NAMA :

NIM : 1
KELOMPOK : A4
FORMULASI GEL DEXAMETHASONE
I. SpesifikasiProduk

1. NamaProduk : dexagel
2. BahanAktif : dexamethasone
3. BentukSediaan : Gel
4. Kemasan : Tube
5. KekuatanSediaan : 0.1g/100 gram
6. Target Pasien : Dewasa dan Anak

II. KajianFormulasi

1. MonografiBahan
a. Dexamethasone
RumusMolekul
C
22
H
29
FO
5

RumusStruktur

Sinonim
Desametasone
Desametasone [DCIT]
Desamethasone
Dexametasona [INN-Spanish]
Dexamethasone Acetate
Dexamethasone Sodium Phosphate
Dexamethasonum [INN-Latin]
Dexamethazone
Fluormethylprednisolone
(2)


Fungsi
Anti-inflammatory Agents
Adrenergic Agents
Antiemetics
Antineoplastic Agents, Hormonal
Glucocorticoids
KajianFarmakologis
Dosis
PemerianBahan
Data Kelarutan
Log P
pH
Stabilitasterhadap pH
StabilitasterhadapSuhu
StabilitasterhadapCahaya
Stabilitasterhadap Air
Kerapatan / BJ
Titikleleh/lebur
Inkompatibilitas
Penyimpanan

b. Propylene glycol

RumusMolekul
C3H8O2

RumusStruktur
Sinonim
1,2-Dihydroxypropane; E1520; 2-hydroxypropanol; methyl ethylene
glycol; methyl glycol; propane-1,2-diol; propylenglycolum.
Fungsi
Antimicrobial preservative; disinfectant; humectant; plasticizer;
Solvent; stabilizing agent; water-miscible cosolvent.
KajianFarmakologis
Dosis
PemerianBahan
Propylene glycol is a clear, colorless, viscous, practically odorless
liquid, with a sweet, slightly acrid taste resembling that of glycerin
Data Kelarutan
Solubility Miscible with acetone, chloroform, ethanol (95%),
glycerin, and water; soluble at 1 in 6 parts of ether; not miscible
with light mineral oil or fixed oils, but will dissolve some
essential oils.
Log P
pH
Stabilitasterhadap pH
StabilitasterhadapSuhu
StabilitasterhadapCahaya
Stabilitasterhadap Air
(2)

Kerapatan / BJ
Density 1.038 g/cm3 at 208C
Titikleleh/lebur
Melting point _598C
Inkompatibilitas
Propylene glycol is incompatible with oxidizing reagents such as
potassium permanganate.
Penyimpanan
At cool temperatures, propylene glycol is stable in a well-closed
container, but at high temperatures, in the open, it tends to oxidize,
giving rise to products such as propionaldehyde, lactic acid, pyruvic
acid, and acetic acid. Propylene glycol is chemically stable when
mixed with ethanol (95%), glycerin, or water; aqueous solutions
may be sterilized by autoclaving.
P
592
Propylene glycol is hygroscopic and should be stored in a wellclosed
container, protected from light, in a cool, dry place.

c. Lutrol F( YANG RENCANA MAU DIMODIFIKASI JADI CARBOMER
)
RumusMolekul
HO(C2H4O)a(C3H6O)b(C2H4O)aH

RumusStruktur
Sinonim
Poloxamer; Lutrol; Monolan; Pluronic; poloxalkol; poloxamera; polyethylene
propylene glycol copolymer; polyoxyethylenepolyoxypropylene
copolymer; Supronic; Synperonic.
Fungsi
Dispersing agent; emulsifying agent; solubilizing agent; tablet
lubricant; wetting agent.
KajianFarmakologis
Dosis
PemerianBahan
Poloxamers generally occur as white, waxy, free-flowing prilled
granules, or as cast solids. They are practically odorless and
tasteless. At room temperature, poloxamer 124 occurs as a colorless
liquid.
Data Kelarutan
Type solvent


