XOIN^® / TOPOCRYL^®

A sterile medical device containing n-butyl-2-cyanoacrylate, a topical tissue adhesive that is easy to use and can be stored at room temperature and even at 40 ^ͦC, unlike its competitors that needs to be stored below 25 ^ͦC . The patented medical device was developed in-house for about three years and has got a distinction as the only device that is stable up to 40 ^ͦC.

INTRODUCTION

n-Butyl-2-cyanoacrylate is a liquid compound that polymerizes rapidly in the presence of moisture and is used for the closure of uncomplicated skin lacerations. It is a surgical adhesive that provide another option for wound closure. When compared to sutures n-Butyl-2-cyanoacrylate is found to be as effective as sutures in low tension lacerations and for the attachment of some full thick ness skin grafts.

CHARACTERISTICS OF n-Butyl-2-cyanoacrylate

n-Butyl-2-cyanoacrylate is a monomer which when comes into contact with moisture of the skin’s surface chemically changes into a polymer that binds to the top epithelial layer. This polymer forms a cyanoacrylate bridge, binding the two wound edges together and allowing normal healing to occur below. n-Butyl-2-cyanoacrylate has also been shown to have antimicrobial properties

• n-Butyl-2-cyanoacrylate was developed in the 1970s, as the first adhesive to have negligible tissue toxicity and good bonding strength, as well as acceptable wound cosmesis.

DESCRIPTION OF PRODUCT

• Xoin^®/Topocryl^® is a topical skin adhesive composed of n-butyl-2-cynoacrylate monomer
• Allows in-situ polymerization to cause adherence of tissue-tissue or tissue to non-tissue surfaces.
• Available in variants of 0.15ml/0.25 ml/0.5 ml/1.0ml

MECHANISM OF ACTION

• n-butyl-2-cynoacrylate, has good bonding properties and has enough strength to hold the tissue margin together.
  When exposed to water or water containing substance, cyanoacrylate polymerizes and this polymerization of the cyanoacrylate monomers leads to the formation of extremely strong bonds.

INTENDED USE

• Indicated for closure of topical skin cuts, wounds and incisions, which have easily approximated edges with minimal tension and are thoroughly cleansed and without any evidence of infection

SPECIAL PROPERTIES

• Long shelf stability
• Ease of application
• Polymerization in presence of moisture and alkali
• Bacteriostatic, Biodegradable
• Forms a strong and flexible bond with tissue
• Negligible histotoxicity & non-carcinogenic

USAGE INSTRUCTION

• Clean the wound with the help of 70% IPA, using a sterile cotton ball
• Open the sterile packaging
• Hold the device vertically from sides, between forefinger and thumb
• Bring the product near wound, tip facing the wound
• Apply on the closely approximated skin edges
• Wait for 30-60 seconds
• Discard the unused adhesive

PRODUCT APPLICATION

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STORAGE

Xoin^®/Topocryl^® should be stored below 40 ^ͦC/104 ^ͦF. Refrigeration not required. Keep away from moisture and direct heat.

STERILITY

Xoin^®/Topocryl^® is supplied as a sterile device with shelf-life of two years, and is sterilized by Ethylene Oxide (EO) gas. It is a single use device. DO NOT REUSE OR RESTERILIZE. Do not use the device after expiration period.

ADVANTAGES OVER PREDICATES?

• Ease of application with the help of needle hub assembled in the product and the filter placed inside the hub maintains the sterility and integrity of the product
• Easy to use and dispose
• Storage at room temperature below 40 ͦC
• Patented product!

XOIN^®/TOPOCRYL^® COMPARISON MATRIX

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BIOCOMPATIBILITY

The products have been tested for Bio-compatibility as per requirement described in EN ISO 10993-1, by a nationally accredited renowned laboratory and found to be bio-compatible.

PRODUCT EQUIVALENCEs

Reevax Pharma did a comparative evaluation of its products with renowned predicates, and concluded it to be equivalent with the predicate.

CLINICAL USAGE

The products are being used extensively all over India by many doctors and surgeons for various types of cuts, lacerations and wounds. Cuts and lacerations closed with painless application of our products exhibit excellent cosmetic outcomes, especially on the facial areas, in comparison with sutures.

CAUTION!

• Not to be used internally or on wet wounds
• Not to be used on patients with hypersensitivity to cyanoacrylate and formaldehyde
• In case of accidental bonding, use acetone or dimethyl formamide to dissolve the polymerized product.