LO3: MANUFACTURE/COMPOUND PRODUCTS

Objective:
This learning Guiide is developed to provide you the necessary information regarding the
Following coverage contents and Topics:
 Preparing liquid dosage forms
 Preparing Semisolids
 Solid dosage forms
 Upon completion of this Learning Guide, you will be able to:
 setting up work station and transfering of all materials and cleaning standards for operator safety
 Allocate approved raw materials to appropriate machinery, where required
 Incorporate raw materials according to batch documentation
 Compound product according to method on work sheet and in compliance with standard
operating procedures for any machinery use
 Obtain required authorization/checks at designated points
 Monitor product and adjust any necessary pharmaceutical/compounding to ensure product
complies with work sheet specifications
 Perform checking procedures and inspect finished product for deviations
 Pack product using appropriate packaging devices/machinery as specified on the work sheet, and
following approval from an authorized person
 Label containers/units according to labeling specifications on the work sheet
 Pack and label a retention sample and/or quality control sample if specified on the work sheet
PREPARING LIQUID DOSAGE FORMS
1.1. Introduction
Definitions
Levigation: The process of grinding an insoluble substance to a fine powder, while wet.
Trituration: The process of creating fine particles from powders by grinding using mortar
and pestle.
Dissolution: The process of mixing solutes with appropriate solvent to get homogeneous
solutions
1.2.Compounding methods
Compounding of pharmaceutical solutions
 A solution is a thermodynamically stable, one-phase system composed of two or more
components, one of which is completely dissolved in the other.
 The solution is homogeneous because the solute, or dispersed phase, is dispersed
throughout the solvent in molecular or ionic sized particles.
 Broadly defined, a solution may be any combination of solids, liquids, and/or gases.We
will restrict our definition of pharmaceutical solutions to those composed of a solid,
liquid, or gas dissolved in a liquid solvent.
 Generally, the solute is the component present in the smallest amount and the solvent is
the larger, liquid component.
 Water is nearly always considered the solvent.
 Pharmaceutical solutes may include
o active drug components,
o flavoring or coloring agents,
o preservatives, and
o stabilizers or buffering salts.
 Water is the most common solvent for pharmaceutical solutions, but ethanol, glycerin,
propylene glycol, isopropyl alcohol or other liquids may be used, depending on the
product requirements.
 To be an appropriate solvent, the liquid must
o completely dissolve the drug and other solid ingredients at the desired
concentration,
 o be nontoxic and safe for ingestion or topical application, and
o be aesthetically acceptable to the patient in terms of appearance, aroma, texture,
and/or taste.
Solutions
 are homogenous liquid preparation containing one or more dissolved ingredients and are
used for a variety of purposes as both internal and external dosage forms.
 In addition to the active ingredient (medicaments), solutions also contain vehicles and
adjuncts.
 The vehicle is the medium in which the ingredient of a medicine is dissolved or
dispersed for solution this is the solvent.
o E.g. water, aromatic waters, alcohol, glycerol, syrup, etc.
o Water is the vehicle of choice for the majority of pharmaceutical solution.
 This is because water is generally available, relatively inexpensive,
palatable, non- toxic for oral use and non-irritant for external use.
 It also acts as a solvent for a wide range of substances.
 The adjuncts are additives that are added to improve the quality of the preparations. E.g.
Chemical stabilizers, colorants, Flavorants, preservatives, etc.
Types of solutions
1. Solution taken orally: mixtures, elixirs, syrups, linctuses draughts
2. Solution used in mouth and throat: - mouth washes and gargles, throat paints, throat
sprays.
3. Solution instilled into body cavities: douches, enemas, eardrops, eyes, drops, nasal
drops, nasal sprays.
4. Solution applied to body surface: collodions, liniments, lotion and paints.
Aromatic water
• Aromatic waters are aqueous solutions usually saturated of volatile oils or other
volatile substances that are characterized by very low water solubilities.
E.g.Chloroform.
• Aromatic waters are used externally as perfumes (e.g. Rose water) and internally as
flavoring agents (e.g. peppermint water, cinnamon water has been used as
carminative and chloroform water was used in expectorant preparations).
Method of Preparation of Aromatic waters
The U.S.P. prescribes 3 general methods of preparation of aromatic waters: Distillation,
Solution and Alternate Solution. A fourth method, Dilution, is also recommended by the
B.P.C.
1. Distillation
• Place the odoriferous portion of the plant or drug in a suitable still with sufficient
purified water.
• Distill most of the water; carefully avoiding the development of an odor of burnt as
a result of decomposition at high temperatures. Separate the excess oil from the
distillate.
• Then the aqueous phase is the product.
2. Solution
• Agitate the volatile substance with purified water for a period of 15 minutes
• The mixture is set aside for at least 12 hrs to ensure saturation
• Then filter through wetted filter paper. The filter paper must be wet to prevent the
passage of excess oil into the filtrate and to eliminate absorption of dissolved
aromatics by the filter.
