Formulasi

Berdasarkan Pertimbangan Ekonomi

Outline

Pendahuluan
Analisis Biaya Produksi
Desain Formula vs Biaya
Pendahuluan

Biaya Obat
• Merupakan komponen yg cukup besar dari biaya
kesehatan (35%)
• Asuransi kesehatan hanya mencakup 10% penduduk
• Sebagian besar biaya obat (80%) berasal dari dana
masyarakat
Produsen :
Produk dgn biaya pokok produksi rendah
memberikan margin keuntungan lebar.
Produk dgn harga terjangkau mempunyai
daya saing lebih.

Marketing :
• Product
• Price
• Promotion
• Place
Formulator Know-How

Karakteristik fisika-kimia bahan baku

Metode of manufacture
Bahan baku fungsional alternatif
Sumber alternatif
Pengembangan Formulasi
Lab Scale
Formulation troubleshooting
 Liquid - suspension

Thickener mixing

Final mixing
API mixing
 Semi solid - Cream

Emulsification

Water phase Final mix

Oil phase

API solution
 Tablet
wet granulation

Mixing Granulating

Drying

Dry Mixing

Compressing
 Tablet
Direct compress

Sieving (optional)
Dry Mixing

Compressing
Syarat formulasi Cetak Langsung

- Struktur internal kubus

- Ukuran partikel identik obat
- Bentuk partikel spheris
- Bobot jenis partikel identik obat
- Kompresibilitas & kompaktibilitas tinggi
Trik Penyiapan Bahan Cetak Langsung

Grinding or sieving
Hybridization
Spray Drying
Grinding / Sieving
Utk mendapatkan DC material
- particle size
- particle shape

Flowability
Compactibility
Surface area

-lactose monohydrate (mesh 100)

Dicalciumphosphate (> 25% 125m)
Hybridization
Prednisolon
Teofilin
Aspirin
Indometasin

Core powder Fine powder

Potato starch

Result
Spray Drying

Spray Dried
Lactose

Porous
Spherical
Uniform size
Analisis Biaya Produksi

Komponen Biaya

1. Direct material + direct labor + direct

engineering + direct expenses = prime cost.
2. Prime cost + factory expenses = mfg cost
3. Mfg cost + administrative expenses =
production cost
4. Production cost + selling/distributing expenses
= total cost
5. Total cost + mark up = selling price
Direct Material

Bahan aktif

Bahan tambahan

Bahan baku

Kemas primer

Kemas sekunder

Kemas tersier

Label tambahan
Bahan kemas
Direct Labor

Manhour
 waktu yg dibutuhkan sejumlah pekerja utk
menghasilkan produk.
= waktu x pekerja

Labor cost
Biaya pekerja utk menghasilkan produk
= Manhour x gaji per jam

Breakdown perhitungan
per batch..??
per unit produk..??
Direct Engineering

Machinehour
 waktu yg dibutuhkan sejumlah mesin utk
menghasilkan produk.
= waktu x mesin

Engineering cost
Biaya operasional mesin utk menghasilkan
produk
= Machinehour x biaya operasional per jam

Breakdown perhitungan
per batch..??
per unit produk..??
Factory expenses

AHU

Penerangan
Listrik

Pencucian ruangan
Air Pencucian mesin

RND & Analisa

BBM

Steam boiler
Administratives
expenses
Biaya/pengeluaran tidak langsung proses
produksi :
• Registrasi obat
• PPN
• Pengarsipan, dokumen2 produksi dll
Desain Formula vs Biaya

Komponen biaya produksi terbesar ada di bahan awal

Formulator harus jeli memilih bahan awal

Komunikasi efektif
internal : dgn purchasing dept
eksternal : supplier
Ada pertanyaan…??
Continued..
Komparasi bahan baku

Common excipients

Excipients Function Price Note

Tartrazin Coloring $$$$ Yellow

-Carotene Coloring $$$$$ Orange

BHT Antioxidant $$$ Oil soluble

Na metabisulfit Antioxidant $$$ Water soluble

-Tocopherol Antioxidant $$$$$ Oil soluble

Citric acid Acidulant $$ Common use

Nipagin Preservative $$ Common use

Komparasi bahan baku

Sediaan cair

Excipients Function Price Note

Ethanol Solvent $ “bikin mabok”

Prop glikol Solvent $$ Little viscous

Na CMC Thickening $$ Fair thickener

MCC Thickening $$$ Smooth low viscous

Xanthan gum Thickening $$ High viscous

Sugar Sweetener $ Caloric

Sucralose Sweetener $$$ Non caloric

Komparasi formula - syrup

Bahan Formula 1 Formula 2 Rp

Ambroxol HCl 15 mg 15 mg
Propilenglikol 100 mg 100 mg
Nipagin 4 mg 4 mg
Gula 300 mg 300 mg
Sorbitol 200 mg 200 mg
Sucralose 100 mg - mg
Aspartam - mg 45 mg
Asam sitrat 2 mg 2 mg
Essence Apple 25 mg - mg
Essence Jeruk - mg 25 mg
Mint green 0,06 mg - mg
Tartrazin - mg 0,06 mg
Aquadem Add 5 ml Add 5 ml
Komparasi bahan baku

Sediaan semi padat

Excipients Function Price Note

Gliserin Water phase $ Little viscous

Prop glikol Wetting $$ Good wetting

Vaselin Oil phase $ Convensional

Adeps lanae Oil phase $$ Rare

Cetyl alcohol Oil phase $$ Self emulsifying

Cire de lanol Oil phase $$ Self emulsifying

Emulgade Oil phase $$$ Self emulsifying

Komparasi formula - Cream

Bahan Formula 1 Formula 2 Rp

Ketokonazol 20 mg 20 mg
Cetyl alcohol 20 mg 30 mg
Cire De Lanol 90 mg - mg
Emulgade SE - mg 120 mg
Paraffin Liq 53 mg 53 mg
Vaselin album 20,7 mg - mg
Propilenglikol 70 mg 70 mg
Nipagin 0,9 mg 0,9 mg
Nipasol 0,1 mg - mg
Gliserin - mg 20 mg
Na EDTA 0,1 mg 0,1 mg
PEG 400 33 mg 33 mg
Aquadem Add 20 g Add 20 g
Komparasi bahan baku

Sediaan padat

Excipients Function Price Note

MCC Filler $$$ Good dry binder

Lactose Filler $$ Fair compressibility

Corn starch Disintegran $ Fair disintegran

Pregel Filler $$$ Bind+Disinteg

Dicafos Filler $$$$ Abrasive

X-carmelose Disintegran $$$$ Super disintegran

Mg stearat Lubricant $$ Most common

Komparasi formula – Tablet

Bahan Formula 1 Formula 2 Rp

Amlodipin besilat 3,47 % 3,47 %

MCC 102 48,03 % 45,78 %

Starch 1500 48,00 % -

Dicafos anhidrat - 45,75 %

SSG - 4,00 %

Cab-O-Sil 0,25 % -

Mg stearat 0,25 % 1,00 %

Biaya Formulasi
OK skala lab
Simulasi perhitungan ongkos produksi