NAMA :

NIM : 1

KELOMPOK : A4

FORMULASI GEL DEXAMETHASONE

I. SpesifikasiProduk

1. NamaProduk : dexagel2. BahanAktif : dexamethasone3. BentukSediaan : Gel4. Kemasan : Tube5. KekuatanSediaan : 0.1g/100 gram6. Target Pasien : Dewasa dan Anak

II. KajianFormulasi

1. MonografiBahana. Dexamethasone

RumusMolekul C22H29FO5

RumusStruktur

Sinonim Desametasone Desametasone [DCIT] Desamethasone Dexametasona [INN-Spanish] Dexamethasone Acetate Dexamethasone Sodium Phosphate Dexamethasonum [INN-Latin]

(2)

Dexamethazone Fluormethylprednisolone

Fungsi Anti-inflammatory Agents Adrenergic Agents Antiemetics Antineoplastic Agents, Hormonal Glucocorticoids

KajianFarmakologisDosisPemerianBahanData KelarutanLog PpHStabilitasterhadap pHStabilitasterhadapSuhuStabilitasterhadapCahayaStabilitasterhadap AirKerapatan / BJTitikleleh/leburInkompatibilitasPenyimpanan

b. Propylene glycol

RumusMolekul C3H8O2

RumusStrukturSinonim 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.

KajianFarmakologisDosisPemerianBahan 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

(2)

with light mineral oil or fixed oils, but will dissolve someessential oils.

Log PpHStabilitasterhadap pHStabilitasterhadapSuhuStabilitasterhadapCahayaStabilitasterhadap AirKerapatan / BJ Density 1.038 g/cm3 at 208C

Titikleleh/lebur Melting point _598C

Inkompatibilitas Propylene glycol is incompatible with oxidizing reagents such aspotassium permanganate.

Penyimpanan At cool temperatures, propylene glycol is stable in a well-closedcontainer, but at high temperatures, in the open, it tends to oxidize,giving rise to products such as propionaldehyde, lactic acid, pyruvicacid, and acetic acid. Propylene glycol is chemically stable whenmixed with ethanol (95%), glycerin, or water; aqueous solutionsmay be sterilized by autoclaving.

P592Propylene glycol is hygroscopic and should be stored in a wellclosedcontainer, 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

RumusStrukturSinonim Poloxamer; Lutrol; Monolan; Pluronic; poloxalkol; poloxamera;

polyethylene–propylene glycol copolymer; polyoxyethylene–polyoxypropylenecopolymer; Supronic; Synperonic.

Fungsi Dispersing agent; emulsifying agent; solubilizing agent; tabletlubricant; wetting agent.

KajianFarmakologisDosisPemerianBahan Poloxamers generally occur as white, waxy, free-flowing prilled

granules, or as cast solids. They are practically odorless andtasteless. At room temperature, poloxamer 124 occurs as a colorlessliquid.

Data Kelarutan Type solvent

Ethanol(95%)

Propan-2-ol

Propyleneglycol Wate Xylen

(2)

r ePoloxamer124

Freelysoluble

Freelysoluble

Freelysoluble

Freelysoluble

FreelySoluble

Poloxamer188

FreelySoluble - - Freely

Soluble -Poloxamer237

FreelySoluble

Sparinglysoluble - Freely

solubleSparinglysoluble

Poloxamer338

FreelySoluble - Sparingly

solubleFreelySoluble -

Poloxamer407

Freelysoluble

Freelysoluble - Freely

soluble -Log PpH Acidity/alkalinity pH = 5.0–7.4 for a 2.5% w/v aqueous solution

Stabilitasterhadap pH

pH (aqueous solution) 5.0–7.5

StabilitasterhadapSuhuStabilitasterhadapCahayaStabilitasterhadap AirKerapatan / BJ Density 1.06 g/cm3 at 258C

Titikleleh/lebur Melting point168C for poloxamer 124;52–578C for poloxamer 188;498C for poloxamer 237;578C for poloxamer 338;52–578C for poloxamer 407.

Inkompatibilitas Depending on the relative concentrations, poloxamer 188 isincompatible with phenols and parabens.

