Estudos de compatibilidade de suspensões orais líquidas e avaliação clínica de suplemento de silício orgânico oral nas formas líquida e sólida

Abstract

In the first chapter, the objective was to determine the shelf life of 89 liquid oral suspensions compounded using the line of vehicles ready-for-use SyrSpend® (SyrSpend® SF PH4 and SyrSpend® Alka Dry), through a compatibility study. For this, analytical methods for each active pharmaceutical ingredient (API) under study were developed and validated by high performance liquid chromatography (HPLC). Afterwards, the suspensions were compounded and stored under refrigeration (2-8 °C) or at room temperature (15-25 °C) for up to 90 days. Samplings of these suspensions were made at 0, 7, 14, 30, 60 and 90 days after compounding, and analyze by HPLC were performed at each sampling point to determine the remaining active content in the formulations as well as possible degradations. High performance liquid chromatography methods were developed and validated in a manner appropriate to the needs of the study and were used throughout the compatibility studies. Compatibility studies demonstrated that most of the suspensions studied were stable for up to 90 days when stored at room (15-25 °C) or refrigerated (2-8 °C) temperatures. There was an indication that SyrSpend® SF PH4 (liquid) and SyrSpend® Alka Dry (powder for reconstitution) are suitable vehicles for the compounding of a range of API of various pharmacological classes. In the second chapter, the objective was to clinically investigate the dermatological effects in human volunteers after oral ingestion of silicon in the form of monomethylsilanetriol (liquid) or ortosilicic acid stabilized in maltodextrin (solid). It was a randomized, double-blind, placebo-controlled study in healthy subjects, divided into three groups (n = 17 per group, allocation ratio = 1: 1: 1): control (G1), placebo: capsules containing maltodextrin; (G2) treated with maltodextrine stabilized ortosilicic acid (capsules, 5 mg elemental silicon per dose) every 12 hours; (G3) treated with monomethylsilanetriol (liquid; one measuring cup containing 5 mg of elemental silicon per dose) every 12 hours. The duration of the intervention was five months, with baseline (T0), 3 months (T3) and 5 months (T5) analyzes after the start of treatment. Clinical evaluation of dermatological parameters, determination of trans-onychial water loss, multispectral image analysis, analysis of hair minerals and application of a self-reported questionnaire on product satisfaction were determined in the volunteers. Maltodextrin-stabilized orthosilicic acid and monomethylsilanetriol were found to be able to provide the following results in patients after 5 months of use: improvements in appearance/ amount of facial wrinkles; improvement in the appearance/quantity of sunspots; reduction of aluminum in the body. In addition, the general notes given by the patients to the treatments showed that they are suitable products for the market, with a high degree of satisfaction. These joint data corroborate the use of silicon supplements in the clinical practice of dermatology, for both forms of presentation.