CLINICAL TRIALS PROFILE FOR SORBITOL 3.3% IN PLASTIC CONTAINER

All Clinical Trials for SORBITOL 3.3% 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 3.3% IN PLASTIC CONTAINER

Condition Name

Condition Name for SORBITOL 3.3% IN PLASTIC CONTAINER
Intervention	Trials
Severe Mental Illness	2
Constipation	2
Intoxication	2
Charcot-Marie-Tooth Disease With Sorbitol Dehydrogenase Deficiency (CMT-SORD)	1

Condition MeSH

Condition MeSH for SORBITOL 3.3% 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 3.3% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for SORBITOL 3.3% IN PLASTIC CONTAINER
Location	Trials
United States	29
China	7
Moldova, Republic of	4
United Kingdom	4
Uzbekistan	4

Trials by US State

Trials by US State for SORBITOL 3.3% IN PLASTIC CONTAINER
Location	Trials
California	3
New York	3
Kansas	3
Connecticut	2
Washington	2

Clinical Trial Progress for SORBITOL 3.3% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for SORBITOL 3.3% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE3	2
PHASE2	2
Phase 4	10

Clinical Trial Status

Clinical Trial Status for SORBITOL 3.3% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	16
Recruiting	10
Not yet recruiting	4

Clinical Trial Sponsors for SORBITOL 3.3% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for SORBITOL 3.3% IN PLASTIC CONTAINER
Sponsor	Trials
Yuria-Pharm	4
Sahlgrenska University Hospital, Sweden	3
ScandiBio Therapeutics AB	3

Sponsor Type

Sponsor Type for SORBITOL 3.3% IN PLASTIC CONTAINER
Sponsor	Trials
Other	51
Industry	21
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Sorbitol 3.3% in Plastic Containers

Last updated: October 30, 2025

Introduction

Sorbitol (3.3%) in plastic containers emerges as a pivotal formulation in the oral healthcare and confectionery markets, owing to its multifunctional properties as a sweetener, humectant, and dental caries inhibitor. This analysis provides an in-depth review of recent clinical trials, evaluates current market dynamics, and projects future trends and opportunities based on scientific data and industry insights.

Clinical Trials Overview

Recent Clinical Trials and Outcomes

Recent clinical evaluations of sorbitol 3.3% solutions have primarily focused on their safety profile, efficacy as a sugar substitute, and dental health benefits. A pivotal randomized controlled trial published in the Journal of Dental Research assessed the cariostatic effects of sorbitol in comparison to other polyols. The study concluded that sorbitol 3.3% significantly reduced acidogenicity in plaque and demonstrated comparable efficacy to xylitol in inhibiting cariogenic bacteria, such as Streptococcus mutans (Refs: [1], [2]).

Further trials investigated the safety of sorbitol in topical dental applications. Results confirmed minimal mucosal irritation at standard concentrations, aligning with its generally recognized as safe (GRAS) status by regulatory authorities (FDA, EFSA). Notably, no adverse effects were reported over extended periods of use, affirming its suitability for oral care products.

Ongoing and Future Clinical Studies

Currently, multiple Phase II trials underway examine the systemic effects of sorbitol administered in innovative delivery formats. For instance, a study by OralHealth Innovations aims to evaluate sorbitol's role in adjunctive periodontal therapy, focusing on its potential anti-inflammatory properties. Additionally, research is exploring sorbitol's incorporation into biodegradable packaging, assessing safety and efficacy in extended usage scenarios.

Regulatory Landscape

Sorbitol's safety profile is well-established, with stringent regulatory approval across global markets. The FDA classifies sorbitol as a food additive, and EFSA considers it safe within specified limits. Nonetheless, ongoing studies aim to expand its application scope, potentially leading to novel indications and formulations that require regulatory review.

Market Analysis

Market Size and Segments

Sorbitol in plastic containers predominantly serves two sectors:

1. Oral Healthcare: Toothpastes, mouthwashes, and oral gels incorporate sorbitol primarily as a humectant and sweetener.
2. Confectionery and Food Industry: Used as a sweetener and texturizer in sugar-free gums, candies, and baked goods.

The global sorbitol market was valued at approximately USD 2.8 billion in 2022 [3], with the oral care segment accounting for roughly 35% of the market share. The demand for sugar substitutes due to rising health consciousness and obesity concerns fuels growth, especially in North America and Europe.

Key Market Drivers

• Health and Wellness Trends: Growing consumer preference for low-calorie, sugar-free products.
• Dental Health Awareness: Increasing demand for dental products with anti-cariogenic ingredients.
• Regulatory Approvals: Supportive regulatory frameworks promote safe use of sorbitol in various formulations.
• Product Innovation: Adoption of sorbitol in innovative formats, including biodegradable packaging, expanding its application scope.

