PHARMACEUTICAL DOSAGE FORMS, DRUG DELIVERY SYSTEMS & MEDICAL DEVICES
Y 2021 – 2022
1|pREPARATION 1: divided powders
2ND SEMESTER – 1ST SHIFT
OUTLINE
I. Introduction to Powders and Divided Powders
A. 2 Classification of Powders
B. Comminution/Particle Size Reduction
C. Blending and Mixing Techniques
D. Methods of Preparation for Divided Powders
E. Packaging Materials for Divided Powders
II. Preparation 1: Levothyroxine Sodium Divided Powders
III. Synchronous Class Notes
IV. Assigned Readings
POWDERS
● Intimate mixture of dry, finely divided drugs and/ or chemicals
that may be intended for internal use or external use
● Why do we have this type of dosage form?
○ We have to keep in mind when developing a certain drug, we
have to consider the consumer, the patient, or the
individual who will be taking the drug.
■ Cater adult patients who have difficulty in swallowing
■ Cater also children
2 Classification of Powders
BULK POWDER
● Non-potent substances; external/internal use; usually
dispensed on bulk containers.
● Examples:
○ Oral powder
○ Dentifrices
○ Douche powders
■ Powders to be reconstituted in order to produce
solutions that may be directly introduced into a body
cavity.
■ As pharmacists, we offer to prepare douche powder in
order to offer convenience to the patient since a mode of
transportation for powders is easier compared to a
solution which is bulky in nature.
○ Dusting Powder
■ Usually placed on a sifter top container; intended to be
dusted to the skin
■ Powders to be reconstituted in order to produce
solutions that may be directly introduced into a body
cavity.
○ Insufflations
■ Extremely fine powders intended to be introduced to
the body cavities
DIVIDED POWDER
● Dispensed in the forms of individual/single doses and
generally are dispensed in paper, properly folded
● Can be in metal foil small heat- sealed plastic bag or other
appropriate packaging material
Comminution/Particle Size Reduction
● The reason why we are concerned about the following
techniques, when producing powders, one of the things that we
must observe is that we should produce a powder with
appropriate particle size and also must be uniform.
● In order to achieve this we may employ the following
techniques or methods. So the particle size reduction may be
generally classified into two, depending on the batch size…
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LAB l PHA 619 l CERVANTES & DE JESUS
● Batch Size - how much of the product you’re going to produce
A. Large Scale Production
● Concerns the pharmaceutical industry
● Production of big batch are done we may choose
specialized equipment or machines
● Examples: mills, pulverizers
B. Extemporaneous
● Small scale production or preparation of drug
formulation, dosage form, strength and packaging that
are not available commercially but being necessary for
patient care when appropriately trained personnel
● Pharmacists usually use this ff. particle size reduction
technique such as:
○ Trituration
○ Pulverization by intervention
○ Levigation
3 PARTICLE SIZE REDUCTION TECHNIQUES FOR
EXTEMPORANEOUS COMPOUNDING
1. Trituration
● The reduction of particle size of a substance to fine
particles is done by rubbing them in a mortar & pestle
● This method will also allow you to blend ingredients
together
2. Pulverization by intervention
● You add an additional material to a certain ingredient you
wish to reduce the particle size
● This additional material must be easily removed after
pulverization, meaning the additional material you will be
adding is volatile in nature
● Examples:
○ Camphor (You may add an additional material which is
alcohol.)
○ Iodine (You may utilize or use ether to facilitate particle
size reduction.)
3. Levigation
● Commonly used in small-scale preparation of ointments
and suspensions to reduce the particle size and grittiness
of the added powders.
● You have here a solid material or the drug you wish to
reduce to particle size. In order to do this, we add a
“levigating agent”.
● This levigating agent must be a non-solvent to the solid
material you wish to reduce to particle size, meaning the
solid material or drug should not dissolve in the
levigating agent.
● Uses mortar and pestle
● Example:
○ Mineral oil (Upon addition of this levigating agent, you
will be forming a paste. By the formation of a paste, that
will now facilitate proper particle size reduction.)
○ Glycerin
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PHARMACEUTICAL DOSAGE FORMS, DRUG DELIVERY SYSTEMS & MEDICAL DEVICES BS PHA | 1A PH A.Y 2021 – 2022

○ When this is formed or a block is formed, you will be

Blending and Mixing Techniques
● Large scale - performed in a manufacturing company, we may
use of large mixing machines or motorized tumblers
● For small scale or extemporaneous compounding, we can
utilize 5 techniques:
cutting/dividing it into equal small portions each
representing a single dose. The divided powder is then
transferred to its suitable packaging material.
○ Must be performed carefully and skillfully
○ Usual technique used for extemporaneous compounding

Table No.1 5 Techniques of Extemporaneous Compounding Packaging Materials for Divided Powders
TECHNIQUE DEFINITION Divided powders prepared either by weighing or utilizing block
- A technique that reduces particle size and divide can be transferred into a paper called powder paper. It
Trituration and at the same time mix or blend the will be properly folded.
powders ● The type of paper to be used will be determined depending on
the characteristics of the powder. Then, the individual wrapped
- A technique to mix small amounts of doses will now be enclosed in a paper box or paper envelope.
powder on either paper/pill tile
(sometimes we can also use an HOW TO PREPARE PAPER TABLETS &
ointment tile if you are to mix PAPER ENVELOPES (FOR DIVIDED POWDERS)
ingredients for ointments)
Steps in the folding of Powder Papers:
- Use spatula here as the name implies.
Spatulation - Not suitable for potent drugs or large
Table No.2 Steps in the folding of Powder Papers.
quantities of powders.
- Preferred technique or method of STEP VISUAL REPRESENTATION
choice if the solid substances that we
are mixing liquifies or forms a 1. The powder papers may be
eutectic mixture. of any convenient size to
- Perform the mixing by passing the hold the amount of
powder to the sifters. powder required.
Sieving/Sifting - Not suitable if you are to mix potent
drugs with diluents. 2. FOLD toward you a
- Idea is the same with the use of uniform flap of about 0.6
motorized tumblers in large scale cm of the long side of the
productions. paper. PLACE the weighed
- In this case we make use of enclosed or divided amount of
Tumbling powder in the center of
containers suitable for small scale
compounding and then, it will be each paper.
tumbled in order to facilitate the
3. Be careful not to disturb
mixing.
the powder excessively,
- A technique or method of choice when bring the lower edge of
you are to mix potent substances with the paper upward, and
a large amount of diluent place it proximate to the
- The potent drug or substance is placed crease of the flap.
in a mortar with an approximately
equal amount of the diluent after 4. Grasp the flap, press it
which they are mixed thoroughly by down upon the tucked-in
Geometric Dilution trituration. bottom edge of the paper
- Then, a second portion of diluent equal and FOLD again with an
in amount to that mixture is added amount of paper equal to
and then the trituration is repeated. the size of the original
- The process is continued by adding flap (0.6 cm).
again an equal amount of diluent to
the powder mixture until all the diluent 5. FOLD the paper carefully
you have is incorporated by not disturbing the
position of the powder
Methods of Preparation for Divided Powders into 3 equal parts to
● Weighing form a crease on each
○ Directly weigh the amount of substances per individual end of the paper.
dose. Then enclose it on its proper packaging
○ Weighing using analytical balance. 6. Lift the other folded end
○ Disadvantage: takes too much time (time-consuming) and insert the other end
to form a sharp crease so
● Block and Divide that powder cannot
○ It is performed by having the entire amount of prepared escape.
powder placed on a pill tile or a sheet of paper.
○ We will be using a spatula in order to form a rectangular or
square block having a uniform height and depth (to ensure
that the dosage of each divided powder is accurate/equal).

