Stabilization of Phenobarbital Sodium for Injection in Specialized Environments
Legal Citation
Summary of the Inventive Concept
The inventive concept adapts the stabilization of phenobarbital sodium for injection to meet the unique demands of high-altitude, disaster relief, extreme weather, high-security, and remote or resource-limited environments.
Background and Problem Solved
The original patent addressed the stabilization of phenobarbital sodium for injection, but it did not consider the specific challenges posed by specialized environments. The new inventive concept addresses these limitations by providing tailored solutions for these niche markets.
Detailed Description of the Inventive Concept
The inventive concept encompasses four specialized variations: 1) a system for stabilizing phenobarbital sodium in high-altitude environments, featuring a specially designed container to maintain pressure; 2) a method for reconstituting the lyophilized composition in disaster relief scenarios, with a focus on rapid administration; 3) a lyophilized composition adapted for extreme cold weather conditions, stored in a thermally insulated container; and 4) a system for stabilizing phenobarbital sodium in high-security facilities, utilizing a tamper-evident container. Additionally, the inventive concept includes a method for treating neonatal seizures in remote or resource-limited environments, incorporating a portable vital signs monitor.
Novelty and Inventive Step
The new inventive concept introduces novel features that adapt the stabilization of phenobarbital sodium for injection to specific, high-demand environments. The inventive step lies in the combination of the original patent's stabilization technology with specialized containers, reconstitution methods, and monitoring systems tailored to each niche market.
Alternative Embodiments and Variations
Alternative embodiments may include using different container materials or designs, modifying the reconstitution process, or incorporating additional monitoring systems. Variations could also involve adapting the inventive concept to other pharmaceutical compounds or medical conditions.
Potential Commercial Applications and Market
The inventive concept has significant commercial potential in the pharmaceutical industry, particularly in the areas of emergency medicine, disaster relief, and high-security facilities. The target markets include hospitals, emergency responders, and specialized medical facilities operating in challenging environments.
CPC Classifications
| Section | Class | Group |
|---|---|---|
| A | A61 | A61K9/19 |
| A | A61 | A61K9/08 |
| A | A61 | A61K31/515 |
| A | A61 | A61K47/10 |
| A | A61 | A61P25/08 |
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical formulation and drug delivery, specifically focused on lyophilized injectable pharmaceutical compositions, with expertise in stabilization techniques, pharmaceutical chemistry, and medical device design
Person of Ordinary Skill (PHOSITA) Profile
A pharmaceutical scientist or chemical engineer with advanced degree, experience in drug formulation, knowledge of stability testing, understanding of container design, and familiarity with specialized medical environments
Obviousness Rationale
A PHOSITA would recognize that the specialized environmental adaptations of the phenobarbital sodium lyophilized composition represent predictable variations of the source patent's core stabilization technology. The fundamental chemical composition remains substantially unchanged, with modifications primarily addressing container design, reconstitution methods, and deployment contexts. These adaptations represent standard engineering problem-solving approaches within pharmaceutical product development.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,683 |
|---|---|
| Title | Stabilization of phenobarbital sodium for injection |
| Assignee(s) | SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED |