FORMULAÇÃO E MÉTODO PARA USO DE ÁCIDO POLI-L-LÁTICO ASSOCIADO A ÁCIDO HIALURÔNICO PARA PREENCHIMENTO E BIOESTIMULAÇÃO DE COLÁGENO

Description

5 Formulation and method for using poly-L-lactic acid combined with hyaluronic acid for filling and collagen biostimulation. Field of invention

[001] The present invention belongs to the technical field of dermatology and aesthetics, focusing on the development of advanced formulations and innovative methods for dermal filler treatments and collagen biostimulation. This solution combines poly-L-lactic acid (PLLA), known for its biostimulating action, with hyaluronic acid (HA), widely used to provide immediate volume. This integrated formulation seeks to overcome the limitations of conventional techniques, offering more effective, safe and personalized clinical results, combining the benefits of immediate filling and prolonged stimulation of collagen production in a single treatment. Fundamentals of the invention

[002] Conventional methods employ PLLA (poly-L-lactic acid) and hyaluronic acid (HA) in isolation, serving distinct purposes: PLLA is used as a biostimulator to stimulate collagen production, while hyaluronic acid is applied to promote immediate volume. However, the isolated use of PLLA presents significant technical challenges, such as a high incidence of clumping and nodule formation after application, resulting in patient discomfort and unpredictable results. Furthermore, traditional approaches limit the benefits to patients, who must choose between immediate filling effects and collagen stimulation, without a combined solution available.

[003] The present invention solves these technical problems by combining PLLA diluted in distilled water with hyaluronic acid, creating a homogeneous formulation that significantly reduces the risks of clumping and nodule formation. This innovative combination allows the benefits of both components to be combined in a single product. Petition 870250006821, dated 01 / 28 / 2025, page 10 / 22 / 5 with hyaluronic acid providing immediate volume to the treatment and complementing the collagen-stimulating action of PLLA. The ratio between the two components can be adjusted according to clinical needs, offering greater flexibility and personalization in treatment, whether for greater volume, greater collagen stimulation, or a balance between both.

[004] When comparing this formulation with isolated state-of-the-art models, it is observed that it provides more efficient results, greater patient comfort, and a safer and more predictable procedure. Thus, the invention represents a significant evolution in the field of dermatology and aesthetics, offering a solution that integrates immediate volume and collagen biostimulation in a single application, eliminating the limitations and side effects associated with traditional practices. Brief description of the drawings Figure 1 shows two syringes with a final volume of 17 ml in both dilutions, one with PLLA diluted only in water for injection and the other with PLLA combined with hyaluronic acid. In both dilutions, 1.5 ml of lidocaine was added for greater patient comfort. Figure 2 shows the result of the diluted solutions in both syringes, where the solution with hyaluronic acid resulted in a more homogeneous mixture, and the solution with PLLA and water resulted in a more precipitated mixture. Figures 3, 4, and 5 show the nodules formed by the agglutination of PLLA when it is diluted in water only. Description of the Invention

[005] The invention presents an innovative formulation for use in aesthetic and therapeutic treatments, which combines poly-L-lactic acid (PLLA) in aqueous form with hyaluronic acid (HA) gel. This combination offers a solution that provides immediate filling and long-term collagen biostimulation, overcoming limitations of conventional techniques. The production method follows steps Petition 870250006821, dated 01 / 28 / 2025, page 11 / 22 / 5 carefully developed to ensure the efficiency and safety of the product. Initially, PLLA is diluted in distilled water using a mechanical propeller stirrer, ensuring its complete dissolution. Then, hyaluronic acid gel is added to the solution, promoting efficient homogenization that ensures a uniform mixture. After this step, the formulation is prepared in syringes, forming a ready-to-use solution with a final volume of 17 mL.

[006] The great advantage of the invention lies in the inclusion of hyaluronic acid, which not only improves the homogeneity of the mixture, but also significantly reduces the risks associated with the application of pure PLLA, such as clumping and nodule formation. These complications, frequently observed in traditional methods that use PLLA diluted only in water, are minimized by the interaction of hyaluronic acid in the formulation, which stabilizes the mixture and facilitates its application. In addition, the HA gel used in the composition exhibits resistance to degradation, which contributes to a longer lifespan of the clinical effects, expanding the benefits for the patient.

[007] The flexibility in the ratio between the components is another highlight of this invention, allowing customizations according to clinical objectives. Larger quantities of hyaluronic acid offer greater immediate volume, ideal for cases where the main objective is dermal filling. On the other hand, smaller proportions of HA prioritize collagen biostimulation, further reducing the risks of complications, such as nodule formation, and offering a solution that meets a wide variety of aesthetic and therapeutic needs.

[008] To increase comfort during application, the invention allows the inclusion of lidocaine in the formulation, making the procedure less painful and more accessible to patients. This patient-experience-focused approach does not compromise the formulation's effectiveness, but complements it, ensuring a more satisfactory end result. The preparation, carried out with technical rigor, ensures that each syringe contains a high-quality solution, ready to be applied safely and efficiently. Petition 870250006821, dated 01 / 28 / 2025, page 12 / 22 / 5

[009] Clinical results demonstrate the superiority of the formulation compared to conventional methods. Randomized controlled studies have shown that areas treated with the combination of PLLA and HA presented better homogeneity, lower incidence of nodules, and greater patient comfort compared to areas treated only with PLLA diluted in water. These results reinforce the efficacy and safety of the formulation, proving its relevance in the field of dermatology and aesthetics. Examples of Implementations of the Invention.

