learn more about pdlla​

Lactic acid (PLA) was originally synthesized from α-hydroxy acids by French chemists in 1954. This polymer is safely used in resorbable suture materials, plates and screws in orthopedic, neurological and craniofacial surgery. PLA creates chiral molecules (cthe starting molecule and its mirror image are not identical, chiral objects cannot be superimposed, they are a property of natural compounds) poly-L type (PLLA), poly-D type, poly-D, L-lactic acid (PDLLA) and  meso-PLA. Only PLLA and PDLLA have been extensively researched with promising results.

In 1999, PLLA for injection was approved for use in Europe (New-Fill; Biotech Industry SA, Luksemburg).Initially, the product was registered as “wrinkle filler”. In 2004, it was approved in Europe to correct large volume losses in patients suffering from lipoatrophy.

On August 3, 2004, the United States Food and Drug Administration (FDA) approved Sculptra ™ (Dermik Laboratories, Berwyn, PA, USA) to correct volume losses resulting from facial lipoatrophy in HIV-infected patients. In 2009, this approval was extended to cosmetic / aesthetic medicine applications.

Plastic and Aesthetic Research

Efficacy and safety of poly-D,L-lactic acid microspheres as subdermal fillers in animals

Chuan-Yuan Lin1, Jui-Yu Lin1, Dae-Yeol Yang2, Seong-Ho Lee3, Jeoung-Yong Kim4, Miyeon Kang5  – Published: 25 Jul 2019

Poly-D,L-lactic acid (PDLLA) is a synthetic, biocompatible, biodegradable polymer.

In soft tissue augmentation, the size and chemical properties of the PDLLA microparticle are critical to its ability to initiate a subclinical inflammatory response,
which stimulates collagen deposition in the extracellular matrix.

The resulting facial volume restoration is controlled, predictable and long-lasting.

The unique physicochemical biostimulating properties of PDLLA set it apart from other available treatments and are the basis of the required unique treatment methodology for optimal results.

PDLLA is currently the most durable of all approved, certified biodegradable products.

Full correction still occurs in 80% of patients after 24 months. PLA (Polylactic Acid) is known as a collagen stimulator and offers unique and effective ways to deal with tissue defects for a natural and lasting effect.

Plastic and Aesthetic Research

“Efficacy and safety of poly-D,L-lactic acid microspheres as subdermal fillers in animals”

Chuan-Yuan Lin1, Jui-Yu Lin1, Dae-Yeol Yang2, Seong-Ho Lee3, Jeoung-Yong Kim4, Miyeon Kang5 – Published: 25 Jul 2019

The injection of polylactic acid causes a biological reaction in the subcutaneous tissue, similar, but less inflammatory to that seen during wound healing and suturing. There is a natural transition from acute to low-grade chronic inflammation.

  1. Intentional inflammatory reaction around a foreign body
  2. Fibroplasia (growth of fibrous connective tissue) in the skin,
  3. Collagenogenesis stimulated by lactates released into the tissues and the slow degradation of PDLLA microparticles are those factors that to varying degrees contribute to the long-term clinical effect that persists after the procedure.

The foreign body inflammatory response leads to microparticle encapsulation followed by fibroplasia and the resulting deposition of type I collagen in the extracellular space.

Stages:

  1. Tissue response to PDLLA from acute inflammation to declining inflammatory response.
  2. Protein adsorption occurs immediately after injection followed by infiltration by neutrophils and then macrophages.
  3. PDLLA degradation, and collagen accumulation over time.
  4. After 6 months, the number of macrophages and fibrocytes decreases (Fibrocyte – a connective tissue cell present as a reduced form of fibroblast with a lower metabolic efficiency – a senile cell, used up)
  5. Collagen production continues to increase and inflammation returns to baseline levels.

LENISNA particles are large enough to avoid phagocytosis via macrophages in the skin,  or penetrate the walls of the capillaries, but at the same time they are small enough to be easily injected with a needle without blocking it. They do not cause lumps under the skin due to their round and porous shape.

Injectable fillers offer simple and minimally invasive techniques to expand tissue. Ideal materials for such treatments must be easy to inject, non-migratory, volume stable, biodegradable and biocompatible. Currently, many types of tissue fillers are used in routine clinical practice for cosmetic and medical indications. These tissue fillers can be classified as temporary, semi-permanent, or permanent, depending on the duration of injection of the product into the tissues. These fillers are also classified according to their composition, and the following has been studied: collagen (bovine, porcine and human), hyaluronic acid (HA), polylactic acid PLA, calcium hydroxylapatite (CaHA), polymethyl methacrylate, polyacrylamide and autologous fat cells. Among these fillers, CaHA and PLA (Polylactic Acid) are known as collagen stimulants and offer unique and effective ways to deal with tissue defects for a natural and lasting effect.

Plastic and Aesthetic Research

Efficacy and safety of poly-D,L-lactic acid microspheres as subdermal fillers in animals

Chuan-Yuan Lin1, Jui-Yu Lin1, Dae-Yeol Yang2, Seong-Ho Lee3, Jeoung-Yong Kim4, Miyeon Kang5  – Published: 25 Jul 2019

The treatment should be repeated 2/3 times at intervals of 6 to 8 weeks. Duration of the procedure from the last visit exceeds 24 months.

Descriptions of the beneficial effects of polylactic acid in patients for up to 40 months can be found in the literature. The percentage of satisfied patients exceeds 90%.

The poly L lactic acid particles have the structure of broken glass, and the poly D, L lactic acid microparticles are round, porous with a mesh structure. This unique structure of molecules allows it to connect with non-cross-linked hyaluronic acid, which makes this preparation unique.

  • Patent : No. 10-1481441 Manufacturing method of polymeric microparticles having network structure
  • Patent : No. 10-1725279 A process for the preparation of polylactic acid microparticles by a spray method