Nevirapine in pro-Pheroid : a preservative efficacy and stability study

Abstract

Human immunodeficiency virus (HIV) is a retrovirus that can lead to acquired immunodeficiency syndrome (AIDS), a condition in humans in which the immune system begins to fall, leading to life-threatening opportunistic infections.• As of January 2006, the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the World Health Organization (WHO) estimate that AIDS has killed more than 25 million people since it was first identified on December 1, 1981, making it one of the most destructive pandemics in recorded history. Pheroid technology is a patented delivery system that consists of both plant and essential fatty acids. It is often confused with lipid-based delivery system. Although there are some similarities, Pheroid™ technology owns its advantages in terms of absorption and/or efficacy of pharmacologically active compounds and other useful molecules. The Pheroid structure can be manipulated in terms of morphology, structure, size and function. The effectiveness of Pheroid technology has been illustrated by several national and international clinical trials with products based on this technology. Pro-Pheroid production is similar to that of Pheroid production, except that no aqueous phase is introduced; instead, the active compounds are dissolved in the oil phase. This study was conducted to determine the stability of both nevirapine and butyiparaben in the pro-Pheroid delivery system as well as the preservative efficacy of butylparaben. High performance liquid chromatography (HPLC) was used to determine the stability of nevirapine and butylparaben in pro-Pheroid. The formulation was stored under controlled conditions, i.e. 5°C, 25°C + 60% RH, 30°C + 65% RH and 40°C + 75% RH, for three months. The accelerated stability study was performed according to ICH guidelines. The preservative efficacy study was done by the EnviroCare Laboratory according to international specifications. The various studies conducted on nevirapine in pro-Pheroid to determine the stability showed that nevirapine could successfully be formulated in the pro-Pheroid system and that butylparaben is an effective preservative in the formulation. It is finally concluded that before nevirapine in pro-Pheroid is further formulated into viable products, the following issues will have to be addressed: •The pro-Pheroid manufacturing process should be assessed and validated to ensure batch to batch uniformity. •In order to establish a sound analytical method, stability of the pro-Pheroid system (without the addition of pharmaceutical actives) should be evaluated over a period of at least six months. •The specific UV detection wavelengths of both nevirapine and butylparaben should be assessed and validated to get the optimum wavelength for the HPLC assay analysis to ensure the integrity of the results obtained. The physical properties (color, smell and taste) of the pro-Pheroid system need to be addressed to make the product acceptable to the consumer.