Arfa Sharif, Naveed Akhtar, Muhammad Shoaib Khan, Bouzid Menaa, Barkat Ali Khan and Barkat Ali Khan
Background: One of the main subsidizing factors to the rising healthcare costs are related to the design and development of visionary pharmaceutical products. As a consequence, healthcare authorities have identified herbal preventive and therapeutic options as possible alternative strategies. In the developing world, there is an urgent need for the pharmaceutical industry field to invest more time and resources in the research and development of complementary and alternative medicines.
Purpose: The main aim of this study was to contribute to the development of an innovative phyto-based formulation for topical application and determine its thermal stability chronically.
Material and Methods: A cream of water-in-oil type emulsion was prepared and implemented or not (placebo aka base) with Muscat hamburg black grape extract (active formulation). M. hamburg-based cream was first mixed with the emulsifier (i.e. Abile EM90® aka Dimethicone) and compared with a placebo. Successful formulations were selected based on their ability to remain significantly (p<0.05) stable during a pre-determined period when stored at different temperatures (i.e. 8ºC, 25ºC, 40ºC ± 75% relative humidity). Different physicochemical parameters like eventual changes in color, centrifugation, phase separation, liquefaction, conductivity, viscosity, and pH were assessed immediately after preparation (time 0) and at various time points (i.e. 12 hours 24 hours, 36 hours, 48 hours, 72 hours, 7th day, 14th day, 21st day and 28th day). For viscosity studies, we extended the analysis to 90 days.
Results: In our experimental conditions and from our comparative analyses, we noticed (i) unchanged organoleptic properties in terms of appearance, color and odor; (ii) unchanged properties after centrifugation and phase separation, and in terms of electrical conductivity, liquefaction, or viscosity. Importantly, we showed that both placebo and active formulation had insignificant mean pH (5.12 ± 0.43 versus 5.04 ± 0.39, p>0.05) when all respective samples were assessed. In spite of a progressive time-dependent and temperature-independent decline of the mean pH in both placebo and active formulation, the mean pH of both emulsions fit the acceptable range of dermal pH (i.e. 4.5-6.5) for 21 days.
Conclusions: The in-vitro evaluation of our newly developed dimethicone based cream containing Muscat hamburg extract showed satisfactory and promising results for its possible use as a topical semi-solid dosage form for various skin ailments.