TUGAS 1 Teknologi Sediaan Setengah Padat

Sabila Robbani (1906408876)

Kriteria Kelarutan (Farmakope Indonesia V)

Jumlah bagian pelarut
Istilah Kelarutan yang diperlukan untuk
melarutkan 1 bagian zat
Sangat mudah larut Kurang dari 1
Mudah larut 1 sampai 10
Larut 10 sampai 30
Agak sukar larut 30 sampai 100
Sukar larut 100 sampai 1000
Sangat sukar larut 1000 sampai 10.000
Praktis tidak larut Lebih dari 10.000

Bahan Eksipien
ANTIOKSIDAN
No. Nama
Nama Kimia Merk Dagang Presentase
Eksipien
L-(+)-Ascorbic
Vitacimin; Vitamin C; Redoxon;
1 Ascorbic acid acid 0.01–0.1%
Extrace
(C6H8C6)
 β-Carotene : 0.01%
 Essential oil : 0.02–
0.5%
 IM injection : 0.03%
2-tert-Butyl-4-  IV injection :
Butylated BHA; E320; Nipanox BHA;
2 methoxyphenol 0.0002–0.0005%
Hydroxyanisole Nipantiox 1-F
(C11H16O2)  Oil & lemak : 0.02%
 Topikal : 0.005–
0.02%
 Vitamin A : 10
mg/million unit
 β-Carotene : 0.01%
 Minyak sayur :
0.01%
 Essential oil : 0.02–
0.5%
 Oil & lemak : 0.02%
Agidol; BHT; Dalpac; E321;  Minyak ikan : 0.01–
2,6-Di-tert-butyl-4-
Butylated Embanox BHT; Impruvol; Ionol 0.1%
3 methylphenol
Hydroxytoluene CP; Nipanox BHT; Sustane;  Inhalation : 0.01%
(C15H24O)
Tenox BHT; Topanol; Vianol  IM injection : 0.03%
 IV injection :
0.0009–0.002%
 Topical : 0.0075–
0.1%
 Vitamin A 10
mg/million unit
2-[Bis[2- Acidicum penteticum; DTPA; 0.1–0.3%
4 Pentetic Acid
(bis(carboxymethyl glycine; Versenex; ZK-43649.
 )amino)ethyl]amin
o]acetic acid
(C14H23N3O10)
 Mengcegah minyak
tengik : 0.1% w/v
 Mencegah
3,4,5-
E310; gallic acid propyl ester; n- pembentukan
Trihydroxybenzoic
5 Propyl Gallate propyl gallate; Progallin P; peroksida : 0.002%
acid propyl ester
propylis gallas; Tenox PG w/v
(C10H12O5)
 Mencegah oksidasi
paraldehyde : 0.01%
w/v
Sodium methanesulfinic acid,
Sodium
formaldehyde Rongalite; sodium Maks.0.1% w/v
6 Formaldehyde
sulfoxylate methanalsulfoxylate; sodium (injection)
Sulfoxylate
(CH3NaO3S) sulfinomethanolate
 0.01–1.0% w/v
Disodium pyrosulfite; disulfurous
(oral, parenteral,
Sodium Sodium pyrosulfite acid, disodium salt; E223; natrii
7 topikal)
Metabisulfite (Na2S2O5) disulfis; natrii metabisulfis;
 Maks. 27% w/v (IM
sodium acid sulfite
injection)
Acido trimico; Intrasol; isopropyl
cresol; isopropyl metacresol;
8 Thymol Thymol (C10H14O) Medophyll; thyme camphor; 0.01%
thymic acid; mthymol; thymolum;
timol
(2RS,40RS,80RS)-
2,5,7,8-
Alpha Tetramethyl-2-
9 Tocopherol/Vit (40,80,120- Alpha Tocopherol 0.001–0.05% v/v
amin E trimethyltridecyl)-
6-chromanol
(C29H50O2)

