CLINICAL TRIALS PROFILE FOR SODIUM BICARBONATE IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for Sodium Bicarbonate In Plastic Container

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT01077076 ↗	Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED)	Completed	Bayer	Phase 3	2008-12-01	This randomized, crossover study is to evaluate the early effectiveness, defined as effect on intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional purposes are to: 1. provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the 1st, 4th, and 11th days of dosing with each of the indicated treatments; 2. compare Zegerid and Prilosec OTC for achieving their steady-state effects for controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing. 3. evaluate early effectiveness, defined as effect on intragastric pH during the first 4 hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid inhibition at steady-state when administered on the 11th day of dosing.
OTC	NCT04651088 ↗	Comparing Alkalinizing Agents Efficacy on Stone Risk in Patients on a Metabolically Controlled Diet	Not yet recruiting	University of Texas Southwestern Medical Center	Early Phase 1	2021-12-01	The purpose of this study is to compare over the counter and alternative prescription urinary alkalinizing agents to slow release potassium citrate in their ability to modify urinary parameters associated with stone formation.

All Clinical Trials for Sodium Bicarbonate In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00045799 ↗	Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill	Completed	Bausch Health Americas, Inc.	Phase 3	2002-05-01	Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.
NCT00045799 ↗	Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill	Completed	Valeant Pharmaceuticals International, Inc.	Phase 3	2002-05-01	Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.
NCT00130598 ↗	PROVOCATION Trial - PROphylactic intraVenOus Hydration for Contrast Agent Toxicity PreventION	Completed	Swiss National Science Foundation	Phase 2/Phase 3	2005-06-01	Contrast nephropathy (CN) remains a common complication of radiographic procedures and an important cause of hospital-acquired acute renal failure. Only hydration with saline is uniformly accepted and used in clinical practice as a cornerstone for the prevention of CN. But the optimal preventive strategy for CN is not known. Sodium bicarbonate might be even more effective than hydration with sodium chloride for prophylaxis of CN. Therefore the aim of the study is to evaluate the efficacy of two regimens of sodium bicarbonate compared with a prolonged infusion of sodium chloride in the prevention of CN. Primary endpoint: Decrease in glomerular filtration rate (GFR) within 48 hours.

Clinical Trial Conditions for Sodium Bicarbonate In Plastic Container

Condition Name

Condition Name for Sodium Bicarbonate In Plastic Container
Intervention	Trials
Acute Kidney Injury	16
Metabolic Acidosis	16
Contrast Induced Nephropathy	15

Condition MeSH

Condition MeSH for Sodium Bicarbonate In Plastic Container
Intervention	Trials
Kidney Diseases	48
Acute Kidney Injury	30
Renal Insufficiency, Chronic	23

Clinical Trial Locations for Sodium Bicarbonate In Plastic Container

Trials by Country

Trials by Country for Sodium Bicarbonate In Plastic Container
Location	Trials
United States	196
Italy	19
Brazil	14
Canada	13
Australia	13

Trials by US State

Trials by US State for Sodium Bicarbonate In Plastic Container
Location	Trials
California	13
Texas	13
Florida	11
Pennsylvania	11
North Carolina	11

Clinical Trial Progress for Sodium Bicarbonate In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Sodium Bicarbonate In Plastic Container
Clinical Trial Phase	Trials
Phase 4	72
Phase 3	40
Phase 2/Phase 3	14

Clinical Trial Status

Clinical Trial Status for Sodium Bicarbonate In Plastic Container
Clinical Trial Phase	Trials
Completed	138
Recruiting	31
Unknown status	30

Clinical Trial Sponsors for Sodium Bicarbonate In Plastic Container

Sponsor Name

Sponsor Name for Sodium Bicarbonate In Plastic Container
Sponsor	Trials
University of Colorado, Denver	5
Bausch Health Americas, Inc.	5
Valeant Pharmaceuticals International, Inc.	5

Sponsor Type

Sponsor Type for Sodium Bicarbonate In Plastic Container
Sponsor	Trials
Other	316
Industry	66
NIH	12

Sodium Bicarbonate in Plastic Containers: Clinical Trials, Market Analysis, and Projections

Introduction

Sodium bicarbonate, a versatile and widely used chemical, is crucial in various medical, industrial, and household applications. When packaged in plastic containers, particularly for medical use, its stability, efficacy, and safety are of paramount importance. This article delves into the clinical trials, market analysis, and projections for sodium bicarbonate injections stored in plastic containers.

Clinical Use and Indications

Sodium bicarbonate injection is a sterile, nonpyrogenic, hypertonic solution used primarily for the correction of metabolic acidosis and other conditions requiring systemic alkalization. It is indicated in the treatment of severe renal disease, uncontrolled diabetes, circulatory insufficiency, cardiac arrest, and certain drug intoxications[4].

Stability and Storage

The stability of sodium bicarbonate injection stored in polypropylene syringes has been a subject of study. Research indicates that the shelf life of sodium bicarbonate injection in polypropylene syringes is inversely related to the storage temperature. When stored at 12-14°C, the suggested expiration date is three months after packaging, or one month after removal from refrigeration, whichever comes first. Sealing the syringes in a polymeric film does not significantly affect the degradation of the solution[1].