Penyimpanan Poloxamers are stable materials. Aqueous solutions are stable in thepresence of acids, alkalis, and metal ions. However, aqueoussolutions support mold growth.The bulk material should be stored in a well-closed container in acool, dry place.

d. Water

RumusMolekul H2ORumusStrukturSinonim Aqua; aqua purificata; hydrogen oxide

Fungsi Solvent

KajianFarmakologisDosisPemerianBahanData Kelarutan Miscible with most polar solvents.

Log P

pH Antara 5 dan 7 (FI4)Stabilitasterhadap pHStabilitasterhadapSuhuStabilitasterhadapCahayaStabilitasterhadap AirKerapatan / BJ Viscosity (dynamic) 0.89 mPa s (0.89 cP) at 258C.

Titikleleh/lebur 0°C

Inkompatibilitas In pharmaceutical formulations, water can react with drugs andotherexcipients that are susceptible to hydrolysis (decomposition inthe presence of water or moisture) at ambient and elevatedtemperatures.Water can react violently with alkali metals and rapidly withalkaline metals and their oxides, such as calcium oxide andmagnesium oxide. Water also reacts with anhydrous salts to formhydrates of various compositions, and with certain organicmaterials and calcium carbide.

Penyimpanan Dalamwadahtertutuprapat( FI4)e. Ethanol

RumusMolekulRumusStruktur

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

KajianFarmakologisDosisPemerianBahanData KelarutanLog PpHStabilitasterhadap pHStabilitasterhadapSuhuStabilitasterhadapCahayaStabilitasterhadap AirKerapatan / BJ 0.812 dan 0.816Titikleleh/leburInkompatibilitasPenyimpanan

F. Carbomer

RumusMolekulRumusStrukturSinonim Acrypol; Acritamer; acrylic acid polymer; carbomera; Carbopol;

carboxypolymethylene; polyacrylic acid; carboxyvinyl polymer;

(2)

Pemulen; TegoCarbomer.

Fungsi Bioadhesive material; controlled-release agent; emulsifying agent;emulsion stabilizer; rheology modifier; stabilizing agent; suspendingagent; tablet binder.

KajianFarmakologisDosisPemerianBahan Carbomers are white-colored, ‘fluffy’, acidic, hygroscopic powders

with a characteristic slight odor. A granular carbomer is alsoavailable (Carbopol 71G).

Data KelarutanLog PpH Acidity/alkalinity

pH = 2.5–4.0 for a 0.2% w/v aqueous dispersion;pH = 2.5–3.0 for Acrypol 1% w/v aqueous dispersion.

Stabilitasterhadap pHStabilitasterhadapSuhuStabilitasterhadapCahayaStabilitasterhadap AirKerapatan / 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 withphenol, cationic polymers, strong acids, and high levels ofelectrolytes. Certain antimicrobial adjuvants should also be avoidedor used at low levels, see Section 11. Trace levels of iron and othertransition metals can catalytically degrade carbomer dispersions.Certain amino-functional actives form complexes with carbomer;often this can be prevented by adjusting the pH of thedispersion and/or the solubility parameter by using appropriatealcohols and polyols.Carbomers also form pH-dependent complexes with certainpolymericexcipients. Adjustment of pH and/or solubility parametercan also work in this situation.

Penyimpanan Carbomer powder should be stored in an airtight, corrosionresistantcontainer and protected from moisture. The use of glass,plastic, or resin-lined containers is recommended for the storage offormulations containing carbomer.

2. Formula Acuan

Dexamethasone Gel dalam 100g(0.1%)1. FormulationI. Dexamethasone ...........................0.1 g

Ethanol 96% ..........................................10.0 gPropylene glycol [1] ................................20.0 gII. Lutrol F 127 [1] .......................................22.0 gWater .....................................................47.0 g

3. Formula Modifikasi

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

4. FormulasiOptimasi

5. Alat dan Bahan

KomposisiDalam 100gram terdapat 0.1 gram dexamethasone

Dexamethasone 0.1Ethanol 96% 10Propylene glycol 20Carbomer 2

Bahan Formula 1Per 100g Penimbangan

Dexamethasone 0.1 g 0.1 gEthanol 96% 10 g 12.32 mlPropylene glycol 20 g 19.27 mlCarbomer 2 g 2 gTEA 3 g 2.79 mlWater 64.9 g 64.9 ml

TEA 3

Penandaannya logonya OBAT KERAS merah ada K-nyaDexamethasone 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.