The pharmaceutical industry is ever thirsty to satisfy patient’s therapeutical needs and apart from active ingredients, inactive excipients play a major role in formulation development. Pharmaceutical excipients are substances other than the Pharmacologically active drug or Prodrug which are included in the manufacturing process or are contained in a finished pharmaceutical product dosage form

1. Pharmaceutical Excipients &
Formulation of a Dosage Form
Presented by Md. Faysal Id: 151-29-760

2. Cellulose acetate
 Non-proprietary name: BP : Cellulose acetate
USP : Cellulose acetate
 Chemical name: Cellulose acetate , Cellulose diacetate ,
Cellulose triacetate.
 Structure formula: C164H174O111
 Functional category:
 Coating agent
 Extended release agent
 Tablet and capsule diluent

3.  Application in pharmaceutical formulation:
 Used as a semipermeable coating on tablets.
 Used in transdermal drug delivery systems.
 Highly absorbent and resistant to moderate temperature.
 They don’t shrink or wrinkle.
 Stability and storage conditions:
 Stable if stored in a well-closed container in a cool, dry place .
 Incompatibilities:
 Incompatible with strongly acidic or alkaline substances.

4. Cellulose Acetate Phthalate
 Non-proprietary Name:
BP: Cellacefate
USP: Cellacefate
 Chemical Name:
Cellulose, acetate, 1,2-benzenedicarboxylate
 Structural Formula:
 Functional Category : Coating agent

5.  Applications in Pharmaceutical Formulation:
 Used as an enteric film coating material.
 Used as a matrix binder for tablets and capsules.
 Commonly applied to solid-dosage forms.
 Stability and Storage Conditions
 Stable if stored in a well-closed container in a cool, dry place.
 Incompatibilities
 Incompatible with ferrous surface, ferric chloride, sodium citrate.

6. Ceratonia
 Non-proprietary Names: None adopted.
 Chemical Name : Carob gum , Ceratonia silique.
 Structural Formula:
 Functional Category:
 Controlled-release agent
 Suspending agent
 Tablet binder
 Viscosity-increasing agent

7.  Applications in Pharmaceutical Formulation:
 Naturally occurring materials generally used as substitute for tragacanth.
 Used as a binder, thickening agent, and stabilizing agent in the cosmetics and
food industry.
 Stability and Storage Conditions
 Stored in a well-closed container in a cool, dry place.
 Ceratonia loses not more than 15% of its weight on drying.
 Incompatibilities
 The viscosity of xanthan gum solutions is increased in the presence of ceratonia.

8. Ceresin
 Non-proprietary Names: None adopted.
 Chemical Name: Ceresin
 Structural Formula:
 Functional Category:
 Coating Agent
 Stabilizing agent
 Stiffening agent

9.  Applications in Pharmaceutical Formulation:
 Used as a stiffening agent in creams and ointments.
 Emulsion stabilizer, viscosity control agent.
 Thickener in pharmaceutical protective, topical, and vaginal creams.
 Used in cosmetics and personal care products.
 Stability and Storage Conditions
 Stored in well-closed containers in a cool, dry, well-ventilated
place, away from extreme heat and strong oxidizing agents.
 Incompatibilities
 Incompatible with strong oxidizing agents.

10. Cetostearyl Alcohol
 Non-proprietary Names
BP: Cetostearyl Alcohol
USP-NF: Cetostearyl Alcohol
 Structural Formula: CH3(CH2)nOH
 Functional Category
 Emollient
 Emulsifying agent
 Viscosity-increasing agent

11.  Applications in Pharmaceutical Formulation:
 Used in cosmetics and topical pharmaceutical preparations.
 Used in the preparation of non aqueous creams sticks, and in non lathering
shaving creams.
 Stability and Storage Conditions
 Stable under normal storage conditions.
 Stored in a well-closed container in a cool, dry place.
 Incompatibilities
 Strong oxidizing agents and metal salts.

12. Cetrimide
 Non-proprietary Names:
BP: Cetrimide
PhEur: Cetrimide
 Structural Formula: C19H42BrN
 Functional Category
 Antimicrobial preservative
 Antiseptic
 Cationic surfactant
 Disinfectants

13.  Applications in Pharmaceutical Formulation:
 Quaternary ammonium compound that is used in cosmetics and pharmaceutical
formulations as an antimicrobial preservative.
 Used as a catholic surfactant.
 Stability and Storage Conditions
 Stable in the dry state, and also in aqueous solution at ambient temperatures.
 Bulk material should be stored in a well-closed container in a cool, dry place.
 Incompatibilities
 Incompatible with soaps, anionic surfactants, high concentrations of non-ionic
surfactants. Aqueous solutions react with metals.

14. Cetyl Alcohol
 Non-proprietary Names:
BP: Cetyl Alcohol
USP-NF: Cetyl Alcohol
 Chemical Name: Hexadecan-1-ol
 Structural Formula: C16H34O
 Functional Category:
 Coating agent
 Emulsifying agent
 Stiffening agent

15.  Applications in Pharmaceutical Formulation:
 Used in cosmetics and pharmaceutical formulations such as suppositories,
modified-release solid dosage forms, emulsions, lotions, creams.
 Used for its water absorption properties in water-in-oil emulsions and ointments.
 Stability and Storage Conditions
 Stable in the presence of acids, alkalis, light, and air.
 It does not become rancid.
 Stored in a well-closed container in a cool, dry place.
 Incompatibilities
 Incompatible with strong oxidizing agents

16. Cetylpyridinium Chloride
 Non-proprietary Names:
BP: Cetylpyridinium Chloride
USP: Cetylpyridinium Chloride
 Chemical Name:
1-Hexadecylpyridinium chloride
 Structural Formula: C21H38ClN
 Functional Category:
 Antimicrobial preservative
 Antiseptic
 Cationic surfactant
 Disinfectant
 Solubilizing agent
 Wetting agent

17.  Applications in Pharmaceutical Formulation:
 Used therapeutically as an antiseptic agent.
 Mouthwashes containing cetylpyridinium chloride have been shown to inhibit
plaque formation.
 Stability and Storage Conditions
 Stable under normal conditions. It should be stored in well-closed containers.
 Incompatibilities
 Incompatible with strong oxidizing agents and bases.

18. Chitosan
 Non-proprietary Names
BP: Chitosan Hydrochloride
PhEur: Chitosan Hydrochloride
 Chemical Name:
Poly-b-(1,4)-2-Amino-2-deoxy-D-glucose
 Structural Formula:
 Functional Category:
 Coating agent
 Disintegrates
 Film-forming agent
 Viscosity increasing agent

19.  Applications in Pharmaceutical Formulation:
 Used in cosmetics and is under investigation for use in a number of
pharmaceutical formulations.
 Stability and Storage Conditions
 Stable material at room temperature, although it is hygroscopic after drying.
Stored in a tightly closed container in a cool, dry place.
 Incompatibilities
 Incompatible with strong oxidizing agents

20. Final weight of tablet=300 mg
API (Ciprofloxacin)=150 mg
Excipients=150 mg
Ingredients
Names
Functions Amounts (mg) Amounts (%)
Ciprofloxacin API 150 mg
Ceratonia Tablet binder 12 mg 4%
Microcrystalline Disintegrates 30 mg 10%
Na Stearate Lubricants 3 mg 1%
Cellulose acetate
phthalate
Coating agents 4.5 mg 1.5%
Cellulose acetate Diluent 100.5 mg 33.5%
Formulation of Tablet