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semisolid dosage forms

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A semisolid dosage form has

a soft solid consistency
Suppositories must be more rigid because
they will be inserted into an orifice
Types of semisolid dosage forms:
1. medication sticks
2. lozenges
3. suppositories
4. lotions
5. creams
6. ointment
7. pastes
8. plasters
Lozenges, sticks, and suppositories require
that molds be used in their preparation.
Lozenges are
oral dosage forms that are placed in the oral cavity

under tongue,
between cheek and gum, and meant to disintegrate in a few minutes
Medication sticks
are used to topically apply
local anesthetics,
sunscreens,
antivirals,
antibiotics, and
cosmetics
Suppositories
are used to administer medication by way of
rectum,
vagina,
or the urethral tract
Suppositories will
1. melt or dissolve at body temperature
2. deliver the active drug either locally or systematically
Lotions, creams, ointments, and pastes
are dermatological preparations applied to the skin for either local or systemic effect
Most compounded semisolids have two predominant components:
1. a fluid base that is most often an emulsion but also can be a suspension
2. an amount of solid material that is dispersed within the fluid base.
The final consistency of the preparation depends on
1. the relative amounts of these two components
2. any excess solid material
3. ingredients used.
Because semisolids are dispersions,
the ingredients must be blended together in some fashion
In majority of preparations
heat will be used to facilitate the incorporation of ingredients
Heat is
typically supplied by a
1. water bath or
2. a direct heat source such as a hot plate
Water baths are used for
low temperature applications
Direct heat sources are used for
preparations that require temperatures
Outcomes of heating semi-solid ingredients
1. the heat is used to simply liquefy some of the preparation ingredients
(allowed to cool and it becomes uniform)

2. Heat melts some of the ingredients but the melted ingredients undergo a series of chemical
reactions that will play a role in the final consistency of the preparations
Most reactions involve ingredients that have
fatty acids
alkyl alcohols
As the preparation ingredients are heated
the acids and alcohols readily form long chain esters
have emulsifying properties
White wax
70%-75% mixture of C18 hydroxyl acids and esters made from straight chain monohydric
alcohols
Cetyl esters wax
a mixture of esters made of saturated fatty alcohols (C14-C18) and
saturated fatty acids (C14-C18)
Mineral oil
refined liquid saturated aliphatic (C14-C18) and
cyclic hydrocarbons obtained from petroleum
The white wax is
melted first
then heat is reduced
The amount of excess solid material in a semisolid mixture
plays a major role in determining the final texture and stiffness of the compounded
preparation.
Unreacted material
1. some of the original material that did not undergo reaction
2. other ingredients added to the preparation that were not intended to undergo reaction
Most ingredients used in compounding semisolids melt at or under
70 C to 75 C
When heat is used to melt ingredients,
a water bath or
a special low-temp hot plate is used.

-provide adequate control over the heating

-ensure that the ingredients are not overheated.
Why are special low-temp hot plates not a standard laboratory type hot plate?
because they heat at 125C to 150C at their lowest setting
When heating is part of a compounding procedure,
1. apply heat only to melt the specified ingredients.
2. Do not constantly apply heat unless instructed to
Continually applying heat can
1. lead to destruction of ingredients
2. start unintended chemical reactions
if more than one ingredients is to be melted
1. melt the compound with the highest melting point first
2. turn down the heat and melt the ingredient with the 2nd highest melting point

-will ensure that the ingredients were exposed to minimum heat

-will enhance stability
When both an oil and an aqueous portion are being heated to make a semisolid,
1. heat the aqueous portion a few degrees higher than the oil portion prior to mixing
2. use the lowest temp
3. keep the heating time as brief as possible to minimize the quantity of water lost through
evaporation
Why do you heat the aqueous portion higher?
because the aqueous phase tens to cool faster than the oil phase
may cause premature solidification of some ingredients
once all of the ingredients have been added
the cooling process should not be interrupted or augmented by SHOCK COOLING the
preparation
Shock cooling is
most often accomplished by putting the preparation in a refrigerator or a freezer but also can
be done by placing a heated melt in cold water

will stop the chemical reactions prematurely, which will change the properties of the final
preparation
Tips for compounding semisolids
1. If a preparation is too "stiff" or is difficult to apply, decrease the waxy ingredients'
concetrations

