Fraxin Filler Ingredients

 

Fraxin™ Filler Alterative's "Feather" and "Q" contains only 4 major ingredients: 

1: Carboxymethylcellulose 

2: PEG 

3: Phosphate Buffered Saline 7.0 

4. Numbing Agent 

 

Fraxin™ Filler Alternative "Cupid" contains only 4 major ingredients: 

1: Hyaluronic Acid 

2: PEG 

3: Phosphate Buffered Saline 7.0 

4. Numbing Agent 

 

Carboxymethyl Cellulose Facts: 

 

2. SAFETY

 

2.1.1 Carboxymethyl cellulose (CMC) Main characteristics

The CMC-based gel represents 85% by volume in Fraxin™ composition. CMC, a polysaccharide is a well-known cellulose derivative with carboxymethyl groups (-CH2-COOH) bound to some of the hydroxyl groups of the glucopyranose monomers that make up the cellulose backbone.

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Cellulose Carboxymethyl cellulose (Na salt)

Cellulose is the most abundant naturally occurring polymer of glucose, found as the main constituent of plants and natural fibers such as cotton and linen. Among the cellulose ethers, only NaCMC is a polyelectrolyte, and thus a ‘smart’ cellulose derivative which shows sensitivity to pH and ionic strength (Sannino et al, 2009). “Smart” materials based on cellulose inherit its unique properties, such as strong mechanical strength, and biocompatibility, thus studies on “smart” materials based on cellulose have bloomed during the last decade (Qiu & Hu, 2013). This shows that CMC not only continues to be widely used but it is at the center of new product developments supporting its biocompatibility.

Properties and uses

Carboxymethyl cellulose is one of the most important cellulose derivatives having wide applications; this polymer is used as a thickener and/or emulsifying agent in many fields in the food, pharmaceutical and cosmetic industries due to its non-toxicity. It is a pharmaceutical excipient used in the formulation of many drugs.

It is extensively used in injectable products containing dexamethasone such as Decadron and Dalalone and applied in drug delivery formulations for the release of drugs such as nifedipine (Barbucci et al, 2004; Pal et al, 2006) and as components of therapies for preventing postsurgical adhesions (e.g. Genzyme’s Seprafilm) (Ito et al, 2007; Lee et al, 2005).

CMC is hygroscopic forming a gel with water and this property, to absorb water, is of particular interest in cosmetics; CMC can produce tissue filling already in its native state.
CMC in the composition of Fraxin™ exerts filling capacity creating immediate volume after injection.

CMC in Fraxin™  is therefore a non-toxic, naturally occurring, cellulose derivative used in a number of applications which provides the immediate volumizing effect seen with Fraxin™

Safety

The safety of CMC is therefore supported by its large use in the food, pharmaceutical and cosmetic industries but also, and specifically with respect to its use as aesthetic products and indications, in the composition of dermal fillers and volumizers such as Radiesse®, Erelle®, Laresse® and Sculptra® as a gel carrier and/or through its filling function.

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CMC is classified as a GRAS (Generally Recognized As Safe) substance in food additives by the FDA:

“Sodium carboxymethyl cellulose is listed in FDA 21 CFR 182 as generally recognized as Safe (GRAS), Section 182.1745.” Glycerin and PBS entering in the composition of the CMC gel are listed in 21 CFR 182; GRAS section 182.1320 and 182.6285 respectively.

It is a non-animal nor human or bacterial but a plant origin substance; it is non-cross linked avoiding the use of cross-linking reticulating agent and the potential related toxicity.

The available literature shows that CMC is an inert substance extremely safe, non-allergenic,
and free of mutagenic or carcinogenic potential. (McElligott & Hurst, 1968). It has been tested in many toxicological studies in various animal species, evaluating acute, chronic and carcinogenic potential evidencing its safety (WHO Food additives series).

Some studies underline a bactericidal effect within the tissues, thus making the substance absolutely safe (Keipert & Voigt, 1979).

In the aesthetic field recent clinical studies have evaluated the efficacy and safety of BDDE cross- linked CMC hydrogel in soft tissue augmentation. From the Leonardis clinical study it is concluded that CMC « proves to be an ideal agent for soft tissue augmentation with regard to safety and ease of application. It did not cause infection, extrusion, migration, or adverse reactions in the patients who have been followed for two years » (Leonardis et al, 2010). Furthermore the follow- up study at 3 years in 350 patients has confirmed the safety (Leonardis & Palange, 2015).

The CMC carrier is gradually absorbed over a period of around 4 to 6 weeks.

Taken together all these findings and the wide use of carboxymethyl cellulose (CMC) in different products, in different application fields are in favour of its safety in humans and of its safety as a component of Fraxin™ , providing an immediate filling effect 

Fraxin™ is a white label variant of Erelle which was been awarded CE certification from ISS Italy.

Following a face to face consultation with a client. a practitioner can choose to mix the two vials together to form a delivery gel.

 

Fraxin make no claims regarding the efficacy of the product or its component parts and any administration must be conducted by a certified practitioner. 

The FDA has not verified any claim.