Handouts - Notes - Activity 3&4 Guaifenesin Oral Solution and Paracetamol Syrup

PHA 6124: PHARMACEUTICAL MANUFACTURING LABORATORY
LIQUID MANUFACTURING
Active pharmaceutical ingredients are developed into dosage-form products before

they are distributed or administered. These ingredients are mixed with pharmaceutical
excipients in order to form a drug product. Liquid pharmaceutical products (i.e. solutions,
suspension etc.) are one of the common examples of dosage form and are manufactured to
cater individuals who are having difficulty in swallowing.
Liquid Manufacturing is a process that involves the intimate mixing of an active

pharmaceutical ingredient with inactive ingredients. Typical liquid manufacturing
process follows certain stages: dispensing of raw material, compounding or mixing,
filtration, filling and packaging. Also, there are several things that should be considered
in liquid manufacturing such as the raw material used, equipment and procedures to be
employed.
Liquid Manufacturing can be classified into two systems: homogenous system and
heterogeneous system. The former refers to a system which the drug/s are in a solution.
These solutions can either be aqueous (i.e. mucilage, gargles, douches) or non -aqueous
(i.e. tinctures, spirits, elixirs, liniments). Heterogeneous system or two -phase systems
involves having a dispersed phase and dispersed medium. (i.e. suspensions, magmas,
emulsion lotions and gels).
Formulating in liquid manufacturing considers certain factors such as solubility

of active pharmaceutical ingredient to its respective solvent, preservation of liquid
preparation, pharmaceutical elegance and stability.
Listed below are solvents that are commonly used in liquid pharmaceutical
products.
1. Purified Water, USP. Most commonly used solvent/vehicle for liquid
preparations having a pH of 5 – 7. Methods of manufacturing Purified Water,
USP includes distillation, reverse osmosis, ion exchange treatment.
2. Alcohol, USP. The most commonly used concentration is 95% Ethanol. This is
the primary solvent for organic compounds and used if the ingredients are not
soluble in water.
3. Glycerin. A polyhydric alcohol (sp.gr. 1.248 – 1.25) which is described as a
clear, syrupy liquid with sweet taste. This can be utilized as a stabilizer and co -
solvent which has the ability to retard crystallization of sucrose.
4. Propylene Glycol. This is described as a viscous liquid, miscible with water
and alcohol which can be used as substitute to glycerin.
pg. 1
mncervantes
In liquid pharmaceutical products, preservatives are also added in the formula in

order to prevent microbial growth. Common examples of preservatives include: benzoic
acid, sodium benzoate, parabens (methyl paraben and propyl paraben).
Conforming to pharmaceutical elegance includes taste, appearance and viscosity

which are essential to ensure patient compliance. Compatible flavoring agents also known
as flavorants are employed in order to mask unpleasant taste of active pharmaceutical
ingredients.
Listed below are the methods employed in flavoring pharmaceutical products:

1. Blending. This is done by blending with particular flavor for a particular taste.
a. Sour taste- add fruity flavor.
b. Bitter taste- add salty, cinnamon or sour or sweet flavor.
c. Salty taste- butterscotch, maple, peach, vanilla, wintergreen.
d. Sweet taste- fruity and berry, vanilla.
2. Masking/Overshadowing. This employs something that has a stronger flavor.
3. Physical
4. Chemical. This involves reaction to mask the taste
5. Physiological. (ie. Menthol- has anesthetizing action; Effervescent- bubbles,
CO 2 gas)
Appearance or color of the product must be consistent with the flavoring agent
used. Colorants employed in the industry may be inorganic or organic. Clarity is also
considered and should be observed every time for solutions. To achieve a clear solution,
filtration and purification may be done.
Lastly, stability of liquid pharmaceutical products is to be assessed since some
drugs are inherently unstable and this is even magnified when it is in a solution. This is
assured by performing stability testing. Examples of pharmaceutical excipients that can
be used: antioxidant, buffers, viscosity enhancing agents, emulsifiers.
ELIXIR
Pharmaceutical elixirs are clear, sweetened hydroalcoholic solution intended for

oral use and are usually flavored to enhance their palatability. Elixirs are usually prepared
by simple solution with agitation and/or by the admixture of two or more liquid
ingredients. Types of Elixirs includes medicated elixir and non-medicated elixir.
pg. 2
mncervantes
GUAIFENESIN ORAL SOLUTION