Clinical Trials and Safety

Clinical studies on sodium bicarbonate injection have shown its efficacy in correcting metabolic acidosis and other conditions. However, these studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently to the treatment. The solutions are sterile and nonpyrogenic, with no bacteriostat, antimicrobial agent, or added buffer. Biological testing supports the safety of the syringe material, although small amounts of chemical components may leach from the plastic container[4].

Market Analysis

The global sodium bicarbonate market, including its pharmaceutical applications, is experiencing significant growth. Here are some key points from the market analysis:

Market Size and Growth

The global sodium bicarbonate market was valued at USD 6.5 billion in 2023 and is estimated to grow at a CAGR of over 3.8% from 2024 to 2032. This growth is driven by its wide range of applications across various industries, including pharmaceuticals, food and beverages, and environmental solutions[5].

Segment Analysis

In the pharmaceutical sector, sodium bicarbonate is used in antacids and dietary supplements. The demand for sodium bicarbonate injections specifically is influenced by their use in hospitals, specialty clinics, and recovery centers. The market report by Reports and Data highlights that the global Sodium Bicarbonate Injection market is segmented by product concentration (0.042, 0.084), application (hospital, specialty clinic, recovery center), and region[3].

Regional Dominance

Asia-Pacific is expected to dominate the sodium bicarbonate market during the forecast period, driven by increasing demand in industries such as plastics, cement, and glass. This regional growth reflects the expanding utilization and popularity of sodium bicarbonate in these sectors[2].

Market Projections

Growth Trends

The sodium bicarbonate injection market is projected to grow steadily, driven by increasing healthcare needs and the expanding use of sodium bicarbonate in medical emergencies. The market is expected to expand from USD 121.50 million to USD 180.88 million by 2031, with a CAGR of 5.10%[2].

Competitive Scenario

The competitive landscape of the sodium bicarbonate injection market includes key players and regional brands. The presence of global brands and local competition, along with regulatory changes and trade routes, significantly impact the market dynamics. Porter's Five Forces analysis and case studies are used to forecast the market scenario for individual countries[3].

Challenges and Opportunities

Storage and Stability Challenges

One of the significant challenges is ensuring the stability of sodium bicarbonate solutions stored in plastic containers. The material of the container can affect the solution's chemical integrity, and storage conditions must be carefully managed to maintain efficacy[1].

Regulatory Considerations

Regulatory changes and compliance are crucial for the market growth of sodium bicarbonate injections. Manufacturers must adhere to strict guidelines regarding the preparation, storage, and packaging of these solutions to ensure safety and efficacy[4].

Emerging Trends

The increasing demand for environmentally friendly products and the use of sodium bicarbonate in air pollution control systems present opportunities for market expansion. Additionally, advancements in packaging technology could improve the shelf life and stability of sodium bicarbonate solutions in plastic containers[5].

Key Takeaways

• Stability and Storage: Sodium bicarbonate injection stored in polypropylene syringes has a shelf life of three months at 12-14°C or one month after removal from refrigeration.
• Clinical Use: Indicated for metabolic acidosis, severe renal disease, uncontrolled diabetes, and certain drug intoxications.
• Market Growth: The global sodium bicarbonate market is expected to grow at a CAGR of over 3.8% from 2024 to 2032.
• Regional Dominance: Asia-Pacific is expected to dominate the market due to increasing demand in various industries.
• Challenges and Opportunities: Ensuring solution stability, regulatory compliance, and leveraging emerging trends in environmental applications.

FAQs

Q: What is the primary use of sodium bicarbonate injection in medical settings?

A: Sodium bicarbonate injection is primarily used for the correction of metabolic acidosis and other conditions requiring systemic alkalization.

Q: How long can sodium bicarbonate injection be stored in polypropylene syringes?

A: The suggested expiration date is three months after packaging when stored at 12-14°C, or one month after removal from refrigeration, whichever comes first.

Q: What are the key drivers of the global sodium bicarbonate market?

A: The market is driven by its wide range of applications across various industries, including pharmaceuticals, food and beverages, and environmental solutions.

Q: Which region is expected to dominate the sodium bicarbonate market?

A: Asia-Pacific is expected to dominate the market due to increasing demand in industries such as plastics, cement, and glass.

Q: What are the challenges associated with storing sodium bicarbonate solutions in plastic containers?

A: The challenges include ensuring the stability of the solution, managing storage conditions, and potential chemical contamination from the plastic container.

Sources

1. Hicks, C. I., Gallardo, J. P. B., & Guillory, J. K. (1972). Stability of Sodium Bicarbonate Injection Stored in Polypropylene Syringes. American Journal of Hospital Pharmacy, 29(3), 210–216. https://doi.org/10.1093/ajhp/29.3.210
2. Data Bridge Market Research. Sodium Bicarbonate Market Size, Growth, Trends And Forecast By 2031. Retrieved from https://www.databridgemarketresearch.com/reports/global-sodium-bicarbonate-market
3. Reports and Data. Sodium Bicarbonate Injection Market Share, Size, Key Players, Trends, Competitive and Regional Forecast to 2027. Retrieved from https://www.biospace.com/sodium-bicarbonate-injection-market-share-size-key-players-trends-competitive-and-regional-forecast-to-2027
4. Pfizer. Sodium Bicarbonate Injection, USP. Retrieved from https://labeling.pfizer.com/ShowLabeling.aspx?id=4606
5. Global Market Insights. Sodium Bicarbonate Market Size, Share, Trends & Forecast – 2032. Retrieved from https://www.gminsights.com/industry-analysis/sodium-bicarbonate-market