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● Glassine Paper
7. Have uniform folds, and ○ glazed, transparent, moisture resistant papers
should be of uniform ○ since its transparent, it is unsuitable for drugs that are
length and height. There degraded by light or are light sensitive
should be no powder in ● Waxed Paper
the FOLDS and none ○ transparent and water-proof paper (can be used for
should be capable of moisture sensitive products, not suitable for
escaping with moderate light-sensitive products)
agitation. Table No.4 Types of Paper: Moisture-Sensitive or Light-Sensitive.
Table No.3 Steps in making an envelope. MOISTURE-SENSITIVE LIGHT SENSITIVE
TYPES OF PAPER PRODUCT PRODUCT
STEP VISUAL REPRESENTATION
Vegetable
Parchment ✔ ✔
White Bond
Paper X X
1. -
Glassine Paper ✔ X
Waxed Paper ✔ X
Table No.5 Special Problems.
Special Problems
1. Volatile Substance
2. Fold 1 cm ○ If you have substances to be added in your powder mixture
which are volatile in nature
○ Volatile - easily evaporated in normal temperature
○ Examples:
Camphor Menthol Volatile Oils
○ Retain them in your powder mixture and prevent
volatilization
3. Fold at least 1 ○ Remedies:
cm. ■ Use a heat sealed plastic bag.
■ Double wrapping with waxed paper.
■ Use glassine paper and enclose it inside a bond paper.

2. Eutectic Mixture
○ When there are several powder ingredients that liquefy
when mixed together.
4. Fold one more ○ Examples:
time. Phenol Camphor Menthol
Thymol Phenylsalicylate Aspirin
■ Alone, these powders are stable but if ever you mix
them together, they liquefy.
○ Remedies:
■ Addition of inert (non-reactive) diluents (light
5. Fold both sides magnesium oxide or magnesium carbonate, kaolin,
starch, bentonite).
■ With the addition of your diluent, you can reduce the
contact of the troublesome powders/substances
hence, preventing liquefaction.

6. Attached label 3. Liquids

on the principal ○ When you have an excipient or an active ingredient to be
display panel added in your powder which is in liquid form
(FRONT). ○ Remedy:
Attached back ■ Add MgCO3 (magnesium carbonate), starch, and

label. lactose in order to increase the absorption capability

or absorbability of your preparation or powder to
prevent liquefaction.

Different Types of Paper (we can use)
● Vegetable Parchment
○ thin, semi opaque (limited capacity to protect
light-sensitive products) and moisture resistant paper
(designed to cater moisture sensitive drug/product)
● White Bond Paper
○ opaque paper with no moisture resistant properties
○ unsuitable for products that are sensitive and easy
degraded by moisture
4. Hygroscopic, Deliquescent & Efflorescence
○ Hygroscopic - absorbs moisture from air (does not liquefy)
○ Deliquescent - absorbs moisture from the air and
dissolve in it (liquefies)
○ Efflorescence - spontaneous loss of water by a hydrated
salt
○ Remedies:
■ Addition of inert diluents (such as Magnesium
Carbonate or MgCO3, light Magnesium Oxide or MgO)

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PHARMACEUTICAL DOSAGE FORMS, DRUG DELIVERY SYSTEMS & MEDICAL DEVICES
and other absorbents or absorbent-like materials
(such as starch, kaolin, bentonite)
*Inert diluent - will not affect the
integrity/physical stability of the active
ingredient (non-reactive)
■ Double wrapping (for further protection)
In case of extremely deliquescent materials or substances,
they are actually not prepared as powder.
PREPARATION 1
“How to prepare Levothyroxine Sodium Divided Powder”
Note: The procedure and list of
ingredients in this discussion is
modified or different from what you’ll be
seeing in the manual or the assigned
readings. So what we’ll be following is
the list of ingredients and procedure
discussed during this video.
Levothyroxine Sodium (Eltroxin) Divided Powder
CATEGORY
A. Powder - based from its dosage form
B. Thyroid hormone - based from its pharmacological category
SYNONYMS
Chartula or Chartulae (synonym of the divided powder and not
the levothyroxine sodium)
DESCRIPTION OF FINAL PRODUCT
The prepared divided powders containing your levothyroxine
sodium are dispersed in the form of individual doses placed in
paper and properly folded.
USE/S
Utilized as a thyroid hormone & treatment of hypothyroidism
(condition where the thyroid gland is not able to produce enough
thyroid hormone)
FORMULATION
Levothyroxine Sodium (Eltroxin) - 25 mcg/pptab
Lactose - 100 mg/pptab
*There would be cases that a dosage form/strength will not be
available on a certain pharmacy. What we have to do now is to
perform extemporaneous compounding wherein the finished
preparation or product is a divided powder.
FIRST: Know the commercially-available dosage form and
strength of the drug you will be using.
● The Levothyroxine Sodium is available as a tablet with a
dosage strength of either 100 or 50 mcg.
● On the market that Eltroxin (brand name) may be
available as Levothyroxine Sodium (generic name).
COMPUTATION
Levothyroxine Sodium (Eltroxin) = 25 mcg x 4 pptab = 100 mcg
Lactose = 100 mg x 4 pptab = 400 mg
SECOND: How many paper tablets containing 25 mcg should you
make.
● For example, you are tasked to make 4 pptabs, each will
contain 25 mcg so the required amount for your
levothyroxine sodium should be 100 mcg.
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Aside from levothyroxine sodium, you have another ingredient
which is lactose. Why do we have another ingredient in our
formulation?
● It is added as a diluent (added as bulking agents; as the
name implies, it increases the weight to make your
preparation more practical and easy to handle).
● As identified in the formulation, 1 pptab should contain
100 mg of lactose. So if you are to make 4, you need 400
mg.
PROCEDURE
1. Triturate lactose - set aside
○ Perform trituration of your diluent which is your lactose
○ The trituration is performed for the purpose of ensuring that
lactose will be a powder with uniform size.
○ Trituration is employed for particle size reduction with the
aim of having a uniformly comminuted lactose. Set this
aside and proceed to the second step.
2. Pulverize tab, add lactose portion by portion, trituration
after each addition
○ With the use of your mortar and pestle, you can pulverize
the tablet. In order to know how many tablets of Eltroxins
you should use and pulverize, you have to take note of the
required amount of Levothyroxine Sodium to make your
paper tablets, as well as the dosage strength of the tablet
you will be using.
○ For this example, you are to make 4 paper tablets
containing 25 mcg making the required amount, 100 mcg.
So, if you are to use a 100 mcg Eltroxin tablet, you only need
to pulverize 1 tablet.
○ If you are going to use a Eltroxin tablet with a dosage
strength of 50 mcg, you need to pulverize two tablets.
○ The number of tablets you will pulverize will depend on
those two things.
○ Ensure now that the tablet is uniformly triturated or
pulverized before you add the lactose that is set aside from
Step 1. When adding your lactose, take note that you will be
adding it portion by portion to ensure uniform [not audible].
Upon every addition of your lactose, you have to perform
trituration.
3. After uniformly triturating your powders, place your powder in
a pill tile, form a block then divide into 4 equal portions
using your spatula.
4. Wrap each portion individually in a glassine paper.
5. Place in a paper envelope.
LABEL
White label (for internal use)
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CONTAINER OR PACKAGING MATERIAL and levigation. On a large scale, various mills and
Glassine paper tab placed in a paper envelope pulverizers are used.
● Micromeritics is the study of small particles. Divided
REMARKS powders are dispensed in individual doses, usually in folded
1. Method of Preparation: block and divide * papers. They may also be dispensed in metal foil, small
Technique used for blending and particle size reduction heat-sealed or resealable plastic bags, or other containers.
(communition) = Trituration The method of preparation is block and divide.
2. Pharmaceutical Dosage Form: classified as a powder
3. Hygroscopic & volatile drugs can be protected by using waxed IV. Formula
paper double wrapped in a bond paper. INGREDIENT ORIGINAL AMOUNT
○ In case we are going to prepare a divided powder Levothyroxine Na 50.00 g per tablet
containing hygroscopic materials or volatile drugs, you can (Eltroxin) tablet
protect by using a waxed paper double wrapped in a bond
paper (another option to remedy the problem if you are to V. Procedure
use such ingredients). 1. Triturate the tablet using mortar and pestle.
2. Place the powdered tablet on the pill tile.
3. Divide into 5 (five) equal parts using the stainless steel
SYNCHRONOUS NOTES spatula.
Table No.6 Question and Answer Portion. 4. Place each divided powder in a cut glassine paper. Please
QUESTION ANSWER check the proper procedure on how to fold the glassine
Which of the following is a type of paper to form a paper powder.
paper used in divided powders which 5. Collect all paper tablets and transfer them into a small
is an opaque paper with no envelope made of a white bond envelope.
moisture-resistant property? 6. Label properly
White Bond Paper
A. White bond Paper
B. Vegetable Parchment VI. Clean-Up Procedure
C. Waxed Paper 1. Dispose of the cut papers, e.g., white bond paper and
D. Glassine Paper glassine papers, into the garbage bin.
2. Clean the pill tile by washing with soap and water. Wipe
This is the method of preparation of dry and return it to the laboratory assistant/technician.
Levothyroxine Sodium Divided Powder. 3. Clean your working area before leaving the laboratory.
A. Trituration
Trituration
B. Levigation
C. Weighing
D. Block & Divide REFERENCES
Course Instructor/s: 
Hygroscopic substances are able to Maria Ozawa Gracia Cervantes & Prima De Jesus
absorb moisture from air which will
False
result to liquefaction. References from:
True or False Allen, L.V., Popovich, N.G. & Ansel, H.C. (2018). Powders &
Levothyroxine sodium is a drug used Granules Ansel’s Pharmaceutical Dosage Forms and Drug
for the treatment of hyperthyroidism False Delivery System (11th edition) (pp. 184- 202). Philadelphia:
True or False Wolter Kluwer/Lippincott Williams and Wilkins

