Eco Formulation Pharmaceutical Industrial

ECOFORMULATION

1. Formulasi
Berdasarkan Pertimbangan Ekonomi

2. Outline
Pendahuluan
Analisis Biaya Produksi
Desain Formula vs Biaya

3. 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

4. Produsen :
Produk dgn biaya pokok produksi rendah
memberikan margin keuntungan lebar.
Produk dgn harga terjangkau mempunyai
daya saing lebih.
Marketing:
•Product
•Price
•Promotion
•Place

5. Formulator Know -How
Karakteristik fisika-kimia bahan baku
Metode of manufacture
Bahan baku fungsional alternatif
Sumber alternatif

6. Pengembangan Formulasi

7. Lab Scale
Formulation troubleshooting

8. Liquid -suspension
Thickener mixing
API mixing
Final mixing

9. Semi solid -Cream
Water phase
Oil phase
API solution
Emulsification
Final mix

10. Mixing Granulating
Drying
Dry Mixing
Compressing
Tablet
wet granulation

11. Sieving (optional)
Dry Mixing
Compressing
Tablet
Direct compress

13. -Struktur internal kubus
-Ukuran partikel identik obat
-Bentuk partikel spheris
-Bobot jenis partikel identik obat
-Kompresibilitas & kompaktibilitas tinggi
Syarat formulasi Cetak Langsung

14. Trik Penyiapan Bahan Cetak Langsung
Grinding or sieving
Hybridization
Spray Drying

15. Grinding / Sieving
Utk mendapatkan DC material
-particle size
-particle shape
Flowability
Compactibility
Surface area
-lactose monohydrate (mesh 100)
Dicalciumphosphate (> 25% 125m)

16. Hybridization
Prednisolon
Teofilin
Aspirin
Indometasin
Result
Fine powderCore powder
+
Potato starch

17. Spray Dried
Lactose
Spray Drying
Porous
Spherical
Uniform size

18. 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

19. Direct Material
Bahan baku
Bahan kemas
Bahan tambahan
Bahan aktif
Label tambahan
Kemas tersier
Kemas sekunder
Kemas primer

20. 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..??

21. 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..??

22. Factory expenses
Air
BBM
Penerangan
AHU
Pencucian mesin
Pencucian ruangan
Steam boiler
Listrik
RND & Analisa

23. Administratives
expenses
Biaya/pengeluaran tidak langsung proses
produksi :
•Registrasi obat
•PPN
•Pengarsipan, dokumen2 produksi dll

24. 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

25. Ada pertanyaan…??

27. Continued..

28. Komparasi bahan baku
Common excipients
Excipients Price NoteFunction
Tartrazin Coloring $$$$ Yellow
-Carotene Coloring $$$$$ Orange
BHT Antioxidant $$$ Oil soluble
Na metabisulfit Antioxidant $$$ Water soluble
-Tocopherol Antioxidant $$$$$ Oil soluble
Citric acid $$
Nipagin $$
Common use
Common use
Acidulant
Preservative

29. Komparasi bahan baku
Sediaan cair
Excipients Price NoteFunction
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

30. Komparasi formula -syrup
Bahan RpFormula 1 Formula 2
Ambroxol HCl
Propilenglikol
Nipagin
Gula
Sorbitol
Sucralose
Aspartam
Asam sitrat
Essence Apple
Essence Jeruk
Mint green
Tartrazin
Aquadem
15 mg
100 mg
4 mg
300 mg
200 mg
100 mg
-mg
2 mg
25 mg
-mg
0,06 mg
-mg
Add 5 ml
15 mg
100 mg
4 mg
300 mg
200 mg
-mg
45 mg
2 mg
-mg
25 mg
-mg
0,06 mg
Add 5 ml

31. Komparasi bahan baku
Sediaan semi padat
Excipients Price NoteFunction
Gliserin Water phase $ Little viscous
Prop glikol Wetting $$ Good wetting
Vaselin Oil phase $ Convensional
Adeps lanae Oil phase $$ Rare
Cetyl alcoholOil phase $$ Self emulsifying
Cire de lanol $$
Emulgade $$$
Self emulsifying
Self emulsifying
Oil phase
Oil phase

32. Komparasi formula -Cream
Bahan RpFormula 1 Formula 2
Ketokonazol
Cetyl alcohol
Cire De Lanol
Emulgade SE
Paraffin Liq
Vaselin album
Propilenglikol
Nipagin
Nipasol
Gliserin
Na EDTA
PEG 400
Aquadem
20 mg
20 mg
90 mg
-mg
53 mg
20,7 mg
70 mg
0,9 mg
0,1 mg
-mg
0,1 mg
33 mg
Add 20 g
20 mg
30 mg
-mg
120 mg
53 mg
-mg
70 mg
0,9 mg
-mg
20 mg
0,1 mg
33 mg
Add 20 g

33. Komparasi bahan baku
Sediaan padat
Excipients Price NoteFunction
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

34. Bahan Formula 1
Amlodipin besilat 3,47 %
Cab-O-Sil
48,03 %MCC 102
48,00 %Starch 1500
-Dicafosanhidrat
-SSG
0,25 %
Mg stearat
Komparasi formula –Tablet
Formula 2
3,47 %
0,25 %
45,78 %
-
45,75 %
4,00 %
-
1,00 %
Rp

35. Biaya
OK
Formulasi
skala lab

36. Simulasi perhitungan ongkos produksi