2. before adding volatile ingredients,

cool the semisolid preparation to fluid (but not hot) before adding them. *this will allow
uniform mixing without evaporation of the volatile

3. APIs can be easily added to ointments and creams using

SPATULAS AND PILL TILE. if a large amount of API is going to be incorporated, use a
heating method system

4. A kitchen mixer may be useful

compounding semisolids often involves
chemical reactions catalyzed by heat
the cooling process must be allowed to occur at its own rate
to ensure that the final preparation has the properties and characteristics expected
What is a reasonable estimate for all of the chemical reactions to stop in a cooling
preparation?
3 to 4 hours
A coal tar lotion formulation
Coal Tar solution = 12 mL
Salicylic Acid = 6g
Tween 80 = 1 mL
Cetyl Alcohol = 6g
Stearyl Alcohol = 6g
Sodium Lauryl sulfate = 6g
Glycerin (5%) in propylene glycol qs 120 mL

-dark brown liquid

-final: golden and stiffens to form lotion or fluid cream
Cold cream
Cetyl esters wax: 125 g
White wax: 120 g
Mineral oil: 560 g
Sodium Borate: 5g
Purified water: 190mL

-does not have luster or sheen

-Overnight: almost luminescent cream
When transferring a heated preparation to a package:
1. Do not pour a heated semisolid preparation into an ointment jar and let cool.
2. Transfer the semisolid from the compounding vessel to the packaging device when the
preparation is just a few degrees above the congealing temperature - a thick and viscous fluid
Why do you not pour a heated semisolid preparation into an ointment jar and let it cool?
the jar is a different temp than the heated preparation
it will act as a shock cooling reservoir
When is it not appropriate to use a thermometer to check temperature
when working with small batches
the mixture may not come up to the mark
A practical method to determine when to transfer the semisolid material to a mold or final
container is to
touch the heated vessel to the back of the hand

- if the vessel is comfortably hot, the semisolid can be poured into the mold or final container
What would be a more objective measure of an appropriate temperature?
a hand-held infrared thermometer
If adding volatile ingredients such as oils, flavors, or drugs to a heated semisolid preparation,
they should be added just before the semisolid is transferred into the final container

-the melt will still be fluid enough for a quantitative transfer

-but not hot enough to evaporate its ingredients
Powders should be
in a very fine state of subdivision prior to incorporation into the semisolid preparation
How can powders be prepared?
use a mortar and pestle
a mechanical grinder
a levigating agent
a pill tile
spatula
Reasons for preparing powders
-will reduce the gritty texture of preparation
-avoid additional injury or irritation to damaged skin
-a more finely divided powder will increase the surface area
-increase the potential availability for therapeutic activity
Solvents that have
low vapor pressure should be used when incorporating a soluble powder
Examples of solvents are
water
propylene glycol
glycerin
Volatile solvents are not used because
if the solvent evaporates during incorporation,
the drug crystallizes out
the crystals cause irritation when applied to skin
What technique should be used when incorporating solubilized powder into a preparation?
geometric dilution
Geometric dilution
blends powders that are in a preparation in different quantities into a uniform powder mixture
Additional considerations
1. Between 2 to 4 grams of a semisolid will be lost during the compounding process (it sticks
to beakers, ointment tiles - --- ADD 10% or 3 grams more material than prescribed

2. If semisolid ingredients are heated on a hot plate,

use the smallest beaker that will contain all of the material.

3. When melting ingredients, add the ingredients to the heating vessel and let the ingredients
melt at their own rate without stirring them with a glass rod or magnetic stirring bar

4. if a large amount of material is lost on the sides of a beaker, put the beaker in a water bath
or use a steam bath to heat the sides of the beaker

5. Most semisolids are dispersion of ingredients and material can settle quickly. When
pouring heated ingredients into molds, or final containers, stir the preparation once more just
prior to pouring the ingredients then pour rapidly

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