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J Cosmet Med 2023; 7(2): 88-93

Published online December 31, 2023

https://doi.org/10.25056/JCM.2023.7.2.88

New method to immediate reconstitute Sculptra to create a more homogenous mixture for immediate use in year 2023

Arthur Yu, MBBS (HK)1 , Cheuk Hung Lee, MBBS (HK), FHKAM (MED), FHKCP, MScPD (Cardiff), MRCP (UK), DPD (Wales), DipDerm (Glasgow), PGDipClinDerm (London), MRCP (London), GradDipDerm (NUS), DipMed (CUHK)2 , Kar Wai Alvin Lee, MBChB (CUHK), DCH (Sydney), Dip Derm (Glasgow), MScClinDerm (Cardiff), MScPD (Cardiff), DipMed (CUHK), DCH (Sydney)2 , Lisa Kwin Wah Chan, MBChB (CUHK), MScPD (Cardiff), PgDipPD (Cardiff), PGDipClinDerm (Lond), DipMed (CUHK), DCH (Sydney)2

1Lightmac, Hong Kong
2Ever Keen Medical Centre, Hong Kong

Correspondence to :
Kar Wai Alvin Lee
E-mail: alvin429@yahoo.com

Received: May 19, 2023; Revised: May 28, 2023; Accepted: May 31, 2023

© Korean Society of Korean Cosmetic Surgery & Medicine

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Background: To create a sterile, non-pyrogenic solution, Sculptra must first be reconstituted with 5 ml sterile water for injection. This reconstitution process has evolved, has become the norm, and has been recommended for use across the globe since it was marketed to the public for aesthetic reasons. The granuloma formation problem of Sculptra Aesthetic is troublesome to some injectors. It can appear anywhere that you injected and is erratic. According to some patients, the inappropriate mixing of Sculptra microparticles with sterile water or the inability of the microparticles to fully dissolve into the solution are to blame for the development of granulomas.
Objective: This article aimed to demonstrate a new reconstitution method (with images) for mixing Sculptra with normal saline.
Methods: In the new reconstitution method, we attached a 21G sterile needle to a sterile, single-use 5 ml syringe. Thereafter, we withdrew 2.5 ml normal saline into the 5 ml syringe. The 21G sterile needle was then introduced into the stopper of the vial, and we slowly added all normal saline into the vial. The vial was shaken vigorously to ensure the full hydration of the content. After shaking, the physician could then add any volume of normal saline.
Results: A homogenous mixture of Sculptra can be achieved using this new reconstitution method. The mixture is ready to use after the immediate reconstitution of Sculptra.
Conclusion: This novel reconstitution technique for Sculptra will result in less unpleasant treatment and less foam wastage on the part of the physician.

Keywords: carboxymethylcellulose sodium, granuloma, injections, lactic acid, pain, New-fill

Sculptra Aesthetic was initially developed as a treatment for facial wasting in patients with human immunodeficiency virus. Today, it is also being used as a cosmetic treatment to add volume, improve the appearance of facial wrinkles and folds, and rejuvenate the skin. It was approved by the United States Food and Drug Administration in 2004 for the treatment of facial lipoatrophy. In addition, Sculptra has also been used “off-label” for cosmetic purposes, such as for restoring volume to the cheeks, temples, and chin and improving the appearance of wrinkles and fine lines. Sculptra Aesthetic is an injectable implant that contains microparticles of poly-L-lactic acid (PLLA), carboxymethylcellulose, non-pyrogenic mannitol, and sterile water for injection, with the last 3 substances meeting the quality standards set by the United States Pharmacopeia. Sculptra Aesthetic is available in 367.5 mg dose vials and is to be reconstituted prior to use by the addition of 5 ml sterile water for injection to form a sterile non-pyrogenic suspension [1].

