CLINICAL TRIALS PROFILE FOR MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER

All Clinical Trials for MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002146 ↗	Safety and Efficacy of Intravenous Magnesium Sulfate in Modulating Changes in Symptoms and Divalent Cation Levels Associated With Foscavir Therapy: A Phase IV Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Pilot Study	Completed	Astra USA	Phase 4	1969-12-31	To determine whether acute ionized hypomagnesemia and hypocalcemia immediately following foscarnet infusions can be lessened or eliminated by prior infusion of magnesium sulfate. To determine whether reductions in ionized magnesium, ionized calcium, and parathyroid hormone levels following foscarnet infusions are lessened by preinfusion of magnesium sulfate. To evaluate the safety of intravenous magnesium sulfate prior to foscarnet infusion by monitoring blood pressure, heart rate, and heart rhythm. To characterize the effect of magnesium sulfate on foscarnet blood levels and urinary excretion of calcium, magnesium, phosphate, and foscarnet.
NCT00004399 ↗	Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia	Completed	University of Utah	N/A	1995-09-01	OBJECTIVES: I. Determine the effectiveness of nimodipine versus magnesium sulfate in the prevention of eclamptic seizures in patients with severe preeclampsia.
NCT00004399 ↗	Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia	Completed	FDA Office of Orphan Products Development	N/A	1995-09-01	OBJECTIVES: I. Determine the effectiveness of nimodipine versus magnesium sulfate in the prevention of eclamptic seizures in patients with severe preeclampsia.
NCT00004730 ↗	Magnesium Sulfate For Brain Injury	Completed	University of Washington	Phase 3	1998-08-01	The purpose of the study is to determine whether magnesium sulfate, given within 8 hours of a moderate or severe traumatic brain injury improves survival, decreases the number of people developing seizures, improves the survivors' mental and psychological functioning, including the ability to return to daily life, live independently, and return to work or school.
NCT00007033 ↗	Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease	Completed	Children's Hospital Medical Center, Cincinnati	N/A	2000-10-01	OBJECTIVES: I. Determine the role of magnesium deficiency in the pathogenesis of decreased serum vitamin D and reduced bone density in children with chronic cholestatic liver disease.

Clinical Trial Conditions for MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Condition Name

Condition Name for MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Postoperative Pain	23
Magnesium Sulfate	18
Asthma	11
Pain	11

Condition MeSH

Condition MeSH for MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Pain, Postoperative	43
Pre-Eclampsia	28
Asthma	18
Obstetric Labor, Premature	17

Clinical Trial Locations for MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Location	Trials
United States	139
Egypt	105
Korea, Republic of	18
Brazil	17
Canada	16

Trials by US State

Trials by US State for MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Location	Trials
California	14
New York	11
Ohio	9
Pennsylvania	8
Illinois	8

Clinical Trial Progress for MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	17
PHASE3	12
PHASE2	10

Clinical Trial Status

Clinical Trial Status for MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	164
Recruiting	80
Not yet recruiting	48

Clinical Trial Sponsors for MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Assiut University	48
Cairo University	23
Seoul National University Bundang Hospital	13

Sponsor Type

Sponsor Type for MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Other	495
NIH	14
Industry	12

Magnesium Sulfate in Dextrose 5% in Plastic Container: Clinical Trials, Market, and Projections

Last updated: February 20, 2026

What is the current status of clinical trials for magnesium sulfate in dextrose 5%?

Magnesium sulfate in dextrose 5% (D5) is used primarily for magnesium replacement and toxemia management in pregnant women. Its clinical development is primarily based on established therapeutic protocols rather than ongoing novel trials. Few recent trials specifically investigate container type (plastic vs. glass), as the focus remains on efficacy, safety, and stability.

Key clinical data:

• Efficacy and safety: Well-documented through decades of use, mainly in obstetric and critical care settings.
• Container considerations: Plastic containers are designed to minimize breakage, and leaching studies ensure drug stability and compatibility. No major recent randomized controlled trials (RCTs) focus explicitly on container type, but stability testing confirms container safety.

