Abstract

ZACARIAS CHAMORRO, Cynthia Adriana; SESTO CABRAL, Maria Eugenia  and  FRETES DE AQUINO, Sonia Lorena. Technological-regulatory interface: development of a drug of biological origin for the treatment of chronic ulcers with a high volume of exudate. Rep. cient. FACEN [online]. 2020, vol.11, n.2, pp.33-47. ISSN 2222-145X.  https://doi.org/10.18004/rcfacen2020.11.02.33.

The infection of a wound and the presence of new exudate to the delay in the healing. The infection is produced by biofilm-forming bacteria, a strategy that confers resistance to antibiotics, disinfectants and the immune response. The absence of specific and accessible treatments in the public health system leads to the ap- plication of palliative treatments, which prevent the patient from remaining ambulatory, reducing their quality of life. Because it is a chronic relapsing disease, with a high requirement of resources, it represents a problem in public health. As an alternative treatment with the use of Lactobacillus plantarum supernatant (LAPS) is available by scientific reports published since 2012; it has metabolites with antipathogenic and procicatrizing activity that act synergistically, which turns this complex mixture into a single Active Pharmaceutical Ingredient (API). The challenge consisted in developing a drug for topical use that conveys LAPS, preserving its activity and allowing the management of a high volume of exudate, to offer a personalized treatment to the patient, using production methods that were carried out according to current regulations, at laboratory scale. All were designed under the principles of (P + L) and Green Chemistry, to contribute to the contribution of environmentally friendly products.

Keywords : LAPS; IFA; topical drugs; P + L; green chemistry.

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