COMPOUNDING LABORATORY JOURNAL

SESSION XIII - OFFLINE

I. Assessment of Prescription III- Session 10- Semi-solid Dosage Form (Unguenta)

a. Prescription

b. Completeness

● Name of Doctor: dr. Adi

● Address of Doctor: Jl. Pulomas Barat Kav 88, Jakarta Timur
● SIP Number: 123/I/DU/2016
● Prescription Number: 18
● Dates of Prescription: Jakarta, 1 January 2018
● Inscription: Kalium Iodide 3g, Iodium 2g, Aqua dest. 5g, Ungt. simplex 90g
● Subscription : m.f.ungt. da 20g
● Signa: S.u.e
● Doctor Signature: INCOMPLETE
● Name of Patient: Bastian
● Age of Patient: 18th
● Weight of Patient: INCOMPLETE
● Address of Patient: Jalan Mawar no 1, Jakarta Timur

II. Drug Classification

Drug Name Class Pharmacological Effect

Potassium Iodide OB/OTC (Obat Bebas) Anti-thyroid
(Medline)

Iodine OBT/W (Obat Bebas Terbatas) Halogen

(PubChem)
III. Preformulation Study
a. Kalium Iodide / Potassium Iodide (API)

Hexa hedral crystals; Transparent or colorless, opaque and white; White granular powder;
Hygroscopic; Very soluble in water; More soluble in boiling water; Soluble in ethanol (95%);
Easily soluble in glycerol. (Farmakope Edisi III)

b. Iodine (API)

Chips or granules, heavy, grayish black color, characteristic odour; Shine like metal; Difficult to
dissolve in water; Easily soluble in carbon disulfide, chloroform, tetrachloride and ether;
Soluble in ethanol and iodide; Slightly soluble in glycerin. (Farmakope Edisi III)

c. Cera Flava (Excipient)

Yellow or light brown pieces or plates with a smooth matt, non-crystalline fracture form and
has a faint characteristic odor; The wax becomes soft and pliable when warm; Soluble in
chloroform, ether, fixed oil, essential oil and warm carbon disulfide; Slightly soluble in ethanol
(95%); Practically insoluble in water. (Farmakope Edisi IV)

d. Ol.Sesami/ Minyak Wijen (API)

Liquid, pale yellow, weak odor, tasteless, does not freeze at 60 degrees Celsius; Slightly
soluble in ethanol (95%); Easily soluble in chloroform, ether and kerosene ether. (Farmakope
Edisi IV)

e. Aquadest. (Excipient)
Colorless & tasteless liquid; No solubility because in general water is a solvent and a
comparison of a solution. (Farmakope Edisi III)

Please use Farmakope Indonesia, National Formulary, Martindale and HOPE as your reference!

Issue Solution
Potassium Iodide/ Kalium Iodide is Store in an airtight container at room
hygroscopic. temperature.
Cera Flava is easily contaminated by Store in a well-closed container, protected
temperature and photosensitive. from light.
Aquadest is easy to evaporate. Store in well-closed container

IV. Dosage Calculation

● Kalium Iodide 3g (API)

● Iodium 2g (API)
● Aqua dest. 5g (Excipient)
● Ungt. simplex 90g Ph.Ned.Ed.V)
R/ Cera flava 30
Ol.Sesami 70

A. Common & Maximum Dosage

(no dosage calculation required as this prescription isn’t for oral use and just
for external use)
B. Weight calculation
● Kalium Iodide = 3g + (3g x 25%) = 3.75g - 3g = 0.75g
● Iodium = 2g + (2g x 25%) = 2.5g - 2g = 0.5g
● Aqua dest. = 5g + (5g x 25%) = 6.25g - 5g = 1.25g
● Ungt. simplex =
Cera Flava = 30g/100g x 90g = 27g + (27g x 25%) = 33.75g - 27g = 6.75g
Ol.Sesami = 70g/100g x 90g = 63g+ (63g x 25%) = 78.75g - 63g = 15.75g

=> Conclusion:
The API ingredient in this prescription are Kalium Iodide and Iodium while the
excipient are Aquadest and Ungt.simplex (cera flava and Ol.sesami). As in this
prescription is not for oral, dosage of the drugs aren’t required to be calculated and
only calculate the weight calculation.

