Polysorb 85/70
Also known as: Polysorb 85/70, partially dehydrated sorbitol, sorbitol liquid, sorbitol, D-glucitol
Overview
Polysorb 85/70 is a partially dehydrated form of sorbitol, a sugar alcohol naturally occurring in fruits and plants. Industrially produced, it is primarily classified as a pharmaceutical excipient and plasticizer, not a nutritional supplement. It is a clear, colorless, odorless liquid known for its anti-crystallization properties. Its main application is in pharmaceutical formulations, specifically as a plasticizer in soft gelatin capsules and orally dissolving films/tablets. It enhances flexibility and stability, preventing issues like migration or crystallization within these dosage forms. While well-characterized in pharmaceutical science for its physical properties and formulation benefits, there is no direct clinical evidence or research supporting its use as an active supplement ingredient for health benefits.
Benefits
Polysorb 85/70 does not offer direct health benefits or clinical effects as a supplement ingredient. Its utility is solely as a pharmaceutical formulation aid. It improves the physical properties of dosage forms, such as increasing the flexibility and stability of soft gelatin capsules and orally dissolving films/tablets. This prevents common manufacturing and storage issues like graining, crystallization, or leaching. There are no reported secondary effects, and it is considered pharmacologically inert. Therefore, it does not provide population-specific benefits, nor are there quantifiable outcomes, effect sizes, or a time course of benefits associated with its consumption as a supplement.
How it works
Polysorb 85/70 functions primarily as a physical plasticizer within pharmaceutical matrices, particularly gelatin. It works by integrating into the gelatin structure, thereby improving its elasticity and flexibility. This action prevents the gelatin from becoming brittle and susceptible to crystallization or cracking. It does not interact with biological systems in a pharmacological manner, as it is considered inert. Its mechanism is purely physicochemical, modifying the material properties of the dosage form rather than exerting any systemic biological activity or targeting specific molecular pathways within the body. It is not intended for systemic absorption or therapeutic action.
Side effects
Polysorb 85/70 is generally recognized as safe for its intended use as a pharmaceutical excipient. No common (>5%), uncommon (1-5%), or rare (<1%) side effects have been documented in scientific literature or product specifications when used within established pharmaceutical guidelines. Impurity levels, such as ethylene glycol and diethylene glycol, are strictly controlled to be very low (≤1000 ppm), and microbial contamination is also managed. There are no known drug interactions or contraindications associated with its use. Special population considerations have not been identified, indicating its broad safety profile as an inert ingredient. Its safety is primarily governed by excipient standards and impurity limits rather than clinical adverse event reporting for an active compound.
Dosage
Polysorb 85/70 is not an active therapeutic agent, so traditional dosage guidelines for health benefits do not apply. Its use is determined by pharmaceutical formulation requirements, where it acts as a plasticizer. There is no established minimum effective dose or optimal dosage range for clinical purposes. The maximum safe dose is not defined in a therapeutic context but is instead governed by excipient safety standards and strict impurity limits within pharmaceutical manufacturing. It is typically incorporated into soft gelatin capsules and orally dissolving films/tablets to improve their physical properties. Timing considerations, absorption factors, and required cofactors are not relevant, as it is not intended for systemic absorption or therapeutic action.
FAQs
Is Polysorb 85/70 an active supplement ingredient?
No, Polysorb 85/70 is a pharmaceutical excipient and plasticizer, not intended for direct health effects or as an active supplement ingredient.
Is it safe for human consumption?
Yes, when used within pharmaceutical excipient specifications, it is considered safe. Its safety is established for its role as an inert formulation aid.
Can it cause side effects?
No known side effects have been documented at typical excipient use levels. It is considered pharmacologically inert.
Does it affect drug release?
It improves capsule flexibility and stability, but it does not have direct pharmacological effects or alter drug release mechanisms.
Is it the same as sorbitol?
It is a partially dehydrated form of sorbitol, specifically designed to have improved physical properties for pharmaceutical formulation applications.
Research Sources
- https://pmc.ncbi.nlm.nih.gov/articles/PMC7594913/ – This article discusses placebo responses in clinical trials, but it does not specifically investigate Polysorb 85/70. It provides context on research methodology but is not directly relevant to the ingredient's efficacy or safety.
- https://www.stobec.com/DATA/PRODUIT/2443~v~data.pdf – This document is a product specification sheet for Polysorb 85/70 from Stobec. It details the chemical and safety profiles of the excipient, focusing on its physical properties and quality control standards for pharmaceutical use.
- https://www.knowde.com/stores/roquette/products/polysorb-85-70-00 – This source provides product information for Polysorb 85/70 from Roquette. It describes the excipient's characteristics and applications in pharmaceutical formulations, particularly as a plasticizer for soft gels.
- https://pubmed.ncbi.nlm.nih.gov/31856331/ – This PubMed entry relates to systematic reviews on placebo effects, similar to the first source. It does not contain specific research on Polysorb 85/70 as an active ingredient or supplement.
- https://www.roquette.com/innovation-hub/pharma/product-profile-pages/polysorb-85-70-00 – This is another product profile page from Roquette, offering details on Polysorb 85/70. It highlights its use as a plasticizer in pharmaceutical applications and its benefits for formulation stability.
- https://www.roquette.com/innovation-hub/pharma/technical-illustration/comparison-different-sorbitol-sorbitan-solutions-as-gelatin-plasticizer – This technical illustration compares various sorbitol and sorbitan solutions as gelatin plasticizers. It provides insights into the specific properties of Polysorb 85/70 that make it suitable for this role in pharmaceutical manufacturing.