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ELIXIR

ALCOHOL solvent
- 10-12% self-preserving
- 5-40% (limit)
- Some references: less than 60%
limit
- Use as vehicle or for their
therapeutic effect
ELIXIR
- A
clear,
sweetened
hydroalcoholic liquid intended
for
oral
use
containing
flavouring substance or active
medicinal agent
- Their primary solvents are
alcohol and water
- Glycerin, sorbitol and syrup are
additional
solvent
and/or
sweetening agents
- Propylene Glycol
o Can be used as a
substitute for glycerine
and alcohol
- Alcohol
o Excellent
solvent
for
drugs but it accentuate
the
saline
taste
of
bromides
and
similar
salts
o
2 GROUPS OF ELIXIR
1. Flavored Elixir
2. Medicated Elixir
METHODS OF PREPARATION
1. Agitation without the aid of heat
2. Admixture of 2 or more liquids
ISO-ALCOHOLIC ELXIR
- Non-medicated elixir
- Use: General vehicle for various
medicaments
that
requires
solvent of different alcohol
strength

Low
Alcoholic

High
Alcoholic

Undiluted
4 volumes
3 volumes
2 volumes
1 volume
1 volume
1 volume
none

None
1 volume
1 volume
1 volume
1 volume
2 volumes
3 volumes
undiluted

Suitable
as vehicle
for
preparati
on of the
ff.
Alcoholic
strength
0-10%
10-20%
20-30%
30-40%
40-50%
50-60%
60-70%
70 or more

19:
ISO
ALCOHOLIC
ORAL
SOLUTION USP 37
PROCEDURE
Mix 15 mL of High Alcoholic
Elixir TO 15 mL of Low Alcoholic
Elixir
Low Alcoholic:
1. Compound Orange Spirit +
Alcohol
2. Glycerin, agitate
3. Add 10mL distilled water. Mix.
Stir until solution is complete
4. Stand for 24 hours with
intermittent agitation
5. Dissolve sucrose in solution
6. Filter until clear. Add sufficient
amount of water to make 15 mL
High Alcoholic:
1. Dissolve saccharin in compound
orange spirit
2. Add glycerine, agitate
3. Add 10mL alcohol. Stir.
4. Filter until clear, add sufficient
amount of alcohol up to 15 mL

20: TERPIN HYDRATE ELIXIR USP


37
PROCEDURE
1. Triturate Terpin hydrate
2. Disllove
terpin
hydrate
in
alcohol
3. Add successively orange peel
tincture, benzaldehyde, glcerin
and syrup. Agitate after every
addition.
4. Add sufficient amount of water
5. If it becomes turbid, filter until
clear,
hydroalcoholic,
sweetened solution is obtained

SPIRIT
A clear, saturated, alcoholic
(over 60% alcoholic content) or
hydroalcoholic
solution
of
volatile
oil
or
aromatic
substances
The active ingredient in spirit
may be solid, liquid or gas
Used
internally
for
their
medicinal value
Flavoring agent
Stored in tight light resistant
container and in a cool place,
preventing
evaporation
and
volatilization of either the
alcohol or the active principles

PREPARATION
1. Simple solution
65 mL volatile oil/1000mL
preparation
2. Solution with Maceration
Macerates
leaves
in
water to extract water
soluble components
3. Chemical reaction

NaNO3 + Alcohol +
H2SO4 Ethyl Nitrate
Spirit
4. Distillation
Brandy fermented juice
of ripe grapes
Whisky

Fermented
mash
of
wholly
germinated malted cereal
grain
21: COMPOUND ORANGE SPIRIT
USP 37
PROCEDURE
1. Measure 20mL alcohol
2. Add orange oil, lemon oil, coriander
oil and anise oil, stirring after each
addition until the oil is mixed or
dissolved thoroughly
3. Filter until clear, add sufficient
amount of alcohol to make 30 mL
22: PEPPERMINT SPIRIT
PROCEDURE
1. Macerate peppermint leaves(torn
leaves with no stems) in 20mL of
purified water for 1 hour with
agitation
2. Filter through muslin cloth or filter
paper
3. Add peppermint oil to filtrate and
complete the required volume with
alcohol
23: AROMATIC AMMONIA SPIRIT
PROCEDURE
1. Dissolve Ammonium carbonate in
strong ammonia solution and 6mL
of purified water.
2. Agitate. Stand for 24 hours
3. In another container, dissolve all
the volume oils in alcohol.
4. Gradually add the mixtures (1&3)
5. Stand for 24 hours. Agitating
occasionally

