CLINICAL TRIALS PROFILE FOR SORBITOL 3% IN PLASTIC CONTAINER

All Clinical Trials for Sorbitol 3% In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000159 ↗	Sorbinil Retinopathy Trial (SRT)	Completed	National Eye Institute (NEI)	Phase 3	1983-08-01	To evaluate the safety and efficacy of the investigational drug sorbinil, an aldose reductase inhibitor, in preventing the development of diabetic retinopathy and neuropathy in persons with insulin-dependent diabetes.
NCT00121433 ↗	Leptin and Endothelial Function	Completed	Amgen	Phase 4	2004-09-01	The purpose of this trial was to determine if injections of leptin would improve vascular function in normal-weight, healthy volunteers.
NCT00121433 ↗	Leptin and Endothelial Function	Completed	University of Michigan	Phase 4	2004-09-01	The purpose of this trial was to determine if injections of leptin would improve vascular function in normal-weight, healthy volunteers.
NCT00226616 ↗	Zinc Supplementation in Cholera Patients	Completed	Thrasher Research Fund	Phase 3	2000-11-01	Cholera is one of the leading causes of morbidity and mortality among children and adult in developing countries. We will evaluate the effect of supplementation of zinc on reduction of duration and severity of cholera. Since cholera is primarily a disease of older children and adults, we intend to study the effects of zinc supplementation among children of 3 to 14 years of age, whose initial stool weight will be >4ml/kg/hour in 1st 6 hours and dark field examination is positive. 90 subjects in each group hospitalized with cholera with diarrhea for less than 24 hours will be selected. After inclusion in the study, informed consent will be obtained from guardian explaining the full procedure in the hospital. The subjects will be randomized to receive either zinc or placebo until diarrhea resolves. History of illness and baseline information will be collected in the hospital through interview, which may take duration of 10 minutes.After 6 hours of initial rehydration, fluid balance study will be carried out on all subjects until diarrhea resolves. 1 ml (1/4 teaspoonful) of blood sample will be taken to assess serum zinc level on admission after initial hydration and will be repeated on the day of recovery. This procedure carries a small risk of infection if not done under sanitary conditions; however, we will maintain proper sanitation, so there is no risk in the procedures. There is no potential risk in this study.20mg elemental Zinc will be given daily in 2 divided doses till cholera resolves. Both groups will receive syrup or tablet Erythromycin 50mg/kg/24 in 4 divided doses for 3 days. Oral rehydration solution/intravenous acetate fluid will be used for rehydration. Daily body weight will be taken and stool will be sent for C/S until the day of recovery or 5 days. Zinc loss in stool will be seen in 20% of random stool samples. Information obtained from history and the laboratory investigations of subject will be kept strictly confidential and no one other than the investigators of this study and the Ethics Committee of this Centre will/ has access to the information. The study will benefit the patients as study physician will do close observation, examination and will take care frequently, as research staff will monitor systematic progress and take necessary action. Study micronutrient (zinc) is shown to have benefit in children in acute diarrhea. If the results of the study is positive, it will benefit the patients in their treatment during this study and thereafter. The data will be analyzed for clinical effects of zinc on diarrhea.The study will help to improve the treatment strategy of cholera in children. The study will use hospital records, which will be returned after completion of the study. Stool, urine and 1 ml (1/4 teaspoonful) of venous blood will be taken to assess serum zinc level.
NCT00226616 ↗	Zinc Supplementation in Cholera Patients	Completed	World Bank	Phase 3	2000-11-01	Cholera is one of the leading causes of morbidity and mortality among children and adult in developing countries. We will evaluate the effect of supplementation of zinc on reduction of duration and severity of cholera. Since cholera is primarily a disease of older children and adults, we intend to study the effects of zinc supplementation among children of 3 to 14 years of age, whose initial stool weight will be >4ml/kg/hour in 1st 6 hours and dark field examination is positive. 90 subjects in each group hospitalized with cholera with diarrhea for less than 24 hours will be selected. After inclusion in the study, informed consent will be obtained from guardian explaining the full procedure in the hospital. The subjects will be randomized to receive either zinc or placebo until diarrhea resolves. History of illness and baseline information will be collected in the hospital through interview, which may take duration of 10 minutes.After 6 hours of initial rehydration, fluid balance study will be carried out on all subjects until diarrhea resolves. 1 ml (1/4 teaspoonful) of blood sample will be taken to assess serum zinc level on admission after initial hydration and will be repeated on the day of recovery. This procedure carries a small risk of infection if not done under sanitary conditions; however, we will maintain proper sanitation, so there is no risk in the procedures. There is no potential risk in this study.20mg elemental Zinc will be given daily in 2 divided doses till cholera resolves. Both groups will receive syrup or tablet Erythromycin 50mg/kg/24 in 4 divided doses for 3 days. Oral rehydration solution/intravenous acetate fluid will be used for rehydration. Daily body weight will be taken and stool will be sent for C/S until the day of recovery or 5 days. Zinc loss in stool will be seen in 20% of random stool samples. Information obtained from history and the laboratory investigations of subject will be kept strictly confidential and no one other than the investigators of this study and the Ethics Committee of this Centre will/ has access to the information. The study will benefit the patients as study physician will do close observation, examination and will take care frequently, as research staff will monitor systematic progress and take necessary action. Study micronutrient (zinc) is shown to have benefit in children in acute diarrhea. If the results of the study is positive, it will benefit the patients in their treatment during this study and thereafter. The data will be analyzed for clinical effects of zinc on diarrhea.The study will help to improve the treatment strategy of cholera in children. The study will use hospital records, which will be returned after completion of the study. Stool, urine and 1 ml (1/4 teaspoonful) of venous blood will be taken to assess serum zinc level.

