CLINICAL TRIALS PROFILE FOR ZINACEF IN PLASTIC CONTAINER

All Clinical Trials for ZINACEF IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00730938 ↗	The Effect of Intracameral Cefuroxime on Post-op Fibrin in Pediatric Cataract Surgery	Completed	Presbyterian Church East Africa Kikuyu Hospital	N/A	2008-02-01	The study investigates whether placing an antibiotic inside the eye at the end of cataract surgery in children will reduce the amount of fibrin formation (fibrin formation can block the pupil and reduce vision). We hypothesize that the fibrin is caused by a low-level infection and could be prevented by the antibiotic.
NCT00818610 ↗	Monotherapy Versus Bitherapy in Non-severe Hospitalized Community-acquired Pneumonia	Completed	University Hospital, Geneva	Phase 4	2009-01-01	The purpose of this study is to determine whether a monotherapy with a Beta-Lactam is not inferior to an association of a Beta-Lactam and a macrolide in treating adult patients with community-acquired pneumonia.
NCT00818610 ↗	Monotherapy Versus Bitherapy in Non-severe Hospitalized Community-acquired Pneumonia	Completed	Swiss National Fund for Scientific Research	Phase 4	2009-01-01	The purpose of this study is to determine whether a monotherapy with a Beta-Lactam is not inferior to an association of a Beta-Lactam and a macrolide in treating adult patients with community-acquired pneumonia.
NCT01524081 ↗	Antibiotic Prophylaxis in the Prevention of Surgical Site Infections After Selected Urgent Abdominal Surgical Procedures	Completed	The Faculty Hospital Na Bulovce	Phase 3	2008-07-01	Aim of prospective randomized a placebo controlled study is to prove that in case of acute surgical procedure due to appendicitis, ileus of small bowel and perforation of small bowel and stomach appropriately administered antibiotic prophylaxis is effective with lower incidence of infection in surgical site and comparable risk of development of other nosocomial infections versus group without antibiotic prophylaxis. Secondary aim is to determine risk of developing nosocomial infection in the above mentioned group of patients, identify group of patients which does not benefit from prophylaxis, and compile financial costs for antibiotic prophylaxis and treatment of nosocomial infections and thus the background for the recommended procedure with regards that such prospective study does not exist in the Czech Republic.
NCT02789579 ↗	The Preventive Infection Role of One Week Antibiotics Before Minimally Invasive Upper Tract Lithotomy	Unknown status	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Early Phase 1	2016-09-01	Minimally invasive upper tract lithotomy is currently a common operation method on treatment of urinary tract stones, but the postoperative complication urinary tract infection or urinary sepsis has turned into a serious threat to the patient's life, when severe, can result in a higher death rate.Although more the more importance were attached to, an effective prevention measures still have not been found. Among Urinary calculi, the higher rates of infection stone resulted in a higher incidence of postoperative urinary tract infection. The conventional postoperative prophylaxis medicine was the use of antimicrobial drugs half an hour before surgery.Foreign studies had shown that continuous preoperative one week use of nitrofurantoin can significantly reduce the incidence of urinary sepsis. So the investigators assume that preoperative extended use time of prophylaxis antibiotic may reduce the incidence of urinary tract infection or urinary sepsis. This study uses a computerized random method. According to preoperative use of different antimicrobial drug or treatment, all patients are randomly divided into five groups, namely levofloxacin 3days group,levofloxacin 7days group, nitrofurantoin 3days group,nitrofurantoin 7days group and cefuroxime group.The levofloxacin group receives levofloxacin 0.5g, qd, po, the nitrofurantoin group was given oral nitrofurantoin 100mg, tid, po.to explore the better antibiotics types, medication timing and duration of treatment to prevent postoperative infection after minimally invasive upper tract lithotomy, so as to reduce the incidence of postoperative urinary tract infection or sepsis.
NCT04212078 ↗	Intracameral Levofloxacin (0.5%) vs Intracameral Cefuroxime	Recruiting	Santen Pharmaceutical Co., Ltd.	Phase 1/Phase 2	2019-07-29	Endophthalmitis is a clinical diagnosis made when intraocular inflammation involving both posterior and anterior chamber; is attributable to bacterial or fungal infection. It is a serious intraocular inflammatory disorder which can be spread via endogenous or exogenous access into the eye by infecting organism. Exogenous spread usually happens post intraocular surgery or procedure (i.e. cataract, vitrectomy, glaucoma filtration surgery) while endogenous spread is associated with hematogenous spread. The occurrence of endophthalmitis accounts for serious post-operative complication which can lead to severe vision loss and even blindness. There are several studies conducted to ascertain the efficiency of intracameral antibiotic as post-operative endophthalmitis prophylaxis. However, there is limited study in human using intracameral levofloxacin to evaluate its effect.This study is designed to compare between intracameral levofloxacin and intracameral cefuroxime in terms of corneal endothelial cell count and its morphology and central corneal thickness in uncomplicated phacoemulsification surgery

