) A project report

On
Different pharmaceutical additives used in the preparation of pharmaceutical produts

Submitted on the pacial filffilment of award of

the degree Of
bachlore of pharmacy

Submitted By
Maryam abubakar ayuba
Enrolment no tph1511001
8th semester
Approved by : Supervisor:
PROF.(DR) K.K.JHA MR. SHEKHAR SINGH
(PRINCIPAL) (ASST. PROFESSOR)
TEERTHANKER MAHAVEER COLLAGE OF PHARMACY
TEERTHANKER MAHAVEER UNIVERSITY ,
MORADABAD INDIA
 CONTENT

 INTRODUCTION
 LITERATURE REVIEW
 RESEARCH OBJECTIVES
 SUMMARY
 INTRODUCTION

Excipient are additives which can be used along side with active pharmaceutical
ingredient to convert pharmacological active compound into pharmaceutical
dosage form suitable for administration to the patient.
Now a days, a large number of pharmaceutical excipients are obtained from
natural sources.
The synthetic excipients are continuously being replaced with natural ones as
recent trend toward the use of the vegetable and nontoxic products has increased.
Today, a large number of naturally obtained pharmaceutical excipients are
available.
Traditionally, excipients were used as inert vehicle and diluents in formulating a
dosage form but in modern pharmaceutical dosage forms they often play
different multi-functional roles.
excipient play an important role in formulating a dosage form To support, protect
or enhance stability of the formulation, It also improve patient acceptance. it can
also consist of a property as tablet binders, disintegrating, emulsifying,
suspending, gelling, stabilizing, thickening and film forming agents, lubricating
agent, coloring agent, sweetening and flavoring agents, preservatives and
glindants.
 DEFINITION

Excipient means any component other then the

active pharmaceutical ingredients which
intentionally added to the formulation of a
dosage form. For the purpose of different
functions, like bulking, cohesiveness, friction,
stability, or bioavailability, mask colour,improved
test, absorption and dissolution, etc.

Excipients are substances which can be formulated

alongside with the pharmaceutical active
ingredient of a medication, which can be included
for the long-term sterilization, bulking up solid
formulations that contain potent active
ingredients in small amounts.
 ADVANTAGE AND DISADVANTAGE OF
EXCIPIENTS

advantage
 it maintain stability of the product for a long
period of time.
 It bulk up the formulation in case of potent drug
for accurate dosage form.
 It improved patient acceptance.
 It enhance overall safety and effectiveness during
it storage and used.
Dis advantages
 it result in denaturation or sticking and poor
stability of pure API
 PROPERTIES AND CHARACTERISTICS OF
EXCIPIENT

 An excipient must be chemically stable

 Non reactive

 Low equipment and process sensitive

 Inert to human body

 Non toxic acceptable with regards to organoleptic

properties
 Economical

 Having efficiency in regards with the intended

used
 TYPES AND FUNCTIONS OF EXCIPIENTS
 Diluents /fillers - it is used to increase bulk of a drug to get adequate weight
size.

 Binders- they are substances that promote cohesiveness by converting powder

into granules.

 Disintegrant-they are used to induce breakup of tablet when placed in an

aqueous environment.

 Lubricants-its used to reduced friction during tablet ejection from die cavity.

 Antioxidants-are added to maintain products stability and shelf life of the

product.

 Antiadherents-are added to reduce sticking or adhesion of tablet.

 Glidants-its used to increased the flow of tablet granulation by reducing

friction between the particles.
 EXCIPIENT SELETION
Excipient selection are generally focuses on the
desirable characteristics of excipients,
 Functionality
 Material consistency
 Regulatory acceptance
 Cost
 Availability
 And Sources
An ideal selection of an excipient most consider the
different properties like micromeritics, chemical, and
mechanical,etc. physicochemical properties, stability,
and compatibility issue etc. also have to be observed
while selecting an excipient.
 EXCIPEINT STANDARDISATION

The Excipient standardization have an important

role to ensure the appropriate standardization of
the products,

 Quality assurance
 Safety

 And efficacy of the drug.

 EXCIPEINT TESTING

 The main objectives of excipient testing is to find

out the appropriate excipient for the particular
API in dosage form under consideration.

 The primary purpose of testing is to retain its

stability throughout the manufacturing process,
packaging up to the time in which the package
will be opened.
 EXCIPEINT INTERACTION
Different interactions occurs with the excipient as
a result of incompatibilities that occurs between
the excipient and the product. E.g.
 Drug excipient interaction

 Excipient – excipient interaction

 Package excipient interaction

Under drug excipient interaction is also classified

into three
1) Physical interaction
2) Chemical interaction
3) Biopharmaceutical interaction
 CLASSIFICATION OF EXCIPEINT
Excipient are generally classified in to three form

1) Classification of excipient based on their origin.

Animals source. e.g. gelatin, honey.
Vegetables source e.g. starch, acacia
Minerals source e.g. calcium phosphate, paraffin.
Synthetic source e.g. lactic acid, saccharin.
2) Classification based on their function.
Excipient are used to performs various function in dosage forms such as, flavors,
sweeteners, colors, preservatives and adsorbents.etc,
3) Classification based on their pharmaceutical dosage forms.
 Solid dosage forms e.g. lubricant-calcium stearate
 Liquid dosage forms e.g. anti oxidant-ascorbic acid
 Semi solid dosage forms e.g. solubulizers-linolin.etc.
 SUMMARY


MASHAALLAHU
ALHAMDULILLAH