3.Alternate Solution
• Mix thoroughly the volatile material with 15g of purified talc. Then agitate the
mixture with a liter of purified water for 10 min., prior to filtration
• The time saving factor is an important advantage of this method.
4. Dilution
• Mix an alcoholic solution of the volatile oil with purified water and add talc.
• Agitate the mixture and set aside for several hours
• Filter and the filtrate is call concentrated aromatic water. The concentrate contains
50 to 55 percent alcohol by volume.
• One volume of concentrated aromatic water is diluted with 39 volumes of water,
producing the aromatic water, which contains less than 1.5% of alcohol.
Spirits and tinctures
Spirits
 Sprits also known as essences are alcoholic or aqueous alcoholic solutions of volatile
substances.
 Like the aromatic water the active ingredients in the sprits may be a solid, liquid or
gas.
 The volatile substance in the majority of case is volatile oils.
 Some sprits are used internally for their medical value a few medically by inhalation.
But a large number are used as flavoring agents.
Preparation
 Most spirits are prepared by simple solution in alcohol, although some can be
prepared by distillation, maceration, and chemical reaction methods.
 In preparing spirits, it must be kept in mind that the oils dissolved in alcohol are
precipitated, causing turbidity when the solution are mixed with water.
 In order to avoid this turbidity, water, except as specified in the formula, should be
avoided.
 Graduates and other equipment used should be thoroughly dry. Filter paper should be
moistened with alcohol.
Storage
 Spirits should be kept in well-closed containers and stored at temperature not
exceeding 25oc.
 Good storage conditions prevent evaporation and volatilization of either the alcohol
or the active ingredient(s).
Tinctures
 Tinctures are alcoholic or hydro alcoholic solution of principles extracted from
natural sources or of pure chemical merely dissolved in these solvent systems an
example of the latter being iodine tincture.
 Tinctures vary widely in their method of preparation the strength of their volatile
ingredients their alcoholic content and their intended use
 Tinctures are prepared by a number of processes: maceration (process M),
percolation (process p), solution and dilution.
Syrups, elixirs and linctuses
Syrups
 Syrups are concentrated aqueous solutions of sucrose other sugars or sweetening
agents to which small quantities of suitable polyhydric alcohols may be added to
retard crystallization or to increase the solubility of the other ingredients
 Syrups usually contain aromatic or other flavoring materials.
Elixirs
 An elixir is a liquid oral preparation that usually contains either potent or unpleasant-
tasting drugs.
 The formulation is clear and generally contains a high proportion of sugar or other
sweetening agent, included to mask offensive or nauseating tastes.
 Pediatric elixirs are usually formulated with fruit syrup as a base flavoring agent.
Linctuses
 A linctus is a liquid oral preparation that is chiefly used for a demulcent, expectorant
or sedative purpose, principally in the treatment of cough.
 A linctus is intended to be sipped slowly and allowed to trickledown the throat in an
undiluted form.
 Consequently, linctuses are formulated as viscous solutions which contain sugars.
Instructions
Choose the best answer from given alternative
1. which of the following is liquid oral preparation that is chiefly used for a demulcent,
expectorant or sedative purpose, principally in the treatment of cough?
A) Linctuses B) Elixirs C) Tinctures D) Syrups
2._______are alcoholic or hydro alcoholic solution of principles extracted from natural
sources or of pure chemical merely dissolved in these solvent systems an example of the
latter being iodine tincture.
A) Linctuses B) Elixirs C) Tinctures D) Syrups
3.Which of the following Solution applied to body surface?
A) collodions B) liniments C) lotion D) paints E) all
4.which of the following is Rose water?
A) chloroform B) perfumes C) peppermint water D) all
General Method of preparation of Solution
The following general method should be used in the preparation of a solution:
1. Write out the working formula either from the prescription (unofficial) or from an official
text (official).
2. Calculate the quantities required for each ingredient in the formula to produce the required
final volume. Additionally, as far as is practically possible, the product will be assembled in
the final measure, thus reducing any transference losses.
3. Complete all sections of the product worksheet.
4. Prepare a suitable label.
5. Weigh all solids.
6. Identify the soluble solids and calculate the quantity of vehicle required to dissolve the
solids fully. If more than one solid is to be dissolved, they are dissolved one by one, in order
of solubility (i.e. the least soluble first). In almost all cases, dissolution will take place in a
glass (or occasionally plastic) beaker, not a conical measure. Remember that the solubility of
the soluble solids will be dependent on the vehicle used.
7. Transfer the appropriate amount of vehicle to a glass beaker.
8. If necessary, transfer the solid to a glass mortar and use the glass pestle to reduce particle
size to aid dissolution.
