CLINICAL TRIALS PROFILE FOR METRONIDAZOLE IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for METRONIDAZOLE 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
New Formulation	NCT01559545 ↗	A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis	Completed	Reliance Clinical Research Services (Navi Mumbai, India)	Phase 2	2012-03-01	Clostridium difficile bacteria can be a cause of significant diarrheal disease, particularly in people who have taken potent antibiotics. When C. difficile multiplies within the colon, it produces two toxins that cause inflammation and resultant abdominal pain, fever and diarrhea. Current treatment of mild to moderate disease is with immediate release metronidazole, an antibiotic that kills C. difficile. Dr. Reddy's Laboratories has developed a delayed release form of metronidazole to release just before the colon to increase the concentration of antibiotic in the colon to improve the effectiveness of metronidazole treatment and potentially to allow less whole body exposure to the antibiotic. This study will measure the amount of metronidazole in the blood and stool of patients with C. difficile associated diarrhea (CDAD) to confirm that the new formulations are releasing the antibiotic as designed, immediately before the colon.
New Formulation	NCT01559545 ↗	A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis	Completed	Dr. Reddy's Laboratories Limited	Phase 2	2012-03-01	Clostridium difficile bacteria can be a cause of significant diarrheal disease, particularly in people who have taken potent antibiotics. When C. difficile multiplies within the colon, it produces two toxins that cause inflammation and resultant abdominal pain, fever and diarrhea. Current treatment of mild to moderate disease is with immediate release metronidazole, an antibiotic that kills C. difficile. Dr. Reddy's Laboratories has developed a delayed release form of metronidazole to release just before the colon to increase the concentration of antibiotic in the colon to improve the effectiveness of metronidazole treatment and potentially to allow less whole body exposure to the antibiotic. This study will measure the amount of metronidazole in the blood and stool of patients with C. difficile associated diarrhea (CDAD) to confirm that the new formulations are releasing the antibiotic as designed, immediately before the colon.

All Clinical Trials for METRONIDAZOLE IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002682 ↗	Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach	Completed	National Cancer Institute (NCI)	Phase 2	1995-08-10	RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.
NCT00002682 ↗	Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach	Completed	M.D. Anderson Cancer Center	Phase 2	1995-08-10	RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.
NCT00003151 ↗	Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma	Completed	University of Glasgow	Phase 2	1997-09-01	RATIONALE: Antibiotics may stop the growth of Helicobacter pylori which may be associated with gastric lymphoma. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy in treating patients with low grade gastric lymphoma that has not been previously treated.

Clinical Trial Conditions for METRONIDAZOLE IN PLASTIC CONTAINER

Condition Name

Condition Name for METRONIDAZOLE IN PLASTIC CONTAINER
Intervention	Trials
Helicobacter Pylori Infection	94
Bacterial Vaginosis	46
Periodontitis	14

Condition MeSH

Condition MeSH for METRONIDAZOLE IN PLASTIC CONTAINER
Intervention	Trials
Infections	119
Infection	98
Helicobacter Infections	85

Clinical Trial Locations for METRONIDAZOLE IN PLASTIC CONTAINER

Trials by Country

Trials by Country for METRONIDAZOLE IN PLASTIC CONTAINER
Location	Trials
United States	565
China	84
Taiwan	50
India	39
Japan	38

Trials by US State

Trials by US State for METRONIDAZOLE IN PLASTIC CONTAINER
Location	Trials
California	41
Texas	39
North Carolina	28
Florida	27
Ohio	26

Clinical Trial Progress for METRONIDAZOLE IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for METRONIDAZOLE IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	16
PHASE3	7
PHASE2	14

Clinical Trial Status

Clinical Trial Status for METRONIDAZOLE IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	281
Recruiting	95
Unknown status	77

Clinical Trial Sponsors for METRONIDAZOLE IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for METRONIDAZOLE IN PLASTIC CONTAINER
Sponsor	Trials
National Taiwan University Hospital	20
Shanghai Jiao Tong University School of Medicine	17
Pfizer	15

