Extemporaneous

Dispensing

COMMUNITY PHARMACY II
Lisa Aditama
Extemporaneous Dispensing
 COMPOUNDING IN PHARMACY PRACTICE
Formulasi langsung dengan senyawa kimia aktif untuk sediaan yang tidak tersedia di
market

EXTEMPORANEOUS PHARMACEUTICAL PHARMACEUTICAL

PREPARATION COMPOUNDING COMPOUNDING
STANDARD FORMULA
CAPTOPRIL SYRUP (Drug KAPSUL GARAM (NaCl) LIQUOR FABERI cum
Information Handbook, 21th LIQUOR(Formularium
500 mg/kapsul, buat sebanyak MENTHOL FABERI (F.M.S.)
ed) 10 kapsul (Obat Keringat Selectum/
Medicamentorum Buntet)
1mg/ml Cara pembuatan : FMS)
Cara pembuatan : Mortir dan stamper CaraR/pembuatanAcid.
: Salicylic
2 tablet Captopril 50 mg dipanaskan dgn air panas, Buat0.5
campuran eutectic dari
dihaluskan, dicampur dgn 50 keringkan. Timbang NaCl yg asam salisilat
Talcumdan
5 menthol,
ml aquadest, kemudian dibutuhkan + 10% bobot, tambahkan bahan-bahan
Zinci Oxyd 5
tambahkan 500 mg asam haluskan sampai air kristalnya serbuk yg sdh ditimbang dan
askorbat 500 mg tablet yang habis di lumpang panas, Amylum
dihaluskan Oryzae 5(aa)
sedikit-sedikit
telah dihaluskan ke dalam timbang 5g. Bagi 2 dengan ke dalam campuran
Spiritustsb,
ad
campuran tsb, tambahkan counterballance, masing2 tambahkan
100 cc alcohol 70%
aquadest sedikit-sedikit ad bagian dibagi 5 sama bagian. sedikit-sedikit ad 50 ml.
100 ml. Stabil selama 56 hari
pada suhu di bawah 22oC
(refrigerator)
 Captopril syrup
(Drug Inf.Hbook 14thed. p. 264)
• Captopril has limited stability in aqueous preparations
• The addition of an antioxidant (sod.ascorbate) has been shown to
increase the stability of captopril in solution
• Captopril (1mg/ml)
– in syrup w/ methylcellulose is stable for 7 days at 4°C or 22°C;
– In distilled water (no additives) is stable for 14 days at 4°C and 7
days at 22°C;
– w/ sod.ascorbate (5mg/ml) in distilled water is stable for 56 days
at 4°C and 14 days at 22°C;
– Captopril 0,75mg/ml was found stable for up to 60 days at 5°C
and 25°C in a mixture 1:1 of cherry syrup
 Captopril in powder paper(puyer)
(Drug Inf.Hbook 14thed. p. 264)
• Stable for 12 weeks when stored at room temperature
Article
American Journal of Hospital Pharmacy, Vol 47, Issue 8, 1799-1801
Copyright © 1990 by American Society of Health-System Pharmacists
Stability of captopril in powder papers under three storage conditions
CK Taketomo, SA Chu, MH Cheng, and RP Corpuz

The stability of captopril in powder papers under three different storage conditions was determined.
Captopril 12.5-mg tablets were triturated with lactose to a final concentration of 2 mg of captopril in
100 mg of powder. A total of 240 powder papers were prepared and stored in class "A" prescription
vials (80 papers), 002G plastic zip-lock bags (80 papers), and Moisture Proof Barrier Bags (80 papers).
Immediately after preparation and at 1, 2, 3, 4, 8, 12, and 24 weeks of storage at room temperature,
powder papers under each storage condition were reweighed and the contents were assayed for
captopril concentration by a stability-indicating high-performance liquid chromatographic method.
More than 90% of the initial captopril concentration was retained under all storage conditions during
the first 12 weeks of the study. Captopril disulfide, a degradation product, was detected in one sample
stored in a plastic zip-lock bag at 24 weeks. Captopril was stable for the entire 24-week period in
powder papers stored in either the class A prescription vial or the Moisture Proof Barrier Bag. Captopril
in powder papers is stable for at least 12 weeks when stored at room temperature under all three
storage conditions.
Contoh Formula Standar yang
diproduksi secara Komersial
Detail Produk : Sirop
Indra
No. REGISTRASI :
DBL8526800240A1
KOMPOSISI :
•Natrium Tetraborat 10 %
•Gliserolum 90 %
INDIKASI : Sariawan
ATURAN PAKAI
: Dioleskan pada luka di
bibir, lidah atau bagian lain
dalam mulut.
PERHATIAN : Obat Luar.
Detail Produk : Salicyl Spiritus
No. REGISTRASI : DBL
8526800341A1
KOMPOSISI : Asam Salisilat 10 %,
Etanol encer 90 %.
INDIKASI : Panu, kadas, kurap,
kuku air, eksim.
ATURAN PAKAI : Dioleskan pada
kulit yang sakit 2-3 kali sehari
sampai sembuh.
PERHATIAN : Obat Luar
 Contoh Formula Standar yang
diproduksi secara Komersial
Detail Produk : Minyak Angin
KOMPOSISI : Tiap ml mengandung