9. Transfer the solid to the beaker and stir to aid dissolution. If a mortar and pestle have been
used to reduce particle size, ensure that the mortar is rinsed with a little vehicle to ensure
complete transfer of the powders.
10. When all the solid(s) has/have dissolved, transfer the solution to the conical measure that
will be used to hold the final solution.
11. Rinse out the beaker in which the solution was made with a portion of the vehicle, and
transfer the rinsing‟s to the conical measure.
12. Add any remaining liquid ingredients to the conical measure and stir.
13. Make up to final volume with remaining vehicle.
14. Transfer to a suitable container, label and dispense to the patient
2. Compounding of pharmaceutical suspension
2.1.Compounding of pharmaceutical suspension
 Suspension are dispersed systems in which finely divided drug practices (called the
disperse phase) are distributed thought out a vehicle (called dispersion medium or
continues phase) in which the drug exhibits a minimum degree of solubility.
 It in include both powders in dry from to be place in suspension and drugs suspended in
liquid vehicles.
 Suspension can be classified in to coarse suspension in which the particles are large than
1um in diameter.
Major applications: suspension dosage forms can be administered orally injected parentally
(intramuscularly or subcutaneously) or applied externally (topically) to the skin eye ear etc.
The physical properties of suspensions and their design depend upon the nature of the
dispersed phase the dispersion medium and the pharmaceutical adjuncts/additives.
The drug particles (dispersed phase) is suspension could be:
 Diffusible solids
 In diffusible solids or
 Poorly wettable solids
Suspensions containing diffusible solids
• Diffusible solid (also called dispersible solids) are light and easily wettable solids.
• They readily mix with water and on shaking diffuse evenly through the liquid for long enough
for a dose to be measured. (Ensure even distribution in each dose.)
• Examples of diffusible solids are light kaolin magnesium Trisilicate light magnesium carbonate
and calcium carbonate.
Suspensions containing indiffusible solids
 Indiffusible solids will not remain evenly distributed in a vehicle long enough to
ensure uniformity of dose.
 Examples include chalk, zinc oxide, calamine aspirin and phenobarbitone. The
simplest way of correcting this problem is to increase the viscosity of the formation
of aggregates that settle rapidly.
 The thickening agents used to stabilize suspensions is substances that spontaneously
form colloidal dispersions in aqueous media because of their affinity to water.
There are three major groups of thickening agents:
1. Polysaccharides include acacia, tragacnath, methylcellulose, sodium alginate,
microcrystalline cellulose sodium carboxymethyl cellulose starch etc.
2. Inorganic agents include bentonite veegum hectorite aluminium hydroxide
3. Synthetic agents include carboxyvinyl polymer(carbomer) colloidal silicon dioxide.
Containers and labeling:
 Suspensions are generally packed in well closed containers appropriate to the class of
dispensed medicine be it mixture lotion ear drop, enema etc.
 If the preparation is particularly viscous a wide mouthed container may be used.
 Containers of suspensions should be of suitable size to allow shaking of the products.
 Labels for suspensions includes:
 Shake well before use
 Store in cool place (not refrigerator)
 Also expiry dates for suspensions that should be prepared recently is one month
and if diluted two weeks.
Instructions: Choose the best answer from given alternative
1. drug particles (dispersed phase) in suspension could be:

A )Diffusible solids B) In diffusible solids or

C) Poorly wettable solids D) all
2.which of the following thickening agent is Inorganic agents?
A) acacia B) tragacnath C) methylcellulose D) bentonite
3. Suspensions containing diffusible solids are readily mix with water and on shaking diffuse
evenly through the liquid for long enough for a dose to be measured.
A) True B) False
4. A type of suspension that consists of two different liquids that are held together by a
specificagent is known as:
A. a gel
B. an elixir
C. an emulsion
D. a magma
5. Which of the following dosage forms is prepared by the heat method?
A. syrups
B. emulsions
C. suspensions
D. elixirs
General methods of preparation of suspension
1. Carefully tare(calibrate) the container to the required volume
2. Finely powder any solid ingredient not already in fine powder
3. Mix the insoluble powders in a mortar adding first the ingredient of
4. Smallest bulk and diluting it with the others in increasing order of bulk using amounts
approximately equal to bulk already in the mortar (geometric dilution).
5. Add enough vehicles to produce a smooth paste.
6. Add non-volatile solid ingredients dissolved in part of the vehicle and mix well
7. Dilute with a vehicle until pourable. Examine the suspension critically and if it contains
foreign particle strain through muslin. (Before use rinse the fabric with a little vehicle to
detach loose fibers).
8. Transfer it to the tarred bottle a measure is not used because complete and accurate
transfer of a suspension is not possible once it has been made up to volume.
9. Add any volatile solid ingredients previously dissolved in some of the vehicle and mix
well.
