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Compositions comprising ephedrine or an ephedrine salt and methods of making and using same

A composition and technology of ephedrine, applied in the field of composition containing ephedrine or ephedrine salt and its preparation and use, can solve the problems of stability not greater than 12 months, stability not greater than 60 days, etc.

Pending Publication Date: 2021-12-21
NEXUS PHARM INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Ephedrine sulfate prepared ready-to-use (e.g., pre-diluted) is known to be stable for not more than 60 days; ready-to-use formulations of other ephedrine salts are known to be stable for not more than 12 months

Method used

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  • Compositions comprising ephedrine or an ephedrine salt and methods of making and using same
  • Compositions comprising ephedrine or an ephedrine salt and methods of making and using same
  • Compositions comprising ephedrine or an ephedrine salt and methods of making and using same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0104] Example 1. Ready-to-use ephedrine sulfate composition.

[0105] The ready-to-use injectable composition of ephedrine sulfate is to pass ephedrine sulfate USP / EP powder (Lot # 18130597, Siegfried PharmaChemikalien, Minden Germany), sodium chloride USP / EP (Lot # 18804697, Merck & Co., Kenilworth, NJ) and water for injection were prepared in a 200L stainless steel vessel combined in the amounts shown in Table 1 below.

[0106] Table 1.

[0107] components Pharmacopoeia designation Amount per 10cc vial ephedrine sulfate USP / EP 50mg Sodium chloride USP / EP 90mg Water for Injection USP / EP Appropriate amount to 10mL

[0108] Sampling of two 20 mL vials of the mixed solution at this stage indicated that ephedrine sulfate was present in solution at 100.2%-102.2% of the expected 50 mg / mL amount. Bioburden testing of 200 mL of the mixed solution at this stage also showed acceptable levels of bioconstituents (0-0.1 CFU / mL).

[0109] Aft...

Embodiment 2

[0119] Example 2. Real-time stability of ready-to-use ephedrine sulfate compositions.

[0120]Prepared in each of 510 10-mL Type I flint glass vials (Gerresheimer / Bormioli) in a production facility employing standard production equipment, processes, personnel, and procedures consistent with the method disclosed in Example 1 10-mL ephedrine sulfate injection batches at 5 mg / mL were closed with 20 mm chlorobutyl fluoride-coated stoppers (West) and sealed with 20 mm flip-over aluminum crimp seals (Capsult). Ephedrine sulfate API was from Siegfried PharmaChemikalien Minden GmbH (Germany).

[0121] Vials were stored for 24 months in a controlled access, safety cabinet or safe room at 25+ / −2°C and 60+ / −5% relative humidity (RH) and removed for testing only. Some vials are stored upright, while others are stored upside down (eg, liquid in contact with vial closure). Samples are identified and records are kept in the Stability Study Log.

[0122] Vials were tested according to the ...

Embodiment 3

[0199] Example 3. Accelerated stability study of ready-to-use ephedrine sulfate compositions.

[0200] Prepared in each of 510 10-mL Type I flint glass vials (Gerresheimer / Bormioli) in a production facility employing standard production equipment, processes, personnel, and procedures consistent with the method disclosed in Example 1 10-mL ephedrine sulfate injection batches at 5 mg / mL were closed with 20 mm chlorobutyl fluoride-coated stoppers (West) and sealed with 20 mm flip-over aluminum crimp seals (Capsult). Ephedrine sulfate API was from Siegfried PharmaChemikalien Minden GmbH (Germany).

[0201] Vials were stored for 6 months in a controlled access, secure stable room at 40+ / -2°C and 75+ / -5% relative humidity (RH) and removed for testing only. Some vials are stored upright, while others are stored upside down (eg, liquid in contact with vial closure). Samples are identified and records are kept in the Stability Study Log.

[0202] Vials were tested according to the p...

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Abstract

The present disclosure provides compositions comprising ephedrine sulfate ready for immediate use in a clinical setting, and methods of making and using same.

Description

[0001] priority statement [0002] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 849,125, filed May 16, 2019, the entire contents of which are incorporated herein by reference and relied upon herein. Background technique [0003] Ephedrine sulfate ((1R,2S)-(–)-2-methylamine-1-phenylpropan-1-ol sulfate ((1R,2S)-(–)-2-methylamine-1-phenylpropan-1- ol sulfate)) is an alpha- and beta-adrenergic agonist and norepinephrine-releasing agent approved by the FDA for the treatment of clinically important (clinically important) hypothyroidism occurring in the anesthesia setting. blood pressure. However, all FDA-approved formulations must be diluted ten-fold before administration to patients. The need for a dilution step is inconvenient, delays the administration of needed therapeutic interventions, and introduces a significant source of danger of potential error in the clinical setting. Dilution just before administration also presents a signific...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/055A61K31/12A61K31/122
CPCA61K31/137A61K9/0019A61K47/02A61K9/08A61P9/02
Inventor 舍希德·艾哈迈德
Owner NEXUS PHARM INC