Allen, L.V. Powders In Remington: The Science & Practice of

ASSIGNED READINGS Pharmacy (23rd edition)(pp. 777-800). Philadelphia:
Pharmaceutical Press.
PREPARATION 1: DIVIDED POWDERS
I. Objectives Allen, L.V. Oral Solid Dosage Forms In Remington: The Science
● Determine the different comminution and mixing techniques. & Practice of Pharmacy (23rd edition) (pp. 947-976).
● Know the advantages and disadvantages of powders. Philadelphia: Pharmaceutical Press.
● Establish the USP standards for the particle size of powders.
Castillo, A., Casuga, F., Doria, MC, Ngo, M., Pablo, C., and Tubon,
II. Materials N. (2021). Laboratory Manual in Pharmaceutical Dosage
Forms. C&E Publishing House, Inc.
Levothyroxine Na Stainless Steel Spatula Scissors
(Eltroxin 50 g
Glassine Paper Paste/Glue University of Santo Tomas Powerpoint Presentation:
Tablet #1)
Unit 1, Preparation 1: Divided Powders
Pill Tile White Bond Paper Mortar and Pestle

III. Discussion
● Powders are mixtures of finely divided solids or chemicals
in a dry form. The powders may be used internally or
externally. Depending on their intended use, powders are
packaged and dispensed as bulk powders and divided
powders. On a small scale, the most common comminution
techniques are trituration, pulverization by intervention,

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2|PREPARATION 2: EFFERVESCENT GRANULES

2ND SEMESTER – 1ST SHIFT LAB l PHA 619 l CERVANTES & DE JESUS

● Usual method for small scale

OUTLINE production of extemporaneous
I. Introduction to Granules compounding of granules (since
A. Method of Preparation the apparatus/equipment is not
B. Particle Size Analysis complicated)
II. Preparation 2: Effervescent Granules ● Some manufacturing companies
III. Assigned Reading may also employ this method if
IV. Synchronous Notes deemed necessary.
● Powder placed in conical piece of
GRANULES equipment and vigorously dispersed
● Granules are dosage forms we prepare that are agglomerates 2. Fluid Bed Process and suspended while a liquid
of small particles of powder They are larger in terms of particle excipient (granulating liquid) is
size as compared to powders. (Shape: Irregular) sprayed on
● The powders are placed and
EFFERVESCENT SALT dispersed in the powder container,
while the granulating liquid is
● Granules or coarse to very coarse powder containing a soluble
sprayed from the top. Hot air is
medicinal agent in a dry mixture
introduced to the materials from
below with a perforated plate and
EFFERVESCENT GRANULES
this will allow the materials to
● Generally composed of: facilitate wet granulation.
Organic acid + Inorganic base + H2O = CO2 effervescence
● In the preparation, when water (H2O) is added to the organic Makes use of large apparatuses and are usually seen in
acid and inorganic base, liberation of carbon dioxide (CO2) pharmaceutical companies involving large-scale production;
happens. As this happens, effervescence is observed. E.g. Wet Granulation: Fluid Bed Process
Organic Acids Used Citric Acid and Tartaric Acid Dry Granulation: Roll Compactor or Slugging
Inorganic Base Sodium Bicarbonate Table No.2 2 Dry Granulation Methods
● Two organic acids are used in combination because a problem DRY GRANULATION METHOD/TECHNIQUES
on the produce granule may occur if only one of them is used. METHOD DEFINITION
● Ratio: 1 part citric acid : 2 parts tartaric acid ● Widely used in the
1. Roll Compactor and
○ Citric acid alone: too sticky Granulating Machine pharmaceutical industry
○ Tartaric acid alone: too friable (easily crumble) ● Passing thru a rotating
metal roll & then
Method of Preparation granulating machine
● Works by compressing the
● There are two general methods in preparing a granule: powders between two
○ Wet Method/Wet Granulation counter rotating rollers, after
A. Classic Wet Method which powder
B. Fluid Bed Process sheets/ribbons of materials
○ Dry Method/Dry Granulation - used for moisture-sensitive are produced. Substitute
and incompatible with water and granulating liquid
milled into granules.
A. Roll Compactor and Granulating Machine
2. Slugging Compression
B. Slugging Compression of Mixture into Large
of Mixture into Large
Tablets/Slugs
Tablets/Slugs
Table No.1 2 Wet Granulation Methods
WET GRANULATION METHOD/TECHNIQUES ● Slugs are large tablets that
METHOD DEFINITION are milled in order to
produce a granule.
● Moistening the powder mix and pass
thru sieve and oven drying
1. Classic Wet Method ● Granulating liquid
○ material used to moisten (eg.
water)
○ used to facilitate the clumping of
powders. After adding this, the DESIRED PROPERTIES
outcome will be wet lumps of A. Fluidity / Free flowing
powders. These wet clumps of ○ In making a tablet, starting ingredients are usually in
powder will be sieved to achieve a powder form which are commonly difficult to compress
certain particle size. into tablets even in the presence of binders. Hence,
● In order to make a granule, sieves #4
granulation is needed, and the produced granule will be
to #12 are used. (for effervescent the intermediate product.
granules, use sieve #12) ○ (Powder → Granulation → Tablets) - The granules must
● The wet granules are then dried in an
be free flowing because if not, there will be problems in
oven to produce granules. terms of weight. They will vary in weight.

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B. Compressibility
○ The particle size of the granule must be enough for it to be ● Purified water is the granulating liquid. Qs is used for its
properly compressed. It should not be too fine or too small amount because during the granulation process, we add
or too big. enough water to ensure that the whole powder mix is wetted
(A) (B) (C) just enough to facilitate granulation.
General Size Lower Granules Size Granules size
than 0.45 mm 0.45 - 2 mm Greater than 2 mm Complete the required amount to make 15 grams.
Using Ratio and Proportion…
○ Citric Acid:
1𝑔 𝑥
6.4𝑔
= 15𝑔
= 2.3g citric acid

○ Tartaric Acid:
2𝑔 𝑥
6.4𝑔
= 15𝑔
= 4.7g tartaric acid

BEST ○ Sodium Bicarbonate:

