Fillers fill out the size of a tablet or capsule, making it practical to produce and convenient for the consumer

to use. By increasing the bulk volume, the fillers make it possible for the final product to have the proper volume for patient handling. A good filler must be inert, compatible with the other components of the formulation, non-hygroscopic, relatively cheap, compactible, and preferably tasteless or pleasant tasting. Plant cellulose (pure plant filler) is a popular filler in tablets or hard gelatin capsules. Dibasic calcium phosphate is another popular tablet filler. A range of vegetable fats and oils can be used in soft gelatin capsules. Other examples of fillers include: lactose, sucrose, glucose, mannitol, sorbitol, calcium carbonate, and magnesium stearate.

Flavours can be used to mask unpleasant tasting active ingredients and improve the acceptance that the patient will complete a course of medication. Flavourings may be natural (e.g. fruit extract) or artificial.[1] For example, to improve:[1]

a bitter product - mint, cherry or anise may be used a salty product - peach, apricot or liquorice may be used a sour product - raspberry or liquorice may be used an excessively sweet product - vanilla may be used

Disintegrants expand and dissolve when wet causing the tablet to break apart in the digestive tract, releasing the active ingredients for absorption. They ensure that when the tablet is in contact with water, it rapidly breaks down into smaller fragments, facilitating dissolution. Examples of disintegrants include:

Crosslinked polymers: crosslinked polyvinylpyrrolidone (crospovidone), sodium carboxymethyl cellulose (croscarmellose sodium). The modified starch sodium starch glycolate...

crosslinked

a suspending agent helps the drug stay in the body of your suspension thereby preventing caking at the bottom. One of the properties of a well-formulated suspension is that it can be easily resuspended by the use of moderate agitation.

Coatings Tablet coatings protect tablet ingredients from deterioration by moisture in the air and make large or unpleasant-tasting tablets easier to swallow. For most coated tablets, a cellulose ether hydroxypropyl methylcellulose (HPMC) film coating is used which is free of sugar and potential allergens. Occasionally, other coating materials are used, for example synthetic polymers, shellac, corn protein zein or other polysaccharides. Capsules are coated with gelatin.

sweetening agent can play a number of important roles in solid and oral liquid formulations such as enhancing flavor, masking bitter taste and increasing viscosity. Sweeteners are often used in combination to provide certain sensory profile and to take advantage of the synergism that occurs with sweetener combinations Bulk sweeteners Artificial agents sweetening

Sugars : xylose, ribose, glucose, mannose, galactose, fructose, dextrose, Sodium cyclamate sucrose, maltose Hydrogenated glucose syrup Na saccharin Sugar alcohols : sorbitol, xylitol, mannitol, glycerin Aspartame Partially hydrolysed star Ammonium glycyrrhizinate Corn syrup solids Mixture of thereof

color additive, as defined by regulation, is any dye, pigment, or other substance that can impart color to a food, drug, or cosmetic or to the human body. Color additives are important components of many products, making them attractive, appealing, appetizing, and informative. Added color serves as a kind of code that allows us to identify products on sight, like candy flavors, medicine dosages, and left or right contact lenses. One of the U.S. Food and Drug Administration's (FDA) roles is to assure that color additives are safely and appropriately used.

Thickening agents, or thickeners, is the term applied to substances which increase the viscosity of a solution or liquid/solid mixture without substantially modifying its other properties; Thickening agents, or thickeners, are substances which, when added to an aqueous mixture, increase its viscosity without substantially modifying its other properties, such as taste. They provide body, increase stability, and improve suspension of added ingredients. Thickening agents are often used as food additives and in cosmetics and personal hygiene products. Some thickening agents are gelling agents, forming a gel. The agents are materials used to thicken and stabilize liquid solutions, emulsions, and suspensions. They

dissolve in the liquid phase as a colloid mixture that forms a weakly cohesive internal structure. Example: polyvinyl alcohol.

Skin penetration enhancers reversibly decrease the barrier resistance of the stratum corneum and allow drugs to penetrate more readily to the viable tissues and the systemic circulation. propylene glycol, IPM,IPP, eugenol, linalool, basil oil (reference), ibuprofen (thanks to the eugenol and acetyl eugenol), possibly Vitamin E, sodium lauryl sulfate (SLS),

Stabilizing Agents: Usually inert substances added to a prescription in order to provide suitable consistency to the dosage form; a binder, matrix, base or diluent in pills, tablets, creams, salves, etc.

