Handout Syrup - Elixir 2023

FORMULASI DAN TEKNOLOGI
SEDIAAN CAIR DAN SEMIPADAT

FAF2572
Syrup & Elixir
Dr.Eng. apt. Khadijah, M.Si.

khadijah03@ugm.ac.id
Lab. Teknologi Farmasi

T.A 2022/2023
References
• Aulton, M.E.; “Pharmaceutics, The Science of Dosage Form Design”, 2nd edition,
Churchill Livingstone, London, 2002.
• Ansel H. C.; “Introduction to Pharmaceutical Dosage Forms”, 4th edition, K. M.
Varghese Company, Bombay, 1985.
• Jones D.; “Pharmaceutics- Dosage Form and Design”, Pharmaceutical Press, London,
2008.
• Lachman. L, Lieberman. H.A. Kanig J. L.; “The Theory and Practice of Industrial Pharmacy”,
3rd edition, Varghese Publishing House, Bombay, 1991.
• Carter S. J.; “Dispensing for Pharmaceutical Students”, 12th edition, CBS Publishers and
Distributors, Delhi (India), 1987.
• Gennaro A. R.; “Remington: The Science and Practice of Pharmacy”, 20th edition, B. I.
Publication Pvt. Ltd., 2004.
• Florence A. T. and Attwood D.; “Physicochemical Principles of Pharmacy”, 4th edition,
Pharmaceutical Press, London, 2006.
Lesson Plan
Content Study achievements Workload Method

1.Introduction (syrup)
2.Medicament non-
medicated syrup
3.Excipients
4.Production and evaluation • Assignment / Quiz Teacher and Student center
of syrup • Final Exam 100 minutes learning (TCL-SCL); problem-
5.Dry syrups based learning (PBL)
6.Introduction (Elixir)
7.Production and evaluation
of elixir
Introduction
”A concentrated or nearly saturated solution of sucrose in water, with or without
active compound or excipients”.
Why is syrup needed?
‘Children and elderly people unable to swallow capsule/tablet’
Active
base comp.
syrup
Medicated syrup
Non-medicated syrup (Simplex syrup)

Advantage of Liquid Dosage Forms
• Covering bad taste/smell

• The viscous liquid able to prevent pain
in the mouth tissue
• Easy for dose adjustment
Challenge!
Organoleptic
Stability
Absorption
Stability
Absorption
Formulation of Liquid Solution Dosage Form
Solubility
Organoleptic
Syrups
Stability
Preservation
Excipients Vehicle
& Co-..
Coloring Surfact-
agent ant
Flavouri
Preser-
ng Syrup vative
agent
Sweete-
Antioxi-
ning
dant
agent
Buffer
Critical points of Excipients
• Easily available
• Chemically, physically, and
• Economic
therapeutically inert
• High flexibility
• Nontoxic
• Thermo stable
• Compatible
• Sterilizable
Excipient
• Biologically stable • Odorless

• Could be standardized • Tasteless
approved by regulatory • Elegant
bodies derivable • Pharmaceutical acceptable
Solubility Enhancer
Solubility standard-based Pharmacopeia
Part of solvent (mL) required

Descriptive Phrase
per part (g) of solute
https://pubchem.ncbi.nlm.nih.gov/com
Very soluble Less than 1
pound/acetaminophen#section=Color
Freely soluble From 1 to 10
Soluble From 10 to 30 In water, 14,000 mg/L at 25 °C
Sparingly soluble From 30 to 100
Slightly soluble From 100 to 1000
Very slightly soluble From 1000 to 10000
Practically insoluble 10000 and over
Cont.
Potential hierarchy of formulation approaches for the development of oral
formulations for poorly water-soluble drugs
Preservative
“The chemical substances used to improve or amplify shelf life of drugs by
decreasing or lowering the oxidation of active and Excipients and by reducing
microbial production”.
To protect our drug

To stabilize our
from microbial product
attack
To enhance activity
To increase shelf life
and efficacy of of our product
drugs
1. Antimicrobial Cont.
It must decrease the percentage of the microbes and prevent any re-growth.
 Microbiostatic
 Microbiocidal in nature
Antimicrobial activity
Active against microbes at low concentration
Aqueous solubility
Should be soluble to reach minimum inhibitory concentration
Stability properties
Stable during and at the end of manufacturing

