parenteral productsscholar.cu.edu.eg/?q=howida/files/parenteral-iii.pdf · 2 days ago ·...

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)


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.


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.


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


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.


Parenteral-products Components


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




Aqueous Non-aqueous


Enhance drug solubility

Increase drug stability

Water insoluble drugs

For depot effect.

well tolerated by the body

safe and easy to administer.




Aqueous Non-aqueous


Disadvantages of water miscible solvents

Large amounts of mixed solvent systems may be irritating or toxic




Aqueous Non-aqueous


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



• 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



• 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)


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


Distillation Reverse Osmosis

Preparation of WFI



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



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.


parenteral productsscholar.cu.edu.eg/?q=howida/files/parenteral-iii.pdf · 2 days ago ·...

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