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A nasal composition containing sea water as stability-improving excipient

A technology of composition and stability, applied in the direction of active ingredients of heterocyclic compounds, medical preparations of non-active ingredients, medical preparations containing active ingredients, etc. Stability and other issues

Inactive Publication Date: 2017-10-13
JADRAN GALENSKI LAB D D
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0018] However, in this document, the effect of seawater on the chemical stability of xylometazoline hydrochloride is not studied or even mentioned

Method used

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  • A nasal composition containing sea water as stability-improving excipient
  • A nasal composition containing sea water as stability-improving excipient
  • A nasal composition containing sea water as stability-improving excipient

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0197] Preparation and Analysis of Pure Seawater

[0198] Pure seawater is produced by pumping natural seawater from specific geographical locations in Plomorsk-Granska County (HR). Raw seawater is filtered through clean sea sand columns to remove all mechanical impurities and marine life. In addition, the seawater thus filtered undergoes a two-step filtration process:

[0199] (1) filtered through a 10m filter; and

[0200] (2) Sterile filtration through a 0.2m filter.

[0201] The purified seawater thus obtained is sterile and suitable for the production of medicinal nasal products similar to those of the present invention. Pure seawater was analyzed by ion chromatography and the specifications of the products for the composition of relevant cations and anions are given in Table 1.

Embodiment 2

[0203] Preparation of control composition without nasal drops of purified sea water

[0204] 85% glycerol (2.73 g; 2.73% w / w) was added to purified seawater (80.00 g; 80% w / w) and stirred for 5 minutes to make it homogeneous. Then, disodium edetate (0.05 g; 0.05% w / w) was added and stirred for 5 minutes to dissolve. Afterwards, xylometazoline hydrochloride (1; 0.05 g; 0.05% w / w) was added and stirred for 5 minutes to dissolve. Then, ipratropium bromide (2; 0.063 g; 0.063% w / w; corresponding to 0.06% w / w anhydrous ipratropium bromide) was added and stirred for 5 minutes to dissolve. The solution thus obtained was filtered through a 1.2 m polypropylene (PP) filter.

[0205] Determine the pH of the solution thus prepared and correct the pH to within the specified pH range (3 to 7) by adding any dilution (0.1 mol / dm3) of hydrochloric acid (HCl) or sodium hydroxide (NaOH) , such as a pH of 6 or 4. The synthesized solution was further diluted with purified water up to a total we...

Embodiment 3

[0208] The preparation of the composition of nasal drop form among the present invention

[0209] Filter pure seawater through a 0.2m resin bonded glass fiber filter. Filtered purified seawater (10.00 g; 10% w / w) and 85% glycerin (2.73 g; 2.73% w / w) were added to purified water (80.00 g; 80% w / w), and stirred for 5 minutes to allow uniform. The solution thus obtained was filtered through a 1.2 m polypropylene (PP) filter. Then, disodium edetate (0.05 g; 0.05% w / w) was added and stirred for 5 minutes to dissolve. Afterwards, xylometazoline hydrochloride (1; 0.05 g; 0.05% w / w) was added and stirred for 5 minutes to dissolve. Then, ipratropium bromide (2; 0.063 g; 0.063% w / w; corresponding to 0.06% w / w anhydrous ipratropium bromide) was added and stirred for 5 minutes to dissolve. The solution thus obtained was filtered through a 1.2 m polypropylene (PP) filter.

[0210]Then, determine the pH of the solution thus prepared. Afterwards, the pH was corrected to 6 by adding any...

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Abstract

The invention discloses a nasal composition of improved stability, their use, and process for production. The nasal composition consists of: xylometazoline hydrochloride (1), 0.01-0.1% w / w; ipratropium bromide (2), 0.01-0.1% w / w; and pharmaceutical excipients required to form final dosage forms selected from the group consisting of: nasal drops, liquid nasal sprays, or nasal washes. Said nasal composition comprises the content of purified sea water as functional, stability-improving excipient, in amounts of 5-25% w / w. A nasal composition has osmolality within the range 270-820 mOsm / kg, the pH value within the range 3-7, preferably within the range 3-4.2 or 5.8-7.0, and most preferably within the range 3.2-4.2 where shows improved stability.

Description

technical field [0001] The invention belongs to the technical field of nasal medicines, in particular to a nasal composition which uses seawater as an excipient to improve stability. Background technique [0002] The technical problem concerns the stability of xylometazoline hydrochloride (1) and ipratropium bromide (2) in nasal pharmaceutical compositions. [0003] [0004] Nasal compositions are usually based on extremely dilute aqueous solutions, often requiring the addition of various excipients with co-solvents, muscular modulators, buffers, preservatives, antioxidants, stabilizers, suspending agents, chelating agents , pH adjuster, penetration enhancer, surfactant and wetting agent. These media will more or less significantly accelerate the chemical degradation of active pharmaceutical ingredients such as Xyllozoline hydrochloride, especially ipratropium bromide, making the active pharmaceutical ingredients easy to hydrolyze. These processes often result in non-co...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/415A61K31/46
CPCA61K9/0043A61K9/0046A61K31/4174A61K31/46A61K47/46A61K2300/00
Inventor 兹德拉夫卡·科内泽维奇妮娜·波波维奇西尔维娅·卡姆波马里纳·马福里纳克
Owner JADRAN GALENSKI LAB D D
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