Methylis Salysilas ................... 0,2 g

Mentholum ............................. 0,5 g
Champora .............................. 0,05 g
Oleum Eucalyptus ..................0,1 g
Essensial Oil ........................ 0,05 g
Green Color .......................... qs
Paraffin Liquidum ad ..............1 ml

INDIKASI : Membantu meredakan encok, pegal-pegal, sakit kepala, sakit perut, mabuk perjalanan, hidung tersumbat dan
gatal-gatal akibat digigit serangga.

NAMA PRODUK NO. REGISTRASI UKURAN ISI PER DOOS

Minyak Angin No. 2 POM QD. 052605341 3 ml 50 Lusin

Minyak Angin No. 3 POM QD. 052605341 2.5 ml 50 Lusin

Minyak Angin No. 4 POM QD. 052605341 2 ml 50 Lusin

Minyak Angin Aromatheraphy POM QD. 112610301 5 ml 24 Lusin

Minyak Angin Aromatheraphy POM QD. 112610301 10 ml 30 Lusin

BACKGROUND
Polypharmacy in Geriatric

Tend to crush the medications

 Critically ILL Condition
(nil by mouth)  need nasogastric tube
 Omeprazole for NG administration
(Drug Inf.Hbook 14thed. p. 1174)
• The manufacturer recommends the use of an
acidic juice for preparation to administer via
nasogastric (NG) tube.
– Use 10-20 ml sod.bicarbonate 8,4% to break down
the enteric coated omeprazole granules
– Use 30 ml water to remove granules to a NG tube
Extemporaneous
Compounding &
Dispensing:
a Pharmaceutical
Problem
Pertimbangan sebelum keputusan
meracik obat:
Pertimbangan sebelum keputusan
meracik obat:
 NEED FOR EXTEMPORANEOUS
COMPOUNDING
• In the context of neonatal and paediatric pharmacy
practice, extemporaneous dispensing or
preparation is the technique used by pharmacists
to produce medicines from ingredients when no
commercially available, authorised,age‐appropriate
dosage form exists.
• Compared to use of authorised medicines there are
significant risks; quality, safety and efficacy can
rarely all be assured and there have been many
errors reported in the preparation of such
medicines.
 NEED FOR EXTEMPORANEOUS
COMPOUNDING
• In some situations extemporaneous
preparation of a medicine for a child may be
the only option when there is no appropriate
dosage form available but there may be other,
safer and more effective ways of delivering the
required dose and the risks associated with
extemporaneous dispensing can be reduced
when used as a last resort.
Liquor Faberi/ Lotio
Anti Miliaria
(FMS)
 In vitro, methylxanthines (at concentrations of
approximately 0.2 mmol/L or higher) generally
cause relaxation of vascular smooth
muscles in the presence of various stimulators of
contraction (eg, norepinephrine and angiotensin).
Although this relaxation probably results from a
reduction of the cytosolic calcium concentration, it
is unclear to what extent methylxanthines can alter
calcium binding and transport, either directly or
indirectly, by altering cyclic nucleotide metabolism.
(Medscape referrence)

Average caffeine consumption from all sources is

approximately 76 mg/person/day but reaches 210-
238 mg/person/day in the United States and
Canada and exceeds 400 mg/person/day in Sweden
and Finland, where 80-100% of the caffeine intake
is from coffee alone. In the United Kingdom, the
consumption of caffeine is similar to that in
Sweden and Finland, but 72% is from tea.
In the United States, the daily intake of caffeine
from all sources is estimated to be 3 mg/kg/person,
with two thirds of it coming from coffee consumed
by subjects older than 10 years.
Piramida Kajian Obat berbasis Bukti
 Compounding
(also known as Extemporaneous Dispensing)

Unlicensed

Standard
The pharmacist prepares and dispenses
compounded products in a manner that
ensures product quality, safety, and efficacy.

