DDS Paracetamol Elixir (Post-Lab)

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Paracetamol

Elixir
GROUP 1
Specific Learning
Objectives
At the end of the activity, the students can:

Produce clear,
1.) flavored, liquid
preparations
known as elixirs,
compatible to
Confidently
procedures
2.) recommend the
learned .
use of the product
they make.
Introduction
Elixirs
• Are clear, sweetened
hydroalcoholic solutions
intended for oral use and
are usually flavored to
enhance their palatability.

• Each elixir requires a


specific blend of alcohol and
water to maintain all of the
components in solution.
Elixirs • Compared with syrups, elixirs
are usually less sweet and less
viscous because they contain a
lower proportion of sugar and
consequently are less effective
than syrups in masking the taste
of medicinal substances.

• All elixirs contain flavorings to


increase their palatability, and
most elixirs have coloring
agents to enhance their
appearance.
Elixirs
• In addition to alcohol and
water, other solvents, such as
glycerin and propylene glycol,
are frequently employed in
elixirs as adjunctive solvents.

• Elixirs containing more than


10% to 12% of alcohol are
usually self-preserving and do
not require the addition of
antimicrobial agent.
Non Medicated Medicated
• ARE EMPLOYED AS VEHICLES
• A.) THE ADDITION OF A
THERAPEUTIC AGENT TO A • USED FOR THE
PLEASANT-TASTING VEHICLE THERAPEUTIC EFFECT OF
AND THE MEDICINAL
B.) DILUTION OF AN EXISTING SUBSTANCE THEY
MEDICATED ELIXIR CONTAIN
• ALL COMPONENTS SHOULD BE • MOST OFFICIAL AND
CHEMICALLY AND PHYSICALLY COMMERCIAL ELIXIRS
compatible CONTAIN A SINGLE
• Three most commonly used: THERAPEUTIC AGENT.
aromatic elixir, compound
benzaldehyde elixir, &
isoalcoholic elixir.
Preparation of Elixirs
• Usually prepared by simple solution with
agitation and/or admixture of two or more
liquid ingredients.

• Alcohol-soluble and water-soluble


components.

• Aqueous solution is added to the alcoholic


solution, rather than reverse, to maintain
Example
formulations for
some medicated
elixirs:
Types of medicated elixirs

Antihistam Barbiturate
ine Elixirs Sedative and
Hypnotic
Elixirs
Phenobar Digoxin
bital Elixir
Elixir
Antihi
• Used primarily in the
symptomatic relief of certain
allergic disorders.

• They suppress symptoms

stamin
caused by histamine, one of the
chemical agents released
during the antigen-antibody
reaction of the allergic
response.

e
• The most common

Antihis
untoward effect is
sedation

• Others include: dryness


of the nose, throat and

tamine
mouth, dizziness,
disturbed
concentrations
• Most antihistaminic agents
are basic amines.

Antihis
acid + amine = salt

salts= water soluble

acid salts are used to

tamine
maintain free solubility of drug
to water

THEY ARE ACIDIC!!!


Barbitu • Are used to produce various degree of
central nervous system depression.

rate • Barbiturates are administered in small


doses in the daytime as sedatives to
reduce restlessness and emotional

Sedativ
tension.

• The long-lasting , including


phenobarbital, are considered most

e and
useful in maintaining daytime sedation
and in treating some convulsive states
and least useful as hypnotics.
Barbitu
• The intermediate-acting barbiturates
include amobarbital; they are used
primarily for short-term daytime sedation
and are effective in treating insomnia.

rate • The barbiturates classified as short


acting include secobarbital; they are
used to similarly to the intermediate-

Sedativ
acting barbiturates.

• The ultra-short acting barbiturates,


including thiopental, are given

e and
intravenously to induce anesthesia.

• The most common untoward effects are


drowsiness and lethargy.
• Is formulated to contain
phenobarbital 0.4% which provides
about 20mg of drug per teaspoon (5
mL) of elixir.

