was prepared in the same manner as in Example 1, except that a hard capsule comprising pullulan as a main material was used.

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Abstract

A composite capsule and a method of preparing the same are provided. The composite capsule includes: a raloxifene separate layer including raloxifene or a pharmaceutically acceptable salt thereof; and a vitamin D separate layer including vitamin D or a derivative thereof, wherein the raloxifene separate layer and the vitamin D separate layer are separated from one another in the composite capsule.

Description

technical field [0001] The present invention relates to a composite capsule comprising raloxifene or a pharmaceutically acceptable salt thereof and vitamin D or a derivative thereof, a composite capsule having improved patient compliance and improved stability of active ingredients, and the composite capsule method of preparation. Background technique [0002] Osteoporosis is a skeletal disease pathologically characterized by an absolute decrease in bone resorption, known to result from an imbalance in overall bone loss resulting from osteoporosis. Bone mineral density (BMD), which is a major determinant of osteoporosis, reaches its maximum level at the age of 20 years, then gradually decreases and sharply decreases after menopause. The sharp decline after menopause has been attributed to: loss of calcium balance due to increased calcium loss due to postmenopausal estrogen deficiency, decreased intestinal calcium absorption, insufficient calcium intake, etc. For the treatm...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/593A61K9/48A61P19/08A61P35/00A61P19/10A61K31/4535
CPCA61K9/5084A61K31/4535A61K31/593A61K2300/00A61K9/1652A61K9/2054A61K9/209A61K9/4808A61P19/08A61P19/10A61P35/00A61K9/2086
Inventor 金永勋权宅灌朴镇泳尹承彬朴宰贤禹钟守金用镒
Owner HANMI PHARMA
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