PENGAWET
No. Nama Eksipien Nama Kimia Merk Dagang Presentase
Ethanolum (96 per centum); ethyl
Alcohol/Ethanol Ethanol (C2H6O)
1 alcohol; ethyl hydroxide; grain >10 % v/v
(96%)
alcohol; methyl carbinol
 IM and IV
injection : 0.17%
Acidum benzoicum;
 Oral solution : 0.01–
benzenecarboxylic acid;
0.1%
Benzoic acid benzeneformic acid;
2 Benzoic Acid  Oral suspension :
(C7H6O2) carboxybenzene; dracylic acid;
0.1%
E210; phenylcarboxylic acid;
 Sirup oral : 0.15%
phenylformic acid.
 Topical : 0.1–0.2%
 Vaginal : 0.1–0.2%
2-Bromo-2-
Topical : 0.01–0.1%
3 Bronopol nitropropane-1,3-diol Myacide
w/v
(C3H6BrNO4)
Methylphenol Cresylic acid; cresylol;
4 Cresol 0.15–0.3% (injection)
(C7H8O) hydroxytoluene; tricresol
 N,N00-
Methylenebis{N0-[3-
(hydroxymethyl)-2,5-
Biopure 100; Germall 115;
5 Imidurea dioxo-4- 0.03–0.5% w/w
imidazolidinyl urea; Tri-Stat IU
imidazolidinyl]urea}
(C11H16N8O)

 IM, IV, SC
injection : 0.005–0.2
 Inhalation
solution :0.015
Aseptoform P; CoSept P; E216; 4-  Intradermal
hydroxybenzoic acid propyl injection : 0.02–0.26
ester; Nipagin P; Nipasol M;  Nasal solution :
Propyl 4-
propagin; Propyl Aseptoform; 0.017
6 Propylparaben hydroxybenzoate
propyl butex; Propyl Chemosept;  Ophthalmic : 0.005–
(C10H12O3)
propyl phydroxybenzoate; Propyl 0.01
Parasept; Solbrol P; Tegosept P;  Oral solution &
Uniphen P-23 suspension: 0.01–
0.02
 Rectal : 0.02–0.01
 Topical : 0.01–0.6
 Vaginal :0.02–0.1
Benzoic acid sodium salt;
benzoate of soda; E211; natrii  0.02–0.5% (oral)
Sodium Sodium benzoate
7 benzoas; natrium benzoicum;  0.5% (parenteral)
Benzoate (C7H5NaO2)
sobenate; sodii benzoas; sodium  0.1–0.5% (kosmetik)
benzoic acid
(E,E)-Hexa-2,4- E200; crotylidene
0.05–0.2% (oral &
8 Sorbic Acid dienoic acid acetic acid; hexadienic acid;
topical)
(C6H8O2 ) hexadienoic acid; Sorbistat K.
 IM, IV, SC injection :
0.01
Ethyl[2-
mercurothiolate; sodium  Ophthalmic solution :
mercaptobenzoato(2–
ethylmercurithiosalicylate; 0.001–0.15
9 Thimerosal )-O,S]-mercurate(1–)
Thimerosal Sigmaultra;  Ophthalmic
sodium
thiomersalate; thiomersalum suspension : 0.001–
(C9H9HgNaO2S)
0.004
 Topical :0.01

