PREFORMULASI

(maaf teman sekelompok, preformulasinya ala kadarnya, banyak yang belum

ditranslate tapi bahasanya ga susah-susah banget kok, maaf yaaa)

1. Ekstrak daun sirih

Pemerian hasil ekstrak + cara pembuatan (bisa dilihat setelah ekstrak

dibuat hari senin)

2. Minyak kelapa
Pemerian
: USNF 26 (Coconut oil). The refined fixed oil obtained
from the seeds of Cocos nucifera. A clear, white to light
Kelarutan

yellow-tan, viscous liquid.

: Practically insoluble in water; very slightly soluble in
alcohol; freely soluble in dichloromethane and in light

petroleum. M.p. 23 to 26.

Penyimpanan
: Store in airtight, well-filled containers. Protect
Aplikasi

from light.
: Coconut oil is used as a basis for topical creams and
ointments, in rectal and vaginal suppositories, and in
solid

dosage

forms.

It

is

also

used

in

food

manufacturing. Topical preparations have been used for

pediculosis. Fractionated coconut oil (thin vegetable oil)
is used as a source of medium-chain triglycerides
(p.1956).
Fungsi
: basis
Hypersensitivitas : Sensitivity

reactions

to

coconut

products,

including coconut oil,1 have been reported rarely.

Cases of anaphylaxis have been reported.
3. Asam Stearat (HoPE, 2009)
Nama Senyawa

: asam stearat

Rumus formula : C18H36O2, BM : 284,47

Densitas

: 0,980

Pemerian

: keras, putih atau kuning, permukaan halus, kristal

padat atau putih atau serbuk putih kekuningan, sedikit
berbau, berasa.

Kelarutan

: terlarut bebas dalam benzene, CCl4, CHCL3, dan eter.

Terlarut di etanol (95%), hexane, dan propilen glikol,
dan praktis tidak larut dalam air.

Penyimpanan

: simpan di wadah yang baik dan terlindung dari

cahaya, dan kering.

Inkompatibilitas: paling inkompatibel dengan logam hidroksida, dan
mungkin inkompatibel dengan basa, agen pereduksi
dan agen pengoksidasi.
Aplikasi

: pada formulasi topikal seperti kosmetik biasanya

berfungsi sebagai emulsifier dan solubilizer.

Fungsi

: emulsifying agent, solubilizing agent.

4. NaOH 30% ((HoPE, 2009) / (Martindale, 2009)

Nama senyawa : Sodium Hydroxide
RM dan BM : NaOH, 40,00
Fungsi
: agen pengalkalis dan buffer
Pemerian
: White or almost white, crystalline masses supplied
as pellets, sticks, or slabs. It is deliquescent and
Kelarutan

readily absorbs carbon dioxide.

:

Propeti khusus

Penyimpanan :

Sodium hydroxide should be stored in an airtight

nonmetallic container in a cool, dry place. When

exposed to air, sodium hydroxide rapidly absorbs
moisture and liquefies, but subsequently becomes

solid again owing to absorption of carbon dioxide and

Aplikasi

formation of sodium carbonate.

: digunakan pada formulasi pharmasetika sebagai
adjust pH dari larutan. Dapat bereaksi dengan asam

lemak membentuk garam.

Inkompatibel : Sodium hydroxide is a strong base

and is incompatible with any

compound that readily undergoes hydrolysis or oxidation. It will react

with acids, esters, and ethers, especially in aqueous solution.

NaOH 30%
: 30 gram NaOH dilarutkan dalam 100 ml air.
Uses and Administration :
Sodium hydroxide is a powerful caustic. A 2.5% solution in glycerol
has been used as a cuticle solvent. An escharotic
preparation of sodium hydroxide and calcium oxide
was known as London paste. Sodium hydroxide is also
used for adjusting the pH of solutions. Disinfection.
(For reference to the possible use of sodium hydroxide
for the disinfection of material contaminated by the
Keamanan

agent causing Creutzfeldt-Jakob disease).

