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.
NCT00130598 ↗	PROVOCATION Trial - PROphylactic intraVenOus Hydration for Contrast Agent Toxicity PreventION	Completed	University Hospital, Basel, Switzerland	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.
NCT00142272 ↗	Single Dose Ciprofloxacin in the Treatment of Childhood Cholera:Randomized Controlled Clinical Trial	Completed	Bayer	Phase 3	2001-05-01	The study will be conducted to compare the efficacy and safety of a single dose of ciprofloxacin oral suspension 20 mg/kg with a 3-day course of erythromycin oral suspension administered in a dose of 12.5 mg/kg every 6 hours (12 doses) in the treatment of children, aged 2-15 years with clinically severe cholera due to V. cholerae O1 or O139. We hypothesize that single dose ciprofloxacin would result in similar outcome in the clinicalcurewith that of erythromycin given in multiple doses.
NCT00142272 ↗	Single Dose Ciprofloxacin in the Treatment of Childhood Cholera:Randomized Controlled Clinical Trial	Completed	NEMC	Phase 3	2001-05-01	The study will be conducted to compare the efficacy and safety of a single dose of ciprofloxacin oral suspension 20 mg/kg with a 3-day course of erythromycin oral suspension administered in a dose of 12.5 mg/kg every 6 hours (12 doses) in the treatment of children, aged 2-15 years with clinically severe cholera due to V. cholerae O1 or O139. We hypothesize that single dose ciprofloxacin would result in similar outcome in the clinicalcurewith that of erythromycin given in multiple doses.

Clinical Trial Conditions for Sodium Bicarbonate In Plastic Container

Condition Name

Condition Name for Sodium Bicarbonate In Plastic Container
Intervention	Trials
Acute Kidney Injury	17
Metabolic Acidosis	16
Chronic Kidney Disease	15
Contrast Induced Nephropathy	15

Condition MeSH

Condition MeSH for Sodium Bicarbonate In Plastic Container
Intervention	Trials
Kidney Diseases	48
Acute Kidney Injury	31
Renal Insufficiency, Chronic	25
Renal Insufficiency	20

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	202
Italy	21
China	17
Brazil	15
Egypt	14

Trials by US State

Trials by US State for Sodium Bicarbonate In Plastic Container
Location	Trials
California	16
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
PHASE4	5
PHASE3	3
PHASE2	9

Clinical Trial Status

Clinical Trial Status for Sodium Bicarbonate In Plastic Container
Clinical Trial Phase	Trials
Completed	143
RECRUITING	45
Unknown status	30

Clinical Trial Sponsors for Sodium Bicarbonate In Plastic Container

Sponsor Name

Sponsor Name for Sodium Bicarbonate In Plastic Container
Sponsor	Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	6
Bausch Health Americas, Inc.	5
Valeant Pharmaceuticals International, Inc.	5

Sponsor Type

Sponsor Type for Sodium Bicarbonate In Plastic Container
Sponsor	Trials
Other	359
Industry	72
NIH	16

Sodium Bicarbonate In Plastic Container Market Analysis and Financial Projection

Last updated: February 5, 2026

What is the current state of clinical trials for sodium bicarbonate in plastic containers?

Sodium bicarbonate (NaHCO₃) designated for medical use in plastic containers is under clinical evaluation primarily for indications such as acid-base imbalance correction, cardiac arrest management, and as an adjunct in dialysis.

As of Q1 2023, there are no ongoing or upcoming clinical trials specifically focusing on sodium bicarbonate packaged solely in plastic containers, according to ClinicalTrials.gov. The existing trials administrate sodium bicarbonate in standard ampules or vials with no specific packaging differentiation.

While some trials involve storing or administering sodium bicarbonate via plastic infusion bags or syringes, these are considered standard practices rather than experimental packaging trials. The safety, stability, and compatibility of sodium bicarbonate in polyethylene or other plastic materials are well-established, reducing the likelihood of dedicated clinical trials for the packaging.

Key points:

• No dedicated clinical trials for sodium bicarbonate in plastic containers are ongoing or planned.
• Existing clinical trials focus on the drug’s efficacy and safety rather than packaging specifics.
• Compatibility and stability in plastic containers are established, reducing experimental need.

How is the market currently structured for sodium bicarbonate in plastic containers?

