CLINICAL TRIALS PROFILE FOR MANNITOL 15% IN PLASTIC CONTAINER

All Clinical Trials for MANNITOL 15% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00003062 ↗	Temozolomide in Patients With Progressive or Recurrent Non-small Cell Lung Cancer	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 2	1997-07-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effect of temozolomide in patients with progressive or recurrent stage IV non-small cell lung cancer, with or without brain metastases, who have not been treated for metastatic disease with chemotherapy.
NCT00004767 ↗	Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders	Completed	Johns Hopkins University	Phase 2	1985-01-01	OBJECTIVES: I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium phenylacetate, and dietary intervention in patients with urea cycle disorders.
NCT00004767 ↗	Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders	Completed	National Center for Research Resources (NCRR)	Phase 2	1985-01-01	OBJECTIVES: I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium phenylacetate, and dietary intervention in patients with urea cycle disorders.

Clinical Trial Conditions for MANNITOL 15% IN PLASTIC CONTAINER

Condition Name

Condition Name for MANNITOL 15% IN PLASTIC CONTAINER
Intervention	Trials
Asthma	20
Cystic Fibrosis	10
Healthy	7
Traumatic Brain Injury	6

Condition MeSH

Condition MeSH for MANNITOL 15% IN PLASTIC CONTAINER
Intervention	Trials
Asthma	23
Intracranial Hypertension	12
Brain Neoplasms	10
Fibrosis	10

Clinical Trial Locations for MANNITOL 15% IN PLASTIC CONTAINER

Trials by Country

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Trials by Country for MANNITOL 15% IN PLASTIC CONTAINER
Location	Trials
United States	137
Canada	38
United Kingdom	35
Australia	34
Italy	20

Trials by US State

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−

Trials by US State for MANNITOL 15% IN PLASTIC CONTAINER
Location	Trials
New York	19
Massachusetts	12
Minnesota	9
Oregon	8
Ohio	7

Clinical Trial Progress for MANNITOL 15% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for MANNITOL 15% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 4	37
Phase 3	34
Phase 2/Phase 3	10

Clinical Trial Status

Clinical Trial Status for MANNITOL 15% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	132
Unknown status	27
Not yet recruiting	18

Clinical Trial Sponsors for MANNITOL 15% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for MANNITOL 15% IN PLASTIC CONTAINER
Sponsor	Trials
Pharmaxis	19
Northwell Health	7
Ain Shams University	6

Sponsor Type

Sponsor Type for MANNITOL 15% IN PLASTIC CONTAINER
Sponsor	Trials
Other	366
Industry	64
NIH	17

Mannitol 15% in Plastic Containers: Clinical Trials, Market Analysis, and Projections

Introduction

Mannitol, a polyol used in various medical, pharmaceutical, and food applications, is a crucial compound in modern healthcare and consumer products. This article will delve into the clinical aspects, market analysis, and future projections of mannitol, particularly focusing on the 15% solution in plastic containers.

Clinical Uses of Mannitol

Mannitol is widely used in clinical settings for several purposes:

Reduction of Intracranial Pressure

Mannitol is administered to reduce intracranial pressure and brain mass. It is given in doses ranging from 0.25 to 2 g/kg body weight as a 15% to 25% solution over 30 to 60 minutes[4].

Reduction of Intraocular Pressure

It is used preoperatively to reduce intraocular pressure before surgery, typically administered 1 to 1.5 hours before the procedure[4].

Promotion of Diuresis

Mannitol helps in promoting the urinary excretion of toxic substances. Adults may receive a 5% to 25% solution, while pediatric patients may receive 2 g/kg of body weight of a 5% or 10% solution[4].

Diagnostic Aid

Mannitol is used as a diagnostic aid for renal function and to treat conditions such as glaucoma[3].

Clinical Trials and Safety

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies on solutions from flexible plastic containers have not been conducted to evaluate carcinogenic potential, mutagenic potential, or effects on fertility. However, biological testing has supported the safety of the plastic container materials[1][4].

Pregnancy and Nursing Mothers

Animal reproduction studies have not been conducted with mannitol injection. It should be given to pregnant women only if clearly needed. Additionally, it is not known whether mannitol is excreted in human milk, so caution is advised when administering to nursing mothers[1].