Since Sculptra was marketed to the public for aesthetic reasons, this reconstitution technique has emerged as the standard method worldwide. Since its creation, Sculptra has undergone extensive research and is widely used [2,3]. In the past, doctors were instructed in some nations to reconstitute the bottle and wait 48 hours before using the product [4,5]. The most recent recommendation stated that a doctor might refill the vial with 5 ml of sterile water and utilize the particles right away after combining the sterile water and Sculptra particle. The guidelines of competing delay-onset collagen stimulators (such as Dermaveil [6] and Aesthefill [7], which permit doctors to mix the dry powder with normal saline and use them immediately after reconstitution) may have contributed to this change in the recommendations. Typically, doctors permit assistants with no medical professional liability to use sterile technique to reconstitute Sculptra. If contamination occurred after 48 hours after reconstitution, injectors might experience difficulty. However, Sculptra Aesthetic has a granuloma formation issue that some injectors find inconvenient. It is unpredictable and can show up wherever you injected. Some patients believe that the development of granulomas is caused by the improper mixing of the Sculptra microparticles with the sterile water or by the inability of the microparticles to completely dissolve into the solution. Furthermore, many injectors also face the problem of syringe blockage even though they were using a 21G needle. Our team developed a novel method that can avoid this problem. This new method can create a more homogenous mixture after reconstitution and allow injectors to immediately use Sculptra. Moreover, injectors can choose the amount of volume to mix so that it can be used in different parts of the body.

The following are the procedures of our new reconstitution method:

1. Remove the flip-off cap from the vial, and clean the penetrable stopper of the vial with an antiseptic. If the vial, seal, or flip-off cap is damaged, do not use the product, and call Galderma Laboratories, L.P. at 1-855-425-8722.

2. Attach a 21G sterile needle to a sterile, single-use 5 ml syringe.

3. Draw 2.5 ml of normal saline into the 5 ml syringe.

4. Introduce the 21G sterile needle into the stopper of the vial, and slowly add all normal saline into the vial.

5. Shake the vial vigorously to ensure full hydration of the content. After shaking, the physician can add any volume of normal saline. Upon reconstitution, Sculptra Aesthetic can be stored for up to 72 hours between 5°C–30°C. Refrigeration is not required.

6. Product should be gently agitated immediately prior to use. Agitate the vial until a uniform translucent suspension is obtained. A single vial swirling agitator may be used. The reconstituted product is usable within 72 hours of reconstitution. Given that it is a single-use vial, discard any material remaining after use or after 72 hours following reconstitution.

7. Clean the penetrable stopper of the vial with an antiseptic, and use a new 21G sterile needle to withdraw an appropriate amount of the suspension (typically 1 ml) into a 1 or 3 ml sterile, single-use syringe. Do not store the reconstituted product in the syringe.

8. Replace the 21G needle with a 26G sterile needle before injecting the product into the deep dermis. Do not inject Sculptra Aesthetic by using needles with an internal diameter smaller than 26G.

9. To withdraw the remaining contents of the vial, repeat steps 6 to 8.

Bolded and Italic words are the new reconstitution steps that we suggested, and the original reconstitution method can be found in page 19 of Galderma Patient Brochure Sculptra Aesthetic (Patient_Brochure_Sculptra_Aesthetic_US_0.pdf [galderma.com]).

Original recommended reconstitution method

1. Remove the flip-off cap from the vial, and clean the penetrable stopper of the vial with an antiseptic. If the vial, seal, or flip-off cap is damaged, do not use the product, and call Galderma Laboratories, L.P. at 1-855-425-8722.

2. Attach an 18G sterile needle to a sterile, single-use 5 ml syringe.

3. Draw 5 ml of sterile water for injection into the 5 ml syringe.

4. Introduce the 18G sterile needle into the stopper of the vial, and slowly add all normal saline into the vial.

5. Let the vial stand for at least 2 hours to ensure complete hydration; do not shake the vial during this period. Upon reconstitution, Sculptra Aesthetic can be stored for up to 72 hours between 5°C–30°C. Refrigeration is not required.

6. The product should be gently agitated immediately prior to use. Agitate the vial until a uniform translucent suspension is obtained. A single vial swirling agitator may be used. The reconstituted product is usable within 72 hours of reconstitution. Given that it is a single-use vial, discard any material remaining after use or after 72 hours following reconstitution.