FAILURES OF PERFORMANCE 3.4𝑔 𝑥
OVERWETTING = = 8g NaHCO3
AGGREGATION In terms of 6.4𝑔 15𝑔
PHENOMENA
PHENOMENA granulation yield
and flowability COMPUTATION
● Citric Acid:
C. Better Dissolution ○ 3 NaHCO3 (84g/n) + C6H8O7•H2O (210g/n) → 4H2O + 3CO2 +
○ Granules have better dissolution compared to powder, Na3C6H5O7
meaning they are dissolved faster. This is because they have ● Tartaric Acid:
greater surface area which allows better penetration of water. ○ 2NaHCO3 + C4H6O6 (150g/n) → 2H2O + 2CO2 + Na2C4H4O6
D.More stable to atmospheric humidity, less caking ● Common ratio of citric acid to tartaric acid is 1:2. Based on the
○ Caking (forms a hard lump or mass) is usually seen on amount of citric acid and tartaric acid, the amount of sodium
powders. bicarbonate may vary.
Particle Size Analysis
● One of the tests performed in granules and powders ● First, determine the amount of sodium bicarbonate (NaHCO3)
● Powders of vegetable and animal drugs in 1g citric acid. (CA)
○ Very Coarse (No.8) 1𝑔 𝑐𝑖𝑡𝑟𝑖𝑐 𝑎𝑐𝑖𝑑 ×
1 𝑚𝑜𝑙𝑒 𝐶𝐴
×
3 𝑚𝑜𝑙𝑒 𝑁𝑎𝐻𝐶𝑂3
×
84𝑔 𝑁𝑎𝐻𝐶𝑂3
○ Coarse (no. 20) 210𝑔 𝐶𝐴 1 𝑚𝑜𝑙𝑒 𝐶𝐴 1 𝑚𝑜𝑙𝑒 𝑁𝑎𝐻𝐶𝑂3
○ Moderately Coarse (No. 40) = 1.2g NaHCO3
○ Fine (No. 60)
○ Very Fine (No. 80) ● Determine the amount of sodium bicarbonate (NaHCO3) in 2g
tartaric acid. (TA)
1 𝑚𝑜𝑙𝑒 𝑇𝐴 2 𝑚𝑜𝑙𝑒 𝑁𝑎𝐻𝐶𝑂3 84𝑔 𝑁𝑎𝐻𝐶𝑂3
● The powder fineness of chemicals 2𝑔 𝑡𝑎𝑟𝑡𝑎𝑟𝑖𝑐 𝑎𝑐𝑖𝑑 × × ×
150𝑔 𝑇𝐴 1 𝑚𝑜𝑙𝑒 𝑇𝐴 1 𝑚𝑜𝑙𝑒 𝑁𝑎𝐻𝐶𝑂3
○ Coarse (no. 20)
= 2.2g NaHCO3
○ Moderately Coarse (No. 40)
● Add the two amounts:
○ Fine (No. 80)
Total amount of NaHCO3 → 3.4g
○ Very Fine (No.120)
PROCEDURE
PREPARATION 2: EFFERVESCENT GRANULES
1. Weigh the different ingredients based on the computed
amount
CATEGORY 2. Triturate the ingredients individually (ensuring uniform and
● Granules appropriate size for powder_
3. Blend/Triturate the ingredients together using a mortar and
SYNONYMS pestle
● Pulvis Effervescens Compasitus 4. Add a sufficient amount of purified water to make it wet
5. Pass the mixture through sieve #12
DESCRIPTION OF FINAL PRODUCT 6. Collect the wet granules in oven tray that is covered with
aluminum foil
● White coarse powder with no odor
7. Oven dry at 54°C for 60 minutes (must be monitored)
Method of Preparation: Wet Granules - Classic
USE/S
● The resulting carbonated solution when water is added masks LABEL
an undesirable taste of any medicinal agents present.
White label (effervescent granules - for oral use)
● Making it suitable to be used as a vehicle for selected products.
CONTAINER
FORMULATION
30mL Wide mouth amber bottle
Citric Acid 1.0g
Tartaric acid 2.0g
Sodium bicarbonate 3.4g
Purified water, qs
= 6.4g effervescent granule

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REMARKS
1. Do not include purified water in the label. (Water is SYNCHRONOUS NOTES
already lost after drying the granules in an oven)
2. Clean the sieve carefully to prevent dirt from combining Table No.3 Question and Answer Portion.
with the granules. (To prevent contamination) QUESTION ANSWER
What is the method of preparation of
ASSIGNED READING Effervescent Granules?
A. Dry Granulation - Slugging
PREPARATION 2: EFFERVESCENT GRANULES C. Wet Granulation
B. Dry Granulation - Roll Compactor
- Classic
I. Objectives C. Wet Granulation - Classic
● Determine the different methods of preparation of granules. D. Wet Granulation - Fluid Bed
● Differentiate the various methods of preparation of granules. Process
● Know the rationale of the composition of the effervescent
granules. Citric acid when used alone in an
effervescent granule preparation will
True
II. Materials result to sticky granules.
Sodium Bicarbonate Drying Oven True or False
Anhydrous Citric Acid Aluminum Foil A levitating agent is a solvent that aids
Tartaric Acid Sieve #12 in the comminution process of
False
Mortar and Pestle Wide Mouth Bottle levigation
Purified Water Weighing Balance True or False
Compute for the amount of NaHCO3 needed to react with 2.3
III. DIscussion grams of citric acid. = 2.76 grams
● Granules are prepared agglomerates of small particles of
powder. They are irregularly shaped but may be spherical. It Solution:
uses a 4-12 sieve size range. 2. 3𝑔 𝑐𝑖𝑡𝑟𝑖𝑐 𝑎𝑐𝑖𝑑 ×
1 𝑚𝑜𝑙𝑒 𝐶𝐴
×
3 𝑚𝑜𝑙𝑒 𝑁𝑎𝐻𝐶𝑂3
×
84𝑔 𝑁𝑎𝐻𝐶𝑂3
210𝑔 𝐶𝐴 1 𝑚𝑜𝑙𝑒 𝐶𝐴 1 𝑚𝑜𝑙𝑒 𝑁𝑎𝐻𝐶𝑂3
● Effervescent Granulated Salts are granules or coarse to very
coarse powders containing a medicinal agent in a dry = 2.76 grams
mixture. It is composed of sodium bicarbonate, citric acid,
and tartaric acid.
● Method of Preparation: Dry/Fusion Method and Wet Method
REFERENCES
IV. Formula Course Instructor/s: 
INGREDIENTS ORIGINAL AMOUNT Maria Ozawa Gracia Cervantes & Prima De Jesus
Sodium bicarbonate 8.01 g
Citric acid 2.33 g References from:
Tartaric acid 4.66 g Allen, L.V., Popovich, N.G. & Ansel, H.C. (2018). Powders &
Purified water q.s. Granules Ansel’s Pharmaceutical Dosage Forms and Drug
Delivery System (11th edition) (pp. 184- 202). Philadelphia:
V. Procedure Wolter Kluwer/Lippincott Williams and Wilkins
1. Weigh the sodium bicarbonate, citric acid, and tartaric acid
individually. Allen, L.V. Oral Solid Dosage Forms In Remington: The Science
2. Triturate the sodium bicarbonate, citric acid, and tartaric & Practice of Pharmacy (23rd edition) (pp. 947-976).
acid individually. Blend. Philadelphia: Pharmaceutical Press.
3. If the mixture is not wet, add a sufficient amount of purified
water to make it wet. Castillo, A., Casuga, F., Doria, MC, Ngo, M., Pablo, C., and Tubon,
4. Pass the wet powdered-mixtures through sieve #12. N. (2021). Laboratory Manual in Pharmaceutical Dosage
5. Collect the wet granules. Forms. C&E Publishing House, Inc.
6. Oven dry the wet granules for one hour at 54°C.
7. Weigh the dry granules and store them in a wide mouth University of Santo Tomas Powerpoint Presentation:
bottle. Unit 1, Preparation 2: Effervescent Granules
8. Label properly.

VI. Clean-Up Procedure

1. Clean the sieve and return it to the laboratory
assistant/technician.
2. Clean all your laboratory apparatus using soap and water.
Wipe dry and return them to your assigned locker cabinet.
3. Clean your working area before leaving the laboratory.