Clinical Trial Conditions for Sorbitol 3% In Plastic Container

Condition Name

Condition Name for Sorbitol 3% In Plastic Container
Intervention	Trials
Severe Mental Illness	2
Constipation	2
Intoxication	2
Ileus	1

Condition MeSH

Condition MeSH for Sorbitol 3% In Plastic Container
Intervention	Trials
Nerve Compression Syndromes	3
Hereditary Sensory and Motor Neuropathy	3
Charcot-Marie-Tooth Disease	3
Tooth Diseases	3

Clinical Trial Locations for Sorbitol 3% In Plastic Container

Trials by Country

Trials by Country for Sorbitol 3% In Plastic Container
Location	Trials
United States	29
China	7
United Kingdom	4
Uzbekistan	4
Ukraine	4

Trials by US State

Trials by US State for Sorbitol 3% In Plastic Container
Location	Trials
New York	3
Kansas	3
California	3
Washington	2
Ohio	2

Clinical Trial Progress for Sorbitol 3% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Sorbitol 3% In Plastic Container
Clinical Trial Phase	Trials
PHASE3	2
PHASE2	2
Phase 4	10

Clinical Trial Status

Clinical Trial Status for Sorbitol 3% In Plastic Container
Clinical Trial Phase	Trials
Completed	17
RECRUITING	10
Unknown status	4

Clinical Trial Sponsors for Sorbitol 3% In Plastic Container

Sponsor Name

Sponsor Name for Sorbitol 3% In Plastic Container
Sponsor	Trials
Yuria-Pharm	4
Sahlgrenska University Hospital, Sweden	3
ScandiBio Therapeutics AB	3

Sponsor Type

Sponsor Type for Sorbitol 3% In Plastic Container
Sponsor	Trials
Other	52
Industry	21
NIH	1

Sorbitol 3% In Plastic Container Market Analysis and Financial Projection

Last updated: February 7, 2026

What is the current status of clinical trials for Sorbitol 3% in Plastic Containers?

As of the latest available data, there are no publicly listed ongoing or upcoming clinical trials specifically for Sorbitol 3% packaged in plastic containers. The majority of clinical research on sorbitol pertains to its systemic effects, laxative use, and application as a sweetener, rather than its specific formulation in plastic packaging.

The absence of dedicated clinical trials for this exact formulation indicates that safety or efficacy studies explicitly focusing on Sorbitol 3% in plastics have not been publicly disclosed or registered with major clinical trial registries such as ClinicalTrials.gov or the WHO International Clinical Trials Registry Platform.

How is Sorbitol 3% in Plastic Containers Marketed?

