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Enhancing photostabilization of oxymetazoline

A technology of oxymetazoline and composition, applied in the field of light-stable composition, capable of solving problems such as reducing exposure level

Inactive Publication Date: 2011-01-19
SCHERING PLOUGH HEALTHCARE PRODUCTS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, minimizing exposure levels in formulations alone is not always sufficient to prevent significant photochemical reactions

Method used

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  • Enhancing photostabilization of oxymetazoline
  • Enhancing photostabilization of oxymetazoline
  • Enhancing photostabilization of oxymetazoline

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] combination

[0052] Using the Mcllvaine buffer system (Solutions I-III), 0.05% (w / v) oxymetazoline HCl solutions with pH ranging from 4 to 6 were prepared. The compositions used for the test solutions are listed in Table 1. At each pH level, 0.05% oxymetazoline HCl solutions containing either povidone 29-32 (approximately 3% w / v) or PEG 1450 (approximately 5% w / v) were also prepared (solutions IV-VIII) .

[0053] The compositions are prepared by conventional means by intimately mixing the ingredients, at room temperature or elevated temperature, in order for the ingredients to achieve their solubility where appropriate.

[0054] Table 1: Composition of Oxymetazoline HCl Solutions Prepared with Mcllvaine Buffer (pH Range: 4-6)

[0055]

[0056]

Embodiment 2

[0058] Photostability of the example embodiments was tested according to the method described in ICH Harmonized Tripartite Guidelines Stability Testing: Photostability Testing of New Drug Substances and Products sex. Each sample used for the photostability study was placed in a sealed quartz container and exposed to the exposure required by the ICH photostability guidelines (total exposure was 2.4 million lux hours and the integrated amount was close to UV energy for 400 Wh / m2) twice.

[0059] result

[0060] Table 2: Photostability of Oxymetazoline HCl in Mcllvaine buffer (pH range: 4-6)

[0061]

[0062] Table 3: Photostability of Oxymetazoline HCl in Mcllvaine buffer (pH range: 4-6) with addition of povidone K29-32 (approximately 3% w / v).

[0063]

[0064] Table 4: Photostability of Oxymetazoline HCl in Mcllvaine buffer (pH range: 4-6) with addition of PEG 1450 (about 5% w / v).

[0065]

[0066] All observed oxymetazoline HCl degradation peaks were calculated ...

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PUM

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Abstract

The photostability of oxymetazoline in a topical decongestant composition is enhanced by lowering the pH of the composition using a buffer solution.

Description

field of invention [0001] The field of the invention relates to topical decongestants, and more specifically to compositions for enhancing the photostability of oxymetazoline and methods of treatment using them. Background of the invention [0002] Many pharmaceutically active agents are susceptible to photodegradation when exposed to ultraviolet light. Generally, the incorporation of light absorbers into the formulation can stabilize these light sensitive drugs to some extent. For example, N. Jamil et al. "Studies of the photostability of reserpine in parenteral solutions (Studies of the photostability of reserpine in parenteral solutions)", Die Pharmazie, 38: 467-469 (1983) mentioned that the gastrointestinal The photostability of reserpine in external preparations and the effect of some commonly used stabilizers were studied. US Patent No. 6,379,697 to Gregoriadis et al., entitled "Stabilization of photosensitive materials," mentions liposomes containing a photosensitiv...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/4174A61P11/02A61K47/10A61K47/32
CPCA61K9/0043A61K47/32A61K47/10A61K31/4174A61P11/02A61P37/08A61P9/00
Inventor N·金H·W·常
Owner SCHERING PLOUGH HEALTHCARE PRODUCTS INC
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