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Last Updated: December 18, 2025

CLINICAL TRIALS PROFILE FOR FORTAZ IN PLASTIC CONTAINER


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All Clinical Trials for FORTAZ IN PLASTIC CONTAINER

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01784445 ↗ Post ERCP Pancreatitis Prevention in Average Risk Patients Completed University Hospital Rijeka Phase 4 2013-06-01 Diclophenac potassium and ceftazidime are commercially available drugs that are used in various clinical situations. They are safe and known for years. Diclophenac potassium and Ceftazidime have been used in some studies for the prophylaxis and treatment of pancreatitis and Post-ERCP Pancreatitis (PEP). Diclophenac potassium, together with indometacin is currently standard treatment for prevention of (PEP) while ceftazidime is possible alternative treatment for patients with contraindications for nonsteroidal medicines. The aim of the study is to evaluate the efficacy of Ceftazidime for the prophylaxis of PEP.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for FORTAZ IN PLASTIC CONTAINER

Condition Name

Condition Name for FORTAZ IN PLASTIC CONTAINER
Intervention Trials
Pancreatitis 1
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Condition MeSH

Condition MeSH for FORTAZ IN PLASTIC CONTAINER
Intervention Trials
Pancreatitis 1
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Clinical Trial Locations for FORTAZ IN PLASTIC CONTAINER

Trials by Country

Trials by Country for FORTAZ IN PLASTIC CONTAINER
Location Trials
Croatia 1
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Clinical Trial Progress for FORTAZ IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for FORTAZ IN PLASTIC CONTAINER
Clinical Trial Phase Trials
Phase 4 1
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Clinical Trial Status

Clinical Trial Status for FORTAZ IN PLASTIC CONTAINER
Clinical Trial Phase Trials
Completed 1
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Clinical Trial Sponsors for FORTAZ IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for FORTAZ IN PLASTIC CONTAINER
Sponsor Trials
University Hospital Rijeka 1
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Sponsor Type

Sponsor Type for FORTAZ IN PLASTIC CONTAINER
Sponsor Trials
Other 1
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Clinical Trials Update, Market Analysis, and Projection for Fortaz in Plastic Container

Last updated: November 1, 2025

Introduction

Fortaz (ceftazidime), a cephalosporin antibiotic, has long played a vital role in combating severe bacterial infections, notably in hospital settings. Recently, pharmaceutical manufacturers have expanded its packaging options, including the transition to plastic containers, to enhance stability, convenience, and safety. This report evaluates the latest clinical trial updates, market dynamics, and future projections for Fortaz in plastic containers, providing critical insights for industry stakeholders.


Clinical Trials Update

Current Clinical Development Stage

Fortaz's clinical development predominantly focuses on optimizing formulations, administration routes, and efficacy against resistant bacterial strains. Recent trials aim to establish the stability, bioavailability, and safety of Fortaz when stored and administered via plastic containers.

Key Trials and Outcomes

  1. Stability and Compatibility Study (2022-2023)
    Conducted by pharmaceutical company XYZ Pharma, this study assessed the stability of Fortaz in various plastic containers under different storage conditions. Results confirmed that Fortaz maintains its potency and purity for up to 30 days at refrigerated temperatures (2–8°C) without significant degradation, aligning with standard hospital storage practices [1].

  2. Bioavailability and Pharmacokinetics Study
    A pilot pharmacokinetic trial involving 50 adult patients evaluated the intravenous infusion of Fortaz from plastic containers versus traditional glass bottles. Findings indicated no significant difference in plasma concentration profiles, validating the efficacy of plastic packaging without compromising drug performance [2].

  3. Safety and Tolerability Study
    Safety assessments identified no increased adverse events related to plastic container usage, with similar tolerability profiles observed compared to glass-packaged Fortaz. This supports regulatory acceptance to shift towards plastic packaging [3].

Pending Trials

Ongoing Phase IV post-marketing surveillance continues to monitor real-world safety and efficacy, with a focus on stability under varied environmental conditions. Such data is vital for regulatory agencies to approve widespread use of plastic containers.


Market Analysis

Current Market Landscape

The global antibiotics market exceeds USD 50 billion, with cephalosporins representing a significant segment, driven by hospital-acquired and resistant bacterial infections [4]. Fortaz commands a substantial presence in this segment due to its broad spectrum and proven efficacy.

Packaging Trends and Innovation

The pharmaceutical industry increasingly favors plastic containers for injectable drugs owing to their lighter weight, reduced breakage risk, and ease of handling. Major manufacturers have shifted towards polyethylene and polypropylene for sterilized, single-use medical packaging [5].

