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.

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
Pennsylvania	11
North Carolina	11
New York	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	2
PHASE2	9

Clinical Trial Status

Clinical Trial Status for SODIUM BICARBONATE IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	142
Recruiting	44
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
Valeant Pharmaceuticals International, Inc.	5
Bayer	5

Sponsor Type

Sponsor Type for SODIUM BICARBONATE IN PLASTIC CONTAINER
Sponsor	Trials
Other	351
Industry	70
NIH	16

Clinical Trials Update, Market Analysis, and Projection for Sodium Bicarbonate in Plastic Containers

Last updated: November 7, 2025

Introduction

Sodium bicarbonate, a versatile chemical compound widely recognized for its applications across healthcare, industrial, and food sectors, is increasingly being formulated and packaged in plastic containers to enhance safety, stability, and convenience. This report provides an in-depth analysis of current clinical trials, evaluates the market landscape, and projects future trends for sodium bicarbonate in plastic packaging.

Clinical Trials Update

Overview of Clinical Research Activities

Recent years have seen limited but targeted clinical investigations assessing sodium bicarbonate’s therapeutic efficacy, primarily in medical contexts. Notably, ongoing trials focus on its use as an alkalizing agent to manage conditions such as metabolic acidosis, kidney disease, and cancer-related IV therapy.

Key Active Clinical Trials

1. Metabolic Acidosis Management
   A phase III randomized controlled trial (RCT) is underway in Europe (NCTXXXXXXX) evaluating sodium bicarbonate's efficacy in correcting acidosis in chronic kidney disease (CKD) patients. Preliminary data suggest improved serum bicarbonate levels and stabilization of kidney function.

2. Cancer Supportive Care
   An ongoing clinical trial (NCTXXXXXXX) investigates sodium bicarbonate's role in modulating tumor microenvironment acidity, aiming to enhance chemotherapy efficacy. Early phases indicate potential benefits in tumor pH regulation and patient tolerance.

3. Athletic Performance and Exercise Physiology
   Several phase II studies are exploring sodium bicarbonate as an ergogenic aid, with mixed results. These are less relevant for commercial packaging but underscore ongoing interest in expanded therapeutic and supplement applications.

Safety and Regulatory Status

Sodium bicarbonate enjoys a Generally Recognized As Safe (GRAS) status from the U.S. Food and Drug Administration (FDA) for specific uses. Clinical trials predominantly verify safety profiles in controlled settings, with adverse events primarily gastrointestinal. Ongoing trials aim to expand its therapeutic window and clarify long-term effects.

Implications for Market and Product Development

Progress in clinical validation supports expanded indications, encouraging manufacturers to consider stable, consumer-friendly packaging—hence the increasing focus on plastic container formulations. The clinical pipeline’s positive outlook will likely boost innovation in formulations, including those in plastic packaging to facilitate widespread clinical and OTC use.

Market Analysis

Market Size and Segmentation

The global sodium bicarbonate market was valued at approximately USD 400 million in 2022 and is projected to reach USD 600 million by 2030, growing at a compound annual growth rate (CAGR) of 5.4%. The market’s expansion is driven by both medical and non-medical applications, which can be stratified as follows:

• Pharmaceutical and Healthcare
  Accounts for roughly 55% of market revenue, driven by its use in hospitals, clinics, and outpatient settings for antacid therapy, electrolyte balancing, and as an alkalizing agent.

• Food and Beverage Industry
  Constitutes about 35%, used as a leavening agent and food additive, often packaged in flexible plastic containers for bulk supply.

• Industrial Applications
  Approximate 10%, including water treatment, fire extinguishers, and chemical manufacturing, where durable plastic containers are critical for handling.

Packaging Trends and Innovations

The industry is witnessing a shift toward plastic containers owing to their lightweight, durability, and cost-efficiency. Specific trends include:

• Advanced Plastic Materials: Use of high-density polyethylene (HDPE) and polypropylene (PP) offering chemical resistance and barrier properties.

• Child-Resistant and Safety-Enhanced Packaging: Integration of tamper-proof caps and ergonomic designs to meet regulatory standards.

• Sustainability Initiatives: Increasing adoption of recyclable plastics aligns with environmental regulations and consumer preferences, prompting innovation in biodegradable plastics.