Pheno • The official elixir contains about 14%


alcohol, which is used to dissolve the
phenobarbital.

barbit • Phenobarbital is a long-acting


barbiturate with a duration of action

al
of about 4-6hrs, a usual adult dose
as a sedative of about 30mg and a
hypnotic dose of about 100mg.
• The elixir is commonly

Pheno
flavored with orange oil,
colored red with an FDA-
approved colorant, and
sweetened with syrup.

barbit • Glycerin is often added to


enhance the solubility of

al
phenobarbital.
• It is required to contain 4.5 to 5.25
mg of digoxin per 100ml of elixir,

Digoxi
or about 0.25 mf/5ml teaspoonful.

• The usual oral adult dose of


digoxin as a cardiotonic agent is
about 1.5mg on initial therapy and

n
about 0.5mg for maintenance
therapy.

• Digoxin is a cardiotonic glycoside


obtained from the leaves of

Elixirs digitalis lanata.


• A white crystalline powder that

Digoxi
is insoluble in water but soluble
in dilute alcohol solutions.

• Digoxin is poisonous, and its


dose must be carefully

n
determined and administered to
each individual patient.

• Digoxin is one of many drugs


available in more than a single

Elixirs
dosage form.
Paracetamo
l Elixir
Acetaminophen Elixir
•Anti pyretic
•analgesic
Table of
Characteristic
s
Ingredie Characteris Functional MethodContainer
nts Category
40 parts tics
Solubility:
of glycerol
Paracetamol 70 parts of water Api
7 parts of ethanol
Flavoring agent 13 parts of acetone
19 parts of propylene
Banana essence
glycol
Coloring agent Simple Amber
Solubilizer solution bottle
Glycerolum Can be mixed with
yellow coloring water and ethanol with
agent agitation
Can be mixed with Diluent
Preservative Propylene water and ethanol
Benzoic acid Glycol 95%

Purified water Hygroscopic, easily


Sorbitol Sweetening
soluble in water,
Solution sparingly soluble in agent
ethanol

Ethanol flammable, colorless


liquid
diluent

Solubility data is very useful in preparations, which include sequences or a


mix of each ingredient must be strictly in accordance with the nature and
solubility.
Procedure
Paracetamol 1.44

Glycerolum 30mL

Propylene Glycol 6ml

Sorbitol Solution 15ml

Ethanol 6ml Adjusted


Apple Essence q.S

Green Coloring Agent q.S

Benzoic Acid 2ml

Purified Water Ad 60ml


PROCEDURE

IN A BEAKER ADD THE


WEIGHT
FF:
COMPONENTS
COLORING AGENT
FLAVORING AGENT
REDUCE THE PARACETAMOL PRESERVATIVE
AND SIEVE WITH MESH #20 PURIFIED WATER

PLACE IN ERLENMEYER FLASK


AND DISSOLVE WITH ETHANOL STORE: TIGHTLY CLOSED
CONTAINER

ADD:
PROPYLENE
POUR INTO CALIBRATION
GLYCEROL
BOTTLE
SOLUTION SORBITOL (70%)
AND STIR UNTIL HOMOGENOUS
Reduce the
Paracetamol with
sieve no.20
me sh
Place in Erlenmeyer
flask and DISSOLVE
w/ ethanol
Add the following:
Propylene
Glycerolum
Sorbiitol sol'n
70%
STIR UNTIL
HOMOGENOUS
Add the following:
Banana Essence
Yellow Coloring
agent
Benzoic acid
Purified water
STORE IN TIGHTLY
CLOSED CONTAINER
DOCUMENTATION
S
Conclusi
on
Elixirs, having a hydrous and alcoholic content requires
special attention in its process of mixing since, when done
wrong, would not promote homogeneity of the produced elixir. It
is important to know the water soluble components to add to
the aqueous mixture and the alcohol soluble components to be
added to the alcoholic mixture in order to promote convenience
in mixing the solution.
It is also important to note the physicochemical property of
the components in order to know the proper procedure of
incorporating it to the elixir.
Learning Evaluation
What are the primary solvents of elixirs?
Alcohol and water, with glycerin, sorbitol and syrup sometimes
as an additional solvent and/or sweetening agents.

What role do glycerin and propylene glycol


play in elixirs?
Presence of glycerin and propylene glycol in elixirs can
assist with dissolution of the solute and enhance
stability of the drug

What are the types of elixirs, and how


are they prepared?
Medicated & Non-medicated, Usually prepared by
simple solution with agitation and/or admixture of
two or more liquid ingredients.
Thank You!!!

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