: Sodium hydroxide is widely used

in

the

pharmaceutical and food industries and is generally

regarded as a nontoxic material at low. At high
concentrations it is a corrosive irritant to the skin,
eyes, and mucous membranes.
LD50 (mouse, IP): 0.04 g/kg(2)
LD50 (rabbit, oral): 0.5 g/kg
5. Ethanol 96%(HoPE, 2009)/(Martindale, 2009)
Nama senyawa : alkohol, ethanol 96%, The BP 2008 gives Alcohol
RM dan BM
Fungsi

(96 per cent) as an approved synonym

: C2H5OH, 46,07
: Antimicrobial preservative; disinfectant;

Pemerian

penetrant; solvent.
: (Ethanol (96 per cent)). It contains not less than

skin

95.1% v/v or 92.6% w/w and not more than 96.9% v/v
or 95.2% w/w of C2H5OH at 20, and water. A
colourless, clear, volatile, flammable, hygroscopic
Titik didih

liquid; it burns with a blue, smokeless flame.

: about 78.

Kelarutan

: Miscible with water, kloroform, eter, gliserin.

Aplikasi

Penyimpanan : Aqueous ethanol solutions may be sterilized by

autoclaving or by filtration and should be stored in
airtight containers, in a cool place.
Incompatibel : In acidic conditions, ethanol solutions may react
vigorously with oxidizing materials. Mixtures with
alkali may darken in color owing to a reaction with
residual amounts of aldehyde. Organic
6. Gliserin (HoPE, 2009)
Nama
senyawa: Gliserol, gliserin
RM dan BM
: C3H8O3
Fungsi
: Antimicrobial preservative; cosolvent; emollient;
humectant; plasticizer; solvent; sweetening agent;
Pemerian

tonicity agent.
: jernih, tidak bewarna, tidak berbau, kental, cairan

Kelarutan

higroskopis, manis (0,6 x manis sukrosa)

:

Aplikasi

In

topical

cosmetics,

pharmaceutical

glycerin

is

used

formulations
primarily

humectant and emollient properties

for

and
its

Stabilitas

: Glycerin is hygroscopic. Pure glycerin is not mudah

dioksidasi by the atmosphere under ordinary storage
conditions, but it decomposes on heating with the
evolution of toxic acrolein. Mixtures of glycerin with
water, ethanol (95%), and propylene glycol are

chemically stable.
Inkompatibel : Glycerin may explode if mixed with strong oxidizing
agents such as chromium trioxide, potassium chlorate,
or potassium permanganate. In dilute solution, the
reaction proceeds at a slower rate with several
oxidation products being formed. Black discoloration
of glycerin occurs in the presence of light, or on
contact with zinc oxide or basic bismuth nitrate. An
iron contaminant in glycerin is responsible for the
darkening in color of mixtures containing phenols,
salicylates, and tannin. Glycerin forms a boric acid
complex, glyceroboric acid, that is a stronger acid
than boric acid.
7. Sukrosa (HoPE, 2009)
Nama
: sukrosa
BM dan RM : C12H22O11, 342,30
Fungsi
: Confectionery base; coating agent; granulation aid;
suspending agent; sweetening agent; tablet binder;
tablet and capsule diluent; tablet filler; therapeutic
Pemerian

agent; viscosity-increasing agent.

: Sucrose occurs as colorless crystals, as crystalline
masses or blocks, or as a white crystalline powder; it is

Kelarutan

Aplikasi

odorless and has a sweet taste.

:

Stabilitas

: Sucrose has good stability at room temperature

and at moderate relative humidity. It absorbs up to 1%
moisture, which is released upon heating at 908C.
Sucrose caramelizes when heated to temperatures
above 1608C. Dilute sucrose solutions are liable to
fermentation

by

microorganisms

but

resist

decomposition at higher concentrations, e.g. above

60% w/w concentration. Aqueous solutions may be
sterilized by autoclaving or filtration.
Inkompatibel : Powdered sucrose may be contaminated with traces
of heavy metals, which can lead to incompatibility
with active ingredients, e.g. ascorbic acid. Sucrose
may also be contaminated with sulfite from the
refining process. With high sulfite content, color
changes can occur in sugar-coated tablets; for certain
colors used in sugarcoating the maximum limit for
sulfite content, calculated as sulfur, is 1 ppm. In the
presence of dilute or concentrated acids, sucrose is
hydrolyzed or inverted to dextrose and fructose (invert
sugar). Sucrose may attack aluminum closures.
8. Disodium EDTA (HoPE, 2009)
Nama lain
: Didoium edeta, disodium edeta hidrat, disodium
etilen diaminetetra assetat, edathamil disodium, aam
RM dan BM

edetat
:
C10H14N2Na2O8

336,2

C10H18N2Na2O10 , 372,2 (hidrat)