10. Add any liquid ingredients raise the measures and mix well after each addition.
11. Rinse the mortar and pestle with successive volumes of the vehicle until they are quite
clean transferring the rinsing to the bottle.
12. Make up to volume with the vehicle and shake thoroughly
3. PREPARING EMULSION
3.1.Compounding of Emulsions
 An emulsion is a disperse system consisting of two immiscible liquids, usually water and oil, one
of which (the disperse phase) is distributed throughout the other (the continuous phase) as small
globules.
 Since this type of dispersion is inherently unstable, the system is stabilized by the presence a
third component, the emulsifying agent (emulgent, emulsifier).
3.1.1.Common types of Emulsions
Emulsions can be classified into:
1. Oil in water (O/W), in which the oil is dispersed in the water, i.e. the continuous phase is
aqueous).
2. Water in oil (W/O) in which the water is dispersed in the oil, i.e. the continuous phase is oily.
Determination of Emulsion Types:
Tests for distinguishing between O/W and W/O emulsions include:
1. Dilution Test (Miscibility Test): It involves dilution of an emulsion with water or oil.
2. Dye-solubility Test (Staining Test): It involves the use of dyes soluble only in either the
aqueous or the oil phase of an emulsion, but not in both phases, e.g. Scarlet red, Sudan III.
3. Conductivity Test: It uses the fact that an O/W emulsion possesses a much higher conductivity
than a W/O emulsion.
3.1.2.Stability of Emulsions
A stable emulsion is one in which the globules:
• Retain their initial character (i.e., mean size and size distribution); and
• Remain uniformly distributed throughout the continuous phase.
3.1.3.Instability in emulsion includes:
1. Cracking (Breaking) coalescence of the dispersed globules and separation of the disperse Phase
as a separate layer. In an emulsion, this has broken; simple mixing fails to re-establish the stable
emulsion.
2. Creaming-the formation of a layer of relatively concentrated emulsion.
 It is a less serious type of instability than cracking because a creamed emulsion may be
made homogenous again by shaking.
 Nevertheless, it is undesirable because the closeness of the globules in the cream favors
 breakdown of interface and consequent coalescence of the globules.
 Large droplets cream more rapidly coalesce more readily in the cream; therefore, the
emulsion may eventually crack.
3.Phase inversion-the change of an emulsion from O/W to W/O emulsion or vice versa.
3.1.4.Small-Scale Preparation an Emulsion
 Good emulsions can be prepared on a small scale using a mortar and pestle although its
efficiency is limited and the globule size may be larger than 10µm.
 Electric Mixer may also be used on a small scale although entrapped air may be a problem
 Since the quality and stability of the product is improved by decreasing globule size and by
reducing the size range of globules in the disperse phase the use of homogenizers
recommended.
 When using may of the highly active synthetic agents, it is possible to obtain excellent
preparations by simply adding the warmed phases to a beaker and stirring until cool. In
place of a beaker, the phases can sometimes be placed into a bottle, which is then shaken.
A. Mortar and pestle: This approach is used for those emulsions that are stabilized by the
presence of a multimolecular film (e.g., Acacia, tragacanth and agar) at the interface.
There are two basic methods.
i) The Wet Gum (or so-called English) Method.
 In this method, the emulsifying agent is placed in the mortar and dispersed in water to form
mucilage.
 The oil is added in small amounts with continuous trituration, each portion of the oil being
emulsified before adding the next increment.
ii) The Dry Gum (or so-called continental) Method.
 In this method, preferred by most pharmacists, the gum is added to the oil, rather than the water
as with the wet gum method.
 In both the Dry Gum and the Wet Gum methods, a primary, or concentrated, emulsion is first
prepared using a set ratio of oil, water, and gum (emulsifying agent) from which the final
product is obtained by dilution with the continuous phase.
3.1.5.Acacia Emulsions
 Unless otherwise specified, extemporaneously prepared emulsions for internal use are made
with acacia gum.
 To prepare acacia emulsions using a pestle and mortar, a thick (primary) emulsion must be
made first.
 The quantities for primary emulsions have been determined by experience. „Parts‟ is interpreted
as parts by volume for fixed, mineral, and volatile oils, and part by weight for oleoresins and
acacia

Problems:
Sometimes the primary emulsion does not form properly and the contents of the mortar become
oily, thin and translucent.
This is due to phase inversion, the product, which has become a W/O emulsion cannot be
diluted with water and must therefore be discarded.
Possible causes are:
• Insufficient shear between the mortar base and the pestle head.
• Inaccurate measurement of water or oil.
• Cross contamination of water or oil.
• Excessive mixing of oil and gum.
• Too early or too rapid dilution of the primary emulsion.
• Poor quality acacia.
Containers and Labeling
Emulsions should be supplied in well-filled containers with airtight closures. For viscous
preparations wide-mouthed amber glass bottles are most appropriate.