Ethanol
(95%)
Propan-2-
ol
Propylene
glycol
Water Xylene
Poloxamer
124
Freely
soluble
Freely
soluble
Freely
soluble
Freely
soluble
Freely
Soluble
Poloxamer
188
Freely
Soluble
- -
Freely
Soluble
-
Poloxamer
237
Freely
Soluble
Sparingly
soluble
-
Freely
soluble
Sparingly
soluble
Poloxamer
338
Freely
Soluble
-
Sparingly
soluble
Freely
Soluble
-
Poloxamer
407
Freely
soluble
Freely
soluble
-
Freely
soluble
-
Log P
pH
Acidity/alkalinity pH = 5.07.4 for a 2.5% w/v aqueous solution
Stabilitasterhadap pH
pH (aqueous solution) 5.07.5
StabilitasterhadapSuhu
StabilitasterhadapCahaya
Stabilitasterhadap Air
Kerapatan / BJ
Density 1.06 g/cm3 at 258C
(2)

Titikleleh/lebur
Melting point
168C for poloxamer 124;
52578C for poloxamer 188;
498C for poloxamer 237;
578C for poloxamer 338;
52578C for poloxamer 407.
Inkompatibilitas
Depending on the relative concentrations, poloxamer 188 is
incompatible with phenols and parabens.
Penyimpanan
Poloxamers are stable materials. Aqueous solutions are stable in the
presence of acids, alkalis, and metal ions. However, aqueous
solutions support mold growth.
The bulk material should be stored in a well-closed container in a
cool, dry place.

d. Water
RumusMolekul H
2
O

RumusStruktur
Sinonim
Aqua; aqua purificata; hydrogen oxide
Fungsi
Solvent
KajianFarmakologis
Dosis
PemerianBahan
Data Kelarutan
Miscible with most polar solvents.
Log P
pH Antara 5 dan 7 (FI4)
Stabilitasterhadap pH
StabilitasterhadapSuhu
StabilitasterhadapCahaya
Stabilitasterhadap Air
Kerapatan / BJ
Viscosity (dynamic) 0.89 mPa s (0.89 cP) at 258C.
Titikleleh/lebur
0C
Inkompatibilitas
In pharmaceutical formulations, water can react with drugs and
otherexcipients that are susceptible to hydrolysis (decomposition in
the presence of water or moisture) at ambient and elevated
temperatures.
Water can react violently with alkali metals and rapidly with
alkaline metals and their oxides, such as calcium oxide and
magnesium oxide. Water also reacts with anhydrous salts to form
hydrates of various compositions, and with certain organic
materials and calcium carbide.
Penyimpanan Dalamwadahtertutuprapat( FI4)
e. Ethanol
RumusMolekul

RumusStruktur

Sinonim
Absolute Alcohol
Absolute Ethanol
Alcohol
Alcohol Anhydrous
Alcohol, Dehydrated
Alcohol, Diluted
AlcoolEthylique
AlcoolEtilico
Alkohol
AlkoholuEtylowego
Aminoethanol
Beta-Aminoethanol
Beta-Aminoethyl Alcohol
Beta-Ethanolamine
Beta-Hydroxyethylamine
Caswell No. 426
Dehydrated Ethanol
Denatured Alcohol
Denatured Ethanol
Etanolo

Fungsi
Anti-Infective Agents, Local
Solvents
Central Nervous System Depressants
Disinfectants

KajianFarmakologis
Dosis
PemerianBahan
Data Kelarutan
Log P
pH
Stabilitasterhadap pH
StabilitasterhadapSuhu
StabilitasterhadapCahaya
Stabilitasterhadap Air
Kerapatan / BJ 0.812 dan 0.816
Titikleleh/lebur
Inkompatibilitas
Penyimpanan

