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Introducción: Las fragancias unisex pretenden borrar la frontera existente en los estereotipos de género, agradando a todos los olfatos, siendo usadas de día o de noche y compartidas por las parejas. El objetivo del trabajo fue desarrollar dos fragancias unisex para una crema humectante y un perfume. Método: Se identificaron los componentes a incluir en las dos fragancias unisex. Se realizaron los controles de calidad y estudios de estabilidad de envejecimiento natural a las fragancias, así como a la crema y el perfume. También se evaluó la influencia de la luz solar en las fragancias. La evaluación sensorial de los productos perfumados se realizó a través de métodos afectivos, incluyendo pruebas de aceptación y pruebas escalares, participando jueces no entrenados, determinando el nivel de aceptación y agrado de los cosméticos desarrollados. Resultados: Se desarrollaron dos fragancias con notas olfativas cítrica-maderable-floral, clasificándolas en la familia olfativa hespéride, subfamilia olfativa maderable. Los controles de calidad y estudios de estabilidad demostraron la calidad física y química de ambas fragancias durante 24 meses, así como de los cosméticos perfumados. Los niveles de agrado del olor y el perfume, de ambos cosméticos, fueron clasificados como “Me gusta”, mientras que los de la fijación fueron “Moderados”. Conclusiones: Las fragancias unisex cumplieron con los criterios de calidad establecidos durante 24 meses, al igual que la crema y el perfume, conservando la nota olfativa inalterada. El grado de aceptación y calidad de los cosméticos estudiados, a través de métodos afectivos, demostraron la aceptación de ambos cosméticos., Introduction: Unisex fragrances aim to erase the existing border in gender stereotypes, pleasing all noses, being used day or night and shared by couples. The objective of the work was to develop two unisex fragrances for a moisturizing cream and a perfume. Method: The components of each unisex fragrance were identified. Quality controls and stability studies of natural aging were carried out on the fragrances, the cream and the perfume. The influence of sunlight on the fragrance’s stability was also evaluated. The sensory evaluation of the perfumed products was carried out through affective methods, including acceptance tests and scalar tests, which judge participants without alterations, determining the level of acceptance and liking of the developed cosmetics. Results: Two fragrances with citrus-woody-floral olfactory notes were developed, classifying them in the hesperid olfactory and woody olfactory family and subfamily, respectively. Quality controls and stability studies demonstrat ed the physical and chemical quality of both fragrances and perfumed cosmetics for 24 months. The liking levels of the smell and the perfume, of both cosmetics, were classified as “I like”, while fixation was “Moderate”. Conclusions: The unisex fragrances met the quality criteria established for 24 months, the same as the cream and the perfume, keeping the olfactory note unchanged. Through affective methods, the degree of acceptance and quality of the studied cosmetics demonstrated the approval of both cosmetics.