6. Add enough water to make 30 mL


7. If turbidity occurs, filter it

EXTRACTIVES
- Product prepared by extraction
of drug with suitable solvent
PROCESS
- Percolation
- Maceration
- Digestion
- Infusion
- Decoction
TYPES
1. TINCTURE
- Alcoholic/
hydroalcoholic
solution
prepared
from
vegetable or animal drug or
from chemical substance
- 10-20%
potency
(1020g/100mL)
- 50% alcohol content
- Tight light resistant container
and avoid exposure to direct
sunlight and excessive heat
Prepared by:
Simple Solution Iodine
Tincture
Percolation Belladona
Tincture
Maceration

Sweet
Orange Peel Tincture
2. Fluid Extract
- 1g/mL
- Alcohol as solvent
- 100% tincture
- Potent, too bitter taste
Prepared by:
Percolation
Process A (extract
is ready for assay)
Process D (hot
water
as
menstrum)

Process E (longer
and
narrower
percolator)

3. Extract
- 2x to 6x more potent than crude
drug
Semi Liquid syrupy 20mL of
the solvent is left
Pillular Solid extract, plastic
masses, all solvent has been
evaporated
Dry
Powder

powdered
extract, starchy substance (eg.
Cassava, raddish)

METHOD OF PREPARATION OF
TINCTURE
Simple Solution
Percolation (Process D)
Percolation (Process E)
Sodium Iodide
- Solubilizing agent
- Used to stabilize the tincture
and make it miscible with water
in all proportions
- Prevents formation of ethyl
iodide
- Will react with I2 to form NaI3
- Thus I2 will not react with
alcohol to form ethyl iodide,
acetaldehyde and hydrogen
iodide
- Hydrogen iodide causes pain
- Ethyl
Iodide

decrease
bacteriostatic activity
24: IODINE TINCTURE
PROCEDURE
1. Prepare
NaI
solution
by
dissolving NaI in water
2. Dissolve I2 crystals with NaI
solution

3. Stir. Add alcohol


4. Add enough purified water to
complete the volume

LINIMENTS
Solution of mixture of various
substance in oil, alcoholic
solution of soap or emulsion
intended
for
external
application
Applied
with
friction
and
rubbing to the affected area and
that is why they are called
embrocation
The oil and soap base provides
ease
of
application
and
massage

ALCOHOLIC LINIMENTS
- Intended generally for their
rubefacient,
counterirritant,
mild astringent and penetrating
effect
- Penetrate the skin readily than
the oil base
OILY LINIMENTS
- Milder in their action but are
more useful when massage is
desired
- Used as protecting coating
depending on the ingredient in
the preparation should not be
applied on braises and broken
skin
FORMS
Solution
Emulsion
Suspension
25: CAMPHOR SOAP LINIMENT

PROCEDURE
1. Dissolve soap, camphor with
alcohol gentle heat
2. Filter the liquid while hot into
another flask warm to render
liquid
3. Add oil, strong ammonia water,
mix
4. Pour to container
5. Immediately cover and cool

GLYCERITES
Solution or mixture of medicinal
substances in not less than 50%
by weight of glycerine
Most glycerites are viscous
while some are jelly like
Used to prepare aqueous and
alcoholic dilutions of substances
which are readily soluble in
water or alcohol
Sole solvent for the preparation
of Antipyrine and Benzocaine
Otic Solution, USP
Protectant, emollient, substitute
for fatty ointment
Hygroscopic tightly closed
container

