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PreCalc Session 13

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

● 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
Dissolve KI in water then add iodine until dissolve, then grind with unguentum
simplex until homogeneous.

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 + 25% = 3.25g
● Iodium = 2g + 25% = 2.25g
● Aqua dest. = 5g+ 25% = 5.25g
● Ungt. simplex =
Cera Flava = 30g/90g x 20g = 6.67g + 25% = 6.92g
Ol.Sesami = 70g/90g x 20g = 15.55g + 25% = 15.77g

=> 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.
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. Iodium (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
B. Prescription II - Prescription III - Session 11- Semi-solid Dosage Form (Cream)

● 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 + 25% = 3.25g
● Ol. sesami = 20/100 x 15 = 3g + 25% = 3.25g
● Aquadest = 20- (3+3) = 14g + 25% = 14.25g
● Hydrocortisone acetate = 1/96 x 20 = 0.208g + 25% = 0.458g
● Chloramphenicol = 2/96 x 20 = 0.416g + 25% = 3.25g
● Propylene glycol = 1/96 x 20 = 0.208g + 25% = 3.25g

=> 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.
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)

a. 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)

b. 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)

c. 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)

d. 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.
C. Prescription III - Prescription III - Session 12 - Semi-solid Dosage Form (Pasta, Gel)

● 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)

c. Common & Maximum Dosage:


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

d. Weight calculation
● Bentonit = 1g + 25% = 1.25g
● Sulfur Praecipitatum = 2g + 25% = 2.25g
● Zinc oxide = 10g + 25% = 10.25g
● Talcum = 10g + 25% = 10.25g
● Ichtamol = 0.5g + 25% = 0.75g
● Glycerin = 5g + 25% = 5.25g
● Aqua dest = 5g+ 25% = 5.25g
TOTAL = 24g

=> 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.
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 (API)

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.

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