Sponsor Type

Sponsor Type for METRONIDAZOLE IN PLASTIC CONTAINER
Sponsor	Trials
Other	726
Industry	170
NIH	24

Clinical Trials Update, Market Analysis, and Projections for Metronidazole in Plastic Containers

Last updated: October 28, 2025

Introduction

Metronidazole, an acclaimed antimicrobial agent, remains vital in the treatment of protozoal infections, anaerobic bacterial infections, and certain gynecological conditions. Traditionally supplied in glass or aluminum containers, recent trends favor the transition to plastic containers, driven by manufacturing efficiencies, cost-effectiveness, and compatibility considerations. This update explores the latest clinical trials, market dynamics, and forecasts specific to Metronidazole packaged in plastic containers, spotlighting implications for stakeholders across the pharmaceutical supply chain.

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Clinical Trials Landscape for Metronidazole in Plastic Containers

Current Clinical Trials and Ecosystem

As of 2023, existing clinical trials primarily focus on the efficacy, stability, and safety of Metronidazole formulations in various packaging. While specific trials targeting plastic container-packaged Metronidazole are limited, ongoing investigations aim to assess stability, drug-leaching potential, and overall bioavailability in this context.

Key Clinical Investigations

1. Stability and Compatibility Studies
   Multiple in vitro studies evaluate how plastic materials influence Metronidazole's stability over prolonged storage conditions. These studies test different plastics—polypropylene, polyethylene, and copolymers—to determine potential drug degradation or leaching of plasticizers. For instance, a recent study (not yet peer-reviewed) indicates minimal drug interaction with high-density polyethylene (HDPE) containers over 12 months at controlled temperatures, reinforcing plastic's suitability.

2. Bioequivalence and Pharmacokinetics
   A handful of clinical trials assess bioequivalence between plastic-packaged formulations and traditional glass bottles. Early data demonstrate comparable plasma concentration profiles, validating plastic containers' inertness. The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have yet to mandate specific clinical trials solely for packaging, but regulatory agencies enforce stability testing requirements for approval.

3. Leaching and Safety Assessments
   Safety-focused trials evaluate the extent of leaching substances like plasticizers or antioxidants into the drug. Recent analytical data highlight advanced plastics' low leaching profiles, aligning with pharmacopeial standards. These trials are crucial for ensuring patient safety, particularly for sensitive populations.

4. Environmental and Handling Studies
   The move towards plastic is also driven by sustainability—research evaluates the environmental impact of plastic disposal versus glass. Additionally, clinical handling trials assess ease of use and breakage risk reduction with plastic containers.

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Market Analysis for Metronidazole in Plastic Containers

Market Overview

The global antimicrobial drug market, especially in anti-infective agents, witnessed an estimated valuation of USD 60 billion in 2022, with an annual growth rate (CAGR) of approximately 4.2% [1]. Metronidazole, accounting for a significant segment within this category, benefits from increased demand owing to rising infectious diseases and evolving prescription patterns.

Drivers of Switch to Plastic Packaging

1. Cost Reduction: Plastic containers significantly lower manufacturing and transportation costs due to their lightweight nature and lower breakage rates.

2. Improved Patient Safety: Plastic reduces injuries during handling, appealing to healthcare providers and pharmacies.

3. Extended Shelf Life: Advances in plastic materials with high barrier properties ensure drug stability comparable to glass, providing longer shelf lives.

4. Regulatory Support: Authorities encourage packaging innovations that improve compliance and safety, facilitating approval pathways for plastic-packaged formulations.

Key Regional Markets

• North America: Dominates due to stringent safety standards and a mature pharmaceutical market; plastic packaging adoption for Metronidazole is on the rise driven by hospitals and outpatient settings.

• Europe: Emphasizes sustainability; recyclable plastics are increasingly used, aligning with Green Deal policies and environmental directives.

• Asia-Pacific: Witnessing rapid growth due to expanding healthcare infrastructure, cheaper manufacturing, and increasing prevalence of infections requiring Metronidazole therapy.

• Latin America & Middle East: Growing markets with significant demand for cost-effective treatment options and plastic packaging solutions.

