LIQUID PREPARATIONS PART II Flashcards
All raw materials should conform to well thought out
specification. These specifications should assure
_______, _________, _________ and freedom from excessive
microbial contamination
identity, purity, uniformity
Although purified water (USP) is required in all
operations, it is particularly important in liquid
manufacturing, if __________ and other water treatment equipment is used, special attention must be given to
________ and ____________
deionized; routine microbiological and chemical testing
Storage tanks for __________ and _______ should
be constructed to facilitate examination as well as
cleaning
glycerin and propylene glycol
Aside from AI, ______________ is usually the most
important constituent in a liquid product
water
Techniques employed to upgrade the microbial purity of water supply in oral liquid:
reverse osmosis purification, UV sterilization, membrane filtration, constant circulation in piping system that have no “dead ends” where microorganism can thrive
most straightforward to scale up, but
require tanks of adequate size and suitable mixing capacity
Simple solutions
Most equipment should have _________ and ________
capabilities for rapid dissolution of formulation components
heating and cooling
Adequate ___________ and ___________transfer systems and filtration equipments are required, but they must be monitored to ensure that they can clarify the product without removing active or adjuvant ingredients
transfer systems and filtration;
All equipments must be made of suitable,____________,
sanitary materials and be designed and constructed to
facilitate easy cleaning
non-reactive
includes tanks, kettles,
pipes, mills, filter, housing are most frequently fabricated from
stainless steel
Liquid pharmaceutical processing
virtually non-reactive but may react with some
acidic pharmaceutical liquids
Stainless steel
Reaction of stainless steels with some acidic pharmaceutical liquids may be minimized by treating the stainless steel with
an acetic acid or nitric acid
solution to remove surface alkalinity
treatment the stainless steel with an acetic acid or nitric acid
solution to remove surface alkalinity
passivation
Interaction with metallic surfaces can be minimized by using
polytetrafluoroethylene (teflon) liners
is inert,
these liners have the potential disadvantages of cracking,
breaking, flaking and peeling with resulting product
contamination
teflon
Equipment and lines can be sterilized by such methods
as
alcohol, boiling water, autoclaving, steam or dry
heat
Dilute solutions of rapidly dissolving materials
are prepared by adding the __________ to the
___________ and __________ until the solution is
_____________
solute to the solvent; agitating; homogenous
Heat maybe required for _____________
solutions or when the solute is slow to dissolve
more concentrated
usually added in a specified
order to increase the rate of dissolution and
facilitate a rapid approach to equilibrium
Excipients
T/F: If the solutes were charged directly to the bulk mixing
tank, it would be difficult to detect small amounts of
undissolved material at the bottom of the tank
T
T/F: complete solution should be confirmed at
every stage in the manufacture of homogenous liquid.
In the laboratory, liquids are usually measured by
volume
T
In large scale production,
______________ means of measurements are used
gravimetric
this stage of
process is termed Polishing
filtered and clarified
requires the removal of
particulate matter down to at least 3 um in size
Highly polished solution
Filters used in the manufacture, processing liquid drug
products intended for human use should not release ____________
fibers
commonly used to improve clarity and
increase the flow rate, thus decreasing filtration time
Filter aids
Amount and type of filter aid must be determined during
the ________________ of the product, the amount usually does
not exceed _____________
development; 0.5 g/L
examples of filter aids are
diatomaceous earth, carbon, expanded perlite and
cellulose
liquid may be transported to the filling
line, either ____________ by filling into portable transport tanks or by
_______________ through a suitable liquid delivery conduit
manually; pumping (gravity flow)
Method of filling a pharmaceutical liquid depend on the
characteristic of the liquid:
viscosity, surface tension, foam
producing, compatibility of the material with the construction of
filling machine, type of package (bottle)
are
delivered by the stroke of the plunger of a syringe, which forces
the liquid through a 2 way valve that provides for alternative
filling of the syringe from a reservoir and delivery to a container.
Small volumes of liquids
For heavy, viscous liquids, ________________provides more
positive action
sliding piston valve
T/F: Large volume filling does not normally require the precision
required for small volumes.
T
bottles of solution are
usually filled by
gravity, pressure or vacuum devices
Methods of filling
gravity filling, pressure pump filling,
vacuum filling
require specially designed equipmen
High viscous solution r
To obtain a reasonable flow rate, ___________ must be
applied or containers with large openings must be used to
permit the entry of large delivery tubes
high pressure
can be employed to raise the
temperature of the product and thereby lower its viscosity
jacketed reservoir tanks
a problem common to all types of
machines that fill containers with liquid but is particularly
bothersome in high speed automatic equipmen
Excessive foaming
Foaming
during the filling operation can be reduced by employing
filling equipment that minimizes product _____________,
closed system filling to limit the introduction of air or other
gases that cause foaming, mechanical defoaming
devices, or reduction in the __________ of the filling line
turbulence; speed
Slow but simple process of filling
Gravity Filling
Often operated semi-automatically and differs
from the gravity filler principally in that the
liquid is under pressure
Pressure Pump Filler