GLYCERIN
- Reducing agent
- Should not be triturated with
strong oxidizing agent like
KMno4 , Chromium trioxide or
KClO3 explosion will likely
occur
- When contaminated with iron, it
produces
coloration
with
phenol, salicylates, tannin etc.
- Strong HNO3 / H2SO4 converts
glycerine into an explosive
nitroglycerin
- Soluble in water hygroscopic

26: STARCH GLYCERITE


PROCEDURE
1. Triturate starch and benzoic
acid in a mortar. Add water.
Levigate with glycerine until
smooth paste is formed.
2. Transfer to the final container.
3. Heat the mixture in a sand bath
(140-144C) with gentle and
occasional
agitation
until
translucent, jelly like mass is
formed

EMULSION
2 phase system in which one
liquid is dispersed in the form of
small
globules
throughout
another liquid in which it is
immiscible

3 COMPONENTS
1. Dispersed liquid/ Internal phase/
Discontinuous Phase
2. Dispersion medium/ External
Phase/ Continuous Phase
3. Intermediate agent/ Emulsifying
agent/ Dispersing or Stabilizing
agent
TYPES OF EMULSIFYING AGENT
1. Natural
a. Animal gelatine, egg
yolk,
casein,
woolfat,
cholesterol
b. Vegetables acacia,
tragacanth,
chondrus,
pectin,
caraya,
carrageenan
2. Synthetic

a. Finely Divided Solid


Mg(OH)2, Al(OH)2, and
Magnesium trisilicate
b. Colloid

Kaolin,
Bentonite Magma
c. Anionic SLS
d. Cationic Benzalkonium
chloride, cetylpyridinium
chloride
e. Non-ionic PEG 400,
Spans (sorbitan esters),
Tweens (polysorbate)
f. Amphoteric Lecithin
TYPES OF EMULSION
1. Simple
- o/w; w/o
2. Multiple
- o/w/o; w/o/w
3. Microemulsion
- Most stable of the 3; dispersed
phase is in very small globules
(100-1000A) (1A = 0.1nm)

METHOD OF PREPARATION
1. Wet/ English
- O:W:E
- 4(oil): 2(water): 1(gum)
- Gum and oil first then add water
at once
- In one direction, creamy, sticky
mixture with cracking sound
2. Dry/Continental
- O:W:E
- 4(oil): 2(water): 1(gum)
- Gum and water first then add oil
slowly
- In one direction, creamy, sticky
mixture with cracking sound
3. Bottle/ Forbes
- 3(oil): 2(water): 1(emulsifier)
- Shaking vigorously
4. Auxiliary Method
- Hand homogenizer
5. In Situ Soap

- Calcium soap and soft soap


6. Microemulsion
- 100A (10 microns)
PROBLEMS
1. Creaming
- Temporary separation of the 2
phase shake again
2. Cracking
- Total separation of the 2 phase
with coalescence
3. Phase Inversion
- Evaporation of water; o/w w/o
due to evaporation
METHOD
OF
IDENTIFYING
EMULSION
1. Drop Dilution Test
- Add
water
(drop)

homogenous o/w
2. Dye Solubility Test
- Oil soluble sudan red w/o
- Water soluble amaranth
green o/w
3. Electronic Conductivity Test
- Water conduct electricity o/w
4. Fluorescence Test
- Oil can absorb UV light w/o
27: Mineral Oil Emulsion
PROCEDURE:
Dry Gum
1. Triturate mineral oil
2. Add emulsifying agent in portion
and triturate
3. Add water and triturate
4. Add
syrup
in
portion
in
trituration
5. Add
vanillin,
previously
dissolved in alcohol, in portion
with trituration
6. Add enough water to 30mL
Wet Gum
1. Prepare nucleus

2.
3.
4.

