CHAPTER ONE

 INTRODUCTION AND LITERATURE REVIEW

1.1       Introduction

    Lubricants are additives which reduce friction and are an essential component of a drug formulation. Lubrication is frequently a requisite ensuring the achievement of a good pharmaceutical manufacturing (Morin and Briens,2013).

   Pharmaceutical lubricants as excipients are added to the tablet formulation in a very small quantity (usually 0.25%-5%w/w), to prevent sticking of tablets to the die cavity as well as sticking of capsules to dosators and tamping pins (Li and Wu, 2014).

    Without lubricants, tablets cannot be produced. However some uncertainty exists in the definition of a lubricant because glidants and anti-adherents perform the same purpose (Majekodunmi and Matthew, 2014). These inter-related groups of tablet excipients are used in tablet production to promote granule flow and prevent powder adhesion to punch faces and minimize die wall friction respectively (Adedokunet al., 2014; Adedokun and Itiola, 2013).

Although magnesium stearate and stearic acid are the most frequently used lubricants in the pharmaceutical industry, there are other lubricants in use as well (Li and Wu, 2014). Lipids (oily and fatty substances) by their nature exert lubricity between surfaces that are in relative motion. It is therefore explicable that when applied in carefully regulated amounts, they could develop the lubricating efficiency of lubricants in general. (Shiparet al., 2013) showed that unlike magnesium stearate, which delays disintegration and dissolution of the active ingredient, the fatty acid esters promotes a reduction in disintegration time. Fatty acid esters have better-quality as lubricant than magnesium stearate because the tablets containing them have better stability and are free from biological problems such as viral contamination as a result of very low moisture content of the granules containing the fatty acid esters compared with those of other lubricants.

            Coconut oil or copra oil (common name) (Cocosnucifera), (Fam.Arecaceae),IsipMbakara in Ibibio, Idi-agbon in Yoruba, Aku-Oyinbo in Igbo, Mosara in Hausa (Aiyeloja and Bello, 2006), belongs to the class of the fixed oil, and is a commercially available edible (vegetable) oil extracted from the kernel or meat of matured coconuts harvested from the coconut palm. Coconut oil has various applications in food, medicine, and industry. Chemical composition of coconut oil includes lauric saturated C12 (46.64-48.03%), myristic saturated C14 (16%), palmitic saturated C16 (9.5%), Oleic monounsaturated C18 (6.5%), free fairly low fatty acid content (0.15-0.25%). All chemical compositions are within the limit of official standard for edible coconut oil (Amaoet al., 2015).  Coconut oil also contains lipid-oily and fatty substances with a high percentage of saturated hydrocarbons mainly glyceride of caprylic acid and glyceride of lauric acid and by their nature exert lubricity over surfaces encountered with (Amaoet al., 2015). It is therefore that when applied in carefully regulated amount they will improve the lubrication efficiency in lubricants used in tableting.

         In terms of powder or granule flow, unit operations can be aided and the flowability of blends can be improved by lubricants. An example, is the blending of active pharmaceutical ingredients (APIs) of a small particles with other excipients, the adhesion force can extensively reduce the powder flowability between particles by increasing inter-particle friction; poor flow can cause insufficient mixing of the blends (content uniformity) and rat-holing in the hopper of a tablet press (segregation issue), impacting both product quality and operation. To overcome these issues, lubricants are added (glidants) to enhance powder flow by reducing inter-particle friction.

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