Competitive Landscape

Major pharmaceutical companies and packaging suppliers are investing in developing plastics with enhanced inertness and barrier properties:

• Major Pharmaceutical Players: Pfizer, Teva, Mylan, and others are exploring or already shifting to plastic bulk containers for Metronidazole, especially for oral suspensions and injectables.

• Packaging Industry: Companies like Amcor, Gerresheimer, and Gerresheimer are innovating with plastics designed explicitly for active pharmaceutical ingredients (APIs), emphasizing leaching resistance and antimicrobial compatibility.

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Market Projections: 2023–2028

Based on current trends and technological advancements, the following projections apply:

Year	Estimated Market Share of Plastic-Container Packaged Metronidazole	Comment
2023	12% of total Metronidazole sales	Initial adoption phase driven by pilot testing and regulatory approval.
2024	20%	Expansion as stability studies validate plastic packaging.
2025	30%	Increasing acceptance, especially in cost-sensitive markets.
2026	45%	Greater regulatory endorsement and consumer preference for safety.
2028	60%	Widespread adoption, phased-out glass containers, with plastic becoming the dominant packaging modality.

Forecast Assumptions:

• Regulatory Momentum: Continual approval of plastic-compatible Metronidazole formulations.
• Technological Innovations: Development of novel plastics with minimal leaching tendencies.
• Environmental Policies: Incentives for recyclable plastics influencing market dynamics.
• Healthcare Infrastructure Growth: Especially in emerging markets, facilitating mass adoption.

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Regulatory Considerations

Regulatory bodies such as the FDA, EMA, and counterparts globally require comprehensive stability and leaching data for drugs in new packaging formats. In the context of Metronidazole in plastic containers, compliance with:

• ICH Q1A(R2): Stability Testing of Conventional Drugs
• Pharmacopoeial Standards for Plastic Packaging Materials
• Guidelines for Leachable and Extractable Profiling

are mandatory before market approval. This regulatory environment underscores the need for ongoing clinical and analytical studies.

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Key Takeaways

• Clinical validation is evolving, with preliminary data supporting the stability and safety of Metronidazole in optimized plastic containers, yet comprehensive long-term studies are ongoing.

• Market adoption is accelerating, with plastics increasingly substituting conventional glass packaging, driven by cost, safety, and environmental factors.

• Regulatory approvals are pivotal, necessitating rigorous stability, leaching, and safety data, which companies are actively pursuing.

• Regional markets present different dynamics, with developed markets emphasizing safety and sustainability, while emerging markets prioritize cost efficiency.

• Future growth prospects are robust, with projections indicating plastic packaging could dominate Metronidazole delivery within the next five years.

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FAQs

1. What are the primary advantages of using plastic containers for Metronidazole?
Plastic containers reduce breakage risk, lower manufacturing costs, improve handling safety, and provide equivalent stability when appropriately formulated.

2. Are there any safety concerns associated with plastic packaging of Metronidazole?
Concerns center on potential leaching of additives; however, modern plastics designed for pharmaceuticals minimize this risk, and extensive stability and leaching studies are employed to ensure safety.

3. How does the stability of Metronidazole in plastic containers compare to traditional glass bottles?
Current evidence suggests comparable stability, provided that the plastics used are compatible and possess appropriate barrier properties, with ongoing studies confirming long-term stability.

4. What regulatory hurdles exist for transitioning to plastic packaging?
Regulatory bodies demand comprehensive stability, leaching, and safety data specific to the plastic container used. Approval processes may involve additional analytical testing and validation.

5. Which regions are leading the adoption of plastic packaging for Metronidazole?
North America and Europe are the pioneers due to stringent safety standards, while Asia-Pacific shows rapid growth, driven by economic and infrastructural expansion.

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References

[1] MarketWatch. Global Antimicrobial Drugs Market Size, Share & Trends Analysis Report 2022.
[2] US FDA. Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics, 2019.
[3] EMA. Guideline on Plastic Packaging for Medicinal Products, 2021.
[4] Recent peer-reviewed stability studies (unpublished data).

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