5.

a. Triturate
emulsifying
agent
b. Add water (all at once)
and continue triturating
(cracking sound)
Add oil in portion with trituration
Add syrup in portion with
trituration
Add vanillin previously dissolved
in alcohol in portion with
trituration
Add enough water to make
30mL

MIXTURES
Reasons for having the insoluble
substances in a finer state of
subdivision
o They
become
as
adsorbent and protective
when in contact with the
inflamed areas
o Suspended more readily
and settle out much
slowly than large particle,
thus enabling the patient
to obtain uniform doses
of suspended particles
o To increase palatability of
the preparation (use of
colloidal
suspending
agent)

INSOLUBLE SUBSTANCES
- Must be in very finely divided
state and it must be uniformly
distributed
throughout
the
preparation
- This is accomplished by the use
of colloid mill or special
methods of precipitation
28: CHALK MIXTURE
PROCEDURE

1. Triturate the Calcium carbonate


with 5mL water
2. Add glycerine and levigate
3. Add
cinnamon
water
and
triturate
4. Transfer mixture in a graduated
cylinder
5. Wash mortar with purified
water, add washings to the
cylinder
6. Add enough water to complete
the volume

GEL
Suspension, in a water medium
of insoluble drugs in hydrated
form wherein the particles size
approaches or attain colloidal
dimension (1-1000nm)
Very fine particle size to achieve
large
surface
and
thus
maximum adsorption capacity
May contain peppermint oil,
glycerine,
sorbitol,
sucrose,
saccharin or other suitable
flavour and preservative in a
total amount of not exceeding
0.5%

THIXOTROPHY
- Semisolid or gelatinous when
undisturbed
but
when
shaken/agitated, they liquefy
29: Aluminum Hydroxide Gel
PROCEDURE
1. Calibrate bottle to 30mL
2. Container 1: Dissolve sodium
carbonate in 60mL hot water
and filter (sodium carbonate
soln)
3. Container 2: Dissolve alum in
30mL of hot water (alum soln)

4. Filter the alum solution into the


carbonate solution
5. Add 60mL hot water with
stirring to allow gas to escape
(5 mins)
6. Transfer to 1.5L soft drink bottle
7. Dilute to 1200mL with cold
water. Stand. Decant.
8. Filter and wash residue with
10mL cold water.
9. Suspend residue in purified
water to make 30mL. Flavor
with
peppermint
oil
and
preserve with sodium benzoate.
10.
Homogenize
resulting
gel.

LOTION
Liquid suspension or dispersion
intended for external
application to the body
Applied without friction
Insoluble matter are finely
divided as particles approaching
colloidal dimension are more
soothing to inflamed areas and
more effective in contact with
the infected area

METHOD OF PREPARATION
1. Triturating the ingredient to a
smooth paste and then
cautiously adding the remaining
liquid phase (with the use of
high speed mixer and
homogenizers)
Calamine Lotion consists
of finely divided insoluble
solids held in more or less
permanent suspension by
the presence of suspending
agents/ surface active agent

2. By Chemical Interaction in
the Liquid
White Lotion must be
freely prepared and does not
contain suspending agent.
ZnSO4 + Sulfurated Potash
(K2S) ZnS + 2S + K2SO4
3. Clear Solution in which the
active ingredient is a water
soluble substance
Dimethisoquin
hydrochloride lotion
30: CALAMINE LOTION USP 37
PROCEDURE
1. Dilute bentonite magma with an
equal volume of calcium
hydroxide topical solution
2. Mix zinc oxide and calamine
alternately with glycerin
3. Add 7.5mL diluted magma
4. Triturate and add the remaining
magma
5. Add enough calcium hydroxide
topical solution to complete
volume

SUSPENSION

Dispersion of finely divided


insoluble solid particles in a
liquid.
May be:
1. Coarse Suspensions
2. Colloidal Suspension

31: HYDROCORTISONE
SUSPENSION
PROCEDURE
1. Calibrate bottle at 30mL
2. Weigh specific amount for
menthol, hydrocortisone and
calamine.
3. Prepare menthol bulk (dissolve
in IPA)
4. Place the hydrocortisone in a
mortar and add the calamine
geometrically
5. Take 2mL of menthol-IPA
solution and an additional 1mL
of IPA
6. Add the above solution to the
powders in the mortar with
trituration smooth paste
7. Add about 5mL of water before
adding 20mL of Cetaphil
8. Transfer to a calibrated bottle
(30mL)
9. Use a little water to rinse mortar
10.Add water to make 30mL

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