Labeling: shake the bottle, store in cool place but avoid freezing

Instructions: Say True or False

1. Emulsions should be supplied in well-filled containers with airtight closures
2. extemporaneously prepared emulsions for internal use are made with acacia gum.
3.peppermint oil is example of volatile oil
4.liquid oil is example of mineral oil
4. COMPOUNDING OF SEMISOLID DOSAGE FORMS
4.1. Introduction to Ointments
 Ointments are semisolid preparations intended for external application to the skin or mucous
membranes.
 Ointments may be medicated or non- medicated the later type being commonly referred to as
ointment bases and are used as such for their emollient or lubricant effect of used as vehicles in
preparation of medicated ointments.
There are four main classes of ointment bases.
 Hydrocarbon bases:
o Hydrocarbon bases are composed of oleaginous compounds having low water content and
hydrophobic.
o On application to the skin, they have an emollient effect, protect against the escape of
moisture, are effective as occlusive dressings, can remain on the skin for long periods
without drying out, and because of their immiscibility with water are difficult to wash off.
Example: white petrolatum and white ointment, USP
 Absorption bases:
o Absorption bases are hydrophilic, anhydrous materials or hydrous bases that have the ability
to absorb additional water.
o The former are anhydrous bases, which absorb water to become W/O emulsions; the latter
are W/O emulsions, which have the ability to absorb additional water.
o The word absorption in this context refers only to the ability of the base to absorb water.
Examples: hydrophilic petrolatum and anhydrous lanolin
 Water-miscible bases:
o These bases are O/W emulsion bases, commonly referred to as creams,and represent the
most commonly used type of ointment base.
o By far the majority of commercial dermatologic drug products are formulated in an emulsion
(or cream) base.
o Emulsion bases are washable and removed easily from skin or clothing.
o Example: Hydrophilic Ointment, USP
 Water soluble bases: Soluble ointment bases, as name implies, are made up of soluble components
or may include gelled aqueous solutions Example: Polyethylene glycol (PEG) ointment, NF
4.1.1.Preparation of ointments
 Ointments are not applied primary to irritated areas it is an on broken wound rule that these
preparations must contain granular or gritty particles, which might cause further irritation regardless
of the condition of the skin.
 Ointments must be smooth and free from granular or gritty particles.Three types of equipments are
available for the preparation of ointments
1. Ointment slab and spatula
2. Mortar and pestle
3. Ointment fill
Packaging of ointments:
• Ointments are dispensed in either ointment or collapsible tube. However, ointments prepared
extemporaneously are usually packed in ointment jar.
• The ointment should be packed and the top surface should be smoothed neatly.
• Ointments jars should be closed tightly when not in use particularly if the ointment consisting
water to prevent loss though operation.
Storage of ointments:
• Ointments should be stored in a cool place to prevent softening and eventually liquefiable in the
base.
• Insoluble medicament may settle to the bottom of the container if the ointment is permit to
liquefy.
• Excessive heat or cold may cause an emulsion base to separate into two phases.
4.2. Pastes
 Pastes are ointment-like preparations intended for external application.
 Most paste differ from ointments in containing large amounts of finely powdered solids, thus they
are usually stiffer than ointments, less greasy and more absorptive.
 They are applied generously, either with a spatula or spread on lint or other dressing and are not
removed for long periods.
Compounding and packaging of pastes:
 For all practical purposes, pastes are prepared in the same manner as ointments
 Pastes are generally packed in glass ointment jars.
 They are often too viscous for easy extrusion from tubes.
4.3.Gels
 Jellies are transparent or translucent, non-greasy, semisolid gels generally applied externally.
 Jellies are used for medication (Medicated jellies), lubrication (Lubricating jellies) and some
miscellaneous applications
Formulation of Gels
• Gelling agents are usually organic hydrocolloids but, occasionally, hydrophilic inorganic
substances
Organic hydrocolloids: Tragacanth, Sodium alginate, Pectin, Starch, Gelatin, Cellulose derivatives
(Methylcellulose, Sodium carboxymethylcellulose, Hydrroxypropyl methylcellulose), Carbomer,
Polyvinyl alcohols, and others
Hydrophilic inorganic substances: Clays like bentonite
Other additives for gels
 Humectants substance used to reduce the loss of moisture from the preparation.
o Loss of water can quickly lead to coarsening of the matrix and humectants such as
glycerol, propylene glycol or Sorbitol Solution may be added to retain water
 Preservatives: Gels have high water content and therefore are liable to support microbial growth
unless a suitable preservative is added
o NB The chosen preservative must be compatible with the gelling agent
 Chelating agents: are ingredients that bind with metal ions or metallic compounds, preventing
contamination or discoloration Bases and medicaments sensitive to heavy metals are sometimes
protected by chelating agents such as EDTA
Packaging
• Lubricating jellies should be packed in collapsible tubes.
• However, stiffer gels for application to the skin may be supplied in ointment jars.