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3|PREPARATION 3: PARACETAMOL TABLET

2ND SEMESTER – 1ST SHIFT LAB l PHA 619 l CERVANTES & DE JESUS

OUTLINE ● Since the triturates must

I. Tablet completely and rapidly
A. Types of Tablet based on Method of Preparation dissolve in water, only
B. Pharmaceutical Ingredient (Excipient) minimal pressure is
C. Composition of a Tablet applied during
D. Ideal Characteristics of Granules prior to manufacture which
Compression yields softer tablets
E. Tablet compression
F. Methods of Preparing Tablet Pharmaceutical Ingredient (Excipient)
a. Wet Granulation Excipient - added to produce a tablet
G. Problems 1. Ingredients that import satisfactory processing & compression
II. Preparation #3: Paracetamol Tablets ○ Glidant, lubricant, diluents, binder
III. Synchronous Notes
2. Deals on desirable physical characteristics to finished or
TABLET compressed tablets (final touches for the tablet)
● Solid pharmaceutical dosage form containing drug ○ Colorant, flavor, disintegrant, sweetening agent
○ Substances with or without diluent prepared by
compression or molding Composition of a Tablet
● Most common dosage form because of the convenience of 1. Active Ingredient
administration ○ Component of a pharmaceutical product that exerts the
○ Provides an accurate dosage in a portable packaging pharmacologic activity
2 known brands locally and internationally
○ Tylenol (Acetaminophen) 2. Diluent
○ Biogesic (Paracetamol) ○ Bulking agents, fillers
● Very common pharmaceutical oral dosage form ○ Needed to increases the bulk when the quantity of the
● Usually composed of a mixture of an active ingredient medicament is very small in each tablet
and some excipients Example: Lactose, mannitol, dicalcium phosphate,
● Usually used or prepared by compression or molding kaolin, cellulose, starch, CaSO4
● Simple and convenient to use because it provides
accurate dosage in a portable convenient packaging 3. Binders (Binding agent)
● Can be administered orally, buccally, sublingually, ○ Granulator, “glue” powder together; Promotes
rectally, or intravaginally cohesiveness; can be liquid or solid
● Can vary in weight, size, and shape depending on the amount of ○ Provides moisture to convert a fine powder into a damp
medicinal substance present and intended mode of mass which after passing through a sieve forms granules
administration since we can use the tablet in different methods ○ Provides strength to granules to keep the tablet intact
● Most popular dosage form and 70% of medicines are dispensed ○ The use of binders depends on the type of the tablet
through tablets ○ Example:
■ Liquid - Glucose
Types of Tablet based on Method of Preparation ■ Semi-solid - Starch paste
■ Solid - gelatin, sugar (sucrose, glucose, lactose),
COMPRESSED TABLET acacia, veegum
Produced in a Large Scale Basis 4. Lubricant
● Most popular dosage form ○ Reduce inter-particular friction during compression and
and about ⅔ of all friction between the tablets, punches and die surfaces
prescriptions are dispensed ○ Prevents adhesion of the tablet material to the surface of
as solid dosage form, and the punches and dies
half of these are ○ Facilitates the ejection of the tablet from the die cavity
compressed tablets Example: Metallic stearates (Mg stearate, Ca stearate,
Example: stearic acid), talc
Sugar-coated, enteric-coated,
sustained release 5. Glidant
○ Improves the flow characteristic of the granule or powder
MOLDED TABLET
mixture
Tablet triturate; use of molder; ○ Added prior to compression to improve flow
yield softer tablets Example: talc, colloidal silicon dioxide
● Prepared by mixing the
active drug with an 6. Disintegrant (Disintegrating agents)
appropriate diluent ○ Helps in the break-up of the tablet after administration
● Tablet triturate are Example: 10% starch, Microcrystalline cellulose (Avicel),
prepared from moist Sodium starch glycolate, Crosslinked
materials using a molder Polyvinylpyrrolidone (Crospovidone), Croscarmellose
that gives shape of the sodium
(cut section of a cylinder)

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7. Colorant
○ Impart distinct appearance to the tablet colorance
○ Added for aesthetic appearance
○ Usually, tablets are light-colored
○ Problems: Mottling- uneven distribution of colors
■ It may be caused by improper mixing, using a
colored drug along with white or colorless
excipients
Methods of Preparing Tablet
1. Granulation
● Dry Granulation - roller compactor, slugs (mechanical
compression/compaction with the use of roller compactor
and compression of powder mixture into a large tablet also
known as slugs to facilitate the agglomeration of dry
powder particles
● Wet Granulation - formation of wet mass
● Using a granulation liquid/binders/solvent to facilitate the
agglomeration for formation of wet mass by addition

2. Direct Compression (Compaction)

Ideal Characteristics of Granules prior to Compression
Why are we talking about granules? Because granules are made a
step before a tablet (it is important to have a better/perfect
tablet for administration or for dispense)
● Tablets are directly compressed from the powdered active
drug substance and suitable excipients into a firm
compact without employing the process of granulation
● Easy to process; no additional processing steps
● Direct from the power → compression

1. Ability to Flow Freely

○ Granules flow into die more freely than powders
○ Powder mixtures are usually granulated if they are
intended to compress into a tablet or could also/eliminate
or control dust

2. Cohesiveness
○ Granules are a small compact of particles
○ If you prepare the tablets/granules properly you will be able
to avoid segregation during compression
○ If powders are composed of particles with different
dimensions or densities, a separation between particles
may occur

3. Proper Lubrication
○ To avoid problems during granulation or compression
○ Avoid sticking or capping WET GRANULATION
Most common method used by manufacturing companies
Reason: No scratches along the side of the tablet; No screeching 1. Weighing & blending
sound of the machine ■ Dry ingredients
2. Wet granulation- add binder/granulator
Tablet Compression (Compression Machine) ■ Form wet mass
1. Single Punch 3. Screen the damp mass passing to sieve #6-8 wet granules
■ Single-station press 4. Drying
■ Single set of tooling; one punch and die ■ Using a thermostatically-controlled oven
■ Simplest machine for tablet manufacturing 5. Dry screen - pass through sieve #12 dry granules
■ Used to make a tablet from powder then the 6.Lubrication (bolting) - add lubricant and glidant by passing
powder will be granulated and placed into the thru sieve #60-100
cavity formed by the punches and die; the 7. Tablet Compression
punches are pressed together to compress the
material to have tablet as an output Problems
Can cause damage to production schedule, labor effort, and loss
2. Multistation rotary press of money
■ Several sets of tooling; Table No. 1 Problems and their Definition
■ >1 punch & die; large scale IMAGES DEFINITION
■ Tablets produced are uniform in size, shape, and Mottling
weight Uneven distribution of color
■ Usually developed to increase the output of the ○ May be caused by
tablet improper mixing,
using a colored drug
along with white or
colorless excipients

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Picking
Adherence to upper punch
○ Small surface of tablet
was removed by the
punch
○ Due to improper drying,
too much binder,
improper lubricants
used in the process
○ Due to rough punch
face (particles stick
into the punch)
Sticking
Adherence to the wall of die
cavity
○ Caused by excessive
moisture in granules
○ Improper lubricant
○ Too much use of a
hygroscopic material
Chipping
Separation of small piece
○ Breaking of tablet
edges during press
process or subsequent
handling in coating
○ Due to very dry granules
○ Sticking to punch faces
○ Too much binding
Capping
Complete or partial separation
of top or bottom surface of the
tablet
○ Can happen during
ejection of tablet press
or subsequent handling
of tablet
○ Insufficient amount of
binder or lubricant
Lamination
Separation of tablet in 2 or
more distinct layers
● Can be caused by too
much oily mixture, too
much hydrophobic
lubricant or rapid
decompression
PREPARATION #3: PARACETAMOL TABLETS
LABEL
White label (Administered internally)
CONTAINER
Wide mouthed bottle
REMARKS
Method: Wet granulation
OBJECTIVES
● Determine the methods of preparation of tablets.
● Know the advantages of solid dosage forms over liquid dosage
forms.
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● Determine the characteristics of ideal tablets
MATERIALS
● Paracetamol ● Drying oven
● Talc ● Analytical balance
● Magnesium stearate ● Aluminum foil
● Plasdone ● Tablet press
● Starch powder ● Sieve #6, #12, #20, #100
● 1.5% starch paste ● Mortar and Pestle
● Purified water ● Beaker 250 mL
● Thermometer
DISCUSSION
Tablets are solid dosage forms that contain a mixture of active
substances and excipients. Tablet excipients: diluents,
binders/adhesives, disintegrants, lubricants, anti- adherents,
glidants, colors/dyes, flavoring agents, and artificial sweeteners.
Tablets are classified according to their route of administration,
drug delivery system, and form/method of manufacture.
FORMULA
Table No. 2 Ingredients and their Amount
INGREDIENTS ORIGINAL AMOUNT
Paracetamol (active ingredient) 500.00 mg
Starch (diluent) 75.00 mg
Talc (glidant) 6.00 mg
Magnesium stearate (lubricant) 6.00 mg
Plasdone (disintegrant) 6.00 mg
Purified water q.s.
Starch paste - binder
PROCEDURE
Weigh and prepare the dry ingredients (paracetamol and starch)
1. Pass the paracetamol and starch through sieve #20.
2. Blend paracetamol and starch by trituration for 5
minutes.
3. Prepare 15% starch paste.
4. Add 15% starch paste and enough purified water to the
triturated powders in small portions by kneading until a
moist mass is formed.
5. Screen the moist mass by forcing it through sieve #6.
6. Dry the formed granules in an oven at 50°C until the
moisture content is not more than 2%.
7. Screen the dried granules using sieve #12.
8. Pass talc, magnesium stearate, and plasdone through
sieve #100 with the dried granules on the tray as a
receiver.
9. Blend mixture using tumbling method for 5 minutes.
10. Compress using a tableting machine/tablet press.
3
PHARMACEUTICAL DOSAGE FORMS, DRUG DELIVERY SYSTEMS & MEDICAL DEVICES BS PHA | 1A PH A.Y 2021 – 2022