Fungsi

: agen pengkhelat

(Anhidrat);

Pemerian
Kelarutan

: kristal putih, tidak berbau, dengan sedikit rasa asam

: praktis tdk larut dalam CHCl3 dan eter, sedikit larut
dalam ethanol (95%), larut 1 bagian dalam 11 bagian

Ph
Aplikasi

air.
: 4,3-4,7
: Disodium edetate is used as a chelating agent in a
wide range of pharmaceutical preparations, including
mouthwashes, ophthalmic preparations, and topical
preparations,(13) typically at concentrations between

Stabilitas

0.005 and 0.1% w/v.

: Edetate salts are more stable than edetic acid
(see also Edetic acid). However, disodium edetate
dihydrate loses water of crystallization when heated to
1208C. Aqueous solutions of disodium edetate may be
sterilized by autoclaving, and should be stored in an
alkali-free container. Disodium edetate is hygroscopic
and is unstable when exposed to moisture. It should
be stored in a well-closed container in a cool, dry

place.
Incompatibel : Disodium edetate behaves as a weak acid, displacing
carbon dioxide from carbonates and reacting with
metals to form hydrogen. It is incompatible with
strong oxidizing agents, strong bases, metal ions, and
metal alloys.
9. Air
Nama lain

: Agua; Aqua; Aqua Communis; Aqua Fontana; Aqua

Potabilis; Eau Potable; Vatten; Vesi; Vz; Wasser; Woda.

RM dan BM : H2O ;18.02.

Penyiapan

: (Water, Purified; Aqua Purificata). air yang disiapkan

untuk keperluan medis. Disiapkan dengan metode yang
sesuai bisa dengan destilasi, ion exchange, reverse
osmosis dll.

10.
Parfum
Rosemary Oil (yang dipilih)

Fungsi
Nama lain

: parfume
: Esencia de Romero; Essence de Romarin; Essncia de
Alecrim;

Oleum

Roris

Marini;

Oleum

Rosmarini;

Romarin, huile essentielle de; Romero, aceite esencial

de; Rosmariiniljy; Rosmarini aetheroleum; Rosmarini
Etheroleum; Rosmarinl; Rosmarinolja; Rozmaringolaj;
Pemerian

Rozmarinu eterinis aliejus; Rozmarnov silice.

: Ph. Eur. 6.2 (Rosemary Oil). esensial iol yang
didapatkan

dari

destilasi

bagiab

dari

Rosmarinus

officinalis. jernih,cairan tidak berwarna sampai kuning

pucat dengan bau khas.simpan dalam wadah kedap
udara dan temperatur tidak lebih dari 25C. Lindungi
Profile

dari cahaya.
: Rosemary oil bersifat karminatif dan sedikit iritan.
biasa digunakan untuk pewangi dan penambah rasa.
digunakan untuk lotion rambut, inhalasi, dan linimen.
digunakan juga sebagai aromaterapi.

PENIMBANGAN BAHAN
A. Formula
Akan dibuat sediaan 100 g sabun padat transparant dengan formula sebagai
berikut:
Ekstrak daun sirih
Asam stearat
8%
Minyak kelapa 20%
NaOH 30%
Etanol 96%
Gliserin
10%
Sukrosa
13%
Na2EDTA
0,2%
Vit. E
0,5%
Parfum
q.s
Aquades ad

5%
22%
15%

100 %

B. Penimbangan Bahan
Adapun penimbangan bahan pada formula 100 g sabun tranparan ini adalah
sebagai berikut:
- Ekstrak daun sirih

- Asam stearat

- Minyak kelapa :
- NaOH 30%

- Ethanol 96%

- Gliserin

- Sukrosa

- Na2EDTA

- Parfum
: secukupnya
- Aquades (tambahkan sampai volume sediaan menjadi 100 g).
Penambahan aquades kira-kira: (100 93,2) g= 6,8 g
*Note : untuk prosedur kerja dan evaluasi sediaan sama kayak di modul
yaa,,, )