• Containers should be well filled and airtight to prevent evaporation.
Storage
• Jellies should be stored in a cool place to prevent loss of water via evaporation
General method of compounding for gels
1. Heat all components of the gel (with the exception of water) to approximately 90°C.
2. Heat water to approximately 90°C.
3. Add water to oil, stirring continuously.
Note:Avoid vigorous stirring as this will introduce bubbles.
4.4.Creams
 In pharmacy the term „cream‟ is reserved for external preparations.
 Creams are viscous semi-solid emulsions for external use.
 Medicaments can be dissolved or suspended in creams.
 A cream may be „water-in-oil‟ or „oil-in-water‟ depending on the emulsifying agent used.
 A cream is always miscible with its continuous phase.
 Water-in-oil creams (oily creams) as bases – These are produced by the emulsifying agents of
natural origin (e.g. beeswax, wool alcohols or wool fat).
 Oil-in-water creams (aqueous creams) as bases –These are produced by the synthetic waxes
(e.g.macrogol and cetomacrogol).
o They are the best bases to use for rapid absorption and penetration of drugs.
o They are thin, white and smooth inconsistency.
Preparation of creams
 Creams may contain one or more medicaments in solution in one or other of the phases.
 Finely powdered insoluble medicaments may also be dispersed in a cream base
 Generally, creams are prepared as follows
o The components of the oily phase (usually including the emulgent) are heated until
molten and the temperature rises to 75oc
o The components of the aqueous phase are mixed in a separate vessel and also heated to
75oc
o The aqueous phase is then added to the oily phase at the same temperature and the
resulting emulsion is stirred gently until cool
 Thermometer should be used to control the temperatures of the two phases
 Rapid cooling may result in separation of high melting point components
 Excessive aeration caused by vigorous stirring may also lead to a granular product
Packaging
 Wide-mouthed jars may be used for creams where the risk of contamination in use is considered
to be minimal, e.g. oily creams.
 The containers must be well closed and prevent water evaporation.
 The mouth of the jar should be covered with a disc of grease proof paper
  Collapsible metal or flexible plastic tubes, however, are to be preferred since these reduce the
risk of contamination in use
NB. Most proprietary cream products are packed in tubes
Storage:Creams should be stored in a cool place but should not be allowed to freeze
Instructions
CHOOSE THE BEST ANSWER FROM GIVEN ALTERNATIVE
1. which of the following cream is produced by the synthetic waxes?
A) O/W emulsion B) W/O emulsion
2. Creams are viscous semi-solid emulsions for external use. A) True B) False
3. Preservatives: Gels have high water content and therefore are liable to support microbial growth
unless a suitable preservative is added A) False B) True
4.which techniques used to mixing ointment when the medicament is a solid insoluble in the bases or
liquid present in small amount ?
A) Mixing by trituration B) Mixing by fusion C) continental method
5.Which of the following are not semisolid drugs?
A. pastes B. creams C. suspension D. ointments
6. Which of the following can be used as an ointment base?
A. oil-in-water emulsions B. water-in-oil emulsions
C. absorption and water-soluble bases D. all of the above
7. Pastes are different from ointments, creams, and gels because:
A. They contain a higher content of solids. B. They contain a lower content of solids.
C. They are compounded in a different manner than ointments D. none of the above
8. Which of the following are the simplest dosage forms compounded extemporaneously?
A. solutions B. suspensions C. emulsions D. suppositories
9. Which of the following must be shaken well before being administered?
A. solutions B. suspensions C. emulsions D. elixir
10. A master formula sheet contains which of the following information?
A. the ingredients of a formulation B. the manufacturer‟s expiration date C. the date it was
prepared D. all
11. What are basic equipments used for the preparation of ointments?
A. ointment slab and spatula B. mortar and pestle C. ointments jar or fill D. all
COMPOUNDING OF SOLID DOSAGE FORMS
5.1.Introduction Powders
 Powders are solid preparations intended for either internal or external use. The following types
of preparation will be considered:
a) Bulk powders for external use – termed dusting powders
b) Bulk oral powders
c) Individual unit dose powders
5.1.1.Bulk powders for external use
• These are dry, free-flowing preparations consisting of one or a mixture of finely powdered
substances and intended for external application.
5.1.2.Bulk oral powders
• Bulk oral powders resemble dusting powders with the exception that they are intended for oral
administration.
• The dose to be taken is measured with a 5 ml spoon, stirred into a quantity of water and then
swallowed.
• Unfortunately, this method of measurement creates considerable problems with regard to the
expected standards of precision of dosage.
5.1.3.Divided Powders
• This form of powder may contain one or more active ingredients together with an inert diluents
to produce a minimum quantity (120mg) that can be weighed by the dispenser and handled by
the patient.
• After the powder blend is prepared, it can be subdivided into the required number of doses by
weighing or by using the block and divide method.