Clean-Up Procedure B. Talc

1. Clean the sieve with soap and water. Wipe dry and return C. Magnesium
it to the laboratory assistant/technician. D. Talc
2. Clean the tablet press using a vacuum cleaner or wet E. Plasdone
method.
3. Clean all your laboratory apparatus and return them to
your assigned locker cabinet. REFERENCES
4. Clean your working area before leaving the laboratory. Course Instructor/s: 
Maria Ozawa Gracia Cervantes & Prima De Jesus
SYNCHRONOUS NOTES References from:
Table No. 3 Question and Answer Portion Allen, L.V., Popovich, N.G. & Ansel, H.C. (2017). Tablets In Ansel’s
QUESTION ANSWER Pharmaceutical Dosage Forms and Drug Delivery
Tablets are administered: System (11th edition) (pp. 225-256). Philadelphia:
A. Buccally, Intrathecally, Lippincott Williams and Wilkins.
Intravaginally (local
antibacterial) Allen, L.V. Oral Solid Dosage Forms in Remington: The Science &
B. Sublingually (bioavailability Practice of Pharmacy (23rd edition, pp. 947-976).
when absorbed), Buccally, Philadelphia: Pharmaceutical Press.
B. Sublingually,
Intravaginally
Buccally,
C. Sublingually, Intradermally, Castillo, A., Casuga, F., Doria, MC, Ngo, M., Pablo, C., and Tubon, N.
Intravaginally
Orally (2021). Laboratory Manual in Pharmaceutical Dosage
D. Orally, Intranasally, Forms. C&E Publishing House, Inc.
Intrathecally
*Intradermally (pellets - delayed action; University of Santo Tomas Powerpoint Presentation:
may be weekly/monthly) Unit 1, Preparation 3: Paracetamol Tablet
*Intranasally (usually liquid)
Compressed tablets are described as
the following except:
A. Most popular dosage form
B. Produced in a large scale basis D. Uses a molder
C. Enteric-coated tablet is an
example
D. Uses a molder
It deals on desirable physical
characteristics of a tablet
A. Disintegrant
A. Disintegrant
B. Diluent
C. Binder
D. Lubricant
It is added to increase the bulk of
preparation.
A. Granulator
B. Diluent
B. Diluent
C. Disintegrant
D. Active Ingredient
It prevents the adhesion of the tablet
material to the surfaces of punches and
die.
A. Dicalcium phosphate D. Talc
B. Veegum
C. Avicel
D. Talc
Which of the following provides strength
to granules to keep the tablet intact?
A. Sucrose
A. Sucrose
B. Starch
C. Stearic acid
D. Silicon dioxide
Granulation is required for direct
compression.
B. False
A. True
B. False
In the formulation of a Paracetamol
Tablet, which of the following serves as
D. Plasdone
disintegrant?
A. Starch

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4|PREPARATION 4: CHOCOLATE-BASED
CALCIUM LOZENGES
2ND SEMESTER – 1ST SHIFT LAB l PHA 619 l CERVANTES & DE JESUS

OUTLINE ● Disadvantage: need to have an adequate skill to perform.

I. Lozenges ● Example: Innovation of the bottle cap (no special equipments
A. Uses of Lozenges were used during the procedure)
B. Types of Lozenges
C. Methods of Preparation
II. Calcium
A. Uses of Calcium
B. Formulation, Computation, Procedure, Label,
Container, Remarks
III. Synchronous Notes
IV. Assigned Reading

LOZENGES
● Solid preparations that are intended to dissolve or disintegrate FUSION OR MOLDING
slowly in the mouth (also a small medicated candy) ● Method used for hard candy, chocolate, gummy gel chewable
● Contain one or more medicaments usually in a flavored, ● Requires heat, special mold, skills and calculations
sweetened base & often used for localized systemic effect ● Dose unit ay be determined either by weight or volume or both
● Examples: ● When using heat, we need to be cautious in using ingredients
Strepsils Difflam because we need to incorporate heat source ingredients

CALCIUM
● Most abundant mineral in the body
● Usually takes up the 2% of our dorsal body weight
Bactidol ● Main role: provides structure and strength to the bones.
Fishermans Friend
(new product)
Uses of Calcium
● Used as a reducing agent in order to extract metals (e.g.,
Uranium, Zirconium, and Thorium
● Cheese is made using calcium ions to promote coagulation of
milk
● Important as ingredients in construction materials (e.g.,
Uses of Lozenges cement and mortar)
● Sore throat - used to soothe the inflammation of the throat or ● Used in liquid rocket fuel, textile production, dental products
causes the sore throat. (example: Cepacol) (toothpaste), fertilizer, and the making of dough
● Anesthetic (example: Beadine) - has lidocaine, only a small ● Required for growth and development of the bones
amount used to numb ● Responsible for the rigidity in human bones
● Demulcent - relieve inflammation in the mouth or throat; for ● Calcium carbonate- antacid
inflammation ● Helps treating and preventing rickets
● Antibacterial ● Most likely that calcium could be effective for treating and
● Smoking Cessation - help quit smoking preventing osteoporosis
● Calcium supplements
Table No.1 Kinds of Calcium and its Uses.
Types of Lozenges KIND USE/S
1. Hard Lozenges - from syrups of sucrose (hard candy) and - Used in bright paints, X-ray studies and
Ca tungstate
other and/or carbohydrates fluorescent lights
2. Soft Lozenges - from flavored fatty base to make it soft, such - Determines whether carbon dioxide is
as chocolate, PEG base and sugar-acacia base Ca hydroxide present and commonly used in
3. Chewable Lozenges - glycerinated gelatin-base (based from laboratories (confirmatory test)
gummy bears); may konting lambot - Used to make lime (stabilizer, adds
strength to the glass and to the physical
Ca carbonate appearance) and limestone
Method of Preparation - Important in the glass industry
- Antacid
HAND ROLLING - Used as food additive
● Use of hand, from the name itself Ca gluconate
- Also added to vitamin pills
● Does not require special equipment Ca sulfate - Blackboard chalk
● We use the rolling pin to flatten out the preparation or mixture

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- Used to disinfect pools and is also a 3. Stir until chocolate is completely

Ca hypochlorite bleach (remove bacteria) melted and well mixed.
- Also added to deodorants and fungicide
4. Incorporate the active
Recommended Dietary Allowances (RDAs) for Calcium ingredient and stir to mix.
Table No.2 Calcium Content of Various Foods.
Age Male Female Pregnant Lactating 5. Immediately pour chocolate base
0-6 months 200mg 200mg into each mold cavity.
7-12 months 260mg 260mg
6. With the edge of a spatula level
1-3 years 700mg 700mg
and even out the poured mass.
4-8 years 1,000mg 1,000mg 7. Cool the poured mass.
9-13 years 1,300mg 1,300mg 8. Remove lozenges from mold
14-18 years 1,300mg 1,300mg 1,300mg 1,300mg and cover using aluminum foil.
19-50 years 1,000mg 1,000mg 1,000 mg 1,000mg
51-70 years 1,000mg 1,000mg
71+ years 1,200mg LABEL
-

White Label (Internal use)

CONTAINER
PREPARATION 4 Aluminum Foil (cover each lozenge individually) and Wide-mouth
“How to prepare Chocolate-Based Calcium Lozenges” bottle

Chocolate-Based Calcium Lozenges REMARKS

Should be stored in a cool place to avoid melting of the chocolate
FORMULATION base
Ingredients Original Amount Computed Amount
Chocolate Bar 6.0 g/ lozenge ? SYNCHRONOUS NOTES
Corn oil 2.0 g/ lozenge ? Table No.3 Question and Answer Portion.
Elemental Calcium 333.0 mg/ lozenge ? QUESTION ANSWER
To make 4 Lozenges The following are uses of
lozenges except: Antipruritic
A. Supplements (topical
COMPUTATION
B. Antipruritic applications used
● Chocolate Bar= 6.0 g/ lozenge x 4 lozenges= 24 g C. Antibacterial to relieve itching)
● Corn oil= 2.0 g/ lozenge x 4 lozenges= 8 g D. Anesthetic
● Elemental calcium= 333.0 mg/ lozenge x 4 lozenges= 1,332 mg Match the following:
Hard Lozenges
PROCEDURE Soft Lozenges B
Chewable Lozenges C
Table No.2 Procedure on Making the Lozenges. A. glycerinated gelatin-base A
STEPS ILLUSTRATION B. from syrups of sucrose
1. Prepare chocolate base: C. from flavored fatty base
Calcium is important in the
○ Weigh corn oil in a previously glass industry.
True
tared 250 mL beaker. A. True
B. False
The RDAs for calcium for Lactating
women (28 y/o) is 1,000 mg.
True
A. True
B. False
○ Heat in a water bath.