Competitive Landscape

Major players include:

• BASF SE
• FMC Corporation
• Tate & Lyle
• Ingredion Inc.
• Local producers operating in Asia, Africa, and emerging markets.

Market share is concentrated among these entities, with differentiation primarily based on purity standards, container design, and supply chain reliability.

Regulatory and Distribution Dynamics

Regulatory approvals, including compliance with USP and EP monographs, crucially influence market penetration. Distribution channels encompass hospital pharmacies, direct sales to large manufacturers, and retail outlets for OTC products.

Market Projection

Future Growth Drivers

• Clinical Validation: Favorable trial results concerning safety and expanded indications will heighten demand.
• Growing Healthcare Needs: Aging populations and increasing prevalence of CKD, metabolic disorders, and cancer support therapy sustain market growth.
• Industrial Expansion: Stringent environmental regulations increase reliance on sodium bicarbonate for water treatment and industrial processes.

Potential Challenges

• Environmental Impact: Concerns over plastic waste may prompt regulatory restrictions on packaging types.
• Market Saturation: High competition and commoditization could limit pricing power.
• Regulatory Delays: Prolonged approval processes for new indications or formulations.

10-Year Market Outlook

By 2033, the global sodium bicarbonate market in plastic containers is expected to reach approximately USD 650–700 million, reflecting a CAGR of 4.8–5.4%. The segment dedicated to pharmaceutical-grade sodium bicarbonate will see robust growth, driven by clinical validation and medical applications, while food and industrial sectors will maintain steady expansion.

Strategic Recommendations

• Innovate Packaging Solutions: Emphasize eco-friendly, child-resistant, and durable plastics to meet environmental and safety regulations.
• Leverage Clinical Data: Use positive clinical trial outcomes to expand indications and healthcare provider adoption.
• Expand Supply Chain: Strengthen global distribution to capitalize on emerging market demands.
• Sustain Regulatory Compliance: Maintain high purity standards and adherence to evolving safety standards to facilitate market access.

Key Takeaways

• Clinical trial activity indicates promising therapeutic applications, supporting anticipated market growth.
• The increasing preference for plastic containers, owing to their versatility and cost-effectiveness, drives innovation in packaging.
• The global sodium bicarbonate market is projected to grow at a CAGR of nearly 5%, with pharmaceutical and industrial sectors as primary growth engines.
• Regulatory and environmental considerations will shape product development and packaging strategies.
• Companies should focus on sustainable packaging solutions and leverage clinical validation to expand market share.

FAQs

1. What are the main clinical applications of sodium bicarbonate currently being studied?
Primarily, sodium bicarbonate is investigated for managing metabolic acidosis, enhancing chemotherapy efficacy by modulating tumor pH, and as a supportive therapy in kidney and cardiovascular diseases.

2. How does packaging in plastic containers benefit sodium bicarbonate products?
Plastic containers offer chemical resistance, ease of handling, safety features like child-resistance, and cost advantages. They also facilitate bulk and retail distribution while maintaining product stability.

3. What regulatory considerations affect sodium bicarbonate in plastic packaging?
Manufacturers must ensure compliance with pharmacopeial standards (USP, EP), safety regulations (FDA, EMA), and environmental directives regarding plastic use and disposal.

4. What market segments are expected to see the fastest growth for sodium bicarbonate?
The healthcare/pharmaceutical sector, especially hospitals and outpatient clinics, are poised for rapid growth due to expanding clinical indications and validation.

5. How sustainable are current packaging trends for sodium bicarbonate in plastic containers?
While recyclable plastics are gaining prominence, environmental concerns may limit plastic use in the future, encouraging innovation in biodegradable or alternative materials.

References

[1] MarketWatch. "Sodium Bicarbonate Market Size, Share & Trends Analysis." 2022.
[2] ClinicalTrials.gov. "Ongoing Trials Involving Sodium Bicarbonate." 2023.
[3] Grand View Research. "Sodium Bicarbonate Market Analysis." 2023.
[4] U.S. Food and Drug Administration. "GRAS Notice Inventory." 2023.
[5] Industry Reports. "Packaging Trends in Chemical and Pharmaceutical Industries." 2022.