7. Clean the penetrable stopper of the vial with an antiseptic, and use a new 18G sterile needle to withdraw an appropriate amount of the suspension (typically 1 ml) into a 1 or 3 ml sterile, single-use syringe. Do not store the reconstituted product in the syringe.

8. Replace the 18G needle with a 26G sterile needle before injecting the product into the deep dermis. Do not inject Sculptra Aesthetic by using needles with an internal diameter smaller than 26G.

9. To withdraw the remaining contents of the vial, repeat steps 6 to 8.

A homogenous mixture of Sculptra can be achieved with this new reconstitution method, and this mixture is ready to use after immediate reconstitution.

Fig. 13 show the new reconstitution method with the old packaging of the Sculptra vial. Fig. 47 show the comparison of the new reconstitution method with the original reconstitution method using the new packaging of the Sculptra vial.

Fig. 1.Normal saline (2.5 ml) injected into a new vial of Sculptra (the Sculptra vial in the image is the old packaging).

Fig. 2.After shaking the vial containing 2.5 ml normal saline, a homogenous appearance of the mixture is achieved.

Fig. 3.Normal saline (2.5 ml) mixed into the vial. The image shows the homogenous appearance of the mixture.

Fig. 4.Sculptra boxes with the new packaging.

Fig. 5.Two Sculptra vials. The left vial will be used for the new reconstitution method, whereas the right vial will be used for the original reconstitution method.

Fig. 6.The Sculptra vial on the left had 2.5 ml of normal saline reconstituted, whereas the Sculptra vial on the right had 5 ml of normal saline reconstituted. Both vials were shaken vigorously. A homogenous mixture was achieved in the left Sculptra vial, and suspension could be observed on the right Sculptra vial. The picture was taken immediately after shaking.

Fig. 7.Normal saline (2.5 ml) was reconstituted into the left Sculptra vial to achieve a 5 ml volume, similar to that in the right Sculptra vial. A homogenous mixture was achieved.

After being reconstituted with water, sodium carboxymethylcellulose was added as a suspending agent to ensure that PLLA particles were distributed evenly. When sodium carboxymethylcellulose powder is mixed with water and forcefully shaken, it immediately begins to hydrate and dissolve [8].

Mannitol was also added to help in the finishing step of lyophilization (freeze drying), which results in a rigid, uniform cake. Mannitol disintegrates quickly in water. However, water cannot dissolve PLLA particles. Regardless of the reconstitution process, the top layer of foam will stay in the product. Although studies have stated that shaking vigorously for 1 minute dissolves the excipients of Sculptra without the need for standing time and that this method has no effect on the physiochemical properties of the PLLA particles, the standing times did not interfere with the properties.

Our new method allows the withdrawal of Sculptra particles from the vial by using a smaller caliber needle than the 18G needle in the previous method, which could damage the stopper or leave behind remnants inside the vial that can contaminate the sample.

Carboxymethylcellulose is not typically considered a surfactant. It is a water-soluble polymer that is commonly used as a thickening and stabilizing agent in various industries, including food, pharmaceuticals, and cosmetics [9,10]. Nevertheless, carboxymethylcellulose can have some surfactant-like properties depending on its concentration and the conditions of the solution it is in. At low concentrations, carboxymethylcellulose can act as a dispersant and can help keep particles suspended in the solution. At higher concentrations, carboxymethylcellulose can form micelles and reduce the surface tension of a solution, which are characteristics of surfactants. However, carboxymethylcellulose is generally not considered a true surfactant because of its primary function as a thickening agent rather than a molecule designed specifically for reducing interfacial tension. Carboxymethylcellulose could be used as a multifunctional ingredient in emulsion systems to provide both thickening and stabilizing effects and surfactant-like properties for enhancing emulsion stability.

The concentration of carboxymethylcellulose in the Sculptra vial may be reduced by using the original reconstitution method, which involved the addition of 5 ml sterile water for injection. Carboxymethylcellulose would then function as a dispersant. By using only 2.5 ml of normal saline in our new procedure, we are able to maintain the concentration of carboxymethylcellulose, thus making it easier for carboxymethylcellulose to serve as a surfactant and decrease surface tension. The result is a homogeneous suspension. After vigorous shaking, you can still observe the homogeneous suspension even if you add any amount of normal saline.