Professional Practice Standard. Ver 4. 2010. Pharmaceutical Society of Australia

EXTEMPORANEOUS PREPARATION
OR COMPOUNDING STANDARDS:
• Sediaan extemporaneous dibuat hanya ketika tidak
ada produk dengan izin edar yang tersedia dan di
mana Anda dapat mempersiapkan produk sesuai
dengan standar yang diharapkan.
• Anda dan staf lain yang terlibat harus kompeten
untuk melakukan tugas-tugas yang akan dilakukan.
• Fasilitas yang diperlukan dan peralatan yang tersedia
harus dijaga agar yang baik untuk memastikan
kinerja baik, dan harus sesuai untuk tujuan yang
dimaksudkan.
 THE STANDARDS: (cont’...)
• Memelihara keselamatan pasien dan ketepatan
formula produk.
• Bahan bersumber dari produsen farmasi secara legal
dan memiliki kualitas yang dapat diterima untuk
digunakan dalam pembuatan sediaan farmasi.
Apabila diperlukan, undang-undang yang relevan
harus dipatuhi.
• Perhatian dan perawatan khusus diberikan untuk zat
yang mungkin berbahaya dan membutuhkan teknik
penanganan khusus.
 THE STANDARDS: (cont’...)
• Produk diberi label dengan keterangan yang
diperlukan, termasuk BUD dan persyaratan
khusus untuk penanganan yang aman atau
penyimpanan dari produk.
• Jika Anda melakukan persiapan skala besar
produk obat, semua standar dan pedoman
yang relevan dipatuhi.
 THE STANDARDS: (cont’...)
• Dokumen disimpan selama minimal dua tahun.
Dokumen harus mencakup:
– formula, bahan, jumlah yang digunakan, sumber mereka,
nomor batch, tanggal kadaluwarsa,
– di mana persiapan yang dibagikan dalam menanggapi
resep, pasien dan rincian resep dan tanggal pengeluaran,
– personel yang terlibat, termasuk identitas apoteker
mengambil tanggung jawab secara keseluruhan.
LAB FARMASI KOMUNITAS

COMPOUNDING
& DISPENSING
 THE EQUIPMENT USED FOR
EXTEMPORANEOUS COMPOUNDING
Balance measurements using a counterbalance
 TECHNIQUE FOR WEIGHING
PHARMACEUTICAL INGREDIENTS

Weighing of the product is one of the most

essential parts of the compounding process.
Weighing the exact amount prescribed is
essential in compounds for several reasons:
the product cannot be “checked” for content
once mixed, the quantities weighed out are
often very small, and a slight overage could
mean a serious overdose for the patient.
 TABEL PENIMBANGAN
Kesesuaian Jumlah
No Nama Obat
Dosis Sediaan
 Penyelesaian akhir:

• Labeling, Record Keeping, and Cleanup:

