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A476 P1 Team 1 - Dacie, Navid, Samantha, Vivien, Zazaa

A476 P01 Y2S2

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Page 1: A476 P01 Y2S2

A476 P1Team 1 - Dacie, Navid, Samantha, Vivien, Zazaa

Page 2: A476 P01 Y2S2

Dextromethorphan hydrobromideChemical Structure: C18H28BrNO2

> Does not contain sulphur

Dosage form: Syrup > Does not contain alcohol

It is a cough suppressant and is suitable for the patient’s current symptoms.

Page 3: A476 P01 Y2S2

Codeine phosphateChemical Structure: C18H24NO7P

Codeine is contraindicated in patients younger than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen (alone).

Promethazine hydrochlorideChemical structure: C17H21CIN2S

> Contains sulfur and patient is allergic to sulphur containing medicine

Therefore, both codeine phosphate and promethazine hydrochloride cannot be used

Page 4: A476 P01 Y2S2

Excipients Chosen Excipients Why is it chosen?

Purified Water (Solvent) Needed to make syrup

Methyl Paraben (Preservatives)

Prevent microbial growth. Soluble in water.

Sacharrin (Sweetener) Soluble in water and acts as a sweetener

Orange flavour D717 (Flavoring Agent)

Mask bad taste of medicine. Orange flavour to match coloring agent.

Sunset Yellow (Coloring Agent)

Make syrup look more attractive for the child & match the flavour

Note:➢ Did not use propyl paraben (preservative) because it is insoluble in water.

○ Soluble in ethanol, ether, acetone, methanol➢ Sodium benzoate (preservative) has low water solubility➢ Aspartame (sweetener) slightly more soluble in ethanol as compared to water➢ Glucose (sweetener) - cannot use since the patient as lactose intolerant

Page 5: A476 P01 Y2S2

Excipients AmountPurified Water (Solvent)

Methyl Paraben (Preservatives)**0.015% - 2%

0.015/100 * 120mL = 0.018ml

Sacharrin (Sweetener)**0.02% to 0.5%

0.02/100 * 120mL = 0.024ml

Orange flavour D717 (Flavoring Agent)

q.s

Sunset Yellow (Coloring Agent) q.s

Page 6: A476 P01 Y2S2

Dextromethorphan hydrobromide 10% w/v in terms of 120 ml= 12ml

Codeine phosphate 10% w/v of 120 ml =12mlChildren 6 to 12 years of age: ½ to 1 teaspoonful (2.5 mL to 5 mL).

These doses may be given every 4 to 6 hours as needed. ( Twice a day )

Suggested Dosing Instruction

Page 7: A476 P01 Y2S2

Process of making Pharmaceutical Syrup Pharmaceutical syrups are produced by mixing purified water, sweeteners, active ingredients (API), aromas, flavors and other ingredients (thickeners) etc.

Generally, there are 4 kinds of processes

The choice depending on the physical and chemical characteristics of the substances entering into the preparation:

1. Solution by heat

2. Agitation without heat

3. Addition of medicating liquid to syrup

4. Percolation

Furthermore, there are precautions taken such as

● A purified water free from foreign substances and clean vessels and containers must be used.

● Ingredients used must be contamination free

● Mixing process must be done gradually if using heat

Page 8: A476 P01 Y2S2