Over the past 10 years, our team has administered Sculptra injections in 5,000 different situations. When reconstituting sterile water for injection or regular saline, we have not discovered any variations in patient effectiveness. Considering that sterile water for injection is hypotonic, it hurts more than regular saline. The solute content in hypotonic solutions is lower than that of bodily fluids. Injecting hypotonic substances into the body, such as sterile water for injection, causes water to shift from the extracellular region to the intracellular region, thus leading to discomfort and swelling. This happens as a result of the swelling and water absorption at the injection site. Pressure is then placed on the adjacent nerve terminals, thus producing pain. By contrast, normal saline is an isotonic solution, i.e., it has the same number of solutes as biological fluids. It does not induce water to enter or exit cells when injected, thus preventing swelling and discomfort [11].

This new method has some limitations, and there may be other mechanisms involved that require further study. In the future, our team hopes to conduct comparison studies that can prove the ability of our reconstitution method to decrease the chance of granuloma formation. To achieve this purpose, significant manpower resources and caseloads are required. Our team also tried using less than 2.5 ml normal saline to reconstitute Sculptra; however, the mixture was not well hydrated, and 2.5 ml is currently our best recommendation for the volume of normal saline. We believe that with a more homogenous mixture, there will be less chances for granuloma formation. However, further studies are needed to prove this claim.

We anticipate that using this novel reconstitution technique for Sculptra will result in less unpleasant treatment and less foam wastage on the part of the physician.

  1. Galderma. A patient's guide to treatment with Sculptra® [Internet]. Fort Worth (TX): Galderma; c2021 [cited 2023 Oct 20].
    Available from: https://www.galderma.com/us/sites/default/files/2021-12/Patient_Brochure_Sculptra_US_1.pdf.
  2. Humble G, Mest D. Soft tissue augmentation using Sculptra. Facial Plast Surg 2004;20:157-63.
    Pubmed CrossRef
  3. Vleggaar D, Bauer U. Facial enhancement and the European experience with Sculptra (poly-l-lactic acid). J Drugs Dermatol 2004;3:542-7.
    Pubmed
  4. Swift R. Mini vortex mixer: a simple way to prevent Sculptra needle clogging. Plast Reconstr Surg 2015;136:407e-408e.
    Pubmed CrossRef
  5. Bravo BSF, Carvalho RM. Safety in immediate reconstitution of poly-l-lactic acid for facial biostimulation treatment. J Cosmet Dermatol 2021;20:1435-8.
    Pubmed CrossRef
  6. Tagle JM, Macchetto PC, Durán Páramo RM. Clinical performance of a dermal filler containing natural glycolic acid and a polylactic acid polymer: results of a clinical trial in human immunodeficiency virus subjects with facial lipoatrophy. J Clin Aesthet Dermatol 2010;3:42-7.
    Pubmed KoreaMed
  7. Hyun MY, Lee Y, No YA, Yoo KH, Kim MN, Hong CK, et al. Efficacy and safety of injection with poly-l-lactic acid compared with hyaluronic acid for correction of nasolabial fold: a randomized, evaluator-blinded, comparative study. Clin Exp Dermatol 2015;40:129-35.
    Pubmed CrossRef
  8. Keller JD. Sodium carboxymethylcellulose (CMC). In: Glicksman M, editor. Food hydrocolloids. Boca Raton (FL): CRC Press; 1986. p. 43-109.
    KoreaMed CrossRef
  9. Barck M, Stenius P. Interactions between carboxymethyl cellulose and cationic surfactants 1. Phase equilibria and surface tensions. Colloids Surf A Physicochem Eng 1994;89:59-69.
    CrossRef
  10. Arancibia C, Navarro-Lisboa R, Zúñiga RN, Matiacevich S. Application of CMC as thickener on nanoemulsions based on olive oil: physical properties and stability. Int J Polym Sci:6280581.
    CrossRef
  11. Mercadante S, Porzio G, Ferrera P, author, author, author, et al. Pain induced by subcutaneous injections of sterile water, normal saline and local anaesthetics. J Pain Symptom Manage 2001;21:310-4.