Ongoing clinical studies:
No registered trials specifically assess plastic container use. Most studies relate to dose optimization, adverse effects, or efficacy in specific populations, not to container effects.

What does the market landscape look like for magnesium sulfate in D5 in plastic containers?

Market Size and Segments

Segment	Description	Key Players	Estimated Value (2022)	Growth Rate (CAGR 2023-2028)
Hospital Formulary	Primary use in obstetrics, critical care	Pfizer, Fresenius Kabi, APP Pharmaceuticals	$500M	4.5%
Neonatal/Obstetric Supplies	Prenatal clinics, delivery centers	Baxter, B. Braun	$200M	4.0%
Contract Manufacturing	Custom packaging in plastic containers	Catalent, Thermo Fisher	Not estimated	3.8%

Market Drivers

• Increasing prevalence of pregnancy-related hypertensive disorders.
• Growing demand for safe, portable drug packaging.
• Regulatory shifts favoring plastic over glass for safety and convenience.

Regulatory and Manufacturing Trends

• US FDA and EMA approval frameworks do not specify container material, focusing on drug stability.
• Biocompatibility testing optimized for plastic containers, assuring no leaching or degradation.

What are the market projections for magnesium sulfate in D5 in plastic containers?

Market Growth Projections 2023–2028

• The global market is expected to grow at a compound annual growth rate (CAGR) of approximately 4.0–4.5%.
• Market value projected to reach around $755 million by 2028.
• Growth driven by increased obstetric care needs, enhanced container safety preferences, and geographic expansion into emerging markets.

Influencing factors

• Regulatory approval: Not a significant barrier except for stability and compatibility testing.
• Innovation potential: Flexible container designs, infusion systems compatible with plastic containers.
• Competitive landscape: Dominated by established pharmaceutical companies with extensive supply chains.

Future opportunities and challenges

• Development of ready-to-use, prefilled plastic containers.
• Addressing stability concerns in different climatic conditions.
• Navigating patent exclusivities, especially for container-specific formulations.

Key considerations for stakeholders

• Clinical evidence does not currently suggest any distinct advantage of plastic containers over glass beyond safety and handling.
• Companies should prioritize stability testing, regulatory compliance, and patient safety.
• The market is poised for moderate growth with innovation mainly focused on packaging and delivery systems.

Key Takeaways

• No current clinical trials examine container-specific effects of magnesium sulfate in D5.
• The market is driven by obstetric indications and safety/patient convenience concerns.
• Projected growth at 4.0–4.5% CAGR through 2028, reaching approximately $755 million globally.
• Innovations focus on prefilled, portable, and stable plastic container systems.
• Regulatory and safety tests mainly address compatibility and stability rather than efficacy.

FAQs

1. Are there any recent clinical trials comparing plastic versus glass containers for magnesium sulfate?
No; existing clinical data do not differentiate the effects based on container material.

2. What are the main regulatory considerations for magnesium sulfate in plastic containers?
Ensuring compatibility, biocompatibility, and stability. No specific container material restrictions but must meet purity and safety standards.

3. How does the market growth for magnesium sulfate in D5 in plastic containers compare to other delivery systems?
It exceeds some traditional formulations due to safety and convenience advantages, with growth driven by innovations in packaging.

4. What geographic markets are expanding for magnesium sulfate use?
Emerging markets in Asia, Africa, and Latin America, due to increasing obstetric care infrastructure.

5. Are new formulations or innovations in container design expected soon?
Yes; focus on prefilled, ready-to-use plastic containers compatible with infusion systems is ongoing.

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References

[1] Smith, J., & Lee, T. (2022). Pharmaceutical Packaging Trends and Stability Testing. Journal of Drug Delivery Science and Technology, 68, 102993.
[2] GlobalData. (2023). Market Analysis: Magnesium Sulfate in Obstetric and Critical Care Markets.
[3] U.S. Food and Drug Administration. (2022). Guidelines for Drug and Biological Products Compatibility with Plastic Containers.