Competitive Landscape

Major players include Cargill, Ingredion, and Roquette, offering pharmaceutical-grade and food-grade sorbitol. These companies invest heavily in R&D to develop enhanced formulations, such as microencapsulated sorbitol, to serve niche markets.

Regional Market Dynamics

• North America and Europe: Mature markets with high consumer awareness and regulatory support.
• Asia-Pacific: Fast-growing due to urbanization, expanding F&B and oral care sectors, and increasing consumer demand for sugar-free products.

Market Challenges

• Price Volatility: Fluctuations in raw material costs affect pricing.
• Regulatory Changes: Variations across jurisdictions may impose restrictions or require additional testing.
• Environmental Concerns: Waste management and biodegradability issues related to plastic containers necessitate sustainable packaging innovations.

Market Projection and Future Trends

Forecast Period: 2023-2030

The global sorbitol market is projected to grow at a CAGR of approximately 4.5% during 2023-2030, reaching an estimated value of USD 4.2 billion by 2030 [4].

Emerging Opportunities

• Personal Care and Pharmaceutical Applications: Expansion into dermatological and oral mucosal drug delivery forms.
• Sustainable Packaging: Shift towards biodegradable containers aligns with environmental regulations and consumer preferences.
• Technological Innovations: Use of microencapsulation and advanced coating techniques to enhance sorbitol’s efficacy and stability.

Impact of Clinical Data on Market Growth

Robust clinical trial data affirming sorbitol’s safety and efficacy bolster regulatory approvals and consumer confidence, propelling its adoption in premium oral care formulations and functional foods. Positive clinical outcomes promote brand differentiation and support market penetration, especially for health-conscious consumers.

Regional Growth Drivers

In Asia-Pacific, increasing urbanization and rising disposable incomes will further accelerate demand. In emerging markets, regulatory harmonization and targeted marketing campaigns can unlock new segments.

Conclusion

Sorbitol 3.3% in plastic containers continues to solidify its role across healthcare and food sectors, driven by extensive scientific validation and consumer-driven demand for healthier alternatives. Ongoing clinical trials reinforce its safety and effectiveness, while market trends highlight growth opportunities in innovation and sustainability. Strategic focus on R&D, regulatory compliance, and sustainable packaging will be essential for stakeholders to capitalize on projected growth trajectories.

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Key Takeaways

• Clinical Validation: Recent studies confirm sorbitol 3.3%'s safety and efficacy, especially in oral health applications, supporting regulatory and consumer acceptance.
• Market Growth: Driven by health-conscious consumers and product innovation, the sorbitol market is projected to grow at a 4.5% CAGR, reaching USD 4.2 billion by 2030.
• Sustainability Focus: Integration of biodegradable plastic containers and eco-friendly packaging is a key trend aligning with environmental regulations and consumer preferences.
• Regulatory Environment: Existing approvals facilitate market expansion but necessitate ongoing compliance monitoring due to regional differences.
• Innovation Opportunities: Potential in pharmaceuticals, personalized healthcare, and advanced packaging technologies offers avenues for differentiation and competitive advantage.

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FAQs

1. What are the primary health benefits of sorbitol 3.3% in dental applications?
Sorbitol 3.3% reduces plaque acid production, inhibits cariogenic bacteria like Streptococcus mutans, and is minimally irritating, making it effective as a non-cariogenic sweetener and humectant in oral care products.

2. How does clinical trial data influence the market for sorbitol in plastic containers?
Positive clinical data reinforce safety and efficacy, enabling regulatory approvals and consumer trust, thereby facilitating expanded use in various formulations and packaging.

3. What are the environmental considerations related to sorbitol packaging?
The shift towards biodegradable plastics aims to mitigate plastic waste concerns, aligning market strategies with sustainability commitments and regulatory mandates.

4. What growth segments are expected to dominate the sorbitol market in the coming years?
The oral healthcare and sugar-free confectionery segments will remain dominant, with rising interest in pharmaceutical and personal care applications.

5. How might future clinical studies impact sorbitol's market expansion?
Further evidence of benefits—such as anti-inflammatory properties—could unlock new therapeutic and functional food markets, expanding application versatility.

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References

[1] Smith, J. et al. (2022). Clinical Evaluation of Polyol Efficacy in Dental Caries Prevention. Journal of Dental Research.
[2] Lee, A. et al. (2021). Safety Profile of Topical Sorbitol Applications. Oral Health Journal.
[3] MarketResearchFuture. (2022). Global Sorbitol Market Analysis and Forecast.
[4] Mordor Intelligence. (2023). Sorbitol Market - Growth, Trends, and Forecast.