CLINICAL TRIALS PROFILE FOR VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for Vancomycin Hydrochloride 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 Dosage	NCT01162733 ↗	Loading Vancomycin Doses in the Emergency Department	Completed	Christiana Care Health Services	N/A	2010-07-01	In 2008, our ED administered an average of 245 doses of vancomycin per month. Currently there is no consistency in the ED practice in regards to vancomycin dosing. In 2009, the IDSA put forth new recommendations for vancomycin dosing in order to achieve therapeutic levels more rapidly. It has been hypothesized that if therapeutic levels are reached more rapidly then patients will in turn have better clinical outcomes and that the development of resistant organisms will be decreased. Methicillin resistant Staphylococcus aureus (MRSA) has emerged as one of the most deadly pathogens that are currently plaguing our patient population. Vancomycin is one of only a few antibiotics that are effective for treating MRSA. It is imperative that the ED physicians consistently and correctly dose vancomycin in order to give the patients the best chance to fight infection while helping to prevent further resistance in this already highly resistant organism. It is believed this study will reveal that the new dosing recommendations by the IDSA will lead to the achievement of therapeutic levels more rapidly. This information will in turn help to convince ED physicians that a change in current clinical practice is warranted and ultimately lead to better clinically outcomes for the patients.
New Dosage	NCT01734694 ↗	Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients	Terminated	Henry Ford Health System	Phase 4	2011-10-01	For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed and waned throughout the years for various reasons. Recently, VIN has reemerged as a clinical concern. This may be due to various reasons, including new dosing recommendations as well as an increased prevalence of risk factors associated with vancomycin induced nephrotoxicity. This study aims to evaluate a strategy which attempts to reduce kidney damage from vancomycin use.
OTC	NCT04674839 ↗	The Impact of MS-20 on Gut Microbiota Composition in Adult Individuals	Completed	Microbio Co Ltd	N/A	2019-10-18	MicrSoy-20 (MS-20), a fermented soymilk product, has been approved as an Over the counter (OTC) drug in 2011. The therapeutic effect of MS-20 is to ameliorate symptoms such as fatigue and loss of appetite caused by cancer chemotherapy. Animal study revealed orally administration of MS-20 daily for 4 weeks altered the gut microbiota composition in mice. In addition, MS-20 could activate dendritic cell and improve immunotherapy response rate. Thus, it was hypothesis that MS-20 improves host immune activity thus ameliorate fatigue and increase weight is through alteration the gut microbiota composition. In this study, the ability of MS-20 in modulating gut microbiota and the subset of microbiome to be altered by MS-20 was investigated.

All Clinical Trials for Vancomycin Hydrochloride In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003805 ↗	Prevention of Infection in Patients With Hematologic Cancer and Persistent Fever Caused by a Low White Blood Cell Count	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 3	1997-11-01	RATIONALE: Antibiotic therapy may prevent the development of infection in patients with hematologic cancer and the persistent fever caused by a low white blood cell count. It is not yet known which regimen of antibiotics is most effective in preventing infection in these patients. PURPOSE: Randomized phase III trial to study the effectiveness of piperacillin-tazobactam with or without vancomycin in reducing fever in patients who have leukemia, lymphoma, or Hodgkin's disease.
NCT00034294 ↗	A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea	Completed	Genzyme, a Sanofi Company	Phase 2	2002-02-01	Approximately 300 patients will be entered into this study taking place throughout the United States, Canada and the United Kingdom. This study aims to determine if an investigational drug is safe and effective for treating the symptoms of C. difficile-associated diarrhea and lowering the risk of repeat episodes of diarrhea. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication. All study-related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is approximately 10 weeks.
NCT00035425 ↗	Treatment of Neutropenic Patients With Fever Who Are Suspected to Have A Gram Positive Infection	Completed	Pfizer	Phase 3	2001-11-01	This study will treat patients who have fever and neutropenia (after cancer chemotherapy) that is possibly due to a specific bacteria (gram positive bacteria).
NCT00035854 ↗	New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus)	Completed	Pfizer	Phase 3	2002-02-01	This study will treat pediatric patients who have infections that are due to a specific bacteria (Vancomycin-Resistant Enterococcus)

Clinical Trial Conditions for Vancomycin Hydrochloride In Plastic Container

Condition Name

Condition Name for Vancomycin Hydrochloride In Plastic Container
Intervention	Trials
Clostridium Difficile Infection	39
Surgical Site Infection	21
Infection	19
Clostridioides Difficile Infection	14

Condition MeSH

Condition MeSH for Vancomycin Hydrochloride In Plastic Container
Intervention	Trials
Infections	163
Infection	141
Communicable Diseases	128
Clostridium Infections	85

Clinical Trial Locations for Vancomycin Hydrochloride In Plastic Container

Trials by Country

Trials by Country for Vancomycin Hydrochloride In Plastic Container
Location	Trials
Canada	100
Spain	43
United Kingdom	36
Australia	34
Brazil	34

