Handouts - Notes - Activity 3&4 Guaifenesin Oral Solution and Paracetamol Syrup
Handouts - Notes - Activity 3&4 Guaifenesin Oral Solution and Paracetamol Syrup
Handouts - Notes - Activity 3&4 Guaifenesin Oral Solution and Paracetamol Syrup
LIQUID MANUFACTURING
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).
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PHA 6124: PHARMACEUTICAL MANUFACTURING LABORATORY
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
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PHA 6124: PHARMACEUTICAL MANUFACTURING LABORATORY
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.
SYRUP
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PHA 6124: PHARMACEUTICAL MANUFACTURING LABORATORY
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.
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
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