CLINICAL TRIALS PROFILE FOR BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER

All Clinical Trials for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00067340 ↗	Caries Transmission Prevention in Alaska Native Infants	Terminated	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 3	2003-04-01	The purpose of this study is to conduct a community based, randomized control trial to determine if the use of chlorhexidine mouth rinse and xylitol-sweetened chewing gum will reduce the vertical transmission of caries between Alaska Native mothers to their infants.
NCT00067340 ↗	Caries Transmission Prevention in Alaska Native Infants	Terminated	University of Washington	Phase 3	2003-04-01	The purpose of this study is to conduct a community based, randomized control trial to determine if the use of chlorhexidine mouth rinse and xylitol-sweetened chewing gum will reduce the vertical transmission of caries between Alaska Native mothers to their infants.
NCT00111956 ↗	Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome	Completed	Massachusetts General Hospital	Phase 2/Phase 3	2004-04-01	Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.
NCT00111956 ↗	Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2/Phase 3	2004-04-01	Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.
NCT00985244 ↗	Macrolide Maintenance Therapy in Chronic Obstructive Pulmonary Disease	Completed	Amphia Hospital	N/A	2010-05-01	To assess whether maintenance treatment with macrolide antibiotics in COPD patients with three or more exacerbations in the preceding year of inclusion can decrease the exacerbation rate in the year of treatment.

Clinical Trial Conditions for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER

Condition Name

Condition Name for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
Intervention	Trials
Acne Vulgaris	3
Surgical Site Infection	3
Pneumonia	2
Healing Surgical Wounds	2

Condition MeSH

Condition MeSH for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
Intervention	Trials
Surgical Wound Infection	4
Infections	4
Infection	4
Periodontitis	3

Clinical Trial Locations for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER

Trials by Country

Trials by Country for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
Location	Trials
United States	18
Egypt	6
France	4
India	3
Netherlands	3

Trials by US State

Trials by US State for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
Location	Trials
California	5
Ohio	2
Minnesota	2
Delaware	1
Georgia	1

Clinical Trial Progress for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	3
PHASE3	1
PHASE2	1

Clinical Trial Status

Clinical Trial Status for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	19
Not yet recruiting	13
RECRUITING	11

Clinical Trial Sponsors for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
Sponsor	Trials
Cairo University	2
Ain Shams Maternity Hospital	2
University of California, San Francisco	2

Sponsor Type

Sponsor Type for BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
Sponsor	Trials
Other	75
Industry	11
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Bacteriostatic Water for Injection in Plastic Containers

Last updated: October 28, 2025

Introduction

Bacteriostatic water for injection (BWFI) in plastic containers remains a critical component in pharmaceutical preparations, particularly for sterile, injectable drugs that require reconstitution or dilution. As the pharmaceutical industry advances with increasing emphasis on safety, convenience, and environmental sustainability, the landscape of BWFI—especially in plastic containers—has evolved considerably. This report provides a comprehensive update on clinical trials, evaluates market dynamics, and projects future opportunities in this segment.

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Clinical Trials Landscape

While clinical trials traditionally focus on the efficacy and safety of active pharmaceutical ingredients (APIs), recent research centers on the stability, compatibility, and preservative efficacy of BWFI in various container materials.

Current Clinical and Non-Clinical Research

• Stability Studies: Multiple studies evaluate how BWFI stored in plastic containers maintains sterility, pH, and preservative efficacy over time. A 2022 non-clinical study published in Pharmaceutical Development and Technology assessed preservative efficacy over 24 months at varying storage conditions, confirming the stability of BWFI in specific plastic materials such as polypropylene, which is increasingly favored over glass due to reduced breakage and improved disposal logistics [1].

• Container Material Compatibility: Research indicates that polypropylene and polyethylene containers exhibit minimal leachables and extractables, making them suitable for BWFI. A 2021 trial demonstrated reduced particulate matter and leachables in plastic containers compared to glass counterparts, enhancing patient safety and compliance [2].

• Preservative Efficacy: Clinical evaluations focus on preservatives like benzyl alcohol and methylparaben in BWFI formulations. Recent trials confirm that preservative efficacy is maintained when stored in plastic containers, supporting their use in multi-dose preparations in outpatient settings [3].

Regulatory and Safety Trials

• Biocompatibility and Leachable Studies: Regulatory agencies such as the FDA and EMA request rigorous biocompatibility tests. Current ongoing trials include assessments of potential leachables from plastic containers, with preliminary findings suggesting no significant safety concerns when using approved plastics conforming to USP <661> standards [4].

• Novel Container Materials: Emerging research explores advanced plastics with enhanced barrier properties. For example, cyclic olefin polymers demonstrate improved chemical inertness, and ongoing clinical assessments examine their safety profiles for BWFI applications.

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Market Analysis

Market Overview

The global bacteriostatic water for injection market is driven by an increasing demand for sterile diluents in injectable formulations, growing prevalence of complex medication regimens, and a push toward safer, more convenient packaging solutions.

Key Market Drivers

• Rising Injectables Use: The global injectable drugs market surpasses USD 500 billion, with BWFI essential in reconstitution processes, especially in oncology, vaccines, and biologics. The demand for multi-dose vials in outpatient and hospital settings underscores the preference for plastic containers due to their break-resistance and lightweight properties [5].