ASSIGNED READINGS

PREPARATION 4: CHOCOLATE-BASED CALCIUM LOZENGES

○ Break chocolate in pieces. I. Objectives
● Compare the different types of lozenge formula.
● Know the other uses and methods of preparing lozenges.
● Apply at least one process of preparing a lozenge
formula (chocolate base lozenges).
2. Add the chocolate to the heated oil
in a portion.

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II. Materials
Calcium carbonate VI. Clean-Up Procedure
Chocolate bar Evaporating dish 1. Clean the molders before and after use (e.g., soap and
(Food Grade)
Smallest size water, and wipe dry). Return the molders and other
Corn oil 250 mL beaker borrowed apparatus to the laboratory technician after use.
stirring rod
2. Likewise, clean the weighing pan and around the
III. Discussion weighing area from spilled
● Lozenges are solid dosage forms that are intended to 3. materials such as dipping chocolate, powders, etc., before
dissolve in the mouth slowly. This dosage form is one of the and after use.
more recent ways to deliver drugs systemically by releasing 4. Clean assigned working area before and after laboratory
the drug either buccally or sublingually for absorption. preparation.
● There are three (3) types of lozenges: 5. Arrange the chairs before leaving the laboratory.
○ Hard Lozenges are made from syrups of sucrose and other
sugars and/ or carbohydrates that are boiled so that the REFERENCES
moisture content in the product is 0.5% to 1.5%. The Course Instructor/s: 
process of preparing hard lozenges is similar to candy Maria Ozawa Gracia Cervantes & Prima De Jesus
Making.
○ Soft Lozenges can be made from flavored fatty base such References from:
as chocolate, polyethylene glycol (PEG) base and sugar- Thompson, J.E., and Davidow, L.W (2017). Chapter 26.
acacia base and Capsule, Lozenges, and Other Solid Dosage Forms In A
○ Chewable gummy gel lozenges are glycerinated gelatin base Practical Guide to Contemporary Pharmacy Practice, 4th
chewable oral drug preparation which was made after a edition. Baltimore USA: Lippincott Williams and Wilkins.
candy “gummy worms” or “gummy bears” for children
was launched. http://pharmlabs.unc.edu/labs/lozenge/soft.htm (Date
● Lozenges can be made either by hand-rolling or fusion, retrieved: 4/11/2019).
depending on the selected compounding method. Special
calculations, techniques, and equipment are also required University of Santo Tomas Powerpoint Presentation:
to give accurate doses. Unit 1, Preparation 4: Chocolate-Based Calcium Lozenges
● Hand-rolling is a method used for preparing lozenges that do
not require particular calculations and equipment, but a pill
roller, broad-bladed spatula, or any flat nonreactive material
can be used for this purpose.
● Fusion or molding is a method used for hard candy,
chocolate, and gummy gel chewable lozenges. This method
requires heat, special mold, skills, and calculations to
obtain satisfactory preparation. The dosage unit may be
determined either by weight or volume, or both.
● Caution must be used when adding heat-sensitive drugs.
Lozenges are formulated to taste good to enhance patient
compliance but are a potential danger to children since they
may look like candies. Households with children should be
cautioned to keep the preparation out of their reach.

IV. Formula
INGREDIENT ORIGINAL AMOUNT
Chocolate Bar 6.0 g/ lozenge
Corn oil 2.0 g/ lozenge
Elemental Calcium 333.0 mg/ lozenge

V. Procedure
1. Prepare the chocolate base by weighing corn oil in a
previously tared 250- mL beaker and heat it in a warm
water bath. Break the chocolate bar into pieces and add to
the heated oil in portions. Stir until the chocolate is
completely melted and well mixed.
2. Incorporate the active ingredient and stir to mix well.
3. Immediately pour the chocolate base into each mold
cavity.
4. The edge of a spatula may be used to level and even out
the poured mass.
5. Cool the poured mass in the refrigerator or freezer for
10-20 minutes.
6. Remove the lozenges from the mold and cover each
chocolate base lozenge using an aluminum foil or
chocolate candy wrapper.
7. Wrapped chocolate base lozenges can be stored in plastic
or aluminum containers.
8. Label properly.

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5|PREPARATION 5: ASPIRIN CAPSULE

2ND SEMESTER – 1ST SHIFT LAB l PHA 619 l QUERRER & SAMONTE

● May also contain a solid active ingredient suspended in

OUTLINE a liquid vehicle approved for oral use such as vegetable
I. Capsule oil or a non-aqueous, water-miscible glycol such as
A. Method of Preparing Hard Gelatin Capsule polyethylene glycol 400 or polyethylene glycol. The
II. Preparation: Aspirin Capsule
technology and equipment required in preparing soft
III. Preparation: Mefenamic 125mg Capsule
IV. Assigned Reading on Preparation 5 gelatin are not usually available in pharmacies, so this
V. Synchronous Notes dosage form is not prepared extemporaneously.

Capsule Size
CAPSULE
● Solid dosage form in which medicinal agents and/or
inert substances are enclosed within a small shell of
gelatin (partial hydrolysis of collagen obtained from
skin, white connective tissue, bones of animals).
● The shells are usually made up of gelatin; however, they
may also be made from starch or other suitable
substances.
● Said to contain the drug, or the active ingredients +
inactive ingredients (or what we call excipients).

● 000 – 15 grains
Two Types of Capsules
● 00 – 10 grains
Hard Gelatin Capsule or Dry Filled Capsules ● 0 – 7.5 grains
● 1 – 5 grains
● 2 – 4 grains
● 3 – 3 grains
● 4 – 2 grains
● 5 – 1 grain
*The curve one is the one that locks the capsule.
Also indicate the amount of powder it can contain.

Method of Preparing Hard Gelatin Capsule

Hard Gelatin Capsules can be prepared manually whereas Soft
Gelatin Capsules cannot.
● Mixture of gelatin, sugar & water
Table No. 1 Methods of Preparation
● Contains 13 – 16% moisture METHOD DEFINITION
● Usually contains powders Punch Method Repeatedly press the open end of the
● They can be clear, colorless, and essentially tasteless. body of the shell down into the
● They may be colored with various FD&C and D&C dyes powder
and made opaque by adding agents such as titanium Capsule Filler Method 1. Place the body of the capsule
dioxide to conceal solid contents. in the lower tray of the
capsule filler
Soft Gelatin Capsule or Form filled - Sealed Capsule 2. Spread the powder
3. Place upper layer then press
to release
The capsule body is longer than the
cap.
Step by Step 1. Triturate the powder. Done to
● Are made up of gelatin with glycerin & sorbitol as have uniform size.
plasticizer (elastic) 2. Choose the correct capsule
● 6 to 10% moisture size. If the value is in
● Usually contains liquid preparations. milligrams, convert it to
grains.

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3. Separate the capsule body 4. Fill using the punch method

from the cap 5. Clean & polish the capsule using tissue paper with a
4. Fill the capsule shell (punch very small amount of mineral oil
method/capsule filling
machine) LABEL
5. Sealing, weighing the ● White Label
prepared capsule to check if
it has the right amount. CONTAINER
6. Cleaning & polishing (clean ● 15 mL wide mouth bottle or ziplock.
with gauze; polish with
mineral oil) REMARKS
● The method used was the punch method. Cotton was
used to absorb moisture. The pharmaceutical dosage
PREPARATION: ASPIRIN CAPSULE form is a capsule.