VI. Procedure

1. Prepare the materials and equipment needed, then weigh all the materials to the amount
that needed.

2. Before starting to make the mixture, make the unguentum simplex from cera flava and
oleum sesame by heating them together using a bunsen burner until the temperature
reaches an estimate for 65°C - 70°C.

3. Add Kalium Iodide into the mortar and then grind them homogeneously.

4. Add melted unguentum simplex immediately into the mortar to prevent it from coagulating
when it reaches room temperature, then mix them together homogeneously and vigorously
to prevent oil and water separation.

5. Add Iodium into the mortar, then add aquadest little by little while mixing them
homogeneously and vigorously until the final result comes out as a condensed mixture.

6. Transfer the unguentum mixture into an airtight container while weighing them to get the
exact amount needed.

7. Store the container in room temperature and in a dry cool place.

VII. Packaging and Etiket

● Etiket: Blue(External use only)

● Label: N.I (Ne Iteratur)
● Packaging: Store in a airtight bottle or container
 II. Assessment of Prescription III - Session 11- Semi-solid Dosage Form (Cream)
a. Prescription

b. Completeness
● Name of Doctor: dr. Adi
● Address of Doctor: Jl. Pulomas Barat Kav 88, Jakarta Timur
● SIP Number: 123/I/DU/2016
● Prescription Number: 21
● Dates of Prescription: Jakarta, 2 January 2018
● Inscription: Hydrocortisone acetate 1%, Chloramphenicol 2%, Propylene glycol 1%, Emulgid
cream 20g
● Subscription : m.f. cream
● Signa: S.u.e
● Doctor Signature: INCOMPLETE
● Name of Patient: Shania
● Age of Patient: 17th
● Weight of Patient: INCOMPLETE
● Address of Patient: Jalan Gunung Agung no 1, Jakarta Timur

II. Drug Classification

Drug Name Class Pharmacological Effect

Hydrocortisone acetate G (Obat Keras) Corticosteroids
(Medline)

Chloramphenicol OBT/W (Obat Bebas Terbatas) Antibiotics or antimicrobial

(NCBI ; Medline)
III. Preformulation Study
a. Hydrocortisone acetate (API)

White crystalline powder; Odorless with bitter taste; Soluble in concentrated sulfuric acid ,
dioxane, methanol, and acetone; Slightly soluble in ether and chloroform; Very soluble in
ethanol and propylene glycol. (PubChem)

b. Chloramphenicol (API)

White to greyish-white or yellowish-white fine solid crystalline powder, needles or elongated

plates; Taste bitter; Very soluble in methanol, ethanol, butanol, ethyl acetate, acetone, and
chloroform; Fairly soluble in ether; Insoluble in benzene, petroleum ether, vegetable oils.
(PubChem)

c. Propylene Glycol (Excipient)

Thick odorless colorless liquid; Hygroscopic and viscous liquid; Tasteless; Soluble in water,
ethanol, ether, and benzene; Miscible with acetone and chloroform; Dissolve in many
essential oils but immiscible with fixed oils.. (PubChem)

d. Emulgid (Excipient)
It is a white or almost white waxy liquid; Almost colorless; tasteless; distinctive smell; Freely
soluble in aerosol propellants, chloroform and hydrocarbons; Moderately soluble in ethanol
(95%); Soluble in the ether part; Insoluble in water. (Farmakope Edisi III)

e. Ol.Sesami/ Minyak Wijen (API)

Liquid, pale yellow, weak odor, tasteless, does not freeze at 60 degrees Celsius; Slightly
soluble in ethanol (95%); Easily soluble in chloroform, ether and kerosene ether. (Farmakope
Edisi IV)

f. Aquadest (Excipient)
Colorless & tasteless liquid; No solubility because in general water is a solvent and a
comparison of a solution. (Farmakope Edisi III)

Please use Farmakope Indonesia, National Formulary, Martindale and HOPE as your reference!