Article

How We Do It

J Cosmet Med 2023; 7(2): 88-93

Published online December 31, 2023 https://doi.org/10.25056/JCM.2023.7.2.88

Copyright © Korean Society of Korean Cosmetic Surgery & Medicine.

New method to immediate reconstitute Sculptra to create a more homogenous mixture for immediate use in year 2023

Arthur Yu, MBBS (HK)1 , Cheuk Hung Lee, MBBS (HK), FHKAM (MED), FHKCP, MScPD (Cardiff), MRCP (UK), DPD (Wales), DipDerm (Glasgow), PGDipClinDerm (London), MRCP (London), GradDipDerm (NUS), DipMed (CUHK)2 , Kar Wai Alvin Lee, MBChB (CUHK), DCH (Sydney), Dip Derm (Glasgow), MScClinDerm (Cardiff), MScPD (Cardiff), DipMed (CUHK), DCH (Sydney)2 , Lisa Kwin Wah Chan, MBChB (CUHK), MScPD (Cardiff), PgDipPD (Cardiff), PGDipClinDerm (Lond), DipMed (CUHK), DCH (Sydney)2

1Lightmac, Hong Kong
2Ever Keen Medical Centre, Hong Kong

Correspondence to:Kar Wai Alvin Lee
E-mail: alvin429@yahoo.com

Received: May 19, 2023; Revised: May 28, 2023; Accepted: May 31, 2023

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background: To create a sterile, non-pyrogenic solution, Sculptra must first be reconstituted with 5 ml sterile water for injection. This reconstitution process has evolved, has become the norm, and has been recommended for use across the globe since it was marketed to the public for aesthetic reasons. The granuloma formation problem of Sculptra Aesthetic is troublesome to some injectors. It can appear anywhere that you injected and is erratic. According to some patients, the inappropriate mixing of Sculptra microparticles with sterile water or the inability of the microparticles to fully dissolve into the solution are to blame for the development of granulomas.
Objective: This article aimed to demonstrate a new reconstitution method (with images) for mixing Sculptra with normal saline.
Methods: In the new reconstitution method, we attached a 21G sterile needle to a sterile, single-use 5 ml syringe. Thereafter, we withdrew 2.5 ml normal saline into the 5 ml syringe. The 21G sterile needle was then introduced into the stopper of the vial, and we slowly added all normal saline into the vial. The vial was shaken vigorously to ensure the full hydration of the content. After shaking, the physician could then add any volume of normal saline.
Results: A homogenous mixture of Sculptra can be achieved using this new reconstitution method. The mixture is ready to use after the immediate reconstitution of Sculptra.
Conclusion: This novel reconstitution technique for Sculptra will result in less unpleasant treatment and less foam wastage on the part of the physician.

Keywords: carboxymethylcellulose sodium, granuloma, injections, lactic acid, pain, New-fill

Introduction

Sculptra Aesthetic was initially developed as a treatment for facial wasting in patients with human immunodeficiency virus. Today, it is also being used as a cosmetic treatment to add volume, improve the appearance of facial wrinkles and folds, and rejuvenate the skin. It was approved by the United States Food and Drug Administration in 2004 for the treatment of facial lipoatrophy. In addition, Sculptra has also been used “off-label” for cosmetic purposes, such as for restoring volume to the cheeks, temples, and chin and improving the appearance of wrinkles and fine lines. Sculptra Aesthetic is an injectable implant that contains microparticles of poly-L-lactic acid (PLLA), carboxymethylcellulose, non-pyrogenic mannitol, and sterile water for injection, with the last 3 substances meeting the quality standards set by the United States Pharmacopeia. Sculptra Aesthetic is available in 367.5 mg dose vials and is to be reconstituted prior to use by the addition of 5 ml sterile water for injection to form a sterile non-pyrogenic suspension [1].