• The papers in which divided powders are traditionally folded are called powder papers. The
paper of choice for hygroscopic or deliquescent powders is waxed paper because of its
waterproof qualities.
• Also powders containing volatile ingredients should be similarly wrapped.
5.2.Packaging:
For bulk powders
• For internal powders: Wide-mouth screw cap glass jars
o A 5ml spoon should be supplied for measuring dose
• For dusting powders: Colored glass or plastic jars with a reclose able perforated lid
For Divided powders
• Folded powder paper packets, Aluminum foils, Heat-sealed plastic bags
Storage and labeling:
• Store in a cool, dry place
• Powders intended to be used externally or locally should always bear “for external use” or
“For local use” auxiliary labels

Instructions; Choose best answer from given alternative

1. To grind a powder into a smoother mixture, using moisture, is a process called:
A. pasteurization B. agitation C. suspension D. levigation
2.which of the following is types of solid powders?
A) dusting powders B) Bulk oral powders C) Individual unit dose powders D) all
3. Which term means “reducing to a fi ne powder by grinding”?
A. trituration B. suspending C. agitation D. atomization
4. To grind a powder into a smoother mixture, using moisture, is a process called:
A. pasteurization B. agitation C. suspension D. levigation
6.1. Introduction to Tablets
Tablets are solid dosage forms containing the active ingredient with or without suitable diluents.
Tables are available in variety of sizes, shapes, color and thickness.
They are formed in molds or produced by compression and are composed of one or more active
ingredients and one or more inert substances.
Most tablets are designed to be swallowed whole and dissolve in the gastrointestinal tract, but some
are also made to be administered sublingually, buccally or vaginally.
6.2.Advantages of tablets
 Compared to liquid dosage forms tablets possess more chemical and physical stability
 Packaging in blister packs can also enhance the stability of tablets
 They provide an accurately measured dose and low content variability of the unit dose
 Low manufacturing cost
 Easy to package and ship
 Simple to identify (Coatings can be colored or stamped to aid tablet recognition)
 Manufacturing processes and techniques can provide tablets special properties for example
enteric coatings or sustained release formulations.
6.3.Disadvantages of tablets as a dosage form
 Poor bioavailability of poorly soluble drugs or poorly absorbable drugs
 Some drugs may cause local irritation and harm gastrointestinal mucosa
 Some drugs resist compression into tablet
 Difficulty in swallowing in some patients e.g. pediatrics and unconscious patients
 they are not suitable in emergency cases; intravenous or intramuscular injections are more
effective
6.4.Common types of tablets include:
 Enteric-coated tablets: are a type of tablets intended to release their contents in the small
intestine bypassing the acidic stomach.
 Sustained-release tablets: are tablets designed to deliver their contents over time.
o Some drugs are formulated to deliver their contents over 24 hours and only need to be
taken once a day.
o Sustained-release drugs should be swallowed whole; crushing may cause the contents to
be released immediately.
  Film coating and sugar coating tablets: are tablets coated to mask their unpleasant taste and
make them easier to swallow.
 Chewable tablets: are formulated for people who have difficulty swallowing pills.
 Many children‟s medicines are available in a chewable dosage form.
 Sublingual tablets and buccal tablets: are tablets that are placed under the tongue (sublingual)
or the cheek (buccal), dissolve in the mouth and absorbed to the blood stream directly.
 Drugs that are destroyed by stomach acids or need to get into the bloodstream rapidly (e.g.,
nitroglycerin) may be formulated for sublingual or buccal administration.
 Tablets for Solution:
 Compressed tablets to be used for preparing solutions or imparting given characteristics to
solutions must be labeled to indicate that they are not to be swallowed. Examples of these tablet:
Potassium Permanganate Tablets for Solution
 Effervescent Tablets:
• In addition to the drug substance, these contain sodium bicarbonate and an
organic acid such as tartaric or citric
• In the presence of water, these additives react liberating carbon dioxide which
acts as a distintegrator and produces effervescence.
• Except for small quantities of lubricants present, effervescent tablets are soluble
6.5.Tablet Ingredients
In addition to the active or therapeutic ingredient, tablets contain a number of inert materials
(excipients).They are classified according to the part they play in the finished tablet.
• those which help to impart satisfactory processing and compression characteristics to the
formulation (diluents, binders, glidants and lubricants) and
• those which help to give additional desirable physical characteristics to the finished tablet
(disintegrants, colors, and in the case of chewable tablets, flavors and sweetening agents, and in
the case of controlled- release tablets, polymers or waxes or other solubility-retarding materials)
Diluents
 is an inert substance added to increase the bulk in order to make the tablet a practical size for
compression.
 Diluents used for this purpose include dicalcium phosphate, calcium sulfate, lactose, cellulose,
kaolin, mannitol, sodium chloride, dry starch and powdered sugar.