[0010] A randomized controlled clinical trial was conducted to evaluate the benefits of the proposed formulation, comparing two distinct approaches. One hemiface was treated with PLLA diluted only in distilled water, while the other received a combination of PLLA with hyaluronic acid (HA). For the hemiface treated with PLLA combined with HA, a standardized protocol was followed: 210 mg of PLLA were diluted in 14 mL of distilled water, using a mixer to ensure complete dissolution. Then, 1.5 mL of hyaluronic acid were added to improve the homogeneity of the solution and 1.5 mL of lidocaine to increase patient comfort during application. The mixture was homogenized in a syringe, ensuring uniform distribution of all components and resulting in a final volume of 17 mL for both formulations.

[0011] The results demonstrated that the side treated with the combined formulation of PLLA and HA presented significantly superior homogeneity, with a lower incidence of nodules and greater patient comfort. This improvement translates into a more uniform application, reducing clumping and consequently minimizing nodule formation, a common complication associated with the isolated use of PLLA diluted only in water.

[0012] The formulation also stands out for its flexibility and customization capabilities. The ratio between hyaluronic acid and PLLA can be adjusted according to specific clinical objectives. Larger amounts of HA provide more evident immediate volume, while smaller proportions prioritize collagen biostimulation, further reducing the risk of complications. This versatility allows Petition 870250006821, dated 01 / 28 / 2025, page 13 / 22 / 5 that the treatment be adapted to meet different aesthetic and therapeutic needs in a precise and safe manner. Petition 870250006821, dated 01 / 28 / 2025, page 14 / 22

Claims

1 / 2 CLAIMS 1. FORMULATION AND METHOD FOR THE USE OF POLY-L-LACTIC ACID ASSOCIATED WITH HYALURONIC ACID FOR FILLING AND COLLAGEN BIOSTIMULATION, characterized by comprising poly-L-lactic acid (PLLA) diluted in distilled water, combined with hyaluronic acid (HA) in gel form, resulting in a homogeneous formulation that provides immediate filling, long-term collagen biostimulation, and reduced risk of nodule formation associated with application.

2. FORMULATION AND METHOD FOR THE USE OF POLY-L-LACTIC ACID ASSOCIATED WITH HYALURONIC ACID FOR FILLING AND COLLAGEN BIOSTIMULATION, according to claim 1, characterized by including lidocaine in the formulation to increase patient comfort during application.

3. FORMULATION AND METHOD FOR THE USE OF POLY-L-LACTIC ACID ASSOCIATED WITH HYALURONIC ACID FOR FILLING AND COLLAGEN BIOSTIMULATION, according to claim 1, characterized by the possibility of adjusting the ratio between hyaluronic acid and poly-L-lactic acid, allowing the treatment to be customized according to the clinical objective, whether for greater volume with an increased proportion of hyaluronic acid or greater collagen stimulation (with an increased proportion of poly-L-lactic acid).

4. FORMULATION AND METHOD FOR THE USE OF POLY-L-LACTIC ACID ASSOCIATED WITH HYALURONIC ACID FOR FILLING AND BIOSTIMULATION OF COLLAGEN, according to claim 1, characterized by the fact that the hyaluronic acid used exhibits resistance to degradation, providing greater durability of clinical effects. Petition 870250006821, dated 01 / 28 / 2025, page 15 / 22 2 / 2 5. FORMULATION AND METHOD FOR THE USE OF POLY-L-LACTIC ACID ASSOCIATED WITH HYALURONIC ACID FOR FILLING AND COLLAGEN BIOSTIMULATION, characterized by comprising the steps of: dilution of poly-L-lactic acid (PLLA) in distilled water until complete dissolution; addition of hyaluronic acid to the PLLA solution to improve homogeneity; homogenization of the mixture in a syringe to ensure uniform distribution of the components; optional inclusion of lidocaine for greater patient comfort.

6. FORMULATION AND METHOD FOR THE USE OF POLY-L-LACTIC ACID ASSOCIATED WITH HYALURONIC ACID FOR FILLING AND BIOSTIMULATION OF COLLAGEN, according to claim 1, characterized by resulting in a homogeneous formulation that reduces the risk of clumping and nodule formation during and after application.

7. FORMULATION AND METHOD FOR THE USE OF POLY-L-LACTIC ACID ASSOCIATED WITH HYALURONIC ACID FOR FILLING AND COLLAGEN BIOSTIMULATION, according to claim 1, characterized by the customization of the formulation based on the proportion of hyaluronic acid and PLLA, according to the treatment objectives.

8. FORMULATION AND METHOD FOR THE USE OF POLY-L-LACTIC ACID ASSOCIATED WITH HYALURONIC ACID FOR FILLING AND BIOSTIMULATION OF COLLAGEN, according to claim 1, characterized by the possibility of preparing the formulation in a single application, ready for immediate application.

9. FORMULATION AND METHOD FOR THE USE OF POLY-L-LACTIC ACID ASSOCIATED WITH HYALURONIC ACID FOR FILLING AND BIOSTIMULATION OF COLLAGEN, according to claim 1, characterized by the use of a mechanical stirrer with a propeller to ensure the complete dissolution of the PLLA before the addition of hyaluronic acid. Petition 870250006821, dated 01 / 28 / 2025, pp. 16 / 22

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