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New nasal spray formulation of calcitonin aqueous solution

A technology of calcitonin and aqueous solution, applied in the field of preparation, can solve problems such as low bioavailability

Active Publication Date: 2009-10-07
BEIJING SL PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] According to the patent of calcitonin spray for nasal administration, citrate is used as stabilizer and penetration enhancer, and its reported bioavailability is still low, being 13.36±3.38% (Chinese patent CN 01807605.X)

Method used

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  • New nasal spray formulation of calcitonin aqueous solution

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Example 1 Take 777 mg of salmon calcitonin and dissolve it with water for injection to make a solution containing 2.22 mg / ml of salmon calcitonin; add 3.5 g of benzze, 3.5 g of disodium edetate, and 25.07 g of disodium hydrogen phosphate , sodium chloride 31.5g, 5% benzalkonium bromide solution 7ml are dissolved in 80% water for injection, adjust the pH value to 3.7 with phosphoric acid, mix, filter and sterilize with a 0.45 μm filter membrane, add water for injection to 3500ml, that is have to.

Embodiment 2

[0058] Example 2 Take 777 mg of salmon calcitonin and dissolve it with water for injection to make a solution containing 2.22 mg / ml of salmon calcitonin; 3.5 g of Benze, 3.5 g of disodium edetate, and 25.07 g of disodium hydrogen phosphate , 3.5mg aprotinin, 31.5g sodium chloride, 7ml 5% benzalkonium bromide solution dissolved in 80% water for injection, adjust the pH value to 3.7 with phosphoric acid, mix, filter with a 0.45μm filter membrane, add Water for injection to 3500ml, that is.

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PUM

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Abstract

The invention relates to a new nasal spray formulation of a calcitonin aqueous solution, belonging to the technical field of formulations. By the screening of various auxiliary materials, the invention obtains a composition different from that reported in any literature documents from a plurality of prescriptions and applications thereof in preparing medicaments for treating osteoporosis, Paget disease, malignant hypercalcemia and the like. The main composition ingredients of the new formulation comprise 0.05-1mg / ml of calcitonin, 10-50mmol / L of phosphate buffer, 0.5-50mmol / L of disodium ethylene diamine tetraacetate, 0.06-2ug / ml of trasylol, 0.5-2 percent of sodium chloride or 0.5-10 percent of mannite, 0.01-5 percent of brij and 0.01-0.2 percent of benzalkonium bromide, thus preparing the formulation with unit volume being 0.1-10ml.

Description

technical field [0001] The invention belongs to the technical field of preparations, in particular to a new aqueous solution nasal spray preparation of calcitonin. Background technique [0002] Calcitonin belongs to the class of polypeptide hormones and is used in the treatment of osteoporosis, Paget's disease and malignant hypercalcemia. Calcitonin can be extracted from a variety of sources, including salmon, eel, pig and human. The calcitonin whose amino acid sequence is the same as the natural form can be prepared by chemical synthesis and recombinant technology. [0003] There are three types of calcitonin commercially available in China: injection, freeze-dried powder injection, and nasal liquid spray, and three routes of administration: subcutaneous injection, intramuscular injection, and nasal spray. Among them, nasal administration dosage forms have stronger applicability due to their convenience and good compliance, and have occupied more and more market shares in...

Claims

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Application Information

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IPC IPC(8): A61K38/23A61K47/24A61K47/42A61K9/12A61P19/10A61P3/14A61K47/18A61K47/26A61K47/40
Inventor 徐明波陈遥李振武刘成东窦学义白玉倩史强张甲鹏王俊玲吴彦卓
Owner BEIJING SL PHARMA
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