Sorbitol 3% in plastic containers mainly serves as a consumable product in the following sectors:

• Oral care products, such as mouthwashes and dental gels
• Topical applications in pharmaceuticals and skincare
• Food industry as a sweetener (though typically in liquids or syrups, not necessarily at 3% concentration)

Manufacturers package Sorbitol 3% in plastic containers primarily for convenience, stability, and ease of dosing. These products are marketed to both consumer and institutional markets based on existing safety profiles and regulatory approval for use as a sweetener and humectant.

What is the Market Size and Growth Projection?

The global sorbitol market was valued at approximately $1.2 billion in 2021 and is projected to reach around $2.2 billion by 2028, growing at a compound annual growth rate (CAGR) of 8.5%.[1] The consumer segment accounts for roughly 60% of this value, with the oral care and food sectors being primary drivers.

The distribution of sorbitol formulations, including the 3% concentration in plastics, is influenced interest in:

• Non-caloric sweeteners in food and beverage segments
• Cosmetic and pharmaceutical topical applications
• Medical oral rinse solutions

The specific niche of Sorbitol 3% in plastic containers is expected to grow proportionally with these broader trends, especially as demand for low-calorie, safe sweeteners increases globally.

How Does Packaging Impact the Market for Sorbitol 3%?

Packaging, especially the use of plastics, influences the market in terms of:

• Cost efficiency: Plastic containers reduce manufacturing costs.
• Stability: Plastic is chemically compatible with sorbitol, minimizing degradation.
• Consumer convenience: Plastic bottles simplify handling and dosing.

The safety profile of plastics, particularly polyethylenes or polypropylenes, aligns with regulatory standards for food and pharmaceutical packaging, supporting widespread adoption.

Regulatory Environment and Safety Profile

Sorbitol is generally recognized as safe (GRAS) by the U.S. Food and Drug Administration (FDA) and similar agencies globally. Packaging materials are compliant with organizations such as the FDA's guidelines for Food Contact Materials and the EU’s Regulation (EC) No 1935/2004.

There are no specific restrictions or additional approvals needed for sorbitol in plastics when used under standard conditions. However, manufacturers must adhere to regulations concerning plastic additive migration limits, especially in products intended for oral or dermal use.

Key Competitors and Market Players

Major companies involved in sorbitol manufacturing, packaging, and distribution include:

• Cargill Incorporated
• Roquette Frères
• Archer Daniels Midland Company (ADM)
• Gulshan Polyols Ltd.
• Tereos Syral

These companies manufacture sorbitol in various purities and formulations, often offering packaging solutions including plastics tailored for specific applications.

Future Market Trends and Opportunities

Potential growth areas include:

• Development of biodegradable plastic containers for sustainability
• Increasing penetration into emerging markets with expanding personal care and food sectors
• Innovation in sachets and single-use packaging to enhance convenience

Investment in R&D to optimize shelf stability, reduce migration, and improve packaging sustainability could create new market opportunities.

Key Takeaways

• No dedicated clinical trials for Sorbitol 3% in plastic containers are publicly registered.
• The broader sorbitol market is expanding, projected to reach $2.2 billion by 2028 with an 8.5% CAGR.
• Packaging in plastics offers cost, stability, and consumer advantages, supporting market growth.
• Regulatory frameworks favor sorbitol’s safety, with packaging compliance being straightforward under existing standards.
• Key competitors focus on manufacturing, with packaging solutions tailored to industry needs.

FAQs

1. Are there safety concerns related to sorbitol in plastic containers?
Sorbitol is safe when used within regulatory limits. Proper packaging ensures chemical stability, and plastics used comply with safety standards for food and pharmaceutical contact.

2. What applications drive demand for Sorbitol in plastic containers?
Demand stems from oral care products, topical formulations, food sweeteners, and consumer products requiring easy-to-handle packaging.

3. Is there potential for clinical research specific to Sorbitol 3% formulations?
Currently, no. Most research focuses on sorbitol's systemic effects or its use as an ingredient, not on specific packaging formats.

4. How does packaging influence sorbitol product distribution?
Plastics enable cost-effective, stable, and user-friendly containers, facilitating wider distribution and consumer compliance.

5. What regulatory changes could impact this market?
Shifts toward sustainability and stricter migration limits in packaging materials could influence packaging choices and formulation strategies.

---

Citations

[1] Research and Markets, "Global Sorbitol Market by Formulation, Application, and Region," 2022.