Issue Solution
Emulgid is easily contaminated by temperature Store in a well closed container and in a cool
and photosensitive. and dry place.
Aquadest is easy to evaporate. Store in a well-closed container at room
temperature.
IV. Dosage Calculation

● Hydrocortisone acetate 1%, (API)

● Chloramphenicol 2%, (API)
● Propylene glycol 1%, (Excipient)
● Emulgid cream 20g (Excipient)
R/ Emulgid 15
Ol. sesami 15
aquadest ad 100

A. Common & Maximum Dosage

(no dosage calculation required as this prescription isn’t for oral use and just
for external use)

B. Weight calculation
● Emulgid = 20/100 x 15 = 3g + (3g x 25%) = 3.75g
● Ol. sesami = 20/100 x 15 = 3g + (3g x 25%) = 3.75g
● Aquadest = 20- (3+3) = 14g + (14g x 25%) = 17.5g
● Hydrocortisone acetate = 1/96 x 20 = 0.2g + (0.2g x 25%) = 0.25g
● Chloramphenicol = 2/96 x 20 = 0.4g + (0.4g x 25%) = 0.5g
● Propylene glycol = 1/96 x 20 = 0.2g + (0.2g x 25%) = 0.25g

=> Conclusion:
The API ingredients in this prescription are Hydrocortisone acetate and
Chloramphenicol while the excipients are propylene glycol, emulgid, ol.sesami and
aquadest. As in this prescription is not for oral, dosage of the drugs aren’t required to
be calculate only the weight calculation.

VI. Procedure

1. Prepare the materials and equipment needed, then weigh all the materials to the amount
that needed.

2. Before starting to make the mixture, make the emulgid mixture from emulgid, oleum
sesame, and aquadest by heating them together using a bunsen burner until the
temperature reaches an estimate for 65°C - 70°C.

3. Followed by the emulgid mixture, heat chloramphenicol, propylene glycol, and aquadest by
heating them together using a bunsen burner until the temperature reaches an estimate for
65°C - 70°C.

4. Add both emulgid mixture and chloramphenicol and propylene glycol mixture together into
the mortar immediately into the mortar to prevent it from coagulating when it reaches room
temperature, then mix them together homogeneously and vigorously to prevent oil and
water separation.
 5. Add Hydrocortisone acetate into the mortar, then grind and mix them homogeneously until
the final result comes out as a condensed mixture like cream texture or when the mixture
has been cooled down and resulted as a cream texture.

6. Transfer the cream mixture into an airtight container while weighing them to get the exact
amount needed.

7. Store the container in room temperature and in a dry cool place.

VII. Packaging and Etiket

● Etiket: Blue(External use only)

● Label: N.I (Ne Iteratur)
● Packaging: Store in a airtight bottle or container
 III. Assessment of Prescription III - Session 12 - Semi-solid Dosage Form (Pasta, Gel)
● Prescription

b. Completeness

● Name of Doctor: dr. Adi

● Address of Doctor: Jl. Pulomas Barat Kav 88, Jakarta Timur
● SIP Number: 123/I/DU/2016
● Prescription Number: 24
● Dates of Prescription: Jakarta, 2 January 2018
● Inscription: Bentonit 1g, Sulfur Praecipitatum 2g, Zinc oxide 10g, Talcum 10g, Ichtamol 0.5g,
Glycerin, Aqua dest aa 5g
● Subscription : m.f. pasta l.a.
● Signa: S.ad.us.ext
● Doctor Signature: INCOMPLETE
● Name of Patient: Bastian
● Age of Patient: 18th
● Weight of Patient: INCOMPLETE
● Address of Patient: Jalan Mawar no 1, Jakarta Timur

II. Drug Classification

Drug Name Class Pharmacological Effect

Bentonite OB/OTC (Obat Bebas) Suspending and rheological
agent

(Science Direct)

Sulfur Praecipitatum OB/OTC (Obat Bebas) keratolytic, antifungal, and

antibacterial properties
 (Drugbank.com)

Zinc oxide OB/OTC (Obat Bebas) Zinc molecular entity

(WebMd)

III. Preformulation Study

a. Bentonite (API)
Very fine powder; Light yellow brown or ivory white; Odorless; Earthy taste; Practically
insoluble in water but expands to a homogeneous mass; Practically insoluble in organic
solvents. (Farmakope Edisi III)

b. Sulfur Praecipitatum (Belerang endapan) (API)

