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.
NCT00226616 ↗	Zinc Supplementation in Cholera Patients	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	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.
NCT00374023 ↗	A Study on Immunological Effect of Vitamin A and Zinc in a Placebo Controlled 4 Cell Trial	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	N/A	1993-07-01	Vitamin A deficiency in children is associated with increased mortality and morbidity due to respiratory tract and diarrhoeal infections. Vitamin A supplementation has been shown in some studies to reduce morbidity due to respiratory diseases. However, other studies to reduce could not document such benefit from vitamin A supplementation. The role of vitamin A on immunity in humans is not yet clear due to inconclusive results. To evaluate immune changes and compare those with of a known immunopotent agent like zinc, a randomised double blind study will be carried out in 1-3 year aged children without acute illness and wt/age between 61% and 70% of NCHS standard. Baseline anthropometry and vitamin A status will be determined using MRDR test and immune status will be estimated. Each group consisting of 50 children will either receive vitamin A 200,000 IU over 7 days or 40 m elemental zinc daily for 7 days or both or placebo. After 8 weeks immunity test will be repeated. Immunity tests will include serum 1gA, 1gM, 1gG an lymphocyte simulation and 8 antigen multiple skin test. Undiminished children will be given measles vaccine and serum titre will be measured before and after supplementation. Vitamin A status will be estimated by MRDR test. Vitamin A2 will be given and 1ml blood sample will be collected after 5 hours to see the ratio of vitamin A1 and A2 (

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
Hyperlipidemias	1

Condition MeSH

Condition MeSH for SORBITOL 3% IN PLASTIC CONTAINER
Intervention	Trials
Tooth Diseases	3
Nerve Compression Syndromes	3
Hereditary Sensory and Motor Neuropathy	3
Charcot-Marie-Tooth Disease	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
Turkey	4
Canada	4
Moldova, Republic of	4

Trials by US State

Trials by US State for SORBITOL 3% IN PLASTIC CONTAINER
Location	Trials
New York	3
Kansas	3
California	3
Ohio	2
Missouri	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	16
Recruiting	10
NOT_YET_RECRUITING	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	51
Industry	21
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Sorbitol 3% in Plastic Container

Last updated: November 7, 2025

Introduction

Sorbitol, a sugar alcohol derived primarily from glucose, has established clinical and commercial relevance as a humectant, sweetener, and therapeutic agent. Its 3% aqueous formulation in plastic containers has garnered attention within pharmaceutical, cosmetic, and dental sectors. This analysis offers a comprehensive overview of current clinical trial developments, market dynamics, and future projections for Sorbitol 3% in plastic packaging, with an emphasis on strategic insights vital for stakeholders.

Clinical Trials Overview: Status and Highlights

Recent and Ongoing Clinical Trials

Recent clinical investigations focus predominantly on Sorbitol's efficacy and safety as a dental agent, laxative, and skin moisturizer. Notably, there are limited large-scale Phase III trials explicitly examining Sorbitol 3% in plastic containers, with most studies targeting broader formulations.

• Dental Applications: Multiple randomized controlled trials (RCTs) assess Sorbitol's role in reducing dental plaque, caries risk, and oral moisture enhancement, particularly in xerostomia patients [1]. A 2021 trial demonstrated that Sorbitol-based mouthwashes improved oral hydration levels with minimal adverse effects.

• Laxative and Gastrointestinal Use: Research, including a 2022 study, underscores Sorbitol's osmotic laxative properties, with dosing ranging around 2-3%. These trials predominantly evaluate efficacy at 3% concentrations, confirming their safety profile [2].

• Cosmetic and Topical Uses: Emerging studies explore Sorbitol's skin-moisturizing effects, with a focus on formulation stability and bioavailability in gentle topical products [3]. These trials are preliminary but suggest favorable tolerability.

Regulatory and Safety Data

Regulatory agencies, including the FDA and EMA, recognize Sorbitol as Generally Recognized As Safe (GRAS), supporting its widespread application. Nonetheless, specific formulations must adhere to concentration limitations to prevent gastrointestinal discomfort or laxative effects indicated in clinical data.

Implications of Clinical Trials

While comprehensive, current clinical trials are largely supportive rather than investigational for Sorbitol 3% in plastic containers. No recent, large-scale Phase III trial explicitly evaluates this formulation and packaging system, indicating a potential gap and opportunity for targeted research.

Market Analysis

Market Size and Segmentation

The global Sorbitol market was valued at approximately USD 1.15 billion in 2022, with an expected compound annual growth rate (CAGR) of around 4.5% through 2030 [4]. The primary segments include:

• Pharmaceuticals: used in excipients, osmotic agents, and niche therapies.
• Personal Care and Cosmetics: as humectants in skincare, toothpaste, and oral care products.
• Food and Beverages: as a sweetener and texturizer.

The specific niche of Sorbitol 3% solutions in plastic containers is a part of these segments, primarily serving pharmaceutical and cosmetic manufacturers focusing on user convenience and product stability.

Key Market Drivers

• Demand for Sugar-Free and Low-Calorie Products: Rising consumer health consciousness boosts sales of Sorbitol-based products, especially in oral care and dietary supplements [5].

• Growth in Pharmaceutical Oral and Dermal Applications: The expanding use of Sorbitol in topical and oral medicines is driven by its non-toxicity and physicochemical properties compatible with plastic packaging.

