CLINICAL TRIALS PROFILE FOR BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

All Clinical Trials for BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00985244 ↗	Macrolide Maintenance Therapy in Chronic Obstructive Pulmonary Disease	Completed	Erasmus Medical Center	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.
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.
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.

Clinical Trial Conditions for BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Condition Name

Condition Name for BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention	Trials
Acne Vulgaris	3
Pneumonia	2
Surgical Site Infection	2
Anesthesia, Local	2

Condition MeSH

Condition MeSH for BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention	Trials
Infections	4
Infection	4
Pneumonia	3
Acne Vulgaris	3

Clinical Trial Locations for BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Trials by Country

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Trials by Country for BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Location	Trials
United States	16
Egypt	5
India	3
Netherlands	3
France	3

Trials by US State

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Trials by US State for BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Location	Trials
California	4
Ohio	2
Minnesota	2
Texas	1
Delaware	1

Clinical Trial Progress for BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 4	23
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	17
Not yet recruiting	13
Unknown status	8

Clinical Trial Sponsors for BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor	Trials
University of California, San Francisco	2
Assiut University	2
Erasmus Medical Center	2

Sponsor Type

Sponsor Type for BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor	Trials
Other	65
Industry	10
NIH	2

Bacteriostatic 0.9% Sodium Chloride Injection, USP: Clinical Trials, Market Analysis, and Projections

Introduction

Bacteriostatic 0.9% Sodium Chloride Injection, USP, is a sterile, nonpyrogenic, isotonic solution designed for parenteral use as a diluent or solvent for drugs that require dilution or dissolution in an aqueous vehicle before injection. Here, we will delve into the clinical trials, market analysis, and projections for this essential medical product.

Clinical Trials and Studies

Efficacy and Safety

Clinical trials and studies have primarily focused on the use of bacteriostatic sodium chloride as a diluent for various medications. For instance, a study on the reconstitution of botulinum toxin type A using bacteriostatic saline versus normal saline showed that patients reported less pain when bacteriostatic saline was used[4].

• Pain Reduction: In a double-blind randomized controlled trial (RCT) conducted by Van Laborde et al., 87% of patients reported less pain on the side treated with botulinum toxin reconstituted with bacteriostatic saline compared to unpreserved saline[4].
• Clinical Effect: The study also indicated that there was no difference in the clinical effect of the botulinum toxin between the two types of saline solutions, suggesting that bacteriostatic saline does not impact the efficacy of the toxin[4].

Pediatric and Neonatal Use

Bacteriostatic sodium chloride solutions containing benzyl alcohol are contraindicated in neonates due to the potential toxicity of benzyl alcohol. This is a critical consideration in pediatric care, highlighting the need for careful selection of diluents in this population[3][5].

Market Analysis

Demand and Usage

Bacteriostatic 0.9% Sodium Chloride Injection is widely used in healthcare settings for various parenteral applications. The demand is driven by its role as a necessary diluent for many intravenous, intramuscular, and subcutaneous injections.

• Healthcare Settings: It is commonly used in hospitals, clinics, and other healthcare facilities where parenteral medications are administered frequently.
• Specialized Uses: It is also used in specialized fields such as aesthetic nursing for reconstituting botulinum toxin and other cosmetic treatments[4].

Market Trends

The market for bacteriostatic sodium chloride solutions is influenced by several trends:

• Increasing Healthcare Needs: The growing demand for parenteral medications due to an aging population and the rise in chronic diseases drives the need for reliable diluents like bacteriostatic sodium chloride.
• Advancements in Medical Technology: Improvements in medical technology and the development of new parenteral drugs further increase the demand for this product.
• Regulatory Compliance: The market is also influenced by regulatory standards, with products needing to comply with USP biological standards for plastic containers and other safety regulations[2][3].

Competitive Landscape

The market for bacteriostatic sodium chloride solutions is competitive, with several manufacturers providing this product. Key players focus on ensuring the quality, sterility, and safety of their products.

• Manufacturing Standards: Companies must adhere to strict manufacturing standards, including the use of specially formulated polyolefin containers that meet USP biological standards[2][3].
• Product Differentiation: While the core product remains the same, differentiation often comes from packaging, convenience of use, and additional certifications such as latex-free and multiple-dose containers[2].

Market Projections

Growth Forecast

The market for bacteriostatic 0.9% sodium chloride injection is expected to grow steadily over the next few years, driven by increasing healthcare needs and advancements in medical technology.

• Global Demand: The global demand for parenteral medications is expected to rise, leading to an increased need for reliable diluents.
• Emerging Markets: Growth in emerging markets, particularly in regions with improving healthcare infrastructure, is also anticipated to drive demand[2].

Economic Factors

Economic factors such as healthcare spending and reimbursement policies can influence the market.

• Healthcare Spending: Increased healthcare spending in developed and developing countries is likely to boost the demand for bacteriostatic sodium chloride solutions.
• Reimbursement Policies: Favorable reimbursement policies for parenteral medications can also contribute to market growth[2].

Key Takeaways

• Clinical Efficacy: Bacteriostatic 0.9% sodium chloride injection is effective as a diluent, with studies showing reduced pain in patients when used for reconstituting certain medications.
• Market Demand: The demand for this product is driven by its essential role in parenteral medication administration across various healthcare settings.
• Regulatory Compliance: Manufacturers must comply with strict regulatory standards to ensure the safety and quality of the product.
• Market Growth: The market is projected to grow due to increasing healthcare needs, advancements in medical technology, and growth in emerging markets.

FAQs

What is Bacteriostatic 0.9% Sodium Chloride Injection used for?

Bacteriostatic 0.9% Sodium Chloride Injection is used as a diluent or solvent for drugs that require dilution or dissolution in an aqueous vehicle before parenteral injection[1][2][5].

Is Bacteriostatic 0.9% Sodium Chloride Injection safe for neonates?

No, solutions containing benzyl alcohol, such as bacteriostatic sodium chloride, are contraindicated in neonates due to potential toxicity[3][5].

Does Bacteriostatic 0.9% Sodium Chloride Injection affect the efficacy of medications?

Studies indicate that bacteriostatic sodium chloride does not impact the efficacy of medications like botulinum toxin type A[4].

What are the key components of Bacteriostatic 0.9% Sodium Chloride Injection?

Each milliliter contains 9 mg of sodium chloride and 0.9% (9 mg/mL) benzyl alcohol as a bacteriostatic preservative. It may also contain hydrochloric acid for pH adjustment[1][2][5].

What is the typical packaging for Bacteriostatic 0.9% Sodium Chloride Injection?

It is supplied in multiple-dose plastic vials, often with a fliptop closure, and is latex-free[2].

Sources

1. Drugs.com: Bacteriostatic Sodium Chloride: Package Insert / Prescribing Info
2. IVF Store: Bacteriostatic 0.9% Sodium Chloride Injection, USP
3. Pfizer Labeling: Bacteriostatic 0.9% Sodium Chloride Injection, USP
4. Aesthetic Nursing: A study on the reconstitution of botulinum toxin type A: normal saline versus bacteriostatic saline
5. DailyMed: Bacteriostatic 0.9% Sodium Chloride Injection, USP