RESUMEN Se desarrolló y validó un método por cromatografía gaseosa para la cuantificación simultánea de mentol (MT), salicilato de metilo (SM), timol (TM) y ácido benzoico (AB) en una solución antiséptica bucal. Se utilizó una columna DB-WAX y dietilenglicol como estándar interno. Se determinó la linealidad en un intervalo de concentraciones de 64,00 a 96,00 µg/mL (MT), 80,00 a 120,00 µg/mL (SM), 96,00 a 144,00 µg/mL (TM) y 48,00 a 72,00 µg/mL (AB), obteniendo coeficientes de correlación superiores a 0,999, y coeficientes de variación de los factores de respuestas de 1,18, 1,95, 3,52 y 1,48%, respectivamente. Se establecieron límites de detección de 0,51; 1,14; 3,34 y 1,402 ng/mL para el MT, SM, TM y AB, respectivamente, mientras los límites de cuantificación fueron de 1,45, 3, 43, 9, 73 y 4, 36 ng/mL en cada caso. Los porcentajes de recuperación fueron de 100,03, 99, 31, 99, 92 y 100,12; con coeficientes de variación de 0,42, 0,79, 0,66 y 0,76% para cada caso. El método fue lineal, exacto, preciso y selectivo para la determinación de los analitos en el control de calidad. SUMMARY A method was developed and validated by gas chromatography for the simultaneous quantification of menthol (MT), methyl salicylate (SM), thymol (TM) and benzoic acid (AB) in an oral antiseptic solution. A DB-WAX column and diethylene glycol was used as internal standard. Linearity was determined in a concentration range of 64.00 to 96.00 µg/mL (MT), 80.00 to 120.00 µg/mL (SM), 96.00 to 144.00 µg/mL (TM) and 48.00 to 72.00 µg/mL (AB) achieving correlation coefficients greater than 0.999, and coefficients of variation of the response factors of 1.18, 1.95, 3.52 and 1.48%, respectively. Detection limits were established: 0.51, 1.14, 3.34 and 1.402 ng/mL for MT, SM, TM, and AB, respectively, while the quantification limits were 1.45, 3.43, 9.73 and 4.36 ng/mL in each case. Recovery percentages were 100.03, 99.31, 99.92 and 100.12; with coefficients of variation of 0.42, 0.79, 0.66 and 0.76% for each case. The method was linear, accurate, precise, and selective for the determination of analytes in quality control.

The replacement of traditional in vivo bioequivalence studies by in vitro dissolution assays, based on the biopharmaceutical classification system (BCS), has emerged as an important tool for demonstrating the interchangeability of multisource products. This paper summarizes the current implementation of the BCS-based biowaiver for the development of multisource products in Latin America, and identifies several challenges and opportunities for greater convergence and application of BCS regulatory requirements. Differences and similarities between the current BCS-based biowaivers’ guidelines proposed by two relevant regulatory agencies for the Latin American region (FDA and WHO) and the new ICH harmonization guideline were identified and compared. An update of the BCS-based biowaiver guideline for Latin American countries was also considered, based on the respective regulatory information on bioequivalence studies, which is publicly available. About 50% of the Latin American countries analyzed have no information on the implementation of any bioequivalence standards, while in the countries where bioequivalence studies are considered, the acceptance and application of BCS-based biowaiver requirements is quite heterogeneous. This situation contrasts with the international trend of global harmonization for BCS-based biowaiver guidance, suggesting the need in Latin America to identify opportunities and overcome challenges to improve the development of BCS-based biowaivers to avoid costly and time-consuming in vivo bioequivalence studies. The study shows that the region is in a position to improve access to safe and effective medicines at a reasonable cost by applying BCS-based biowaiver guidance.

The accuracy of the provisional estimation of the Biopharmaceutics Classification System (BCS) is heavily influenced by the permeability measurement. In this study, several theoretical and experimental models currently employed for BCS permeability classification have been analysed. The experimental models included the in situ rat intestinal perfusion, the ex vivo rat intestinal tissue in an Ussing chamber, the MDCK and Caco-2 cell monolayers, and the parallel artificial membrane (PAMPA). The theoretical models included the octanol-water partition coefficient and the QSPeR (Quantitative Structure-Permeability Relationship) model recently developed. For model validation, a dataset of 43 compounds has been recompiled and analysed for the suitability for BCS permeability classification in comparison with the use of human intestinal absorption and oral bioavailability values. The application of the final model, based on a majority voting system showed a 95.3% accuracy for predicting human permeability. Finally, the present approach was applied to the 186 orally administered drugs in immediate-release dosage forms of the WHO Model List of Essential Medicines. The percentages of the drugs that were provisionally classified as BCS Class I and Class III was 62.4%, suggesting that in vivo bioequivalence (BE) may potentially be assured with a less expensive and more easily implemented in vitro dissolution test, ensuring the efficiency and quality of pharmaceutical products. The results of the current study improve the accuracy of provisional BCS classification by combining different permeability models.