Specialized Hydrocortisone Formulations for Niche Environments

Publication ID: 24-11857555_0009_PTD
Published: October 28, 2025
Category:Specialized Variations & Niche Solutions

Legal Citation

pr1or.art Inc., “Specialized Hydrocortisone Formulations for Niche Environments,” Published Technical Disclosure No. 24-11857555_0009_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857555_0009_PTD
This technical disclosure describes improvements that would be readily apparent to a Person Having Ordinary Skill In The Art (PHOSITA) when considered in combination with the foundational architecture disclosed in U.S. Patent No. 11,857,555.

Summary of the Inventive Concept

This inventive concept adapts the original aqueous pharmaceutical formulation of hydrocortisone sodium phosphate and monothioglycerol for specific, high-stakes scenarios, such as disaster relief, high-security facilities, extreme weather conditions, and remote, off-grid locations.

Background and Problem Solved

The original patent provided a broad formulation for hydrocortisone sodium phosphate and monothioglycerol. However, these formulations may not be suitable for unique operational environments, such as disaster relief or high-security facilities, where specific packaging, storage, and administration requirements must be met. This inventive concept addresses these limitations by providing specialized formulations and systems tailored to these niche environments.

Detailed Description of the Inventive Concept

The new inventive concept encompasses a range of specialized formulations and systems that adapt the original aqueous pharmaceutical formulation to specific, high-stakes scenarios. For example, Claim 1 describes a system for emergency response, packaged in a waterproof container for use in disaster relief scenarios. Claim 2 outlines a method for treating allergic reactions in high-security facilities, using a controlled environment and intravenous injection. Claim 3 describes a portable kit for treating skin conditions in extreme weather conditions, featuring a waterproof storage container. Claim 4 outlines a system for co-administering hydrocortisone sodium phosphate and monothioglycerol in a sterile, hermetically-sealed environment, for use in high-security medical facilities. Claim 5 details a method for treating eczema in remote, off-grid locations, using a portable, solar-powered refrigeration unit.

Novelty and Inventive Step

The novelty of this inventive concept lies in its adaptation of the original formulation to specific, high-stakes scenarios, requiring unique packaging, storage, and administration considerations. The inventive step is in the recognition of the need for specialized formulations and systems in these niche environments and the development of solutions that address these specific requirements.

Alternative Embodiments and Variations

Alternative embodiments of this inventive concept could include formulations tailored to specific types of disasters (e.g., earthquake, hurricane, or wildfire relief), high-security facilities with varying levels of clearance, or extreme weather conditions (e.g., arctic, desert, or tropical environments). Variations could also include different modes of administration (e.g., oral, topical, or injectable) or alternative packaging materials (e.g., biodegradable or recyclable materials).

Potential Commercial Applications and Market

The commercial potential of this inventive concept lies in its ability to provide specialized solutions for high-stakes scenarios, addressing unmet needs in disaster relief, high-security facilities, extreme weather conditions, and remote, off-grid locations. Target industries could include pharmaceutical companies, medical device manufacturers, disaster relief organizations, and government agencies.

Field of Art

Pharmaceutical formulations, specifically aqueous steroid preparations with stabilizing agents, requiring expertise in pharmaceutical chemistry, drug delivery systems, and medical applications

Person of Ordinary Skill (PHOSITA) Profile

A pharmaceutical chemist or formulation specialist with advanced degree, experience in steroid drug development, knowledge of pharmaceutical stabilization techniques, and understanding of drug delivery variations

Obviousness Rationale

A PHOSITA would recognize that the source patent's hydrocortisone sodium phosphate formulation provides a foundational template for adapting pharmaceutical delivery to specialized environments. The PTD's variations represent predictable extensions of known pharmaceutical engineering principles, applying standard packaging, storage, and administration techniques to an established drug formulation. The core chemical composition remains substantially unchanged, with modifications focusing on contextual delivery methods.

Obvious Combinations & Variations

Source Patent Element
Aqueous pharmaceutical formulation with hydrocortisone sodium phosphate and monothioglycerol
PTD Variation
Packaging formulation in waterproof container for disaster relief scenarios
Obviousness Reasoning
Standard pharmaceutical packaging adaptation using known protective materials, representing a predictable design choice for maintaining drug stability in challenging environments
Source Patent Element
Intravenous administration method for hydrocortisone sodium phosphate
PTD Variation
Controlled environment administration in high-security facilities
Obviousness Reasoning
Routine modification of existing administration protocol, applying standard medical containment procedures to established injection technique
Source Patent Element
Topical application of hydrocortisone sodium phosphate
PTD Variation
Portable kit with solar-powered refrigeration for remote location treatment
Obviousness Reasoning
Predictable engineering solution combining known drug formulation with portable refrigeration technology, representing a standard approach to maintaining pharmaceutical integrity
Source Patent Element
Hydrocortisone sodium phosphate concentration ranges (130-140 mg/mL)
PTD Variation
Specialized formulation concentrations for extreme environmental conditions
Obviousness Reasoning
Routine optimization of existing concentration ranges through empirical testing, representing a standard pharmaceutical development approach
Source Patent Element
Base pharmaceutical formulation with stabilizing agents
PTD Variation
Alternative packaging materials like biodegradable containers
Obviousness Reasoning
Known material science technique of substituting packaging substrates while maintaining core pharmaceutical composition, representing a predictable design variation
35 U.S.C. § 103 Summary: Pursuant to 35 U.S.C. ยง 103, the variations disclosed in this publication would be obvious to a person having ordinary skill in pharmaceutical formulation arts, as they represent predictable extensions of the foundational teachings in US Patent 11857555, involving routine modifications to packaging, administration, and environmental adaptation of an established hydrocortisone sodium phosphate formulation.

Original Patent Information

Patent NumberUS 11,857,555
TitleAqueous pharmaceutical formulation of hydrocortisone sodium phosphate and monothioglycerol
Assignee(s)Antares Pharma, Inc.