Pharmaceutical excipients is very important for pharmaceutical industry

1. Pharmaceutical Excipients and
Formulation of a Dosage Form
MD.Noman Shekh
ID: 151-29-776
13th (B)

2. Synonyms: Amalty, hydrogenated maltose, Malbit;
Chemical Name: 4-O-a-D-Glucopyranosyl-D-glucitol
Chemical Formula:C12H24O11
Structure formula:
Functional category:
• Coating agent
• Diluent
• Granulation aid
• Sweetening agent
Description :
• It has a slightly laxative effect.
• It occurs in nature, chicory leaves contain a small amount, and as such it is sometime
described as a natural sweetener.
Application :
• In the pharmaceutical industry in the formulation of oral dosage forms
• It is a non-cariogenic bulk sweetener, approximately as sweet as sucrose
Maltitol

3. Synonyms: Hydrogenated glucose syrup; Finmalt.
Chemical Name: Maltitol solution.
Chemical Formula :C12H24O11
Functional Category:
• Suspending agent
• Sweetening agent.
Description: It is a clear, colorless, syrupy liquid, miscible with water.
Applications in Pharmaceutical Formulation:
• Used as a suspending agent in oral suspensions as an alternative to sucrose syrup.
Safety: The WHO, in considering the safety of maltitol solution, did not set a value for
the acceptable daily intake since the levels used in food to achieve a desired effect were
not considered a hazard to health.
Maltitol Solution

4. Chemical Name: Maltodextrin
Formula: C6nH(10n+2)O(5n+1)
Functional Category:
• Coating agent.
• Tablet and capsule diluent;
• Tablet binder.
• Viscosity increasing agent.
Description:
• Maltodextrin occurs as a nonsweet, odorless, white powder or granules.
• The solubility, hygroscopicity, sweetness, and compressibility of maltodextrin increase as the DE
increases.
Application:
• In food.
• In Beverages.
• In Pharmaceutical.
• In Health & Personal care products.
Incompatibilities: Under certain pH and temperature conditions maltodextrin may undergo maillard reactions
with amino acids to produce yellowing or browning. Incompatible with strong oxidizing agents.
Maltodextrin:

5. Chemical Name: 3-Hydroxy-2-methyl-4 H -pyran-4-one
Chemical Formula and structural formula : C6H6O3
Functional Category: Flavor enhancer; flavoring agent.
Description:
• White crystalline solid with a characteristic, caramel-like odor and taste.
• In dilute solution it possesses a sweet, strawberry-like or pineapple-like flavor and odor.
Application:
• In Food: It can be used as flavor enhancer in food such as in soft drink, sorbets, roasted
food, pudding, jelly, ketchup, chocolate and candy.
• In Beverage: Maltol can be used as flavor enhancer in beverage.
• In Pharmaceutical: It can be used as intermediate in Pharmaceutical.
• In Health and Personal care: Maltol can be used as flavoring agent in Cosmetics.
Maltol

6. Chemical Name: 4-O-a-D-Glucopyranosyl-b-D-glucopyranose anhydrous.
Empirical Formula: C12H22O11
Structural Formula:
Functional Category:
• Sweetening agent
• Tablet diluent.
Description: Maltose occurs as white crystals or as a crystalline powder. It is
odorless and has a sweet taste approximately 30% that of sucrose.
Application:
• Fermentation .
• Extending shelf life of various foods.
• Excellent for treatment of dry mouth .
• Excellent for treatment of dry mouth .
Stability and Storage Condition: Maltose should be stored in a well-closed
container in a cool, dry place.
Maltose

7. Chemical Name: D-Mannitol
Chemical Formula: C6H14O6
Structural Formula:
Functional Category :
• Diluent.
• Sweetening agent.
• Tablet and capsule diluent.
• Therapeutic agent.
Description: Mannitol occurs as a white, odorless, crystalline powder, or freeflowing granules.
Applications:
• Pharmaceutical formulations and food products.
• In pharmaceutical preparations it is primarily used as a diluent (10–90% w/w) in tablet
formulations
Mannitol

8. Chemical Name : Medium-chain triglycerides.
Structural Formula:
Functional Category: Emulsifying agent; solvent; suspending agent; therapeutic agent.
Description: A colorless to slightly yellowish oily liquid that is practically odorless and
tasteless.
Application:
• In oral formulations, it is used as the base for the preparation of oral emulsions, micro
emulsions, self-emulsifying systems, solutions, or suspensions of drugs .
• That are unstable or insoluble in aqueous media, e.g. calciferol.
Medium-chain Triglycerides

9. Chemical Name: 1-Deoxy-1-(methylamino)-D-glucitol
Chemical Formula : C7H17NO5
Structural Formula:
Functional Category:
• Organic base.
Description:
• It occurs as a white to slightly yellow-colored crystalline powder.
• It is odorless or with a slight odor.
Applications:
• It is an organic base used as a pH-adjusting agent and solubilizing agent.
• Primarily in the preparation of soluble salts of iodinated organic acids used as X-ray contrast
media.
Meglumine

10. Chemical Name: (1R,2S,5R)-2-isopropyl-5-methylcyclohexanol.
Empirical Formula: C10H20O
Structural Formula:
Functional Category:
• Flavoring agent;
• Therapeutic agent.
Description:
• Menthol is an organic compound made synthetically or obtained from corn
mint, peppermint, or other mint oils.
• It is a waxy, crystalline substance, clear or white in color, which is solid at room
temperature and melts slightly above.
Application : Menthol is widely used in pharmaceuticals, confectionery, and
toiletry products as a flavoring agent or odor enhancer.
Menthol

11. Formulation of Febuxastat 40 mg Tablet:-
Ingredients Name Amount(mg) Amount (%) Functionality
Febuxastat 40 44.4 Used as Core ingredient
Maltodextrin 9 10 Used as binder
Crosscarmelose Sodium 4.5 5 Used as crosscarmellose
Magnesium Stearate .45 .50 Lubricant
Sodium Benzoate 1.8 2 Glidant
Alpha Tocopherol 0.045 0.05 Preservative
Dextrose 36 38 Diluent
Coloring agent q.s. q.s Color
In total 90

12. Overall
Total weight of tablet : 90 mg
API : 40 mg
Excipients : 50mg