FA3131 TEKNOLOGI LIQUID SEMISOLID

FA3132 PRAKTIKUM TEKNOLOGI LIQUID SEMISOLID

SASANTI TARINI
TRI SUCIATI
DIKY MUDHAKIR
ANNISA RAHMA
ANINDJA
AMIRAH ADLIA
PRODUK
Materi
FORMULASI

MANUFAKTURING

EVALUASI SEDIAAN
REQUIREMENTS OF PARENTERAL PRODUCTS

 STERILITY : free from microbes (sterile) or

prepared from sterile materials under conditions that
minimize microorganism contamination (aseptic),
closure integrity
 PYROGEN : free from bacterial endotoxin or other
pyrogen
 PARTICULAT MATTER

 TONICITY

 pH
1.STERILITY TEST
2.PYROGEN TEST
3.PARTICULATE EVALUATION
4.CONTAINER/CLOSURE INTEGRITY TEST
5.SAFETY TEST
 References
• CPOB (Guidelines on Good Manufacturing Practices), Badan POM
(National Agency of Drug and Food Control, RI, 2012
– Annex 1 Manufacture of Sterile Pharmaceuticals

1. Lieberman.H.A, et al, (1992) Pharmaceutical Dosage Form : Parenteral

Medication, vol. 1, 2, 3, Marcel Dekker
2. Banker, G. S. (ed.), 2002, Modern Pharmaceutics, 2th ed. , Marcel Dekker.
3. Trissel.A.L., 2001,Handbook of Injectable Drugs, American Society of Health-
System Pharmacists,
4. Gibson, M. (ed.), 2004, Pharmaceutical Preformulation and Formulation: a
Practical Guide from Candidate Drug Selection to Commercial Dosage Form,
CRC Press.
5. Niazi, S. K., 2009, Handbook of Pharmaceutical Manufacturing Technology:
Sterile Product, 2nd ed. vol 6, Informa Healthcare.
6. WHO, 2011, WHO Technical Report Series, No. 961, Annex 6: WHO good
manufacturing practices for sterile pharmaceutical products
7. PIC/S, 2009, PE 009-9 Annex 1: Manufacture of Sterile Medicinal Products
8. Suplemen Farmakope Indonesia edisi IV, 2006, Ministry of Health RI.,
9. Swarbrick, J. (ed), 2007, Encyclopedia of Pharmaceutical Technology ,
Informa Healthcare
Pustaka - sterile
Pustaka-sterile
Pustaka-sterile
Pustaka-sterile
 Pustaka - sterile
• Lieberman.H.A, et al, (1992) Pharmaceutical
Dosage Form : Parenteral Medication, vol. 1, 2,
3, Marcel Dekker
• Trissel.A.L., 2001,Handbook of Injectable Drugs,
American Society of Health-System
Pharmacists,
• Niazi, S. K., 2009, Handbook of Pharmaceutical
Manufacturing Technology: Sterile Product, 2 nd
ed. vol 6, Informa Healthcare.
Pustaka sterile
 Pustaka – sterile
Free articles
• WHO, 2011, WHO Technical Report Series, No.
961, Annex 6: WHO good manufacturing
practices for sterile pharmaceutical products
• WHO, 2005, Annex 3: Water for pharmaceutical
use
• PIC/S, 2009, PE 009-9 Annex 1: Manufacture of
Sterile Medicinal Products
Topik Sub Topik

1. Rute pemberian sediaan injeksi SVP & LVP: indikasi umum,

faktor farmasetika,
2. Dosis tunggal & ganda
Pengantar sediaan 3. Persyaratan sediaan parenteral
parenteral 4. Konsep clean room & clean air device, serta klasifikasinya
5. LAF & isolator
6. Konsep sterility assurance level (SAL)
7. Berbagai faktor penentu sterilitas sediaan

1. Strategi meningkatkan kelarutan: pengaturan pH, pelarut

campur, surfaktan, dll
Formulasi sediaan
parenteral 1 2. Strategi meningkatkan stabilitas: buffer, antioksidan,
penggunan pelarut non-air dll
3. Studi kasus untuk permasalahan 1 & 2

1. Perhitungan tonisitas & osmolaritas, serta pemilihan bahan

Formulasi sediaan pengisotonis
parenteral 2 2. Formula umum sediaan parenteral SVP & LVP berupa larutan
3. Studi kasus pengembangan formula SVP & LVP berupa larutan
 1. Cara pemilihan proses manufaktur sediaan steril dengan
sterilisasi akhir atau tehnik aseptik
Proses manufaktur
2. Metoda sterilisasi: panas lembab & kering, radiasi, etilen
sediaan parenteral
1 oksida
3. Sterilisasi panas: SIP, validasi proses sterilisasi,
4. Tehnik membebaskan pirogen

1. Filtrasi sediaan untuk bahan aktif yang termolabil

Proses manufaktur 2. Jenis filter & penentuan integritas filter
sediaan parenteral 3. Tehnik aseptic
2 4. Blow/fill/seal technology
5. Monitoring proses aseptik

1. Formulasi sediaan parenteral berbentuk suspensi dan

nanosuspensi
Sediaan parenteral
berupa suspensi 2. Sediaan parenteral rekonstitusi : dry filled & freeze drying
techniques
3. Evaluasi sediaan suspense, nanosuspensi, dan rekonstitusi
Sediaan parenteral Formulasi injeksi emulsi & microemulsi
berupa emulsi Parenteral nutrition
 1. Uji sterilitas
Evaluasi 2. Uji pirogen
sediaan
parenteral 3. Bahan partikulat
4. Kebocoran

1. Pemilihan obat
2. Product design & optimization
Ophthalmic 3. Formulasi obat tetes mata dan salep mata
4. Processing conditions, IPC
5. Evaluasi sediaan

1. Pemilihan obat
Obat tetes 1. Formulasi obat tetes mata, hidung, dan telinga
hidung dan
telinga 2. Processing conditions, IPC
3. Evaluasi sediaan

1. Pemilihan obat
Sediaan 2. Formulasi krim steril
semisolid
topical steril 3. Processing conditions, IPC
4. Evaluasi sediaan

1. Jenis-jenis wadah gelas, plastik, elastomer

Wadah 2. Pemilihan wadah primer & sekunder untuk sediaan steril
3. Analisis & kontrol kemasan
4. Aturan penandaan sediaan parenteral, obat tetes, dan semisolida steril
REVIEW
 Kelarutan vs Kekuatan sediaan

BATASAN KELARUTAN:
Very soluble <1 Slightly soluble 100 –
1,000
Freely soluble 1 - 10 Very slightly 1,000 –
soluble 10,000
Soluble 10 – 30 Practically >
insoluble/ 10,000
Sparingly 10 - insoluble
soluble 100

 Kelarutan ditentukan pada Freely soluble

kondisi jenuh & suhu tertentu 200 mg / mL ?
2 mg/mL
 Asam Lemah – Basa Lemah
pKa

Strong Weak Weak Strong

acid acid base base

2 7 10

pH – pKa = log (Cgaram / Casam)

 Kelarutan
Asam Lemah – Basa Lemah

DH (solid)  DH (solution)
DH (solution) = kelarutan molekul yang
tidak terdisosiasi (mol/liter, Ks)

DH (solution)  D- + H+
Ka = [D-] [H+] / [DH]
[D- = Ka . [DH] / [H+]
ST = total kelarutan

Kelarutan asam/basa lemah tergantung

pada pKa &pH
pH vs kelarutan obat

asam lemah

basa lemah

21
Tonisitas