Title: Preparation of 5% Dextrose and 0.

45% Sodium Chloride Injection, USP 100

mL

Introduction:

Parenteral products are products that are administered to the body by

injection, which include intravenous, intramuscular, subcutaneous and
intraperitoneal. Medication administered via this route bypasses the normal body
defence mechanisms, hence it is essential that these products are prepared with
a higher degree of care and skills than utilised in preparing conventional oral or
topical products. Injections are administered using a hypodermic (hollow
pointed) needle. It can be formulated as liquids or powders/lyophilisate for
preparation of the solution. The solutions, emulsions or suspensions prepared
must be sterile (free from microorganisms), pyrogen free (must be test for
pyrogens thoroughly), isotonic (compatible with body osmolarity of
300mOsmol/L) and free from particulate matters. The purporse of this
experiment is to prepare a sterile injection intended for parenteral
administration.

Literature Review:

Dextrose with Sodium Chloride is an intravenous (IV) solution used to supply

water, calories and electrolytes (e.g., sodium, chloride) to the body. It is a perfect
example of parenteral fluid. Dextrose 5% Sodium Chloride 0.45% is a common
solution for maintenance and rehydration. Dextrose restore blood glucose levels
and provide calories. This may due the characteristic of dextrose in minimizing
liver glycogen depletion and exerts a protein-sparing action. Dextrose injected
parenterally undergoes oxidation to carbon dioxide and water. Thus it also acts
to supply water to a dehydrated body.

Sodium chloride in water dissociates to provide sodium (Na) and chloride (Cl¯)
ions. Water distribution depends primarily on the concentration of electrolytes in
the body compartments and sodium (Na) plays a major role in maintaining
physiologic equilibrium. Since Sodium (Na) is the principal cation of the
extracellular fluid, infusing 0.45% of sodium (Na) will provide electrolyte
replacement.

The osmolality of 5% Dextrose with 0.45% Sodium Chloride is 405mOsm/L and

its pH is about 4.4. It is a hypertonic solution. A hypertonic solution is one that
has an osmolality greater than 300mOsm/kg. Hypertonic solutions exert more
osmotic pressure than the extracellular fluid so when these solutions are
infused, fluid gets pulled into the vascular system.

The intravenous administration of these solutions can cause fluid and/or solute
overloading resulting in dilution of serum electrolyte concentrations,
overhydration, congested states or pulmonary edema. Patients receiving any
hypertonic solutions need to be monitored for fluid overload, particularly if they
are being given at a rapid rate of infusion. Patients with congestive heart failure,
severe renal insufficiency and in clinical states in which there exists edema with
sodium retention should be given extra care when being administered with this
injection. Due te presence of dextrose, this injection should be used with caution
in patients with known subclinical or overt diabetes mellitus.

Method:

5g Dextrose and 0.45g Sodium Chloride were weighed using an electronic

weighing balance and dissolved in a beaker containing 100mL of deionised
water. The solution was stirred using a glass rod until completely dissolved.
Then, solution was filtered with a membrane filter while transferring it into a
glass bottle (type I/II glass). A 10mL syringe was used to transfer the solution.
Care was taken in order to make sure contamination did not occur during this
process. The bottle was sealed with a rubber cork and clamped to avoid
leakage. Finally bottle containing the solution was labelled and sterilized using
moist heat (autoclave) of 121oC for 15 minutes.

Result and discussion:

Molar concentration of solute in solution is measured in mOsmol/L.

mOsmol/L= weight of substance (g/L) x Number of species x 1000

Molecular weight

For 5% Dextrose:

50g x 1 x 1000 = 252.5 mOsmol/L

198

For 0.45% Sodium Chloride:

4.5g x 2 x 1000 = 153.8 mOsmol/L

 58.5

Total osmolarity = 252.5 + 153.8 = 406.3 mOsmol/L

Finish product was examined under magnification to ensure clearness of the

solution.

By:
Wan Nur Khairiyah Binti W Hassan
MEF090072