Formula
Raw Materials Original Amount
Guaifenesin 20.0 g
Alcohol 40.0 mL
Methylparaben 1.0 g
Propylparaben 0.1 g
Orange flavor 40.0 mL
Glycerin 450.0 mL
Sucrose 127.5 g
Colorant q.s
Purified water, q.s. ad 1000.0 mL
Manufacturing Procedure
1. Charge 36% of purified water required in a beaker (Tank A)
2. Heat to 60˚C
3. Add Methyl paraben & Propyl paraben.
4. Mix for 5 minutes.
5. Continue heating up to 80˚C and continue mixing for 10 minutes
6. Check for complete solution.
7. Turn off the heat. Cool to 60˚C.
8. Add API, sucrose and glycerin. (Ensure that the ingredient added is dissolved before adding the
next)
9. Mix for 15 minutes and check for complete solution. Cool to 40˚C
10. In a separate beaker (Tank B), mix alcohol & orange flavor
11. Charge the water solution to alcoholic solution slowly.
12. Add enough water to complete the volume. Agitate for 5 minutes
13. Add colorant, then agitate
14. Adjust pH to 3 – 4 (if applicable)
15. Proceed to filling.
Note: The alcohol content when present in a pharmaceutical product must be expressed in % alcohol
strength in the formulation.
𝒗𝒐𝒍𝒖𝒎𝒆 𝒐𝒇 𝒂𝒍𝒄𝒐𝒉𝒐𝒍 𝒙 𝒄𝒐𝒏𝒄𝒆𝒏𝒕𝒓𝒂𝒕𝒊𝒐𝒏 𝒐𝒇 𝒂𝒍𝒄𝒐𝒉𝒐𝒍

%𝑨𝒍𝒄𝒐𝒉𝒐𝒍 = 𝒙 𝟏𝟎𝟎
𝑻𝒐𝒕𝒂𝒍 𝒗𝒐𝒍𝒖𝒎𝒆
Standard concentration of alcohol used: 95 %
SYRUP
Syrups are defined as concentrated aqueous preparation of sugar or sugar substitute

with or without added flavorant and medicinal agent intended for oral use. Examples of
pg. 3
mncervantes
sugar substitutes that can be used are glycerin, sorbitol and propylene glycol. Syrup s can
be medicated or non-medicated. Medicated syrups are those with active pharmaceutical
ingredient. Non-medicated syrups can either be a flavored syrup (with flavorant) or
simple syrup. Simple syrups are near saturated solution containing water and sucr ose.
Listed below are methods of preparation for pharmaceutical syrups:

1. Percolation.
2. Solution with aid of heat.
3. Solution without aid of heat.
4. Addition of sucrose to a medicated liquid.
PARACETAMOL SYRUP
Formula
Raw Materials Original Amount
Paracetamol 24.0 g
Sodium benzoate 1.0 g
Propylene glycol 150.0 mL
Saccharin 1.8 g
Purified water 200.0 mL
Strawberry flavor conc. 2.0 mL
Glycerin q.s. ad. 1000.0 mL
Colorant q.s
Manufacturing Procedure:
1. Charge 400 mL (volume for 1L) of glycerin in a mixing tank.
2. Add purified water
3. Add propylene glycol
4. Heat to 70°C.
5. Add Paracetamol. Mix for 10 minutes
6. Add saccharin. Mix for 5 minutes
7. Add sodium benzoate. Mix for 5 minutes
8. Cool compounding vessel to 40°C.
9. Add strawberry flavor
10. Add enough amount of glycerin to make the req. volume.
11. Add colorant
12. Filter the solution, if necessary
pg. 4
mncervantes

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PHA 6124: PHARMACEUTICAL MANUFACTURING LABORATORY

Active pharmaceutical ingredients are developed into dosage-form products before

Liquid Manufacturing is a process that involves the intimate mixing of an active

Formulating in liquid manufacturing considers certain factors such as solubility

In liquid pharmaceutical products, preservatives are also added in the formula in

Conforming to pharmaceutical elegance includes taste, appearance and viscosity

Listed below are the methods employed in flavoring pharmaceutical products:

Pharmaceutical elixirs are clear, sweetened hydroalcoholic solution intended for

GUAIFENESIN ORAL SOLUTION

𝒗𝒐𝒍𝒖𝒎𝒆 𝒐𝒇 𝒂𝒍𝒄𝒐𝒉𝒐𝒍 𝒙 𝒄𝒐𝒏𝒄𝒆𝒏𝒕𝒓𝒂𝒕𝒊𝒐𝒏 𝒐𝒇 𝒂𝒍𝒄𝒐𝒉𝒐𝒍

Standard concentration of alcohol used: 95 %

Syrups are defined as concentrated aqueous preparation of sugar or sugar substitute

Listed below are methods of preparation for pharmaceutical syrups:

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