Development of a lipstick based drug delivery system for amelioration of menopause related symptoms

Background and Objective: Menopause is a significant transition phase in a woman's life that brings number of physiological changes and often worsens their quality of life drastically. Symptoms are hot flashes/night sweats, paresthesia, insomnia, nervousness, mood/depression, vertigo, fatigue, rheumatic pain, formication, vaginal dryness etc collectively called as post-menopausal syndrome (PMS) which generally lasts for ۱ to ۲ years after menopause, in some cases may be get extended over ۱۰ years. It is expected that nearly ۱.۲ billion females in the world will be affected by ۲۰۳۰ [۲]. The standard of care still revolves around the use of hormones or synthetic molecules which normally leads to severe side effects. Use of herbal actives may address these challenges. The predilection of females towards lipstick could be exploited positively and a translabial drug delivery (lipstick based drug delivery) be designed serving both as a vanity product and a menopause amelioration tool. It may also address the biological shortcomings like hepatic metabolism, liver toxicity, systemic side effects, shorter half life, drug interactions in case of polytherapy, patient compliance and other pharmacotechnical issues. For the given indication this route has not been exploited so far. The genesis of the project is based on Iodine bindi project- named Life Saving Dot-Jeevan Bindi, which looks like a regular bindi and delivers the daily required amount of iodine (۱۰۰-۱۵۰ micrograms) to female by absorption through the forehead skin. [۳].Materials and Methods: Based on indigenous literature and preclinical and clinical evidences, the drug(s) will be selected. Some commonly used herbs are Black cohosh, Soy, Licorice, Evening primrose oil, Dong quai, Flaxseed, Alfaalfa, Fenugreek, St. John’s Wort and Kava. Analytical method will be developed and excipient compatibility studies will be carried out. As per the QTPP, the lab scale batches of medicated lipstick will be developed. Appropriate Quality by design approach will be applied for scaling up the lab scale batch to commercial scale. Pilot scale or commercial scale batches will be charged for stability studies and preclinical evaluation (skin irritation, Photo-toxicity, animal efficacy model and histopathological assessment) will be carried out.Finding: Exact result/data of the project can be found only after the actual execution. But being herbal it can be claimed as an OTC category of product. So the regulatory requirement for product approval may be less stringent.Conclusions: We have already worked on several nanotechnology-based development of herbal products. So, the project can be executed in line with the same.

کلیدواژه ها:

Menopause ، PMS ، lipstick ، Nanotechnology ، Herbal products