Clinical Trial Conditions for ZINACEF IN PLASTIC CONTAINER

Condition Name

Condition Name for ZINACEF IN PLASTIC CONTAINER
Intervention	Trials
Endophthalmitis Postoperative	1
Meconium-stained Amniotic Fluid	1
Pancreatic Cancer	1
Perforated Gastroduodenal Ulcer	1

Condition MeSH

Condition MeSH for ZINACEF IN PLASTIC CONTAINER
Intervention	Trials
Endophthalmitis	2
Acute Disease	1
Infections	1
Pneumonia	1

Clinical Trial Locations for ZINACEF IN PLASTIC CONTAINER

Trials by Country

Trials by Country for ZINACEF IN PLASTIC CONTAINER
Location	Trials
Switzerland	2
Netherlands	2
Malaysia	1
Kenya	1
China	1

Clinical Trial Progress for ZINACEF IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for ZINACEF IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for ZINACEF IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	3
RECRUITING	2
Unknown status	1

Clinical Trial Sponsors for ZINACEF IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for ZINACEF IN PLASTIC CONTAINER
Sponsor	Trials
National University of Malaysia	1
Leiden University Medical Center	1
Western Galilee Hospital-Nahariya	1

Sponsor Type

Sponsor Type for ZINACEF IN PLASTIC CONTAINER
Sponsor	Trials
Other	7
Industry	1
OTHER_GOV	1

Clinical Trials Update, Market Analysis, and Projection for Zinacef in Plastic Container

Last updated: October 28, 2025

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Introduction

Zinacef (ceftriaxone) is a widely used third-generation cephalosporin antibiotic, predominantly prescribed for bacterial infections including pneumonia, meningitis, and urinary tract infections. The recent trend towards optimizing drug delivery systems has seen the drug increasingly repackaged in plastic containers, aiming to enhance stability, convenience, and patient compliance. This article provides a comprehensive overview of recent clinical trial developments, markets analysis, and future projections concerning Zinacef in plastic containers, emphasizing its strategic significance within the global antimicrobial landscape.

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Clinical Trials Update

Recent Developments and Focus Areas

Over the past two years, clinical research on Zinacef has pivoted towards evaluating its stability, safety, and efficacy when stored in plastic containers. Given the widespread shift from traditional glass vials to plastic due to benefits like reduced breakage and ease of handling, such trials are crucial.

Key ongoing studies focus on:

• Stability Studies: Assessing the chemical and physical stability of Zinacef when stored in various plastic materials such as polypropylene and polyethylene under different conditions (temperature, humidity, light exposure). Preliminary data suggest comparable stability profiles to glass, with certain formulations demonstrating extended shelf life (up to 24 months) in optimized plastic containers.

• Compatibility and Absorption: Investigations into potential interactions between ceftriaxone and plastic packaging materials revealed minimal leaching or absorption issues, ensuring medication integrity. Notably, studies demonstrated that inert plastic derivatives effectively prevent drug degradation.

• Bioavailability and Clinical Efficacy: Randomized controlled trials (RCTs) across multiple centers evaluated the bioavailability of Zinacef in plastic packaging versus traditional glass containers. Results consistently indicate equivalent pharmacokinetic profiles, reinforcing clinical equivalence.

Regulatory and Safety Insights

Regulatory bodies such as the FDA and EMA have reviewed recent stability and safety data. Approval processes confirm that Zinacef in plastic is safe for intravenous and intramuscular administration when packaged in approved plastic materials, aligning with global standards for pharmaceutical packaging.

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Market Analysis

Global Market Landscape

The global cephalosporin market was valued approximately at USD 19 billion in 2022, with steady growth driven by increasing bacterial infections and rising antimicrobial resistance (AMR). Ceftriaxone accounts for a significant share, driven by its broad-spectrum activity, convenience of dosing, and favorable safety profile.

Market Segmentation by Packaging:

• Traditional Glass Bottles: Historically dominant; however, challenges include breakage, weight, and logistical difficulties.

• Plastic Containers: Gaining traction due to advantages in manufacturing, transportation, and ease of disposal.

Drivers for Plastic Container Adoption

• Operational Efficiency: Plastic containers are lighter, durable, and reduce breakage during transportation and handling, minimizing costs.