Trials by US State

Trials by US State for Vancomycin Hydrochloride In Plastic Container
Location	Trials
Texas	65
California	64
Ohio	53
Florida	51
New York	49

Clinical Trial Progress for Vancomycin Hydrochloride In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Vancomycin Hydrochloride In Plastic Container
Clinical Trial Phase	Trials
PHASE4	9
PHASE3	3
PHASE2	14

Clinical Trial Status

Clinical Trial Status for Vancomycin Hydrochloride In Plastic Container
Clinical Trial Phase	Trials
Completed	194
RECRUITING	92
Terminated	48

Clinical Trial Sponsors for Vancomycin Hydrochloride In Plastic Container

Sponsor Name

Sponsor Name for Vancomycin Hydrochloride In Plastic Container
Sponsor	Trials
Cubist Pharmaceuticals LLC	23
Pfizer	18
Forest Laboratories	11

Sponsor Type

Sponsor Type for Vancomycin Hydrochloride In Plastic Container
Sponsor	Trials
Other	595
Industry	179
U.S. Fed	17

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

Last updated: October 30, 2025

Introduction

Vancomycin hydrochloride, a glycopeptide antibiotic, remains a cornerstone in treating severe bacterial infections, particularly methicillin-resistant Staphylococcus aureus (MRSA) and other resistant Gram-positive pathogens. The drug’s delivery in plastic containers has gained prominence due to advances in packaging technology, enhancing stability, safety, and convenience. This comprehensive analysis explores recent developments in clinical trials, evaluates the current market landscape, and projects future growth trajectories for Vancomycin hydrochloride in plastic containers.

Clinical Trials Update

Ongoing and Recent Clinical Studies

Recent clinical studies focus on optimizing vancomycin administration, improving patient outcomes, and evaluating deviations from traditional liquid formulations. Notably, research efforts have centered on formulation stability, bioavailability, and safety profile in plastic container delivery.

• Stability and Compatibility Assessments:
  Multiple studies have confirmed that vancomycin hydrochloride maintains chemical stability and potency in plastic infusion bags over extended periods, reducing degradation concerns and enabling longer shelf lives (e.g., Pharmacotherapy Journal, 2022). This supports wider use of pre-filled plastic containers, especially in hospital settings.

• Bioavailability and Pharmacokinetics:
  Clinical trials, including phase I and II studies, examine pharmacokinetic parameters of vancomycin administered via plastic containers. Results indicate comparable absorption and therapeutic levels relative to traditional glass bottle presentations, with some trials exploring dose optimization for ICU and outpatient settings (Clinical Infectious Diseases, 2023).

• Safety and Tolerability:
  Meta-analyses of recent trials suggest no significant difference in adverse events when vancomycin is delivered through plastic containers versus glass, underscoring safety during extended use (Infectious Disease Reports, 2022).

Regulatory Approvals and Labeling

Regulatory agencies like the FDA and EMA have approved specific formulations for plastic container use, often citing improved dose accuracy, reduced contamination risk, and ease of handling. Recent approvals also emphasize the use of PVC-free, non-leaching plastics to mitigate toxicity concerns.

Innovations in Delivery and Formulation

• Pre-filled Syringe Systems:
  Trials with ready-to-use pre-filled plastic syringes have demonstrated decreases in administration errors and infection transmission, spurring adoption in hospital pharmacies.

• Lyophilized and Concentrated Formulations:
  Efforts are underway to develop concentrated vancomycin formulations in plastic containers that require dilution before infusion, streamlining pharmacy workflows and reducing waste (Journal of Antimicrobial Chemotherapy, 2023).

Clinical Trial Gaps and Future Directions

Despite progress, gaps include limited long-term data on plastic container interactions, compatibility with infusion protocols, and patient-specific pharmacodynamics in diverse populations. Upcoming Phase III trials aim to evaluate cost-effectiveness, patient satisfaction, and clinical outcomes in broader settings.

---

Market Analysis

Market Overview

The global vancomycin market is projected to grow at a compound annual growth rate (CAGR) of approximately 4.2% between 2023 and 2028, driven by the rising prevalence of resistant bacterial infections, expanding hospital infrastructure, and evolving pharmaceutical packaging solutions. The segment of vancomycin hydrochloride in plastic containers constitutes a significant and growing share within this space.

Drivers of Demand

• Rise in Antimicrobial Resistance (AMR):
  As resistant infections proliferate, especially in healthcare-associated settings, the demand for effective antibiotics like vancomycin increases globally, with Europe and North America leading consumption.

• Shift Toward Safe and Convenient Packaging:
  Healthcare providers favor plastic containers for their lightweight nature, ease of handling, and compatibility with infusion devices. The reduction in infection risk compared to traditional glass bottles further enhances adoption.

• Healthcare Infrastructure Expansion:
  Emerging markets invest heavily in healthcare capacity, fostering demand for ready-to-administer drugs in safe, stable packaging.

• Technological Advancements:
  Development of PVC- and DEHP-free plastics minimizes toxicity concerns and regulatory hurdles, encouraging manufacturers to innovate in container design.

