August 7, 2021: Pharmaceutical Interview Questions and Answers
#Excipient #RoleOfExcipient #ExamplesOfExcipient
1. What is excipient?
The word excipient originates from the Latin excipere, which means to receive; hence, the excipient receives the active substance.
As per European Pharmacopoeia (Ph. Eur.) “An excipient is any component, other than the active substance(s), present in a medicinal product or used in the manufacture of the product. The intended function of an excipient is to act as the carrier (vehicle or basis) or as a component of the carrier of the active substance(s) and, in so doing, to contribute to product attributes such as stability, biopharmaceutical profile, appearance and patient acceptability and to the ease with which the product can be manufactured. Usually, more than one excipient is used in the formulation of a medicinal product.”
2. What are the typical functions of excipients?
Excipients plays role in the formulation as Diluent, Binder, Disintegrant, Glidant, Lubricant, Coatings agent, or Coloring agent. It can further classified depending on its functions in the dosage form, which includes:
(i) Modulating solubility and bioavailability of the drug,
(ii) Enhancing stability of the drug in its dosage forms,
(iii) Maintaining a required polymorphic form,
(iv) Maintaining pH and osmolarity of liquid products,
(vi) Preventing aggregation or dissociation agent,
(vii) Modulating the immunogenic response of drug,
(viii) Suspending agent,
(x) Aerosol propellants,
(xi) Base or tablet diluent
3. What is role of Diluents as an excipient?
Diluents are the material which provides bulk to the formulation and enable accurate dosing of potent ingredients.
4. Give few examples of Diluents as an excipient?
Microcrystalline cellulose, Lactose, dextrin, glucose, sucrose, sorbitol, silicates, calcium and magnesium salts, sodium or potassium chloride, starch, lactose
5. What is role of Binder as an excipient?
Binders, compression aids, granulating agents are the materials which bind the ingredients together giving form and mechanical strength and form granules for tablet, capsule or relevant formualtions
6. Give few examples of Binder as an excipient?
Polyvinyl pyrrolidone, starch, gelatin, cellulose derivatives, sugars, sugar alcohols and cellulose derivatives
7. What is role of Disintegrant as an excipient?
Disintegrant aid in dispersion of the tablet in the gastrointestinal tract, releasing the active ingredient and increasing the surface area for dissolution.
8. Give few examples of Disintegrant as an excipient?
Starch, sodium starch glycollate, cross – linked polyvinyl pyrrolidone super disintegrants, cellulose derivatives and alginates, and crospovidone.
9. What is role of Glidant as an excipient?
Glidant improves the flow of powders during tablet manufacturing by reducing friction and adhesion between particles. It also used as anti-caking agents.
10. Give few examples of Glidant as an excipient?
Colloidal anhydrous silicon and other silica compounds, talc, magnesium stearate
11. What is role of Lubricant as an excipient?
Lubricants are used to prevent sticking of granule from die and punch wall during compression.
12. Give few examples of Lubricant as an excipient?
Stearic acid and its salts (e.g. magnesium stearate), polyethylene glycol, sodium chloride
13. What is role of coating agents as an excipient?
Coating agents has various functions such as, protect tablet from the environment (air, light and moisture), increase the mechanical strength, mask taste and smell, aid swallowing, assist in product identification.
It also can be used to modify release of the active ingredient.
14. Give few examples of coating agents as an excipient?
Sugar, cellulose acetate phthalate etc.
15. What is role of Colouring agent as an excipient?
Coloring agent improves acceptability to patients, aid identification and prevents counterfeiting. It also increases stability of light-sensitive drugs.
16. Give few examples of Colouring agent as an excipient?
Iron oxide, natural pigments, and other synthetic dyes.