Pediatric Use

The safety and effectiveness of mannitol solutions in pediatric patients have not been well established, although it is used in pediatric doses based on body weight or body surface area[1].

Market Analysis

Current Market Size

As of 2022, the global mannitol market was estimated to be around $418.65 million. This market is projected to grow significantly over the next decade[2].

Growth Projections

The global mannitol market is expected to reach $890.31 million by 2033, growing at a CAGR of 7.1% from 2023 to 2033. This growth is driven by increasing demand in pharmaceutical, food, and industrial applications[2].

Key Market Segments

• Pharmaceutical Sector: This sector is the leading segment, expected to grow at a CAGR of 7.91% and hold a market value share of 24.5% by 2033. Mannitol is used as an excipient in tablets, capsules, and injectables due to its low toxicity and good solubility[2].
• Food and Beverage: Mannitol is increasingly used in the food industry as a sweetener, sugar replacer, and texturizing agent. This segment is projected to continue as the largest end-use sector, accounting for over 50% of global mannitol consumption[5].

Regional Dominance

The Asia-Pacific region is expected to maintain its dominance in the mannitol market, driven by high demand from countries like China and India[5].

Market Trends

Increasing Demand for Low-Calorie Sweeteners

The rising demand for low-calorie sweeteners and sugar alternatives is a major growth driver for the mannitol market. Consumers are increasingly seeking healthier options, which has led to an increased use of mannitol in food products[2][5].

Technological Advancements

Technological advancements in pharmaceutical manufacturing are expanding the use of mannitol as an excipient. Its properties, such as low toxicity and good solubility, make it an ideal component in various pharmaceutical formulations[5].

Industrial Applications

Mannitol is also used in the production of adhesives, paints, and plastics, contributing to its market growth in the industrial sector[5].

Form and Application of Mannitol

Forms of Mannitol

Mannitol is available in various forms, including powdered, granular, and crystalline. The crystalline form is the most preferred and holds a dominant share of more than 62% of the market[2].

Applications in Food Products

Mannitol is used as a moisturizer, coating agent, and to control moisture in food products. Its non-hygroscopic properties make it highly suitable for applications in chewing gum, ice cream, and frozen desserts[2].

Key Takeaways

• Clinical Uses: Mannitol is used to reduce intracranial and intraocular pressure, promote diuresis, and as a diagnostic aid.
• Market Growth: The global mannitol market is projected to reach $890.31 million by 2033, growing at a CAGR of 7.1%.
• Key Segments: The pharmaceutical and food sectors are the primary drivers of market growth.
• Regional Dominance: The Asia-Pacific region is expected to dominate the market.
• Market Trends: Increasing demand for low-calorie sweeteners, technological advancements in pharmaceuticals, and industrial applications are key trends.

FAQs

What are the primary clinical uses of mannitol?

Mannitol is primarily used to reduce intracranial and intraocular pressure, promote diuresis, and as a diagnostic aid for renal function.

What is the projected market size of mannitol by 2033?

The global mannitol market is expected to reach $890.31 million by 2033, growing at a CAGR of 7.1% from 2023 to 2033[2].

Which region is expected to dominate the mannitol market?

The Asia-Pacific region is expected to maintain its dominance in the mannitol market, driven by high demand from countries like China and India[5].

What are the key trends driving the growth of the mannitol market?

Key trends include the increasing demand for low-calorie sweeteners, technological advancements in pharmaceutical manufacturing, and growing industrial applications[2][5].

Is mannitol safe for use in pediatric patients?

The safety and effectiveness of mannitol solutions in pediatric patients have not been well established, although it is used in pediatric doses based on body weight or body surface area[1].

Sources

1. Mannitol Intravenous - accessdata.fda.gov
2. Mannitol Market Size, Share, Outlook & Forecast by 2033 | FMI
3. Mannitol Market 2020 - 2025 - IndustryARC
4. Mannitol IV (Mannitol Injection): Side Effects, Uses, Dosage ... - RxList
5. Mannitol Market Navigating Dynamics Comprehensive Analysis and ...