PURITE^® is a proprietary, registered preservative widely used in medical and cosmetic applications. This stabilized solution of oxychloro complexes is recognized for its broad-spectrum antimicrobial properties, making it effective in preventing contamination and preserving the integrity of formulations. Due to its safety profile and efficacy, PURITE® is particularly suitable for sensitive applications, such as ophthalmic solutions and personal care products.

Chemical Composition and Structure

PURITE® is a stabilized oxychloro complex (SOC) consisting of chlorine dioxide, chlorite, and chlorate ions.

• Core Components:

  • Chlorine Dioxide (ClO₂): The active antimicrobial agent.
  • Chlorite (ClO₂⁻) and Chlorate (ClO₃⁻): Act as stabilizers, enhancing shelf life and providing a controlled release of active chlorine species.

• Properties:

  • Effective against a wide range of bacteria, fungi, and viruses.
  • Decomposes into non-toxic byproducts (sodium chloride and water).

Physicochemical Properties

• Appearance: Clear, colorless to pale yellow liquid.
• Odor: Slight chlorine-like smell.
• Solubility: Fully soluble in water.
• Stability: Stable under controlled conditions; sensitive to high temperatures and UV light.

Production Process

1. Synthesis:

   • Formulated by combining sodium chlorite and stabilizing agents under controlled conditions to produce a balanced oxychloro complex.

2. Stabilization:

   • Stabilized with buffers and specific chelating agents to ensure controlled release of active chlorine.

3. Quality Control:

   • Subjected to rigorous testing to meet regulatory standards for safety and efficacy.

Applications

Medical Applications

• Ophthalmic Solutions: Used in eye drops to prevent microbial contamination while being gentle on sensitive tissues.
• Topical Antiseptics: Provides microbial protection in wound care products.
• Device Preservation: Used to maintain sterility in medical devices and contact lens solutions.

Cosmetics

1. Preservative:

   • Effective in creams, serums, and lotions, preventing bacterial, fungal, and viral contamination.

2. Gentle Formulations:

   • Ideal for sensitive skin products due to its minimal risk of irritation and non-toxic byproducts.

3. Clean Beauty:

   • Compatible with natural and minimalistic formulations, offering effective preservation without harsh chemicals.

Industrial Applications

• Used in formulations requiring broad-spectrum antimicrobial activity while ensuring safety for skin-contact products.
• Found in water purification systems for its environmentally friendly decomposition.

Environmental and Safety Considerations

• Biodegradability:

  • Breaks down into non-toxic byproducts such as sodium chloride, oxygen, and water, posing minimal environmental risk.

• Safety Profile:

  • Considered safe for use in medical and cosmetic products within regulated concentrations.
  • Non-cumulative, making it suitable for repeated exposure in sensitive applications.

• Sustainability:

  • Designed to provide effective preservation with a minimal environmental footprint.

Conclusion

PURITE® is an advanced preservative solution offering effective, broad-spectrum antimicrobial protection with a gentle safety profile. Its ability to decompose into environmentally safe byproducts, coupled with its suitability for sensitive applications, makes it a valuable choice in ophthalmic, cosmetic, and personal care formulations.

References__________________________________________________________________________

Messmer EM. Preservatives in ophthalmology. Ophthalmologe. 2012 Nov;109(11):1064-70. 

Abstract. Preservatives are a legal requirement for eye drops in multidose containers. Moreover, they are necessary for stabilization and intraocular penetration for a number of ophthalmic preparations. Most preservatives act in a relatively unspecific manner as detergents or by oxidative mechanisms and thereby cause side effects at the ocular surface. They may also affect the lens, trabecular meshwork and the retina. Benzalkonium chloride is the most commonly used preservative in ophthalmology and is more toxic than other or newer preservatives, such as polyquaternium-1 (Polyquad), sodium perborate, oxychloro-complex (Purite®) and SofZia. Preservative-free topical medication is highly recommended for patients with ocular surface disease, frequent eye drop administration, proven allergy to preservatives and contact lens wear.

Kahook MY, Rapuano CJ, Messmer EM, Radcliffe NM, Galor A, Baudouin C. Preservatives and ocular surface disease: A review. Ocul Surf. 2024 Oct;34:213-224. doi: 10.1016/j.jtos.2024.08.001. 

Abstract. Ocular surface disease (OSD) is a complex condition that can cause a range of symptoms (e.g, dryness, irritation, and pain) and can significantly impact the quality of life of affected individuals. Iatrogenic OSD, a common finding in patients with glaucoma who receive chronic therapy with topical ocular antihypertensive drugs containing preservatives such as benzalkonium chloride (BAK), has been linked to damage to the ocular surface barrier, corneal epithelial cells, nerves, conjunctival goblet cells, and trabecular meshwork. Chronic BAK exposure activates inflammatory pathways and worsens symptoms, compromising the success of subsequent filtration surgery in an exposure-dependent manner. In eyes being treated for glaucoma, symptomatic treatment of OSD may provide some relief, but addressing the root cause of the OSD often necessitates reducing or, ideally, eliminating BAK toxicity. Strategies to decrease BAK exposure in patients with glaucoma encompass the use of preservative-free formulations or drugs with alternative and less toxic preservatives such as SofZia®, Polyquad, potassium sorbate, or Purite®. Though the benefits of these alternative preservatives are largely unproven, they might be considered when financial constraints prevent the use of preservative-free versions. For patients receiving multiple topical preserved drugs, the best practice is to switch to nonpreserved equivalents wherever feasible, regardless of OSD severity. Furthermore, nonpharmacological approaches, including laser or incisional procedures, should be considered. This review explores the effects of BAK on the ocular surface and reviews strategies for minimizing or eliminating BAK exposure in patients with glaucoma in order to significantly improve their quality of life and prevent complications associated with chronic exposure to BAK. Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.