Chapter 3 esvpptedine PHARMACEUTICAL AIDS ees @ LEARNING OBJECTIVES After completing the chapter, students will be able to: © Define and list out various organoleptic agents. Select the appropriate organoleptic agent for pharmaceutical formulations. . . Define and classify various preservatives. Select the appropriate preservative for pharmaceutical formulations. EX] INTRODUCTION ‘Active Pharmaceutical Ingredients (APIs) are not generally used as suc appropriately formulated in dosage forms or drug delivery systems to ensure a safe, efficient, reproducible, and convenient mode of drug delivery. The formulation thus contains ‘API and other additional ingredients for different objectives such as organoleptic (colour, ‘odour and taste), diluent, preservative, stabilizer, lubricant and many more. These additional ingredients are known as excipients or pharmaceutical aids. Pharmaceutical aids are defined as “substances that have little or no therapeutic value, but are mainly used in the manufacture or composition of various pharmaceutical formulations”. They are also called as pharmaceutical auxiliaries and are not active pharmaceutical ingredients. EE oRGANOLEPTIC AGENTS The organoleptic agents are one type of pharmaceutical aids used for particularly flavouring, sweetening and colouring of the pharmaceutical product. Most of the drugs administered orally, must have challenges of acceptability by the patient. Compliance with the medication by the patient is most important to achieve.an optimal result of the drug. Medication compliance is often closely related to the odour, taste, and colour of the product aed ite acceptance. Flavours, sweeteners and colours are grouped together as organoleptic agents. Organoleptic agents occupy an important place in the field of pharmaceutical aids. These agents comprise a number of additives that are responsible for colouring, fl it sweetening and texturing formulations. ke 3.2.1 Colouring Agents According to the US F ini rang sacs food rt Drug Administration (FDA), colouring agents defined Loe of other substances that can add fae - | cosmetic, In body. Colorants are also Bet 3 i E generally referred to as cosmetics for (3.1) h but are