Pharmaceutical Excipients & Formulation of a Dosage Form
Presented by Md. Faysal Id: 151-29-760
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
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.
Cellulose Acetate Phthalate
Non-proprietary Name:
BP: Cellacefate
USP: Cellacefate
Chemical Name:
Cellulose, acetate, 1,2-benzenedicarboxylate
Structural Formula:
Functional Category : Coating agent
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.
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
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.
Ceresin
Non-proprietary Names: None adopted.
Chemical Name: Ceresin
Structural Formula:
Functional Category:
Coating Agent
Stabilizing agent
Stiffening agent
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.
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
Applications in Pharmaceutical Formulation:
Used in cosmetics and topical pharmaceutical preparations.
Used in the preparation of non aqueous creams sticks, and in non latheringshaving 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.
Cetrimide
Non-proprietary Names:
BP: Cetrimide
PhEur: Cetrimide
Structural Formula: C19H42BrN
Functional Category
Antimicrobial preservative
Antiseptic
Cationic surfactant
Disinfectants
Applications in Pharmaceutical Formulation:
Quaternary ammonium compound that is used in cosmetics and pharmaceuticalformulations 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-ionicsurfactants. Aqueous solutions react with metals.
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
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
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
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.
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
Applications in Pharmaceutical Formulation:
Used in cosmetics and is under investigation for use in a number ofpharmaceutical 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
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