DEVELOPMENT OF A TOPICAL FUNCTIONALIZED FORMULATION FOR THE PROPER SKIN CARE: PREFORMULATION, FORMULATION, AND QUALITY CONTROL STUDIES

MARIA E SESTO CABRAL

Cordoba-Capital

Congreso; I Reunión Internacional de Ciencias Farmacéuticas RICiFA; 2010

Facultad de Ciencias Quimicas- UNC

Introduction: The skin is one of the most delicate organs of the body. May be affected by many external factors such as sun exposure, wind or cold temperatures and it is therefore necessary the use of creams formulated to reduce or prevent damage. There are many treatments aimed at keeping it in good condition and prevent or reduce wrinkles, such as daily cleaning, adequate hydration and use of sunscreen formulations. One reason of the lack lubrication in the skin is the incorrect functionality of sebaceous glands. Some cares that could help solve the problem are: not to use too aggressive facial cleansers, to avoid excessive sun exposure, a balance diet, not to abuse of scrubs products and to use creams for each type of skin. In this work we developed the study of preformulation, formulation and quality control of a pharmaceutical dosage form suitable for the proper skin care in dry climates or extreme temperatures, providing protection from daily irritants such as wind and salt or chlorinated water. The pharmaceutical dosage forms was formulated whit the following active principles: Karité butter, avenal milk, Aloe vera glycolic extract, omega 6. This formulation serves to promote cell desquamation resulting in an increase of epidermal water content which restores elasticity, brightness, tone and skin functionality. Materials and methods: Studies were performed in triplicate, following the protocols required by Argentina Pharmacopoeia VI th edition, Food and Drug Administration and Spanish Pharmacopoeia I st edition. The semi-solid pharmaceutical form was subjected to stability studies at different times (0, 2, 7, 15.21 and 60 days). - Pre formulation studies: design and elaboration of three pharmaceutical topic dosage forms: emulsion and creams whit different exipients were development. - Stability tests: pH , water loss, reversibility, thermal effects, mechanical stress (extensibility and centrifuga-tion assays), stability , emulsion type determination, spontaneous separation of phases, organoleptic test, sensory tests, microscopy study, gross appearance study, short-term physical stability, long term physical and functional stability. -Microbiological studies: antimicrobial activity against pathogenic bacteria and fungi, environmental fungal contamination test and health monitoring. Results and conclusions: the microbiological studies showed that the formulations contain the optimal dose of methylparaben and propylparaben ensuring the conservation of the pharmaceutical dosage forms. Stability studies allow characterized these formulations in relation to stability and represent a valid indication of the suitability of the manufacturing processes used and the correct choice of components in the formula-tion. Organoleptic and sensory tests showed emulsion as a very good acceptance in terms of appearance, smell and color, uniformity and good absorption, making it the product of choice in the double-blind study. Accelerated stability studies showed preservation for a period of one year.