After compounding, the product must be
labeled with a prescription label, and a careful
record of the compounding operation should
be kept.
• Once the compounding operation is finished,
the equipment and area should be cleaned
and everything should be returned to their
proper places in storage.
 When a prescription is received for an
extemporaneous product, there are a number of
considerations to be prior to dispensing.
1. Use of the product
2. Is it safe and suitable for the intended purpose?
3. Calculation of formula for preparation
4. Method of preparation
1. Solubility when applicable
2. Vehicle/ diluent
3. Preservative
4. Flavouring when appropriate
5. Choice of container
6. Labelling considerations
– Title
– Quantitative particulars
– Product specific cautions (additional labelling
requirements)
– Directions to patient – interpretation of Latin
abbreviations when necessary
– Recommended BNF cautions when suitable
– Discard date
– Sample label
7. Advice to patient
 Alternatives to extemporaneous
preparation
• The extemporaneous preparation of a liquid
medicine from solid dose form (tablet or
capsule) should generally be considered as a
last resort and it is important to first consider
alternatives that will give greater assurance of
clinical effectiveness and safety.
• The risks and benefits of a particular dosing
strategy should be evaluated on a case by case
basis.
 Alternatives to extemporaneous
preparation
• For example, if the stability and method of
preparation of an extemporaneous oral liquid
are well documented and all the facilities and
ingredients are available it may be less
compelling to seek an alternative.
• On the other hand, if there are no stability
data and the drug forms a caking suspension
in the only available excipient (syrup), an
alternative must be considered to ensure safe
and effective treatment.
 Studi Kasus Resep:
• Seorang pasien laki2 72 thn terbaring lemah di
tempat tidur, riwayat penyakit stroke 2x dgn terakhir
mengalami stroke ulang sekitar 2 tahun yang lalu dan
lebih dari 5 tahun mengalami parkinson. Pasien
susah menelan, sehingga istrinya menggerus semua
obatnya dan diberikan dalam bentuk suspensi
extemporaneous yang dikerjakan sendiri di rumah.
Istri pasien akhirnya depresi dengan kegiatan yang
selama ini dilakukan, mencari solusi dengan bertanya
kepada Apoteker. Sebagai seorang Apoteker, langkah
pelayanan kefarmasian apa yang akan Anda berikan?
 Berikut ini adalah daftar semua
No
obat yg diminum pasien:
Nama Obat Komposisi Aturan pakai
.
1. Stalevo 100 mg Levodopa 100 mg, carbidopa 25 mg, entacapone 1-0-1
200 mg
2. Aricept evess Donepezil HCl10 mg 0-0-1
3. Neulin PS Choline citrate 147,5 ,g. Cytidine monophosphate 1-0-1
121,5 mg, phopatidyl serine 20@ 125 mg
4. Nerviton E Vit.B1 100 mg, Vit.B6 200 mg, Vit.B12 200 mcg 1-0-0
5. Sifrol 0,375 Pramipexole 0.,375 mg 1-0-0
6. Haloperidol 1,5 mg Haloperidol 1,5 mg 2dd1
7. Trihexyphenidil 2 Trihexyphenidil 2 mg 2dd1
mg
8. Depakote 500 mg Valproic acid 500 mg 1-0-0
9. Clozaril 25 mg Clozapine 25 mg 0-0-1
10. Cipralex 10 mg Escitalopram 10 mg 0-0-½
11. Paride 2 mg Glimepiride 2 mg ½-0-0 ac
12. Trajenta Linagliptin 5 mg 1dd1
13. Irbesartan 300 Irbesartan 300 ½-0-0
14. Cedocard 5 mg ISDN 5 mg 2dd½
15. Concor 5 mg Bisoprolol 2,5 mg ½-0-0
16. Harnal D Tamsulosin 2 mg Prn kl susah
kencing
Pertimbangan keamanan sediaan yg diracik
Pertimbangan keamanan sediaan yg diracik,
lanjutan...
 Masalah yg sering terjadi dalam
Compounding (Penyiapan obat yg
diracik)
Problem kualitas Problem perhitungan
1. Suhu dan kelembaban ruangan 1. Kesesuaian dosis
2. Kesiapan tenaga kefarmasian
yg melakukan peracikan (jas 2. Jumlah bahan yang diambil/
lab, masker, handscoen, ditimbang
antiseptik)
3. Kebersihan peralatan yang
3. Perhitungan pengenceran
digunakan
4. Kontaminasi dari peracikan
sediaan penisilin
5. Penggunaan blender untuk
menggantikan mortir &
stamper
6. Validitas alat ukur
 Masalah yg sering terjadi dalam Compounding
(Penyiapan obat yg diracik), lanjutan...
Problem Ketersediaan
farmasetik Problem stabilitas
1. Bentuk sediaan 1. Peracikan obat dgn
– Granul (Omeprazole,
karakteristik khusus
Lansoprazole)
(higroskopis, stabilitas suhu)
a. Kapsul garam
– EC, SR, MR, XR, Odis, dll
b. Kalium/asam klavulanat
2. Strength yg berbeda 2. Kemasan yg dipilih tidak sesuai
dgn karakterisik bahan obat
3. Penyerahan obat stabilitas
khusus (rantai dingin)
4. Penyimpanan
5. Pencantuman beyond use date
 Masalah yg sering terjadi dalam Compounding
Problem(Penyiapan obat yg diracik), lanjutan...
Kompatibilitas/inkompatibilit
as Problem keamanan
1. Pencampuran dapat 1. Obat yg diracik menjadi
menyebabkan interaksi: tidak efektif
a. Fisik 2. Sediaan sitotoksik
 Menjadi basah (garam-garam HCl,
Na, dll)
 Mencampur sediaan krim dan
salep
b. Klinis
Pertimbangan keamanan sediaan yg diracik,
lanjutan...
Pertimbangan keamanan sediaan yg diracik,
lanjutan...
 Referensi
1. Permenkes No. 35 tentang Standar Pelayanan Kefarmasian di
Apotek
2. Pharmaceutical Society of Australia. Professional Practice Standards
version 4. 2010
3. Langley C, Belcher D. Pharmaceutical Compounding and Dispensing.
Pharmaceutical Press. 2008
4. Wright D. Tablet crushing is a widespread practice but it is not safe
and may not be legal. The Pharmaceutical Journal. 2006; 269: 132.
5. Church C and Smith J. How stable are medicines moved from
original packs into compliance aids? The Pharmaceutical Journal
2006; 276: 75–81.