Design and Evaluation of Controlled Transdermal Drug Delivery of Testosterone
Dr.Indira Paraba Saba Wahid Khanb,
Main author ,Mumbai university , Mumbai , indiaa
Department of phamaceutics ,research student ,Mumbai university ,Mumbai , india b
Keywords: Male hypogonadism, pituitary, sex hormone, testosterone, testis
Background
TDD is a painless method of delivering drugs systemically by applying a drug formulation onto intact and healthy skin (Han T et al. 2015).TDD has many advantages over other conventional routes of drug delivery (Donenelly et al.2012).It can improve patient compliance due to the reduction of dosing frequencies and is also suitable for patients who are unconscious or vomiting, or those who rely on self-administration (Prausnitz M et al.2008).Transdermal delivery provides a leading edge over injectables and oral routes by increasing patient compliance and avoiding first pass metabolism, respectively (Selvam et al. 2010).The success of transdermal delivery system in pharmaceutical market is evident from the fact that currently, more than 35 transdermal drug delivery products are approved in the USA for wide variety of pathophysiological conditions including hypertension, angina pectoris, motion sickness, female menopause, and male hypogonadism,(Barry 2001).The formulation of drugs into a transdermal drug delivery system requires a selection of physicochemical and biological properties (Rani et al. 2011).Testosterone is considered to be a suitable candidate for transdermal delivery due to the hydrophobic nature (log P o/w=3.3) and low molecular weight (M.W.=288 g/mol) of testosterone which are favorable factors for transdermal delivery (Sitruk-ware R et al.1989).Testosterone is one of the primary naturally occurring androgens in man. The androgens have a key role in the production of secondary sexual characteristics in men (Mazur A et al.1998)..Male hypogonadism is defined as low testosterone levels with serum total testosterone <10–12 nmolL-1 (~2.88–3.46 ngml-1) (Nieschlag E et al.2004).
Normal aging
Older men generally have lower testosterone levels than younger men do. As men age, there's a slow and continuous decrease in testosterone production. The rate that testosterone declines varies greatly among men. As many as 30% of men older than 75 have a testosterone level that is below normal, according to the American Association of Clinical Endocrinologists. Whether or not treatment is necessary remains a matter of debate.[Harman S.M et al.2001]