SUSPENDING AGENT
No. Nama Eksipien Nama Kimia Merk Dagang Presentase
Acaciae gummi; acacia gum;
arabic gum; E414; gum acacia;
5–10%
1 Acacia Acacia gummi africanum; gum arabic;
gummi arabicum; gummi
mimosae; talha gum
Albagel; bentonitum; E558;
Bentonite 0.5–5.0% (oral)
2 Bentonite mineral soap; Polargel; soap clay;
(Al2O34SiO2H2O)
taylorite; Veegum HS; wilkinite
Acrypol; Acritamer; acrylic acid
polymer; carbomera; Carbopol;
3 Carbomer Carbomer 0.5–1.0%
carboxy polymethylene;
polyacrylic acid; carboxyvinyl
 polymer;
Pemulen; Tego Carbomer
Akucell; Aqualon CMC;
Aquasorb; Blanose; Carbose D;
Carboxymethyl carmellosum natricum; Cel-O-
cellulose Cellulose, Brandt; cellulose gum; Cethylose;  0.1-1.0% (oral)
4 Sodium/ carboxymethyl ether, CMC sodium; E466; Finnfix;  0.05-0.75%
Carmellose sodium salt Glykocellan; Nymcel ZSB; (injection)
Sodium SCMC; Sunrose; Tylose CB;
Tylose MGA; Walocel C; Xylo-
Mucine.
Aerosil; Cab-O-Sil; Cab-O-Sil M-
Colloidal silicon 5P; colloidal silica; SAS; silica 2.0–10.0% (gel &
5 Silica (SiO2)
dioxide sol; silicic anhydride; Wacker semisolid)
HDK
Benecel MHPC; E464;  0.25–5.0% (liquid
Cellulose hydroxypropyl methylcellulose; oral)
6 Hypromellose hydroxypropyl HPMC; hypromellosum;  0.1% (liquid nasal)
methyl ether Methocel; Metolose; MHPC;  0.45–1.0% w/w
Pharmacoat; Tylopur; Tylose MO (tetes mata)
Aluminii magnesii silicas;
aluminosilicic acid, magnesium
Magnesium salt; Carrisorb; Gelsorb;
Aluminum  oral : 0.5–2.5%
7 Aluminum Magnabrite; magnesium
magnesium silicate  topical : 1–10%
Silicate aluminum silicate, complex
colloidal; Neusilin; Pharmasorb;
Veegum
Alginato sodico; algin; alginic
Sodium acid, sodium salt; E401; Kelcosol; 1–5%
8 Sodium alginate
Alginate Keltone; natrii alginas; Protanal; (pasta, cream, gel)
sodium polymannuronate

SURFAKTAN
No. Nama Eksipien Nama Kimia Merk Dagang Presentase
dodecyl sodium
sulfate; dodecylsulfate sodium salt;
Sulfuric acid
Sodium Lauryl Elfan 240; monododecyl sodium
monododecyl
1 Sulfate sulfate; natrii laurilsulfas; SDS; 0.5–2.5%
ester sodium salt
(anionic) SLS; sulfuric acid monododecyl
(C12H25NaO4S)
ester, sodium salt; Texapon K12P;
EMAL 10P HD
Sodium 1,4-bis(2- 0.01–1.0 %
dioctyl sodium sulfosuccinate;
Docusate Sodium ethylhexyl) (wetting/dispersing/e
2 DSS; natrii docusas; sodium
(anionic) sulfosuccinate mulsifying agent)
dioctyl sulfosuccinate;
(C20H37NaO7S)
 Emulsi o/w : 1–15%
Polysorbate 21 :  Kombinasi dengan
Polyoxyethylene
Polyoxyethylene emulsifier hidrofilik
Sorbitan Fatty Polysorbate 21 : Crillet 11; Hodag
3 (4) sorbitan o/w : 1–10%
Acid PSML-4; Protasorb L-5; Tween 21
monolaurate  Meningkatkan
Esters/polysorbate
water-holding pada
salep : 1–10%
 Polyoxyethylene  Aux. emulsifier
stearates Polyoxyl 2 stearate Hodag DGS; o/w :0.5–5%
Polyethylene
4 /Polyoxyl 40 Lipo DGS; Lipopeg 2-DEGS;  Emulsifier o/w
glycol stearate
Stearate PEG-2 stearate (cream/lotion) :
(nonionic) 0.5–10%
Arlacel 20; Armotan ML; Crill 1;  Emulsi w/o : 1–15%
Dehymuls SML; E493; Glycomul  Kombinasi dengan
Sorbitan Esters Sorbitan L; Hodag SML; Liposorb L; emulsifier hidrofilik
5 (Sorbitan monododecanoate Montane 20; ProtachemSML; o/w : 1–10%
monolaurate) (C18H34O6) Sorbester P12; Sorbirol L; sorbitan  Meningkatkan
laurate; sorbitani lauras; Span 20; water-holding pada
Tego SML salep : 1–10%