Disusun Oleh:

PREFORMULASI Kelompok 5
1. Ikhwan Setyo W. 1920384311

RIFAXIMIN 2. Nilma Abdiriani Tifany

3. Vilza Dwiki Yuvita
1920384317
1920384324
ZAT AKTIF
Nama Rifaximin
Nama kimia Dehydro Rifaximin
Rifaximin 
Sinonim [2S(2R*,16Z,18E,20R*,21R*,22S*,23S*,24S*,25R*,26S*,2
7R*,28E)]-25-(Acetyloxy)-5,21,23-trihydroxy-27-methoxy-
2,4,11,16,20,22,24,26-octamethyl-6H-27-
(epoxypentadeca[1,11,13]trienonitrilo)benzofuro[4,5-
e]pyrido[1,2-a]benzimidazole-1,6,15(2H)-trione; Rifaximin
EP Impurity G
Struktur kimia

Rumus molekul C43H51N3O11

Berat molekul 783.86 g/mol
DSC FTIR
FISIKA KIMIA Disolusi

Method: 100 mg of rifaximin were pressed by a 5- or 10-tonne

Pemerian Serbuk higroskopis, kristal, berwarna
hydraulic press to form compacted pellets. The holder of the
orange kemerahan
apparatus (AT7 Smart, Sotax) was rotated at 100 rpm and dipped
Golongan obat BCS IV
into a dissolution medium of 0.1 M phosphate buffer at pH 7.4 and
Kelarutan Air: 0,00738 mg/ml (Prediksi ChemAxon)
DMSO: 47mg/mL 0.45% (w/v) sodium laurylsulfate (SLS) at 37±0.5°C. After 15, 30,
EtOH: 157mg/mL 45, and 60 min samples of the dissolution medium were analysed
by HPLC: a liquid chromatographic Alltima C18 column, 5 mm,
pKa Asam 3,66
(250 x 4.6 mm) (Alltech), thermostated at 40°C, equipped with a
Basa 11,87 (AKSci) (Prediksi ChemAxon)
variable wavelength UV detector (HP1100 series, Agilent) set at
Pelarut Aseton, kloroform, methanol
Koefisien 276 nm was used in isocratic conditions. The mobile phase was
4,94 (Prediksi ALOGPS)
partisi (Log P) 31.5% methanol, 31.5% acetonitrile and 37.0% (v/v) 0.05 M
formate buffer. The flow rate was 1.4 ml min-1 and 100 ml of
Titik Leleh 218-228°C
samples were injected (US Pharmacopoeia.32).

FISIKA DAN MEKANIS

Densitas Partikel: 14±0,1 g/cm3
METODE ANALISA
λ max : 276 nm
Metode : HPLC
Kolom : ods c18 (150 mm x 4,6 mm x 5µm)
Suhu : 40°C
Fase gerak : Ammonium formate R pH 7,2:Acetonitril:Methanol (37:32:31)
Kecepatan alir : 1,4 ml/menit
Detektor : UV-Vis 276 nm
Injeksi : 20 µl larutan uji dan larutan baku
Tr : 12 menit
STABILITAS

Rifaximin mengalami degradasi oleh asam, basa, oksidasi dan panas

(800)C) (Annapurna, 2012)
MIKROSKOPIS
Fig.2: SEM photomicrograph of (a)
rifaximin loaded pellets at 100 x
magnification, (b) rifaximin pellets after
polymer coating at 80 x magnification, (c)
cross section of coated pellets at 90 x
magnification and (d) cross section of
coated pellets at 250 x magnification.
(Nicholas, 2016)
 KRISTAL & POLIMORFI

Poolymorphs α, β, γ, δ, ε
Polymorph α adalah
bentuk paling stabil
secara termodinamik dan
bentuk komersial.
ZAT TAMBAHAN
RANCANGAN FORMULA
Bahan aktif : Rifaximin
Dosis sediaan : 200 mg , 550 mg
Bentuk sediaan : tablet salut selaput.
Alasan : rifaximin dibuat dalam bentuk sediaan tablet salut selaput karena obat ini
bertujuan untuk menghindari bau dan rasa yang tidak enak dari rifaximin, serta
melindungi zat aktif agar tidak rusak dan hancur saat melewati asam lambung.
FORMULA
NO NAMA BAHAN KONSENTRASI
1 First Layer :
Rifaximin 30%
Hidroxy propil metil selulosa 10%
Poloxamer 188 10%
Maanitol 40%
Coloidal silicon dioxide 5%
Mg. stearat 5%
2 Second Layer :
Hidroxy propil metil selulosa 50%
Polietilen oxide 35%
Koloidal silicon dioide 10%
Mg. Stearat 5%
3 Salut :
Hipromellose 67%
Lactose monohydrat 17%
Polyetilen glikol 3%
Talkum 4%
Titanium dioxide 3%
Water Q.S.
REFERENSI
Annapurna MM, Kumar BSP, Venkatesh B, Prakash JR. 2012. Development and Validation of a Stability-Indicating High Performance Liquid Chromatographic
Assay for Rifaximin in Bulk and Pharmaceutical Dosage Forms.

Departemen Kesehatan Indonesia. 1985. Farmakope Indonesia Edisi 3. Jakarta: Departemen Kesehatan RI.

Departemen Kesehatan Indonesia. 1985. Farmakope Indonesia Edisi 5. Jakarta: Departemen Kesehatan RI.

Directorate for The Quality of Medicines of The Council of Europe. 2004. European Pharmacopeia Fifth Edition Volume 2. Stras Bourg. Council of Europe.

Gorla S. Reddy and Chava V. N. Rao. 2018. Determination Of Relative Polymorphic Distribution Between Various Polymorphic Forms Of Rifaximin Drug In
Rifaximin Tablets Using Powder X-Ray Diffraction Technique.

Kalpana G. Patel,1,2 Nitesh R. Jain,1 and Purvi A. Shah. 2013. Stability Indicating HPTLC Method for Analysis of Rifaximin in Pharmaceutical Formulations
and an Application to Acidic Degradation Kinetic Study. Hindawi Publishing Corporation ISRN Analytical Chemistry. Article ID 613218, 9 pages.

Kogawa, Peltonen, Antonio, Salgado. 2019. Submission of Rifaximin to Different Techniques: Characterization, Solubility Study and Microbiological
Evaluation. AAPS PhamSciTech. Vol 20:125.

Madhu E Nicholas, Laxman Prabakaran and Srimanta Sarkar. 2016. A Pragmatic Approach On Colonic Delivery Of Rifaximin Using Polymer Coated Multi-
Particulate System. IJPSR, Vol. 7(6): 2465-2475.

Rowe, R.C., Sheskey, P.J. & Quenn, M.E. 2009. Handbook of Pharmaceutical Exipient (6th) Ed). London: Pharmaceutical Press.

Toronto Research Chemicals Inc. 2019. Canada.

Viscomi GC, Campana, Barbanti, Grepioni, Polito M, D. Confortini, Rosini, P. Righi, V. Cannata, D. Braga. 2008. Crystal forms of rifaximin and their effect on
pharmaceutical properties. Advance Article.
TERIMAKASIH