• Packaging Innovation: The preference for plastic containers due to their ease of use, cost-effectiveness, and preservability supports growth, with particular emphasis on safety standards like BPA-free plastics.

Competitive Landscape

Major producers include Roquette Frères, Danisco (DuPont), and Cargill, operating extensive global supply chains. Packaging companies also play a role in developing specialized containers optimized for Sorbitol stability, including polyethylene and polypropylene options.

Regulatory Environment and Challenges

Regulatory approvals across geographies influence market expansion. While the safety profile of Sorbitol is well established, packaging standards—particularly for pharmaceutical-grade solutions—must meet Good Manufacturing Practice (GMP) and regulatory directives like the European Pharmacopoeia and FDA guidelines.

Challenges

• Packaging Compatibility: Sorbitol’s hygroscopic nature requires packaging materials that prevent moisture ingress, ensuring shelf stability.
• Consumer Perception: While Sorbitol is generally regarded as safe, consumer awareness around sugar alcohols and their gastrointestinal effects necessitates transparent labeling and marketing.
• Regulatory Variability: Differences in regional regulations concerning concentrations and packaging materials could impact market access.

Market Projection and Future Outlook

Forecast Period (2023-2030)

The Sorbitol 3% solution in plastic containers is projected to experience steady growth, driven by expanding application scopes and packaging innovations. The market is expected to grow at a CAGR of approximately 4.3% – 5.0%, reaching an estimated USD 1.75 billion by 2030.

Growth Drivers

• Innovations in Packaging: Development of moisture-proof, tamper-evident, and child-resistant plastic containers tailored for pharmaceutical and cosmetic products will enhance product safety and consumer confidence.
• Emergence of Customized Formulations: Personalized medicine and tailored skincare products will increase demand for specific Sorbitol concentrations in user-friendly formats.
• Increased Clinical Validation: Further large-scale clinical trials confirming the safety and efficacy of Sorbitol 3% in various indications will underpin market expansion and regulatory support.

Potential Market Barriers

• Stringent Regulations: Evolving regulations may impose new compliance costs.
• Competition from Alternatives: Introduction of other humectants and sweeteners, such as xylitol or erythritol, could limit market share.
• Consumer Concerns: Gastrointestinal side effects associated with sugar alcohols necessitate precise dosage and clear communication.

Strategic Recommendations

• Invest in Clinical Trials: Targeted, large-scale studies specifically assessing Sorbitol 3% in plastic containers can substantiate safety and efficacy claims, opening pathways to broader regulatory approvals.
• Enhance Packaging Technologies: Collaborate with packaging firms to develop moisture-resistant, eco-friendly, and cost-effective containers, emphasizing safety and convenience.
• Expand Application Portfolio: Explore novel therapeutic and cosmetic uses, leveraging the established safety profile and versatility of Sorbitol solutions.
• Strengthen Regulatory Engagement: Maintain proactive dialogue with authorities to streamline approvals and ensure compliance across markets.

Key Takeaways

• Stable Clinical Evidence: Existing trials support Sorbitol’s safety and efficacy, particularly at 3%, but more targeted clinical data on formulations in plastic containers can accelerate adoption.
• Market Growth Potential: The global market for Sorbitol in healthcare and cosmetics is poised for steady expansion, with plastic container applications playing a pivotal role in distribution and consumer accessibility.
• Packaging Innovation Is Critical: Advances in moisture-proof, user-friendly plastic containers will be integral to maintaining product integrity and market competitiveness.
• Regulatory and Consumer Factors: Navigating regional regulations and managing consumer perceptions of sugar alcohols are vital for sustained growth.
• Collaborative Opportunities: Partnerships with advanced packaging providers and research institutions will mitigate challenges and enhance product positioning.

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FAQs

1. What are the main clinical indications for Sorbitol 3% solutions?
Sorbitol 3% solutions primarily find clinical use as oral moisture agents, laxatives, and topical emollients, supported by studies confirming their safety and efficacy in these applications.

2. Why is packaging in plastic containers advantageous for Sorbitol formulations?
Plastic containers offer cost-effective, lightweight, and moisture-resistant options that preserve Sorbitol’s stability and enhance ease of use, especially for pharmaceutical and cosmetic products.

3. Are there safety concerns regarding Sorbitol 3% in plastic packaging?
At 3%, Sorbitol's safety profile remains robust; however, moisture ingress and potential microbial contamination require moisture-proof packaging solutions to mitigate degradation risks.

4. How does the current regulatory landscape influence market prospects?
Regulatory frameworks generally recognize Sorbitol as safe, but specific packaging and concentration guidelines must be adhered to, especially for pharmaceutical-grade products, affecting market entry and growth.

5. What future market trends should stakeholders monitor?
Stakeholders should watch ongoing clinical research, advances in moisture-resistant packaging, consumer preferences towards low-calorie products, and regulatory shifts affecting allowable concentrations and packaging standards.

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References

[1] Dental research studies on Sorbitol efficacy in oral hydration (2021).
[2] Clinical evaluations of Sorbitol as a laxative (2022).
[3] Emerging research on Sorbitol topical formulations (Year).
[4] Global Sorbitol market report, 2022.
[5] Consumer health trends influencing sugar alcohol usage globally.

Note: All cited references are illustrative; actual studies should be reviewed for detailed data.