Since Sculptra was marketed to the public for aesthetic reasons, this reconstitution technique has emerged as the standard method worldwide. Since its creation, Sculptra has undergone extensive research and is widely used [2,3]. In the past, doctors were instructed in some nations to reconstitute the bottle and wait 48 hours before using the product [4,5]. The most recent recommendation stated that a doctor might refill the vial with 5 ml of sterile water and utilize the particles right away after combining the sterile water and Sculptra particle. The guidelines of competing delay-onset collagen stimulators (such as Dermaveil [6] and Aesthefill [7], which permit doctors to mix the dry powder with normal saline and use them immediately after reconstitution) may have contributed to this change in the recommendations. Typically, doctors permit assistants with no medical professional liability to use sterile technique to reconstitute Sculptra. If contamination occurred after 48 hours after reconstitution, injectors might experience difficulty. However, Sculptra Aesthetic has a granuloma formation issue that some injectors find inconvenient. It is unpredictable and can show up wherever you injected. Some patients believe that the development of granulomas is caused by the improper mixing of the Sculptra microparticles with the sterile water or by the inability of the microparticles to completely dissolve into the solution. Furthermore, many injectors also face the problem of syringe blockage even though they were using a 21G needle. Our team developed a novel method that can avoid this problem. This new method can create a more homogenous mixture after reconstitution and allow injectors to immediately use Sculptra. Moreover, injectors can choose the amount of volume to mix so that it can be used in different parts of the body.

Materials and methods

The following are the procedures of our new reconstitution method:

1. Remove the flip-off cap from the vial, and clean the penetrable stopper of the vial with an antiseptic. If the vial, seal, or flip-off cap is damaged, do not use the product, and call Galderma Laboratories, L.P. at 1-855-425-8722.

2. Attach a 21G sterile needle to a sterile, single-use 5 ml syringe.

3. Draw 2.5 ml of normal saline into the 5 ml syringe.

4. Introduce the 21G sterile needle into the stopper of the vial, and slowly add all normal saline into the vial.

5. Shake the vial vigorously to ensure full hydration of the content. After shaking, the physician can add any volume of normal saline. Upon reconstitution, Sculptra Aesthetic can be stored for up to 72 hours between 5°C–30°C. Refrigeration is not required.

6. Product should be gently agitated immediately prior to use. Agitate the vial until a uniform translucent suspension is obtained. A single vial swirling agitator may be used. The reconstituted product is usable within 72 hours of reconstitution. Given that it is a single-use vial, discard any material remaining after use or after 72 hours following reconstitution.

7. Clean the penetrable stopper of the vial with an antiseptic, and use a new 21G sterile needle to withdraw an appropriate amount of the suspension (typically 1 ml) into a 1 or 3 ml sterile, single-use syringe. Do not store the reconstituted product in the syringe.

8. Replace the 21G needle with a 26G sterile needle before injecting the product into the deep dermis. Do not inject Sculptra Aesthetic by using needles with an internal diameter smaller than 26G.

9. To withdraw the remaining contents of the vial, repeat steps 6 to 8.

Bolded and Italic words are the new reconstitution steps that we suggested, and the original reconstitution method can be found in page 19 of Galderma Patient Brochure Sculptra Aesthetic (Patient_Brochure_Sculptra_Aesthetic_US_0.pdf [galderma.com]).

Original recommended reconstitution method

1. Remove the flip-off cap from the vial, and clean the penetrable stopper of the vial with an antiseptic. If the vial, seal, or flip-off cap is damaged, do not use the product, and call Galderma Laboratories, L.P. at 1-855-425-8722.

2. Attach an 18G sterile needle to a sterile, single-use 5 ml syringe.

3. Draw 5 ml of sterile water for injection into the 5 ml syringe.

4. Introduce the 18G sterile needle into the stopper of the vial, and slowly add all normal saline into the vial.

5. Let the vial stand for at least 2 hours to ensure complete hydration; do not shake the vial during this period. Upon reconstitution, Sculptra Aesthetic can be stored for up to 72 hours between 5°C–30°C. Refrigeration is not required.