Binders
 Are agents used to impart cohesive qualities to the powdered material to insures the tablet
remaining intact after compression, as well as improving the free- flowing qualities by the
formulation of granules of desired hardness and size.
 Commonly used binders include: starch, gelatin and sugars such as sucrose, glucose, dextrose,
and lactose.
Lubricants
• Lubricant have roles in tablet manufacturing
• Prevent adhesion of the tablet material to the surface of the dies and punches.
• Reduce inter particle friction.
• Facilitate the ejection of the tablets from the die cavity.
• May improve the rate of flow of the tablet granulation.
• Commonly used lubricants include: talc, magnesium stearate, calcium stearate, stearic acid,
hydrogenated vegetable oils and (PEG).
Glidants
 promote the flow of the tablet granulation or powder materials by reducing friction among
particles
Disintegrants
 Is a substance, or a mixture of substances, added to a tablet to facilitate its breakup or
disintegration after administration.
 Materials serving as disintegrants have been classified chemically as starches, clays, celluloses,
algins, gums and cross-linked polymers.
 The oldest and still the most popular disintegrants are corn and potato starch which have been
well-dried and powdered.
Starch has a great affinity for water and swells when moistened, thus facilitating the rupture of the
tablet matrix.
Colors and dyes
1. For attractiveness.
2. Provide product identification.
3. Produce a more elegant product. Flavoring agents
4. Are agents used to impart good odors for the formulation.
5. Are usually limited to chewable tablets or tablets intended to dissolve in the mouth.
Artificial sweeteners: like flavors, are usually used only with chewable tablets or tablets dissolve in the
mouth.
Adsorbents: (e.g., magnesium oxide, magnesium carbonate, bentonite, silicon dioxide) are substances
capable of holding quantities of fluid in an apparently dry state
Instructions:
Choose best answer from given alternative
1.a substance promote the flow of the tablet granulation or powder materials by reducing friction among
particles is called:
A) Glidants B) Adsorbents C) Starch D) Disintegrants
2.which is true about Lubricants?
A) Lubricant have roles in tablet manufacturing
B) Prevent adhesion of the tablet material to the surface of the dies and punches.
C) Reduce inter particle friction D) all
3. Diluents is an inert substance added to increase the bulk in order to make the tablet a practical size for
compression
A) True B) False
4. which of the following is tablet Ingredients?
A) diluents B) lubricants C) Glidants D) binders E) all
7.1. Introduction to Capsules
Are solid dosage forms which the solid or liquid drug is enclosed in a hard or soft soluble gelatin shell to
mask its bad taste and odour. The gelatin shell dissolves in the stomach, releasing the drug. A capsule
may contain powders, granules or crushed tablets with one or more active ingredients and one or more
inert ingredients.

7.1.Advantage of encapsulation:
 Taste concealment (unpleasant taste)
 Elegance, smooth slippery, easily swallowed shell
 Nice presentation of the drug
 Portability, convenient
 Light weight
 Rapid drug release
 Can be used for the extemporaneous compounding of prescriptions
7.2.Types of capsule
1.Hard gelatin capsules
The empty capsule shells are made from a mixture of
 gelatin
 plasticizer
 sugar and water (and may contain FD&C dyes and / or opacifying agent, preservative, enteric
agent, flavour).
Gelatin:
 is obtained by partial hydrolysis of collagen obtained from bones, skin, connective tissue
of animals.
 Non-toxic, used in food stuff.
 Readily soluble in biological fluid at body temperature
 Good film forming material
 Undergoes a reversible phase change at a little high temperature
Plasticizers: Glycerol, sorbitol, propylene glycol.
 The ratio by weight of dry plasticizer to dry gelatin determine the hardness of the gelatin shell.
2. Soft Gelatin Capsules(SGC) or Soft elastic gelatin (SEG)

Pharmaceutical applications:
1-As an oral dosage form for human or veterinary use
2-As a suppository dosage form for rectal or vaginal use
3-As a specialty package in tube form, for single dose application of topical and ophthalmic
preparations; rectal ointments; ear and nose drops.
Advantages of SGC as a dosage form:
1-A compression stage is not included.
2-The dose content uniformity is optimized, with reduction of the cost through the use of smaller
averages.
3-Protection of sensitive drug from oxidation and hydrolysis.
4-The drug is dissolved or dispersed in vehicle which provides high surface area and good
bioavailability
Instructions: True or False
1.Gelatin is obtained by partial hydrolysis of collagen obtained from bones, skin, connective tissue of
animals
2. The empty capsule shells are made from a mixture of gelatin ,plasticizersugar and water
3. Capsules are solid dosage forms which the solid or liquid drug is enclosed in a hard or soft soluble
gelatin shell to mask its bad taste and odour.
4.The gelatin shell dissolves in the stomach, releasing the drug.