Elixir
In a separate vessel (Tank B), charge alcohol &
-elixirs containing over 10-12% of alcohol are usually
self-preserving and do not require the addition of an
antimicrobial agent for their preservation
-although USP monograph for medicated elixirs provide
standards, they do not generally provide official
formula
Preparation of Elixir
1. Elixirs are usually prepared by simple solution with
agitation and/or by the admixture of two or more liquid
ingredients
2. Alcohol-soluble and water-soluble components are
generally dissolved separately in alcohol and in purified
water, respectively
3. Aqueous solution is added to the alcoholic solution
rather that the reverse
4. When to solutions are completely mixed, the mixture
is made to volume with the specified solvent or vehicle
5. Finally, a clear solution is obtained
*Note: frequently, the final mixture will not be clear,
but cloudy
Prparation # 1 Guaifenesin Oral Solution
Guaifenesin active ingredient
Alcohol solvent for water-insoluble compound
Methyl and Propyl Paraben preservatives
Glycerin co-solvent
Purified water solvent, vehicle
Colorant qs add until you get the desired color
Pharmaceutical Category: Expectorant
Procedure:
1. Charge 360 mL (1% volume for 1L) of purified water
in stainless steel tank (Tank A)
2. Heat to 60OC
3. Add methyl paraben & propyl paraben for 15
minutes. Continue heating up to 80OC
4. Check for complete solution. Turn off the heat. Cool
to 60OC
5. Add Guaifenesin, sucrose and glycerin
6. Continue agitation until complete solution. Cool to
40OC
7.
orange flavor
8. Charge the water solution to alcoholic solution
slowly (Tank B to Tank A)
9. Adjust the pH to 3.5
10. Add enough water. Agitate for 5 minutes
11. Add colorant, then agitate
(1) Charge term used in manufacturing lab
360 mL for 1L batch (1O volume)
Ratio & proportion if lower batch size will be
used
(5) Guaifenesin
50-70 mL of water soluble
Make sure guaifenesin is dissolved first before
adding the glycerin
(6) Heat to 60OC to 80OC + Alcohol after cooling at 40OC
Importance of decreasing the temperature if
alcoholic phase is asses it will volatilize if there
is an increase in temperature
(8) Maintain
W A gives an increase concentration of
alcohol
A W used in the lab for practical purpose
since the amount of alcohol < water (for this
formula only)
(9) qs ad water before qs colorant
The solution must not be turbid, if turbid (1) add
filtering aid (talc capable of absorbing excess oil;
solubility: 5g in 1000 mL), then stir; (2) stand over night
Syrups
-concentrated aqueous preparation of sugar substitute
with or without added flavoring substance and
medicinal agents intended for oral use
Sugar substitute they have the characteristic of sugar
polyhydric alcohol/polyols
eg. glycerin, sorbitol, propylene glycol
Types of Syrup:
 1. medicated employed in the therapy for the
value of the medicinal agent present
-syrup + active ingredient
2. non-medicated flavored syrup, contains
flavoring agent but not the medicinal
substances
Simple syrup syrup NF
-near saturated solution, as the concentration
of sucrose approaches saturation, syrup
becomes self-preserving if saturated, it
crystalizes at fluctuating temperature 65% -
85% by volume solution
-85% - self-preserving (85g of sucrose qs ad
water to make 100 ml syrup), this
concentration will retard the growth of such
microorganism because of the unavailability of
the requirement for their growth
Characteristics of a Syrup
1. Syrup has a low solvent capacity for water-soluble
substances because the hydrogen bonding of sucrose
and water is very strong
2. Sucrose concentration of syrup plays a critical role in
the control of microorganic growth
Dilute sucrose solution excellent media for
microorganism
Components of Syrup
1. Active ingredient
2. Water
3. Sugar usually have sucrose or sugar substitute used
to provide sweetness and viscosity
4. Antimicrobial preservative
Benzoic acid & parabens 0.1-1.2%
Na Benzoate
Alcohol is used in the preparation of syrup to
assist in the dissolving of alcohol-soluble
ingredients but must be present in the final
product in amounts adequate for preservation
Preparation of Syrup
1. Solution/Agitation with heat
-faster, shorter duration of time required
-syrup with yellow solution
-cannot be used to prepare syrup containing
thermolabile or volatile ingredients
-procedure:
Sugar + Pur. Water heated until
solution is effected + other heat stable
components added to the hot syrup. Allow to
cool and qs ad water
2. Solution by agitation w/o heat
-for maximum stability
-to avoid heat-induced inversion of sucrose
-more time consuming
-procedure
Sucrose + other ingredients qs ad
water mix syrup
-when solid agents are to be added to a syrup,
it is best to dissolve them in minimal amount of
purified water and then incorporate the
resulting solution into the syrup
3. Addition of sucrose to a medicated liquid (tincture or
fluidextract) or to a flavored liquid
4. Percolation extraction of active ingredient
-either sucrose maybe percolated to prepare
the syrups or the source of the medicinal
component may be percolated to form an
extractive to which sucrose or syrup may be
added
-eg. Ipecac syrup
Paracetamol Syrup
Paracetamol (Acetaminophen) A/A
-Analgesic relieves pain; elevating pain threshold
-Anti-pyretic lowers elevated body temperature
(fever) acting on hypothalamic heat regulatory center
-Fever defense mechanism against infection; present
when the body temperature is higher than normal
(37OC)
-Adverse effect: Hepatotoxicity

More than 10g in adults

More than 3g in 2 yrs old

N-acetyl-p-benzoquinone-imine

-toxic metabolite of acetaminophen

-toxicity can be treated with n-acetylcysteine
-treatment of overdosage (p.o.):
-140mg/kg loading dose
-70mg.kg maintenance dose 17 doses every 4
hours

Ferrous Sulfate Syrup

-Hematinic
-Anti-anemic (iron deficiency; anemia)
-Hematopoietic
-Aid in the production of red and white blood cells
-Increase in the Hgb content of blood through an
increase in the Hgb content of erythrocytes

-Iron is used in medicines in the form of inorganic and

simple organic ferrous sulfate compounds because of
less irritation and better absorption
-May exist in several salts: Sulfate, Gluconate,
Fumarate

Causes of Anemia
1. Nutritional
2. Chronic blood loss

-severe intoxication in overdoses especially in children.

Iron preparation is common cause of lethal intoxication
in children
-indicated as the amount of elemental iron present
(written on the label)