Odorless & tasteless amorphous or microcrystalline powder; Very smooth with pale yellow
color; Practically insoluble in water and ethanol ; very soluble in carbon disulfide; poorly
soluble in olive oil. (Farmakope IV, hal. 771)

c. Zinc Oxide

Odorless, white or yellowish-white powder or hexagonal crystals; Bitter taste; Insoluble in

water and alcohol, soluble acids and alkalis (PubChem)

d. Talcum (Excipient)

A light, homogeneous, white or almost white powder, greasy to the touch (non abrasive).
Practically insoluble in water, in alcohol, and in dilute solutions of acids and of alkali
hydroxides,soluble in hot concentrated phosphoric acid. (Martindale & PubChem)

e. Ichtamol (Excipient)

Thick liquid, almost black, characteristic odor cold ethanol; More soluble in hot ethanol; Easily
soluble in ether and chloroform; Weak fluorescence, even when thawed; Odorless; Almost
tasteless. (Farmakope Edisi III))

f. Glycerine (Excipient)

Liquid like syrup; Clear; Colorless; Odorless; Sweetness followed by warmth; Hygroscopic;
Miscible with water and ethanol (95%); Insoluble in chloroform. (Farmakope Edisi III)

g. Aquadest (Excipient)
Colorless & tasteless liquid; No solubility because in general water is a solvent and a
comparison of a solution. (Farmakope Edisi III)

Please use Farmakope Indonesia, National Formulary, Martindale and HOPE as your reference!

Issue Solution
Bentonite may be contaminated by Store in an airtight container at room
temperature (can be hardened). temperature.

Sulfur Praecipitatum may cause toxicity and Store in a well-closed container and keep it in
easily react with some product/solution. a well ventilated dry place.
 Glycerin is hygroscopic. Store in a well-closed container and keep it in
a cool dry place.

Aquadest is easy to evaporate. Store in a well-closed container at room

temperature.

IV. Dosage Calculation

● Bentonit 1g,(API)
● Sulfur Praecipitatum 2g, (API)
● Zinc oxide 10g, (API)
● Talcum 10g, (Excipient)
● Ichtamol 0.5g, (Excipient)
● Glycerin, (Excipient)
● Aqua dest aa 5g (Excipient)

A. Common & Maximum Dosage

(no dosage calculation required as this prescription isn’t for oral use and just
for external use)

a. Weight calculation
● Bentonit (offline sess. substitute by CMC-Na)= 1g + (1g x 25%) = 1.25g
● Sulfur Praecipitatum = 2g + (2g x 25%) = 2.5g
● Zinc oxide = 10g + (10g x 25%) = 12.5g
● Talcum = 10g + (10g x 25%) = 12.5g
● Ichtamol = 0.5g + (0.5g x 25%) = 0.625g
● Glycerin = 5g + (5g x 25%) = 6.25g
● Aqua dest = 5g + (5g x 25%) = 6.25g

=> Conclusion:
The API ingredients in this prescription are Bentonite, Sulfur Praecipitatum and ZInc
Oxide while the excipients are talcum, ichtamol, glycerin, and aquadest. As in this
prescription is not for oral, dosage of the drugs aren’t required to be calculated
only calculate the weight calculation.

VI. Procedure

1. Prepare the materials and equipment needed, then weigh all the materials to the amount
that needed.

2. Add aquadest and CMC Na as the substitute of bentonite into the mortar and wait for a few
minutes for CMC Na to disperse, then grind them homogeneously.
 3. Add a few grams of talcum into the mortar and grind them homogeneously to cover the
moles in the mortar.

4. Add zinc oxide into the mortar and grind them homogeneously.

5. Add glycerine to ichthammol and mix them homogeneously.

6. Add the previous mixture of glycerine and ichthammol into the mortar, then add Sulfur
Praecipitatum into the mortar and grind them together homogeneously.

7. Add the remaining talcum into the mortar and grind them together homogeneously and
vigorously until the final result comes out as a pasta mixture (the mixture is more condensed
and sticky than cream texture).

8. Transfer the pasta mixture into an airtight container while weighing them to get the exact
amount needed.

9. Store the container in room temperature and in a dry cool place.

VII. Packaging and Etiket

● Etiket: Blue(External use only)

● Label: N.I (Ne Iteratur)
● Packaging: Store in a airtight bottle or container