6. The product should be gently agitated immediately prior to use. Agitate the vial until a uniform translucent suspension is obtained. A single vial swirling agitator may be used. The reconstituted product is usable within 72 hours of reconstitution. Given that it is a single-use vial, discard any material remaining after use or after 72 hours following reconstitution.

7. Clean the penetrable stopper of the vial with an antiseptic, and use a new 18G sterile needle to withdraw an appropriate amount of the suspension (typically 1 ml) into a 1 or 3 ml sterile, single-use syringe. Do not store the reconstituted product in the syringe.

8. Replace the 18G needle with a 26G sterile needle before injecting the product into the deep dermis. Do not inject Sculptra Aesthetic by using needles with an internal diameter smaller than 26G.

9. To withdraw the remaining contents of the vial, repeat steps 6 to 8.

Results

A homogenous mixture of Sculptra can be achieved with this new reconstitution method, and this mixture is ready to use after immediate reconstitution.

Fig. 13 show the new reconstitution method with the old packaging of the Sculptra vial. Fig. 47 show the comparison of the new reconstitution method with the original reconstitution method using the new packaging of the Sculptra vial.

Figure 1. Normal saline (2.5 ml) injected into a new vial of Sculptra (the Sculptra vial in the image is the old packaging).

Figure 2. After shaking the vial containing 2.5 ml normal saline, a homogenous appearance of the mixture is achieved.

Figure 3. Normal saline (2.5 ml) mixed into the vial. The image shows the homogenous appearance of the mixture.

Figure 4. Sculptra boxes with the new packaging.

Figure 5. Two Sculptra vials. The left vial will be used for the new reconstitution method, whereas the right vial will be used for the original reconstitution method.

Figure 6. The Sculptra vial on the left had 2.5 ml of normal saline reconstituted, whereas the Sculptra vial on the right had 5 ml of normal saline reconstituted. Both vials were shaken vigorously. A homogenous mixture was achieved in the left Sculptra vial, and suspension could be observed on the right Sculptra vial. The picture was taken immediately after shaking.

Figure 7. Normal saline (2.5 ml) was reconstituted into the left Sculptra vial to achieve a 5 ml volume, similar to that in the right Sculptra vial. A homogenous mixture was achieved.

Discussion

After being reconstituted with water, sodium carboxymethylcellulose was added as a suspending agent to ensure that PLLA particles were distributed evenly. When sodium carboxymethylcellulose powder is mixed with water and forcefully shaken, it immediately begins to hydrate and dissolve [8].

Mannitol was also added to help in the finishing step of lyophilization (freeze drying), which results in a rigid, uniform cake. Mannitol disintegrates quickly in water. However, water cannot dissolve PLLA particles. Regardless of the reconstitution process, the top layer of foam will stay in the product. Although studies have stated that shaking vigorously for 1 minute dissolves the excipients of Sculptra without the need for standing time and that this method has no effect on the physiochemical properties of the PLLA particles, the standing times did not interfere with the properties.

Our new method allows the withdrawal of Sculptra particles from the vial by using a smaller caliber needle than the 18G needle in the previous method, which could damage the stopper or leave behind remnants inside the vial that can contaminate the sample.

Carboxymethylcellulose is not typically considered a surfactant. It is a water-soluble polymer that is commonly used as a thickening and stabilizing agent in various industries, including food, pharmaceuticals, and cosmetics [9,10]. Nevertheless, carboxymethylcellulose can have some surfactant-like properties depending on its concentration and the conditions of the solution it is in. At low concentrations, carboxymethylcellulose can act as a dispersant and can help keep particles suspended in the solution. At higher concentrations, carboxymethylcellulose can form micelles and reduce the surface tension of a solution, which are characteristics of surfactants. However, carboxymethylcellulose is generally not considered a true surfactant because of its primary function as a thickening agent rather than a molecule designed specifically for reducing interfacial tension. Carboxymethylcellulose could be used as a multifunctional ingredient in emulsion systems to provide both thickening and stabilizing effects and surfactant-like properties for enhancing emulsion stability.