The pharmaceutical market for sodium bicarbonate is mature, with broad availability for both hospital and outpatient settings. Major pharmaceutical suppliers provide the drug primarily in:

• Plastic infusion bags (polyethylene or PVC-lined)
• Ready-to-use syringes
• Pre-filled ampules

Most sodium bicarbonate is produced by generic drug manufacturers, with the market highly competitive.

The global sodium bicarbonate market size was valued at approximately $800 million in 2022 and is projected to grow at an annual rate of about 3.2% through 2030 [1]. The growth drivers include increasing demand in hospitals, dialysis centers, and emergency medicine.

Market segments:

• Hospital pharmacies: supplies usually include large-volume infusion bags.
• Outpatient clinics: use pre-filled syringes.
• Dialysis centers: rely heavily on infusion bags for acid-base correction.

North America dominates the market with an approximate share of 50%, led by healthcare infrastructure and high healthcare expenditure. Europe accounts for about 30%, with Asia-Pacific targeting the fastest growth due to expanding healthcare access and infrastructure.

What are the key factors influencing the market outlook?

Regulatory Environment:
Regulatory bodies such as the FDA and EMA approve sodium bicarbonate for multiple indications with standardized manufacturing practices, including packaging. New packaging formulations or container types require stability and compatibility data but are not presently a major regulatory hurdle due to established use.

Technological Advances:
Advances in plastic manufacturing have improved stability, reduced leaching, and enhanced container durability. These developments potentially foster increased use of specialized plastic containers for sodium bicarbonate to extend shelf life or improve safety.

Clinical and Safety Data:
Given the extensive clinical history of sodium bicarbonate, innovations primarily focus on packaging enhancements rather than drug formulation advancements.

Market Drivers:

• Increasing use in emergency medicine and dialysis.
• Demand for safe, stable, and easy-to-administer packaging solutions.
• Potential regulatory requirements for new sterile or single-use containers.

What are the projections for the market over the next five years?

The market for sodium bicarbonate in plastic containers is expected to expand moderately, driven by the growing healthcare infrastructure and increased use in emergent and chronic care settings.

Projected growth:

• CAGR (2023-2028): approximately 3.2%, aligned with overall market growth.
• Market value in 2030 forecasted at around $1 billion, assuming steady growth and minimal disruption.

Potential market shifts:

• Adoption of new barrier plastic materials could improve stability and reduce contamination risk.
• Introduction of pre-filled, single-dose plastic syringes tailored to specific indications.
• Increased regulation requiring advanced packaging safety features.

Competitive landscape:
Top players include Baxter International, Pfizer, and Fresenius Kabi, which have the capacity to introduce new container formats aligned with safety and regulatory standards.

What are the key challenges and opportunities?

Challenges:

• Entrenched use of existing packaging reduces incentive for innovation.
• Regulatory pathways for new container types involve thorough stability and compatibility testing.
• Cost implications for transitioning to new packaging formats.

Opportunities:

• Developing specialized, stable plastic containers that extend shelf life.
• Incorporating smart packaging features for better safety and traceability.
• Expanding use in emerging markets with increasing healthcare investments.

Key Takeaways

• No current clinical trials focus specifically on sodium bicarbonate in plastic containers.
• The drug's packaging in plastic, primarily infusion bags and syringes, is well established.
• The global market is mature, with steady growth driven by hospital and dialysis usage.
• Innovations in packaging materials and safety features represent the main growth opportunities.
• Regulatory and economic factors influence packaging development but currently pose minimal barriers.

FAQs

1. Are there any concerns about the stability of sodium bicarbonate in plastic containers?
Stability data show sodium bicarbonate maintains efficacy and stability in polyethylene and PVC-lined containers, which are currently standard.

2. What regulatory hurdles exist for new packaging of sodium bicarbonate?
Regulatory approval requires stability testing, compatibility studies, and adherence to sterile manufacturing standards, which are well-understood due to existing use.

3. Which regions show the highest demand for sodium bicarbonate in plastic containers?
North America leads, followed by Europe and Asia-Pacific, with demand driven by hospital use, dialysis, and emergency care.

4. How might innovation in packaging affect the market?
New packaging options could improve safety, extend shelf life, and foster market share expansion, especially in emerging markets.

5. What future trends could impact the market?
Increase in single-dose, pre-filled plastic containers, integration of safety features, and regional healthcare infrastructure development are trending factors.

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Sources:

[1] Market Research Future Report, 2022.