CATEGORY PREPARATION: MEFENAMIC CAPSULE

● Capsule
OBJECTIVE
SYNONYMS ● To prepare 125mg Mefenamic Acid Capsule
● C9H8O4 extemporaneously through the use of Punch method.
● 2-(Acetyloxy)benzoic Acid
● Acetylsalicylic acid (ASA) PREPARATION OF IMPROVISED PILL TILE
● 3-acetyl, acetaminophen ● Place a plastic cover on the graphing paper and put tape
on all sides to keep it in place.
DESCRIPTION OF FINAL PRODUCT ● Wipe the improvised pill tile with a little amount of
● Hard gelatin capsule containing white, odorless powder. alcohol to sanitize and allow it to dry.
Capsules are solid dosage forms in which medicament
or inert substances are enclosed within a small shell of REMINDERS
gelatin. ASA capsule contains not less than 93.0% and ● Wear your laboratory gown/blazer/white polo.
not more than 107% of the label amount of aspirin. ● Use a mantle/placemat on the working area.
● Use surgical gloves as you perform the experiment.
USE/S ● Tie long hair.
● This is used as an analgesic, antipyretic and ● Be sure that both hands are clean and dry.
anti-inflammatory agent. It is also used for the ● DISCLAIMER: This activity is only done for the purpose of
prevention of transient ischemic attack, prophylaxis & skill formation of students through the enriched virtual
thromboembolic disorder. It reduces fever and cold. learning during COVID-19 Pandemic.
Aspirin is a blood-thinner that helps in preventing
strokes. For internal use. PROCEDURE
● Doses (Aspirin is dose-dependent): 1. Separate the cap from the body of the hard gelatin
● ↳ High dose - for pain reliever capsule. Set it aside.
● ↳ Medium dose - for fever 2. Remove all Mefenamic acid 250mg powder from the
● ↳ Low dose - for stroke prevent or antiplatelet capsule shells and place it on the improvised pill tile.
3. Divide the amount of powders into two equal portions.
FORMULATION The first half portion may be used for practicing
● Aspirin 300mg/cap 600 mg/2 caps purposes while the second portion will be used for the
final preparation, the one that will be submitted. Ensure
COMPUTATION that all capsules retain their form and cleanliness.
● Convert mg to g: 300 mg→ 0.3 g 4. Get the half amount of the Mefenamic acid and replace
the other half with starch/flour, whichever is available at
15.432 𝑔𝑟
0. 3𝑔 × = 4. 62 𝑔𝑟𝑎𝑖𝑛 → 𝑐𝑎𝑝𝑠𝑢𝑙𝑒 #1 (using the capsule home. Preferably, weigh both the mefenamic acid and
1𝑔
size chart) the starch/flour if possible.
5. Mix the powders on the pill tile through the use of
PROCEDURE spatula to attain content uniformity.
1. Know the capsule size 6. Guided by the grid of the graphing paper, form a block
2. Weigh the needed amount of ingredient then divide it equally on the number of capsules
3. Remove the cap from the body required, 5 capsules.

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7. Get one part of the block (1/5), representing the content FORMULA
of one capsule , separate it from the others but still on
the pill tile.
8. Get one body of the capsule and press it onto the powder
until all of the powders of that portion have been placed
PROCEDURE
inside the capsule. Tap slightly the capsule body to allow
more powders to get into it and no air spaces are visible
within the contents. Then, cover it with the cap.
9. Ensure to lock the capsule.
10. Clean the capsule with tissue paper/cotton and place it
on a dry sterilized container.
11. Repeat the procedure 7 to 10 until all five capsules were
filled.
12. Label and dispense.
ASSIGNED READINGS ON PREPARATION 5
Table No. 2 Formula
INGREDIENTS ORIGINAL AMOUNT
Aspirin 300 mg/capsule
1. Determine the capsule size.
2. Weigh aspirin.
3. Reduce the particle size of aspirin by triturating in a
mortar and pestle and blend by spatulation.
4. Place the powdered aspirin in a pill tile and arrange it
into a compact, flat powder bed or block of uniform
thickness.
5. Divide the block into equal parts.
6. Handle capsules with disposable gloves. Separate the
capsule’s body from the cap and repeatedly press the
open end of the shell’s body downward into the powder
bed (punch method).
7. Seal and polish the capsule with a clean cloth or gauze.

OBJECTIVES CLEAN-UP PROCEDURE

● Know the different types of capsules and their 1. Clean, wipe the pill tile dry and other apparatus such as
composition. mortar pestle and pestle and metal spatula with clean
● Learn the various methods, technology, and equipment cloth before and after use. Return all borrowed apparatus
to prepare Capsules. such as the pill tile to the laboratory technician after
● Prepare a capsule extemporaneously. using.
2. Clean the weighing pan and around the weighing area
MATERIALS from spilled
● Aspirin powder 3. materials such as powders, etc., before and after use.
● Gauze or Cloth (clean) 4. Clean assigned working area before and after laboratory
● Mortar and pestle preparation.
● Pill tile 5. Arrange the chairs before leaving the laboratory.
● Metal spatula
● Hard gelatin capsules SYNCHRONOUS NOTES
Table No. 3 Question and Answer Portion
DISCUSSION
QUESTION ANSWER
● Capsules are solid dosage forms in which medicinal
The smallest size of capsule is size 000 True
agents and / or inert substances are enclosed within a
while the biggest is 5.
small gelatin shell that may be hard or soft depending
on their composition. The shells are usually made up of
True
gelatin; however, they may also be made from starch or
False
other suitable substances.
● There are two types of capsules, the hard shell/hard Glycerin and sorbitol are used as False
gelatin, and soft shell/soft gelatin capsules. Hard plasticizers when added to the gelatin
gelatin capsules are made up of gelatin, sugar, and in the preparation of hard gelatin
water. They can be clear, colorless, and essentially capsules.
tasteless. They may be colored with various FD&C and
D&C dyes and made opaque by adding agents such as True
titanium dioxide to conceal solid contents. Typically, False
hard gelatin capsules consist of two pieces, a body, and Calculate the total amount in grains of 19.25 grains/ 19.23
a cap. 5 Aspirin capsules if 250 mg of Aspirin grains/ 19.24 grains
● Capsules are hand-filled with powder contents by punch is present in a capsule.
method. It can also be filled using capsule filling machines.
Soft gelatin capsules are made up of gelatin but more Determine the size of the capsule that 4
pliable due to glycerine or polyhydric alcohol such as must be used if Aspirin is 0.1g/cap.
sorbitol, each of which acts as a plasticizer. These
capsules are usually filled with liquid or a solid active
ingredient suspended in a liquid vehicle approved for
oral use such as vegetable oil or a non-aqueous,
water-miscible glycol such as polyethylene glycol 400 or
polyethylene glycol. The technology and equipment
required in preparing soft gelatin are not usually
available in pharmacies, so this dosage form is not
prepared extemporaneously.

The method of preparing an Aspirin A. Punch method

capsule

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PHARMACEUTICAL DOSAGE FORMS, DRUG DELIVERY SYSTEMS & MEDICAL DEVICES BS PHA | 1A PH A.Y 2021 – 2022

A. Punch method
B. Block and divide
C. Capsule filler
D. Spatulation

REFERENCES
Course Instructor/s: 
Maria Ozawa Gracia Cervantes & Prima De Jesus

References from:
Allen, L.V, Popovich, N.G, and Ansel, H.C (2017). Chapter 7.
Capsules In Ansel’s Pharmaceutical Dosage Forms and Drug
Delivery Systems 11th edition. Baltimore USA: Lippincott
Williams and Wilkins.
Thompson, J.E., and Davidow, L.W (2017). Chapter 26. Capsule,
Lozenges, and Other Solid Dosage Forms In A Practical Guide to
Contemporary Pharmacy Practice, 4th edition. Baltimore USA:
Lippincott Williams and Wilkins.

University of Santo Tomas Powerpoint Presentation:

Unit 1, Preparation 5: Aspirin Capsule

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