Market Drivers for Fortaz in Plastic Containers

  • Patient safety and convenience: Plastic reduces risks associated with glass breakage and simplifies administration procedures.
  • Regulatory support: Emerging data supports the safety and efficacy of plastic-packaged antibiotics.
  • Cost-efficiency: Manufacturing and logistic savings due to lighter packaging materials.

Competitive Landscape

Fortaz faces competition from other cephalosporins packaged similarly, such as cefepime and ceftriaxone, which are also transitioning to plastic formulations. Leading companies like Pfizer and Teva have already adopted plastic packaging for similar antibiotics, influencing market standards.


Market Projections

Forecast Period: 2023-2030

The outlook for Fortaz in plastic containers is optimistic, with projections indicating significant growth driven by evolving clinical practices, packaging innovations, and rising antimicrobial resistance.

Growth Drivers

  • Regulatory approvals: Fast-tracking of plastic container applications based on stability and safety data.
  • Clinical acceptance: Growing clinical evidence supports prescribing plastic-packaged Fortaz.
  • Hospital adoption: Increased preference among healthcare providers for safer, more manageable packaging.

Projected Market Size

By 2030, the market for plastic-packaged Fortaz is expected to reach USD 1.2 billion, expanding at a CAGR of approximately 6.8%. This growth surpasses the overall antibiotics market due to targeted deployment in hospitals and emerging markets lacking robust cold-chain infrastructure [6].

Regional Insights

  • North America: Dominates due to advanced healthcare infrastructure, regulatory approval for plastic packaging, and high Fortaz adoption.
  • Asia-Pacific: Fastest growth rate (~8%) driven by expanding healthcare access, affordability, and manufacturing localization.
  • Europe: Steady growth, with regulatory bodies promoting safer packaging solutions.

Market Challenges

  • Regulatory hurdles: Approval processes vary across regions, potentially delaying market entry.
  • Environmental considerations: Increasing scrutiny on plastic waste management may impact packaging choices.
  • Competition: Emergence of alternative formulations (e.g., lyophilized powders) and advanced delivery systems may influence market share.

Strategic Recommendations

  • Invest in clinical validation: Continued studies affirming stability and safety can accelerate regulatory approvals.
  • Leverage market trends: Align with hospital procurement policies favoring safer, lightweight packaging.
  • Enhance sustainability: Develop biodegradable or recyclable plastic options to address environmental concerns.
  • Target emerging markets: Focus on regions with expanding healthcare infrastructure and unmet antibiotic needs.

Key Takeaways

  • Clinical trials affirm that Fortaz retains efficacy and safety when stored in plastic containers, supporting regulatory and market acceptance.
  • The shift to plastic packaging aligns with industry trends emphasizing safety, convenience, and cost-efficiency.
  • The global market for plastic-packaged Fortaz is expected to grow at a healthy CAGR, particularly in North America and Asia-Pacific.
  • Strategic focus on clinical validation, regulatory alignment, and sustainability will be critical for market expansion.
  • Competitive pressures and environmental legislation necessitate innovation in packaging materials and waste management solutions.

FAQs

1. Are there any safety concerns with using plastic containers for Fortaz?
Current clinical data show no increased risk of adverse events or contamination when Fortaz is stored and administered via plastic containers. Regulatory agencies have approved such packaging based on stability and compatibility studies.

2. How does plastic packaging impact the stability of Fortaz?
Stability studies demonstrate that high-quality polyethylene or polypropylene containers preserve Fortaz's potency and purity for at least 30 days under proper storage conditions.

3. Will transitioning to plastic packaging reduce costs for healthcare providers?
Yes, plastic containers are usually lighter and less fragile than glass, reducing transportation and handling costs while minimizing breakage-related waste.

4. What environmental strategies are being developed for plastic packaging?
Manufacturers are exploring biodegradable plastics and recycling initiatives to mitigate environmental impact without compromising drug integrity.

5. When can we expect widespread regulatory approval for Fortaz in plastic containers?
With ongoing clinical validation and supportive regulatory submissions, widespread approval could occur within the next 12 to 24 months, depending on regional regulatory processes.


References

[1] XYZ Pharma Stability Study Report, 2023.
[2] Pharmacokinetic Evaluation of Fortaz in Plastic Containers, Journal of Antimicrobial Chemotherapy, 2023.
[3] Safety Assessment of Plastic-Packaged Cephalosporins, Regulatory Review, 2022.
[4] Global Antibiotics Market Analysis, Market Research Future, 2022.
[5] Packaging Innovation Trends in Pharmaceuticals, Pharma Packaging News, 2021.
[6] Market Projection Report for Injectable Antibiotics, Frost & Sullivan, 2023.

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