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Parenteral Products
By: Howida Kamal, Ph.D
Small volume parenterals
(SVP) Large volume parenterals
(LVP)
Formulation of Injections
Volume of Injection
Injected by a syringe Administered by an infusion unit
must be made isotonic
Must NOT contain a bactericide
must be pyrogen free
Could be made hypertonic
Could be pyrogenic
Could contain a bactericide
Most routs are used Mainly I.V., less common,
SC, IM, and ED
< 100 ml
(Up to 20 ml)
> 100 ml
≥ 250 ml
Small volume parenterals
(SVP) Large volume parenterals
(LVP)
Formulation of Injections
Volume of Injection
Hyperalimentation
Solution
Dialysis
Solutions
Peritoneal Dialysis
Solutions
Hemodialysis
Solutions
Irrigating
solutions
Cardioplegia
Solutions
for patients with chronic renal failure is dialysisThe goal of
to restore the composition of the body’s fluid environment
toward normal.
Formulation of Injections
This is accomplished principally by formulating a dialysate
whose constituent concentrations are set to approximate
normal values in the body. Over time, by diffusional transfer
along favorable concentration gradients, the concentrations of
solutes that were initially increased or decreased tend to be
corrected.
When an abnormal electrolyte concentration poses immediate
danger, the dialysate concentration of that electrolyte can be
set at a nonphysiologic level to achieve a more rapid
correction.
On a more chronic basis the composition of the dialysate can
be individually adjusted in order to meet the specific needs of
each patient
Solutes are transported across a semi-membrane by
diffusion by concentration gradient between the dialysis
fluid and the body as a driving force
for patients with chronic renal failure is dialysisThe goal of
to restore the composition of the body’s fluid environment
toward normal.
Formulation of Injections
Electrolytes Osmotic agents Buffer
Components of dialysis fluid
Sodium is the
most abundant
Lactate
(Lactate is metabolised to
form bicarbonate, the most
important buffer in the blood)
Glucose
Formulation of Injections
Formulation of Injections
Hyperalimentation Solution:
Parenteral hyperalimentation involves administration
of large amount of nutrients (carbohydrate, amino
acids, and vitamins) for periods up to several
hundred days, at caloric intake levels of 4,000 cal/
day or more.
The method permits administration of life–saving or
sustaining nutrients to:
a. Comatose patient
b. Patients undergoing treatment for esophageal
obstruction,
c. Patients undergoing treatment for GI diseases
including cancer and ulcerative colitis.
Formulation of Injections
Parenteral-products Components
Formulation of Injections
Vehicles for parenteral products
Aqueous Non-aqueous
Water miscible Water immiscible
Alcohol
Glycerol
Propylene glycol
Polyethylene glycol
Fixed Vegetable oils
corn oil
cottonseed oil
peanut oil
sesame oil
Water for injection (WFI)
Sterile WFI
Bacteriostatic WFI
Normal Saline
Ringer solution
Parenteral-products Components
Formulation of Injections
Vehicles for parenteral products
Aqueous Non-aqueous
Water miscible Water immiscible
Enhance drug solubility
Increase drug stability
Water insoluble drugs
For depot effect.
well tolerated by the body
safe and easy to administer.
Parenteral-products Components
Formulation of Injections
Vehicles for parenteral products
Aqueous Non-aqueous
Water miscible Water immiscible
Disadvantages of water miscible solvents
Large amounts of mixed solvent systems may be irritating or toxic
Parenteral-products Components
Formulation of Injections
Vehicles for parenteral products
Aqueous Non-aqueous
Water miscible Water immiscible
Disadvantages of oily injections
• May be too viscous in cold weather for administration without warming.
• They often cause pain on injection.
• They must be injected with great care to avoid accidental I.V. injection which
could lead to thrombosis.
• May cause sensitivity reactions in some patients
• Used for Intramuscular use only
Formulation of Injections Aqueous Vehicles
WFI Bacteriostatic WFI Sterile WFI
Formulation of Injections Aqueous Vehicles
WFI Bacteriostatic WFI Sterile WFI
• It is purified water
• Pyrogen free
• Not sterile.
• Stored at 5oC or 60oC - 90oC
• Must be used within 24 hours
• Used on large scale in the manufacture of injection
which are to be sterilized after preparation
• Sterilized to produce sterile WFI
Formulation of Injections Aqueous Vehicles
WFI Bacteriostatic WFI Sterile WFI
• It is sterilized WFI
• Pyrogen free.
• Contain NO antimicrobial agent or other added
substances.
• May contain slightly higher level of total solids than
the WFI (leaching of glass constituents during
sterilization).
• Packaged in single container ≤ 1-liter size.
• Used as a vehicle for injectables that are already
sterilized and packaged (e.g in Vials)
Formulation of Injections Aqueous Vehicles
WFI WFI Bacteriostatic Sterile WFI
• It is sterile
• Pyrogen free.
• Contain antimicrobial agent
• Packaged in single container ≤ 30 ml.
• Used in the preparation of small volume of injectable
preparation
Formulation of Injections
Distillation Reverse Osmosis
Preparation of WFI
Formulation of Injections
Distillation Reverse Osmosis
Preparation of WFI
The still should be properly constructed and operated to
get high quality water
1. All parts of the still contacted by the vapor or distillate
must be constructed from high quality materials,
stainless steel, or glass to prevent metal contamination.
2. The vapor generated by the still must be free of
entrapped water droplets, possibly will contain pyrogens
from the feed water
a.Still should contain devices to "scrub" the vapor
b.Stills must operate at a suitable pre established rate
Formulation of Injections
Distillation Reverse Osmosis
Preparation of WFI
Spiral wound cellulose
acetate membranes
Hollow fiber polyamide
membranes
Reverse Osmosis
Osmosis: The transfer of water across a semi-permeable
membrane from solution of low concentration to solution of
high concentration until the concentration of the two
solutions are equal.
The driving force of osmosis is the osmotic pressure of the
concentrated solution.
Reverse Osmosis: the direction of passage of water through
the semi-permeable membrane is reversed by applying
pressure exceeding the osmotic pressure of the feed water.
The pure water passes through the membrane leaving
particulates and most dissolved solids behind.
Formulation of Injections
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