F. Carbomer

RumusMolekul

RumusStruktur
Sinonim
Acrypol; Acritamer; acrylic acid polymer; carbomera; Carbopol;
carboxypolymethylene; polyacrylic acid; carboxyvinyl polymer;
Pemulen; TegoCarbomer.
Fungsi
Bioadhesive material; controlled-release agent; emulsifying agent;
emulsion stabilizer; rheology modifier; stabilizing agent; suspending
agent; tablet binder.
KajianFarmakologis
Dosis
PemerianBahan
Carbomers are white-colored, fluffy, acidic, hygroscopic powders
with a characteristic slight odor. A granular carbomer is also
available (Carbopol 71G).
Data Kelarutan
Log P
pH
Acidity/alkalinity
pH = 2.54.0 for a 0.2% w/v aqueous dispersion;
pH = 2.53.0 for Acrypol 1% w/v aqueous dispersion.
Stabilitasterhadap pH
StabilitasterhadapSuhu
StabilitasterhadapCahaya
Stabilitasterhadap Air
Kerapatan / BJ
Density (bulk) 0.2 g/cm3 (powder); 0.4 g/cm3 (granular).
Density (tapped) 0.3 g/cm3 (powder); 0.4 g/cm3 (granular).
Titikleleh/lebur
Melting point Decomposition occurs within 30 minutes at 2608C.
Inkompatibilitas
Carbomers are discolored by resorcinol and are incompatible with
phenol, cationic polymers, strong acids, and high levels of
electrolytes. Certain antimicrobial adjuvants should also be avoided
or used at low levels, see Section 11. Trace levels of iron and other
transition metals can catalytically degrade carbomer dispersions.
Certain amino-functional actives form complexes with carbomer;
often this can be prevented by adjusting the pH of the
dispersion and/or the solubility parameter by using appropriate
alcohols and polyols.
Carbomers also form pH-dependent complexes with certain
polymericexcipients. Adjustment of pH and/or solubility parameter
can also work in this situation.
Penyimpanan
Carbomer powder should be stored in an airtight, corrosionresistant
container and protected from moisture. The use of glass,
plastic, or resin-lined containers is recommended for the storage of
formulations containing carbomer.

(2)


2. Formula Acuan
Dexamethasone Gel dalam 100g
(0.1%)
1. Formulation
I. Dexamethasone ...........................0.1 g
Ethanol 96% ..........................................10.0 g
Propylene glycol [1] ................................20.0 g
II. Lutrol F 127 [1] .......................................22.0 g
Water .....................................................47.0 g

3. Formula Modifikasi

Nama % Teoritis Dalam 100g % Terpakai
Dexamethasone
0.1% 0.1 0.1
Ethanol 96%
10 % 10 10
Propylene glycol
5-80 % 20 20
Carbomer 0.5-2 % 2 2
TEA 2-4 % 3 3
Water
- 64.9 64.9 ml

4. FormulasiOptimasi








5. Alat dan Bahan

Komposisi
Dalam 100gram terdapat 0.1 gram dexamethasone

Dexamethasone
0.1
Bahan Formula 1
Per 100g Penimbangan
Dexamethasone
0.1 g 0.1 g
Ethanol 96%
10 g 12.32 ml
Propylene glycol
20 g 19.27 ml
Carbomer 2 g 2 g
TEA 3 g 2.79 ml
Water
64.9 g 64.9 ml
Ethanol 96%
10
Propylene glycol
20
Carbomer 2
TEA 3



Penandaannya logonya OBAT KERAS merah ada K-nya
Dexamethasone 0,1%
Liat contoh yg dikirim elisa diedit lagi kata-katanya
disesuaikan. Okeyy?


Indikasi :
Meringankan inflamasi dari dermatosis yang responsive
terhadap kortikosteroid.

Kontra Indikasi : Tuberkulosis kulit, mikosis.

Aturan Pakai : Oleskan tipis dan merata pada bagian kulit yang
meradang sehari 2-3 x.

Efek Samping Obat : Kulit kering, pruritus, iritasi, rasa
nyeri/terbakar sementara yang ringan/ sedang.

Peringatan dan Perhatian : Tidak untuk pemakaian jangka
panjang atau untuk profilaksis. Hindari penghentian terapi
secara mendadak . Hindari dengan kontak mata, kerusakan kulit
berat.

Penyimpanan : Simpan di tempat yang sejuk terlindung dari
sinar matahari langsung , jauhkan dari jangkauan anak anak.