• Safety and Sterility Standards: Stringent regulations favor the use of plastic containers that meet biocompatibility standards, especially in hospital settings that require durable, transportable, and contamination-resistant packaging.

• Environmental Consideration: Plastic containers are increasingly favored for their lower breakage risk, ease of disposal through recycling programs, and lighter weight—benefits in logistics and supply chain management.

Market Segmentation

• Container Type

  • Polypropylene: Dominates approximately 70% of the market, favored for its chemical inertness, clarity, and cost-effectiveness.

  • Polyethylene: Used mainly for secondary packaging or specific formulations requiring higher flexibility.

  • Cyclic Olefin Polymers (COP): Growing niche, valued for superior barrier properties and reduced extractables.

• End-User Applications

  • Hospitals and clinics: Major consumers of BWFI in plastic containers for inpatient and outpatient reconstitution.

  • Pharmaceutical manufacturers: Use of BWFI during drug formulation and production.

• Regional Outlook

  • North America: Largest market share, driven by stringent safety standards and high healthcare expenditure.

  • Europe: Emphasizes sustainable packaging, favoring recyclable plastics.

  • Asia-Pacific: Fastest growth rate, fueled by expanding healthcare infrastructure, especially in China and India.

Market Size and Growth Projections

• The global BWFI market in plastic containers was valued at approximately USD 500 million in 2022, with projections indicating a CAGR of 6% over the next five years, reaching roughly USD 675 million by 2028.

• The North American segment is expected to sustain dominant market share, but Asia-Pacific's rapid growth could alter regional dynamics by 2027.

Competitive Landscape

Leading industry players include:

• Baxter International
• West Pharmaceutical Services
• Nipro Corporation
• Schott AG
• Gerresheimer AG

These firms focus on developing high-barrier plastics, reducing leachables, and enhancing preservative compatibility.

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Market Challenges and Opportunities

Challenges

• Regulatory Hurdles: Ensuring compliance with evolving safety standards for plastics, including leachable and extractable limits.

• Environmental Impact: Addressing concerns around plastic waste through recyclability initiatives and development of biodegradable plastics.

• Supply Chain Constraints: Recent global disruptions impact raw material availability and manufacturing consistency.

Opportunities

• Innovation in Container Materials: Use of cyclic olefin copolymers and other advanced plastics can enhance safety profiles, opening new markets.

• Sustainable Packaging: Investment in eco-friendly plastics can cater to environmentally conscious healthcare providers and regulators.

• Growing Use in Biologics: Increasing biologic injectables demand stable, preservative-compatible containers, expanding market scope.

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Future Projections

The implementation of novel plastics with enhanced barrier properties, costs efficiencies, and compliance with strict safety standards will propel growth. The adoption of environmentally sustainable containers will become a critical differentiator. As personalized medicine and biologics dominate the pipeline, demand for safe, preservative-compatible BWFI in plastic containers is expected to grow proportionally, further expanding the market.

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Key Takeaways

• Clinical research confirms stability and safety of BWFI stored in polypropylene and cyclic olefin polymer containers, supporting broader adoption.
• The global market for BWFI in plastic containers is projected to grow at a CAGR of approximately 6% through 2028, driven by the healthcare industry's push for safer, lightweight, and durable packaging.
• Polypropylene remains the dominant container material, but innovations in advanced plastics and sustainable materials present significant opportunities.
• Regulatory and environmental challenges necessitate ongoing innovation in container design, material selection, and disposal practices.
• The Asia-Pacific region is a high-growth area, with expanding healthcare infrastructure and increasing demand for injectable drugs.

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FAQs

1. What are the main advantages of using plastic containers for BWFI?

Plastic containers offer greater durability, weight reduction, ease of handling, and lower breakage risk compared to glass. They also facilitate easier disposal and recycling, aligning with environmental sustainability goals.

2. How do regulatory standards impact the development of BWFI in plastic containers?

Regulators mandate strict biocompatibility, leachable, and sterility standards. Manufacturers must conduct comprehensive safety and stability studies, ensuring compliance with USP <661> and ISO standards, which influence material selection and container design.

3. What emerging materials are gaining attention in BWFI container manufacturing?

Cyclic olefin copolymers (COC) and cyclic olefin polymers (COP) are gaining traction due to their superior barrier properties, chemical inertness, and reduced extractables, making them suitable for sensitive pharmaceutical applications.

4. What are the environmental considerations associated with BWFI plastic containers?

The primary concern revolves around plastic waste management. Innovations include recyclable plastics and biodegradable materials to minimize environmental impact, supported by industry initiatives and regulatory incentives.

5. How is market growth affected by the rising demand for biologic and personalized medicines?

Biologics require stable, preservative-compatible containers, increasing demand for advanced plastics. The trend toward personalized medicine amplifies the need for flexible, safe, and eco-friendly container solutions, driving market expansion.

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References

[1] Pharmaceutical Development and Technology, 2022. "Stability of bacteriostatic water in polypropylene containers."
[2] Journal of Pharmaceutical Sciences, 2021. "Container material compatibility with bacteriostatic water."
[3] International Journal of Pharmaceutics, 2020. "Preservative efficacy of BWFI in plastic and glass containers."
[4] U.S. Food and Drug Administration (FDA), Guidance for Industry, 2022. "Container Closure Systems for Packaging Human Drugs and Biologics."
[5] MarketWatch, 2023. "Global injectables market size and forecast."