Excipient used in the formulation of Emulsion

This slide contains information about some common pharmaceutical excipients used in the formulation of a pharmaceutical dosage form named Emulsion.

1. Pharmaceutical excipients used in the formulation of Emulsion

2. Definition: An emulsion is a two phase system prepared by combining two immiscible liquids, one of which uniformly dispersed throughout the other and consists of globules that have diameters equal to or greater than those of the largest colloidal particles

3. Ideal Properties of an emulsion: It should able to reduce the interfacial tension between the two immiscible liquids It should be physically and chemically stable inert It should be non irritant and non toxic in the concentration used It should be able to produce and maintain the required viscosity of the preparation. It should prevent the coalescence of the droplet of the dispersed phase

4. Types of emulsion Simple- Oil-in-water (O/W) Water-in-oil (W/O) Multiple emulsion- Oil-in-water-in-oil (O/W/O) Water-in-oil-in-water (W/O/W) Micro emulsion- Clear transparent solutions. Particle size ranges from 10-200nm

5. Why do we prefer emulsion?

6. Excipients Excipients are substances other than the active pharmaceutical ingredient (API) that have been appropriately evaluated for safety and are intentionally included in a drug delivery system.

7. Ideal Properties of excipient No interaction with drug Physical and chemical stability Non toxic and non irritant Cost effective Pharmacologically and physiologically inert No interference with drug bioavailability Should be effective at low concentration

8. Excipients are used in emulsion production: Emulsifying agent Antioxidant Buffering agent Preservative Solvent Co-solvent Flavoring agent Vehicle Antimicrobial agent

9. Emulsifying agent An emulsifier is a substance that stabilizes an emulsion by increasing its kinetic stability. One class of emulsifiers is known as "surface active agents", or surfactants.

10. Why are they added in emulsion? To prevent the coalescence of globules of dispersed phase They help In formation of emulsion by three mechanisms: Reduction in interfacial tension Formation of a rigid interfacial film Formation of an electrical double layer

11. Examples: Glyceryl behenate Glyceryl monooleate Glyceryl stearate Hectorite Glyceryl stearate

12. Antioxidant An antioxidant is a molecule that inhibits the oxidation of other molecules. Oxidation is a chemical reaction that can produce free radicals, leading to chain reactions that may damage cells. Why it is used?? To prevent degradation by oxidation

13. Examples: Ascorbic acid (AA, E300) and tocopherols (E306propyl gallate (PG, E310), Tertiary butylhydroquinone (TBHQ), Butylated hydroxyanisole (BHA, E320) Butylated hydroxytoluene (BHT, E321) Tertiary butylhydroquinone

14. Buffering agents These are materials which, when dissolved in solvent will enable the solution to resist any change in pH should an acid or an alkali be added. The choice of suitable buffer depends on the pH and buffer in capacity required. Why it is used?? To prevent a rapid change in pH when acids or bases are added to the solution.

15. Examples: Citrate Phosphate Acetate Carbonate

16. Preservatives They are substances that are commonly added to various foods and pharmaceutical products in order to prolong their shelf life. Why it is used? To protect products.

17. Example: Sorbic acid, sodium sorbate and sorbates Benzoic acid, sodium benzoate and benzoates Hydroxybenzoate and derivatives Sulfur dioxide and sulfites Sodium benzoate

18. Solvents and co-solvents: A solvent is a substance that dissolves a solute, resulting in a solution. Co-solvent is a solvent that in conjunction with another solvent can dissolve a solute. Why it is used??? They provide molecules to build some drugs. For other drugs, solvents are used for extraction and purification.

19. Example: Water Sorbitol Glycerol Propylene glycol Ether Alcohol

20. Flavoring agent: Our pharmaceutical flavors are available in liquid or powder form, in a variety of concentrations, formulations and sizes. Flavors may be natural or artificial. Why it is used?? To mask unpleasant flavor and to improve the acceptance

21. Examples: Essential oils- To improve a bitter product - mint, cherry or anise a salty product - peach, apricot a sour product - raspberry Amyl acetate -banana flavoring Ethyl butyrate- pineapple. Note: Diethylene Glycol and Monoethyl ether, shall not be used as solvent in flavors.

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