Antimicrobial preservatives Preservatives are antimicrobials put into products to kill or prevent the growth of microorganisms over a relatively long period of time. PHARMACEUTICAL EXCIPIENTS Prof. Reza-ul Jalil, Dept. of Pharma. Tech. DU. Page- 17 ANTIMICROBIAL PRESERVATIVESDEFINITION OF TERMS Disinfectants, antiseptics, and preservatives arechemicals that have the ability to destroy or inhibit thegrowth of microorganisms, and are used for this purpose.These and other terms commonly employed are definedas follows: _ Disinfectants : Chemical agents or formulations thatare too irritant or toxic on body surfaces, but are used toreduce the level of microorganisms from the surface ofinanimate objects to one that is safe for a definedpurpose. _ Antiseptics : Chemical agents or formulations that canbe used as an antimicrobial agents on body surfaces. _ Preservatives : Chemical agents or formulations thatare capable of reducing the number of viablemicroorganisms within an object or field to a level that issafe for its designated use and will maintain the numbersof viable microorganisms at or below a level for the use/ shelflife of the product. _ Bacteriostasis : A state in which the growth ofmicroorganisms is halted or inhibited. _ Bactericide : A chemical antimicrobial agent thatreduces the viability of a population of microorganismsexposed to it. This term is meaningless without specifyingthe concentration range over which this effect isobtained; such concentration ranges will vary betweendifferent species of microorganisms. _ Bacteriostat

: A chemical antimicrobial agent that canprevent the growth of microorganisms within anotherwise nutritious environment. This term ismeaningless without specifying the concentration atwhich this effect is achieved. Bacteriostaticconcentrations do vary between different species ofmicroorganism

PHARMACEUTICAL EXCIPIENTS Prof. Reza-ul Jalil, Dept. of Pharma. Tech. DU. Page- 19 SOLVENT / VEHICLEWater :The vast majority of injectable products and oral liquidformulations are aqueous solutions because of thephysiological compatibility of water with body tissues.Additionally, the high dielectric constant of water makes itpossible to dissolve ionizable electrolytes, and itshydrogen-bonding potential facili-tates the solution ofalcohols, aldehydes, ketones, and amines. The current USP has monographs for 1. Purified Water,2. Water for Injec-tion (WFI),3. Sterile WFI,4. Bacteriostatic WFI, and5. Sterile Water for Irrigation

PHARMACEUTICAL EXCIPIENTS Prof. Reza-ul Jalil, Dept. of Pharma. Tech. DU. Page- 13 DEFINITION A material that is a dye, pigment, or other substancemade by a process or similar artifice, or extracted,isolated, or otherwise derived with or withoutintermediate or final change of identity, from a vegetable,animal, mineral or other source and when added orapplied to a food, drug, or cosmetic or to the human bodyor any part thereof, is capable (alone or through reactionwith other substances) of imparting color.According to the Code of Federal Regulation of USA,color additives are: "Any substance, synthetic orotherwise, that when added or applied to food, drug, orcosmetic, or to the human body or any part thereof, iscapable of imparting a color thereto".The use of coloring agents in pharmaceuticalpreparations for purpose of esthetics, as sensory adjunctto the flavors employed, and for purposes of productdistinctiveness is important.The need to identify tablets in order to minimize the riskof confusion to the patient is an important factor to beconsidered in formulation. Color provides a relativelysimple and convenient solution to this problem, so iswidely used in tablet film coating.Colorants commonly used can be divided into threegroups; the synthetic organic dyes and their respective lakes, inorganic pigments and miscellaneous natural colorant Chemical classification of dyes:

1. Acridine Dyes Acriflavine 2. Azo dyes -Scarlet red, FD&C Red 1, Red 2,Orange 2. 3. Phthalein Dyes - FD&C red 3 4. Thiazine dyes - Methylene blue 5. Triphenylmethane - FD&C green 1, green 2 6. Nitro dyes - FD&C yellow 1, yellow 2 7. Indigo dyes - FD&C blue

Suspending agents
Examples: Carboxymethylcellulose