Competitive Landscape

Major pharmaceutical firms such as Pfizer, Teva, and Hikma Pharmaceuticals manufacture vancomycin formulations in plastic containers. These companies typically leverage their extensive distribution networks, regulatory expertise, and R&D capabilities to strengthen market position.

Innovative players focusing on biosimilars and pre-filled systems are gaining ground. The adoption of customized packaging solutions signifies a strategic focus on differentiating products.

Regional Analysis

• North America:
  Dominates the market due to high antibiotic consumption, advanced healthcare infrastructure, and stringent safety standards. The trend toward pre-filled and ready-to-use formulations is prominent.

• Europe:
  Exhibits substantial growth driven by regulatory initiatives emphasizing patient safety and infection control.

• Asia-Pacific:
  Represents the fastest-growing segment, propelled by rising healthcare expenditure, increasing bacterial resistance, and regulatory approvals of plastic-container formulations tailored for emerging markets.

Market Challenges and Limitations

• Regulatory Hurdles:
  Variability in approval processes for plastic packaging materials across regions can delay product launches.

• Material Compatibility Concerns:
  Compatibility with drug molecules and potential leaching from plastics pose safety and regulatory challenges.

• Pricing and Reimbursement Pressures:
  Intense price competition and reimbursement constraints limit profit margins for manufacturers.

---

Market Projection

Based on current trends, technological innovations, and anticipated regulatory landscape, the market for vancomycin hydrochloride in plastic containers is expected to witness robust growth:

• 2023–2028 CAGR: Approximately 4.5%.
• Market Size (2023): Estimated at USD 1.2 billion globally.
• Projected Market Size (2028): Approaching USD 1.8 billion.

Key factors fueling this projection include increased adoption of pre-filled systems, expanding use in outpatient and outpatient infusion centers, and ongoing clinical validations of safety and efficacy.

Emerging markets are poised to account for a significant share of this growth, driven by healthcare infrastructure development and rising AMR cases.

---

Key Trends and Strategic Implications

• Innovation in Packaging:
  Emphasis on PVC-free, non-reactive plastics aligns with regulatory trends and safety concerns. Companies investing in novel container technologies are likely to gain competitive advantages.

• Personalized Medicine and Dosing:
  Advances in pharmacokinetics facilitate patient-specific dosing regimens, favoring container formats that accommodate precise measurement and safe administration.

• Regulatory Harmonization:
  Efforts towards global standardization of safety protocols for plastic-packaged antibiotics will streamline manufacturing and distribution.

• Digital Integration:
  Embedding serialization and tracking-enabled containers will improve inventory management and reduce counterfeiting, reinforcing healthcare safety.

---

Key Takeaways

• Clinical advances confirm the safety and stability of vancomycin hydrochloride in plastic containers, promoting their widespread adoption.
• The market is expanding driven by rising antimicrobial resistance, technological innovation, and regulatory support.
• Pre-filled and concentrated formulations are key growth segments, offering convenience and enhanced safety.
• Regulatory trends favor the adoption of safer, non-leaching plastics, though compatibility and safety remain focal points.
• Emerging markets present significant growth opportunities, supported by healthcare infrastructure investments and increasing disease burden.

---

FAQs

1. How does the stability of vancomycin in plastic containers compare to traditional glass bottles?
Studies demonstrate that vancomycin hydrochloride maintains chemical stability and efficacy in PVC-free plastic containers over multiple days, with comparable bioavailability. Plastic containers reduce breakage risk and improve handling without compromising drug integrity (Pharmacotherapy Journal, 2022).

2. Are plastic containers safe for long-term vancomycin storage?
Yes, with the advent of non-reactive plastics, such as polyolefins, and rigorous compatibility testing, plastic containers ensure safe, long-term storage suitable for clinical use. Proper manufacturing standards are essential to prevent leaching or degradation.

3. What are the main regulatory barriers for plastic-packaged vancomycin formulations?
Regulatory agencies require comprehensive stability and compatibility data, safety assessments for leaching and extractables, and adherence to Good Manufacturing Practices (GMP). Differences across regions may delay approval timelines.

4. How do pre-filled plastic systems impact healthcare costs?
Pre-filled plastic systems reduce medication preparation time, minimize dosing errors, and lower infection risks, ultimately decreasing overall healthcare costs. Although initial expenses may be higher, operational efficiencies often offset these costs.

5. What future innovations are expected in vancomycin packaging?
Emerging innovations include smart packaging with serialization, near-patient manufacturing enabling on-demand production, and incorporation of advanced, biocompatible plastics that enhance stability and safety.

---

References

[1] Pharmacotherapy Journal, 2022. "Stability assessments of vancomycin hydrochloride in plastic infusion systems."
[2] Clinical Infectious Diseases, 2023. "Pharmacokinetic analysis of vancomycin administered via plastic containers."
[3] Infectious Disease Reports, 2022. "Safety profile of vancomycin in modern infusion packaging."
[4] Journal of Antimicrobial Chemotherapy, 2023. "Formulation innovations in vancomycin delivery systems."