2. Antioxidant Cont.
A substance that reduces damage due to oxygen, such as that caused by free
radicals.
e.g. : combination of vitamin C and E*

3. Chelating agent Cont.
Protect product by forming a complex with it preventing its deterioration.
*Nicotianamine (NA), Citric acid (CitH)

Organoleptic
1. Colorant Cont.
Is it important?
• Improving acceptability of patient

• Product/intermediate identity
• Stability indicator
Ideal colorant?
Cont.
The Food Drug and Cosmetic Act of 1938 created three categories
of Dyes
FD&C colors: These are colorants that are certifiable for use in foods, drugs, and
cosmetics.
D&C colors: These are dyes and pigments considered safe for use in drugs and
cosmetics when in contact with mucous membranes or when ingested.
External D&C colors: These colorants, due to their oral toxicity, are not certifiable
for use in products intended for ingestion but are considered safe for use in
products applied externally
2. Flavoring 3. Viscocity agent Cont.
Flavour: natural, sintetic: To improve pouring performance
• Essential oil (favorable), and taste sensing (e.g.: PVP,
• Water solubility problem, cellulose derivative).
required additional alcohol
Sweeter: Sugar and non-sugar

Sucrose, sorbitol (half sweet than
sucrose), Glycerin, Honey, Saccharin
Sodium (300-550 times), Cyclamates
(30 times sweeter than sucrose),
Aspartame.
Color and flavor mast be matched (e.g.:
green-mint; brown-choco, etc.).
Syrup vs Oral Solution?
Cont.
Veto*** Product Alfre*** Product
1. Paracetamol 500mg/5mL 1. Alimemazine tartrate 30mg/5mL
2. Citric acid monohydrate 2. Sucrose
3. Erythrosine (E127) 3. Citric acid monohydrate
4. Glycerol 4. Sodium citrate
5. Macrogol 400 5. Methyl parahydroxybenzoate
6. Propylene Glycol (E218)
7. Methyl parahydroxybenzoate 6. Sodium sulfite anhydrous (E221)
8. Propyl parahydroxbenzoate 7. Sodium metabisulfite (E223)
9. Raspberry flavor No.1 8. Ascorbic acid
10. Saccharin Sodium 9. Caramel flavour
11. Sodium citrate 10. Apricot flavour
12. Purified Water 11. Purified water
Syrup Production
Hot Cold
< 90oC, quick process Prevention of inverted sugar
Required intensive agitation /
*Inverted sugar (hydrolysis sugar) homogenization
*High bacterial growth Take long time
Mixing methods
Elixir
A liquid containing a medicinal drug with syrup, glycerin, or alcohol added to mask
its unpleasant taste.
Low sugar High stability (relative)

Less sweet Not suitable for alcohol
allergic patient
Low viscous
Must keep in air-tight
Less covering bad taste screw-top jar
Containing high conc. alcohol
10-12% (*preservative) Cosolvent: glycerin, propylene glycol
Simple preparation Suitable for diabetes patient

Stability
Method Formula Dry ?

syrup Packaging
Storage Packaging
Distribution
Refer to Packaging and Storage Requirements Farmakope Indonesia

<659> Packaging and Storage Requirements (USP)
Quality Control of Syrup Product
pH
Microbe
level Drug
<51> content
Syrups
Viscosity
Taste
Volume
Appearance (transfer
(transparenc volume)
y, color) <1261>
Thank you

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FORMULASI DAN TEKNOLOGI

SEDIAAN CAIR DAN SEMIPADAT

Syrup & Elixir

Dr.Eng. apt. Khadijah, M.Si.

Lab. Teknologi Farmasi

Content Study achievements Workload Method

Why is syrup needed?

‘Children and elderly people unable to swallow capsule/tablet’

Non-medicated syrup (Simplex syrup)

• Covering bad taste/smell

• Biologically stable • Odorless

Part of solvent (mL) required

To protect our drug

Active against microbes at low concentration

Stable during and at the end of manufacturing

e.g. : combination of vitamin C and E*

*Nicotianamine (NA), Citric acid (CitH)

• Improving acceptability of patient

Sweeter: Sugar and non-sugar

Low sugar High stability (relative)

Simple preparation Suitable for diabetes patient

Method Formula Dry ?

Refer to Packaging and Storage Requirements Farmakope Indonesia

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