Development of natural cosmetic emulsion using the by-product of Lecythis pisonis seed.

Natural products and their biological activities are currently a subject of great interest to the industrial and scientific sector, due to society's awareness of the proper use of biodiversity and economic and sustainability. To promote the sustainable use of biomass the extract of the by-product of the shell seed of Lecythis pisonis was applied to develop a natural cosmetic emulsion. To ensure safety for its topical use the cytotoxic activity of its crude extract was evaluated by the colorimetric method of 3- bromide (4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium, MTT, in cell culture of fibroblasts L929, human keratinocytes HaCat, and human endothelium EA.hy926 cell lines. The triplicate of the cosmetic formulation containing the extract was obtained regarding stability according to the procedures of the Brazilian Health Regulatory Agency (Anvisa). The irritability tests were performed using alternative methods, in vitro, chorioallantoic membrane assay (HET-CAM and CAM-TBS), and hemolysis test (RBC). The crude extract was not cytotoxic, IC50 index >780 mg/mL. The preservative system was effective against Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, and Aspergillus niger. The emulsion was classified as non-irritable. The crude extract of the by-product of sapucaia seeds can be incorporated into a natural emulsion, safe for topical use.

Impact of concerning excipients on animal safety: insights for veterinary pharmacotherapy and regulatory considerations.

OBJECTIVES: Veterinarians and pharmacists are familiar with the efficacy and safety aspects attributed to active pharmaceutical ingredients included in medicines, but they are rarely concerned with the safety of excipients present in medicines. Although generally recognized as safe, excipients are not chemically inert and may produce adverse events in certain animal populations. This review aims to present excipients of concern to these populations and highlight their relevance for rational veterinary pharmacotherapy. EVIDENCE ACQUISITION: A comprehensive review of the literature about the existence of adverse reactions in animals caused by pharmaceutical excipients was carried out based on an exploratory study. An overview of the correct conditions of use and safety of these excipients has also been provided, with information about their function, the proportion in which they are included in the different pharmaceutical dosage forms and the usual routes of administration. RESULTS: We identified 18 excipients considered of concern due to their potential to cause harm to the health of specific animal populations: bentonite, benzalkonium chloride, benzoic acid, benzyl alcohol, ethanol, lactose, mannitol, mineral oil, monosodium glutamate, polyethylene glycol, polysorbate, propylene glycol, sodium benzoate, sodium carboxymethylcellulose, sodium lauryl sulfate, sulfites, polyoxyethylene castor oil derivatives, and xylitol. Among the 135 manuscripts listed, only 24 referred to studies in which the substances were correctly evaluated as excipients. CONCLUSIONS: Based on the information presented in this review, the authors hope to draw the attention of professionals involved in veterinary pharmacotherapy to the existence of excipients of concern in medicines. This information contributes to rational veterinary pharmacotherapy and supports veterinary pharmacovigilance actions. We hope to shed light on the subject and encourage studies and new manuscripts that address the safety of pharmaceutical excipients to the animal population.

Study of the pilot production process of long-circulating and pH-sensitive liposomes containing cisplatin.

Long-circulating and pH-sensitive liposomes, containing cisplatin (SpHL-CDDP), have been developed as an alternative aimed at avoiding severe side effects as well as the appearance of resistance, which can limit the use of free cisplatin. However, physical (i.e., aggregation/fusion) and chemical instabilities limit the use of these drug carriers as pharmaceutical products. The preparation of freeze-dried pharmaceuticals has proven to be a successful strategy implemented to improve the stability of these formulations. In addition, the development of an economically feasible, reproducible process of liposome production, on a large scale, has also become necessary. A pilot production process, using three stages (i.e., reverse-phase evaporation, homogenization under high pressure, and ultrafiltration), was used to prepare SpHL-CDDP. The optimization of factors related to the homonogenization under high pressure (i.e., pressure and number of cycles), ultrafiltration (i.e., number of cycles), and storage stability at 4°C were assessed by means of particle size, zeta potential, and encapsulation percentage. A 500-bar pressure and 9 cycles were adopted as measures for the production of SpHL-CDDP, which presented a mean diameter of 99.0 ± 3.9 nm and an encapsulation percentage of 12.9 ± 2.3. The use of trehalose as a cryoprotectant was investigated, regarding its effective ability to control the vesicle diameter and retain encapsulated CDDP after the freeze-drying/rehydration step. After 135 days of storage, freeze-dried or liquid SpHL-CDDP showed no significant change in mean diameter. However, the freeze-dried SpHL-CDDP proved to be more efficient, in terms of CDDP retention, than did the liposomal liquid dispersion.