The concentration of carboxymethylcellulose in the Sculptra vial may be reduced by using the original reconstitution method, which involved the addition of 5 ml sterile water for injection. Carboxymethylcellulose would then function as a dispersant. By using only 2.5 ml of normal saline in our new procedure, we are able to maintain the concentration of carboxymethylcellulose, thus making it easier for carboxymethylcellulose to serve as a surfactant and decrease surface tension. The result is a homogeneous suspension. After vigorous shaking, you can still observe the homogeneous suspension even if you add any amount of normal saline.

Over the past 10 years, our team has administered Sculptra injections in 5,000 different situations. When reconstituting sterile water for injection or regular saline, we have not discovered any variations in patient effectiveness. Considering that sterile water for injection is hypotonic, it hurts more than regular saline. The solute content in hypotonic solutions is lower than that of bodily fluids. Injecting hypotonic substances into the body, such as sterile water for injection, causes water to shift from the extracellular region to the intracellular region, thus leading to discomfort and swelling. This happens as a result of the swelling and water absorption at the injection site. Pressure is then placed on the adjacent nerve terminals, thus producing pain. By contrast, normal saline is an isotonic solution, i.e., it has the same number of solutes as biological fluids. It does not induce water to enter or exit cells when injected, thus preventing swelling and discomfort [11].

This new method has some limitations, and there may be other mechanisms involved that require further study. In the future, our team hopes to conduct comparison studies that can prove the ability of our reconstitution method to decrease the chance of granuloma formation. To achieve this purpose, significant manpower resources and caseloads are required. Our team also tried using less than 2.5 ml normal saline to reconstitute Sculptra; however, the mixture was not well hydrated, and 2.5 ml is currently our best recommendation for the volume of normal saline. We believe that with a more homogenous mixture, there will be less chances for granuloma formation. However, further studies are needed to prove this claim.

We anticipate that using this novel reconstitution technique for Sculptra will result in less unpleasant treatment and less foam wastage on the part of the physician.

Conflicts of interest

The authors have nothing to disclose.

Fig 1.

Figure 1.Normal saline (2.5 ml) injected into a new vial of Sculptra (the Sculptra vial in the image is the old packaging).
Journal of Cosmetic Medicine 2023; 7: 88-93https://doi.org/10.25056/JCM.2023.7.2.88

Fig 2.

Figure 2.After shaking the vial containing 2.5 ml normal saline, a homogenous appearance of the mixture is achieved.
Journal of Cosmetic Medicine 2023; 7: 88-93https://doi.org/10.25056/JCM.2023.7.2.88

Fig 3.

Figure 3.Normal saline (2.5 ml) mixed into the vial. The image shows the homogenous appearance of the mixture.
Journal of Cosmetic Medicine 2023; 7: 88-93https://doi.org/10.25056/JCM.2023.7.2.88

Fig 4.

Figure 4.Sculptra boxes with the new packaging.
Journal of Cosmetic Medicine 2023; 7: 88-93https://doi.org/10.25056/JCM.2023.7.2.88

Fig 5.

Figure 5.Two Sculptra vials. The left vial will be used for the new reconstitution method, whereas the right vial will be used for the original reconstitution method.
Journal of Cosmetic Medicine 2023; 7: 88-93https://doi.org/10.25056/JCM.2023.7.2.88

Fig 6.

Figure 6.The Sculptra vial on the left had 2.5 ml of normal saline reconstituted, whereas the Sculptra vial on the right had 5 ml of normal saline reconstituted. Both vials were shaken vigorously. A homogenous mixture was achieved in the left Sculptra vial, and suspension could be observed on the right Sculptra vial. The picture was taken immediately after shaking.
Journal of Cosmetic Medicine 2023; 7: 88-93https://doi.org/10.25056/JCM.2023.7.2.88

Fig 7.

Figure 7.Normal saline (2.5 ml) was reconstituted into the left Sculptra vial to achieve a 5 ml volume, similar to that in the right Sculptra vial. A homogenous mixture was achieved.
Journal of Cosmetic Medicine 2023; 7: 88-93https://doi.org/10.25056/JCM.2023.7.2.88

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