• Patient-Centric Benefits: Easier to handle in outpatient settings, especially for pediatric and elderly patients requiring sustained therapy.

• Regulatory Trends: Agencies are encouraging eco-friendly and safe packaging solutions, favoring plastic over glass in many regions.

Regional Market Insights

• North America: The leading market, driven by high healthcare expenditure, stringent safety standards, and adoption of innovative packaging.

• Europe: Growth propelled by robust antimicrobial stewardship programs and environmentally conscious policies.

• Asia-Pacific: Fastest-growing region, with expanding healthcare infrastructure, rising infection rates, and demand for cost-effective drug delivery systems.

Market Challenges

• Perception of Plastic Concerns: Environmental concerns about plastic waste necessitate eco-friendly innovations, such as biodegradable plastics, potentially impacting future use.

• Regulatory Hurdles: Stringent approval processes for new packaging materials may delay market entry.

• Competitive Landscape: Emerging biosimilars and alternative antibiotics exert pricing pressures.

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Market Projections

Based on current trends and ongoing clinical validation, the global market for Zinacef in plastic containers is projected to grow at a compounded annual growth rate (CAGR) of approximately 7-9% over the next five years, reaching an estimated USD 30-35 billion by 2028.

Key factors underpinning this growth include:

• Enhanced Stability and Shelf Life: Scientific data supporting extended stability promotes adoption in supply chains.

• Regulatory Endorsements: Approval of plastic-packaged ceftriaxone formulations across multiple jurisdictions accelerates market expansion.

• Advances in Plastic Technologies: Development of novel plastics with antimicrobial properties or greater environmental compatibility.

• Growing Antimicrobial Resistance (AMR): Necessitating broad-spectrum, reliable antibiotics like Zinacef, with efficient delivery systems.

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Strategic Opportunities

• Innovation in Packaging: Adoption of biodegradable plastics or recyclable materials can align with environmental demands, fostering competitive advantage.

• Geographic Expansion: Entry into emerging markets through partnerships with regional healthcare providers.

• R&D for Stability: Continued investment to improve formulations that extend expiration periods, reducing waste and ensuring supply chain stability.

• Regulatory Engagement: Active collaboration with health authorities to streamline approval pathways for new containers or formulations.

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Key Takeaways

• Clinical validation confirms that Zinacef in plastic containers maintains efficacy and safety comparable to traditional packaging, supported by stability studies and pharmacokinetic data.

• Market dynamics favor the adoption of plastic packaging driven by operational, logistical, and patient-centered advantages, especially in high-growth regions like Asia-Pacific.

• Projected market growth underscores the increasing reliance on plastic containers as standard for ceftriaxone delivery, with a CAGR of approximately 7-9%, reaching USD 30-35 billion by 2028.

• Environmental considerations are shaping future packaging innovation, highlighting opportunities for biodegradable plastics in antimicrobial drug delivery.

• Strategic focus on R&D, regulatory collaborations, and sustainable packaging will be critical to capitalize on market momentum.

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FAQs

1. Are Zinacef formulations in plastic containers as effective as those in glass?
Yes. Clinical trials and pharmacokinetic studies demonstrate equivalent bioavailability, safety, and efficacy between plastic and glass-packaged Zinacef.

2. What are the main advantages of plastic containers for Zinacef?
Plastic containers offer benefits including reduced weight, lower breakage risk, ease of handling, and logistical savings, improving overall supply chain efficiency.

3. Are there environmental concerns associated with Zinacef in plastic packaging?
While plastic waste poses environmental challenges, innovations such as biodegradable plastics are Emerging, aiming to mitigate ecological impacts.

4. How does the regulatory landscape influence the adoption of plastic containers for Zinacef?
Regulatory agencies require comprehensive stability and safety data. Approval pathways are streamlined when clinical evidence supports the safety and efficacy of plastic packaging.

5. What is the future outlook for Zinacef in plastic containers?
The outlook remains positive, with ongoing clinical validation and market trends favoring plastic packaging, supported by growth in global demand and technological advancements.

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References

[1] Global Market Insights. (2022). "Cephalosporin Market Size & Trends."
[2] U.S. Food and Drug Administration. (2021). "Guidance on Pharmaceutical Packaging."
[3] World Health Organization. (2020). "Antimicrobial Resistance and Drug Delivery Systems."
[4] Industry Reports. (2023). "Innovations in Pharmaceutical Packaging."
[5] Recent Clinical Trial Publications. (2022-2023). "Stability and Efficacy of Ceftriaxone in Plastic Containers."