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PRESENTED BY:
M.SUPRAJA DEEP,
B.PHARMACY,
ST.PETERS INSTITUTE OF
PHARMACEUTICAL SCIENCES.
INTRODUCTION :
DEFINITION:
Parenteral preparations are pyrogen-free
preparations intended to be administered other
than oral routes.
The term parenteral is derived from two Greek
words ,
Para outside enteron intestine
CLASSIFICATION:
Based on volume they are classified into two types:
These generally
provide electrolytes,
nutrition to the body.
FORMULATION ASPECTS :
Therapeutic agents.
ex: Insulin, Antibiotics, Vaccines, Antipyretics,
Analgesics, Dextrose, Nacl, Electrolytes.
Vehicles.
1) Water.
WFI, BWFI, SWFI.
2) Aqueous vehicles.
ex: Ethyl alcohol, PEG, PG.
3) Non-aqueous vehicles.
ex: Fixed oils ( corn oil, peanut oil, cotton
seed oil.)
. Added substances(Additives)
1) Antimicrobials.
ex: phenyl mercuric acetate - 0.01%
Thiomersal - 0.01%
Benzothenium chloride - 0.01%
Phenol and cresol - 0.5%
2) Anti oxidants.
ex: sodium bisulfide.
ascorbic acid – 0.02- 0.1%
thiourea - 0.005%
3) Buffers.
ex: acetic acid, adipic acid, benzoic acid.
4)Bulking agents.
ex: lactose – 0.14- 0.5%
mannitol – 0.4 – 2.5%
5) Chelating agents.
. ex: Disodium edetate – 0.003 - 0.05 %
Tetra sodium edetate – 0.01 %
6) Protectants.
ex: sucrose, lactose (2-5%)
7) Solubilizing agents.
ex: PEG 300, PG
8) Tonicity adjusting agents.
ex: sodium sulfate – 1.1%
sorbitol – 2%
9) Surfactants.
ex: polyethylene- 0.1 -0.5%
sorbitan monooleate-0.05-0.25%
VEHICLES:
WATER FOR INJECTION(WFI):
water that is intended for use in the
manufacture of parenteral (i.e. injectable) drugs
whose solvent is water.
The USP (United States Pharmacopeia)
defines this as highly purified waters containing
less than 10 CFU/100 ml of Aerobic bacteria.
STERILIZED WATER FOR INJECTION
(SWFI):
sterile, nonpyrogenic, distilled water in a
single dose container for intravenous
administration after addition of a suitable solute.
It may also be used as a dispensing
container for diluent use.
.
No antimicrobial or other substance has
been added.
The pH is 5.5 (5.0 to 7.0).
BACTERIOSTATIC WATER FOR
INJECTION (BWFI):
Sterile water containing 0.9% benzyl
alcohol that is used to dilute or dissolve
medications.
The container can be reentered multiple
times (usually by a sterile needle) and the benzyl
alcohol suppresses or stops the growth of most
potentially contaminating.
PRETREATMENT OF
WATER:
The water for injection is most commonly used
solvent.
Water for injection is the water prepared by
reverse osmosis or distillation and contains no
added substances.
The water must be adequately pretreated to
ensure the uniformity and to promote constant
quality and high efficiency.
Some of the important elements include:
Chlorination or treatment with ozone to suppress
the microbial growth throughout the system.
Prefiltration through depth filters to remove iron
and any suspended matter
Injecting a flocculating agent to remove the
suspending agents, if any.
Water softening by ion-exchange to remove
alkaline earth metals, calcium and magnesium, and
thus minimize the formation of scale deposits.
Ph adjustment to 6.0-6.5 to reduce scale deposits.
Deionization by ion exchange resins to removal of
ions from feed water.
Activated carbon beds for removal of chlorine and
organics and then treatment with UV radiation to
suppress the microbial growth.
REVERSE OSMOSIS (RO) :
This is defined as a process for the separation of
solutes from the water by applying pressure on
more concentrated solution in contact with semi
permeable membrane to give less concentrated
solution.
The solutes may be charged (ions) or essentially
neutral (organics) .
Each is excluded or removed by different
mechanisms.
Charged particles are repelled or excluded due to
interfacial tension at the water membrane
iinterface.
.
.
Organics are excluded by sieve mechanism so that
size and molecular weight are important attributes.
The higher the size or molecular weight of a
substance, the most efficiently it is excluded.
Thus virus, bacteria, and pyrogen are removed by
reverse osmosis.
The overall system primarily depends on the
composition of feed water and the quality of the
final water desired.
In addition to RO unit, other type of systems may
include chlorinators, flocculating agents, filters,
water softeners, heat exchangers, active carbon
beds, decarbonators, deionizers etc.,
DISTILLATION:
The action of purifying a liquid by a process of
heating and cooling.
The process of removal of impurities from the
liquid by continuous heating above 100 degrees
and at atmospheric pressure cooling
simultaneously.
This aids in killing the living microorganisms.
Prior to distillation, water used as source for WFI
should be done with pretreatment
Perfect phase change would leave all the
impurities behind producing pure water vapor.
After this the vapor is condensed to liquid water.
.
It is maintained at pressure greater than the water
of lower purity.