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A new aqueous solution nasal spray formulation of calcitonin

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

Active Publication Date: 2011-12-28
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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  • A new aqueous solution nasal spray formulation of calcitonin
  • A new aqueous solution nasal spray formulation of calcitonin
  • A new aqueous solution nasal spray formulation of calcitonin

Examples

Experimental program
Comparison scheme
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Embodiment 1

[0057] Prescription 1 Take 777 mg of salmon calcitonin and dissolve it in 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, 25.07 g of disodium hydrogen phosphate, Dissolve 31.5g of sodium chloride and 7ml of 5% benzalkonium bromide solution in 80% water for injection, adjust the pH value to 3.7 with phosphoric acid, mix, filter and sterilize with a 0.45μm filter membrane, add water for injection to 3500ml, and obtain .

Embodiment 2

[0059] Prescription 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; add 3.5 g of benzze, 3.5 g of disodium edetate, 25.07 g of disodium hydrogen phosphate, Dissolve 3.5mg of aprotinin, 31.5g of sodium chloride, and 7ml of 5% benzalkonium bromide solution in 80% water for injection, adjust the pH value to 3.7 with phosphoric acid, mix, filter and sterilize with a 0.45μm filter membrane, and add additional injection Water to 3500ml, that is.

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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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Patent Type & Authority Patents(China)
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